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OPERATOR’S MANUAL



MELODY III D C



MELODY III D C OPERATOR’S MANUAL MODM10C-U02



VILLA SISTEMI MEDICALI S.p.a. Via Delle Azalee, 3 20090 Buccinasco (MI) - ITALY Tel. (+39) 02 48859.1 Fax (+39) 02 4881844 Manufacturer’s web site www.metaltronica.com Manufacturer´s address Metaltronica X-Ray Equipment & Supplies Via delle Monachelle, 66 00071 Pomezia (Rome) Italy Customer contact [email protected]



© 2018 Metaltronica 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. Printed in Italy



DOCUMENT STATUS SHEET Title of Document: OPERATOR’S MANUAL (MODM10C-U02) Version



Release



Date (dd/mm/yy)



Reason of change



ENGLISH



01



05/06/2018



First release



ENGLISH



02



03/08/2018



Add technical details, new temperature range for detectors, corrections and general review



OPERATOR’S MANUAL



DECLARATION ACCORDING TO IEC 60601-1 STANDARD The Manufacturer declares its responsibility concerning safety, reliability and equipment features included in this manual only if the following items are fully satisfied: 1)-installation; - room temperature and humidity; - updates; -recalibrations; -repairs and/or modifications carried out by technical personnel officially authorized from the Manufacturer. 2) Electrical pre-installation performed in the site where the system has to be put into operation, carried out according to prescription given by IEC rules concerning Medical Application. 3) Service personnel must ensure that they receive training on the mammographic unit with



the Manufacturer training programs prior to service the Unit. 4) Use of the equipment according to instruction in this manual. In case of difficulties concerning interpretation, English translation shall prevail.



Using and keeping X-Ray equipment and device must WARNING



conform



the



local



Regulations



and



national



laws



concerning Medical X-Ray handling.



According to CE 93/42 Directive for Medical Devices concerning product traceability, the Manufacturer must be NOTE



informed of any owner or installation address change. Medical Devices traceability is prerequisite to assure their safety and reliability over the time.



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Table of Contents  SECTION 1: GENERAL INFORMATION ............................................................................................................................... 6  INTRODUCTION ..................................................................................................................................................................... 7  INTENDED USE ...................................................................................................................................................................... 7  CONTRAINDICATIONS ........................................................................................................................................................... 7  POTENTIAL ADVERSE EFFECTS ............................................................................................................................................... 7  GENERAL DESCRIPTION ......................................................................................................................................................... 8  SAFETY INFORMATION ........................................................................................................................................................ 13  INTERNATIONAL SYMBOLS .................................................................................................................................................. 15  ACRONYMS ......................................................................................................................................................................... 18  DEVICE CLASSIFICATION ...................................................................................................................................................... 19  MELODY III D C IDENTIFICATION LABELS ............................................................................................................................. 20  ANTI‐X BARRIER/AWS IDENTIFICATION LABELS .................................................................................................................. 21  MELODY III D C DIMENSIONAL DRAWINGS ......................................................................................................................... 23  MELODY III D C DIMENSIONAL DRAWINGS .......................................................................................................................... 24  ANTI‐X PROTECTIVE BARRIERS: DIMENSIONS AND WEIGHT (OPTIONAL) ............................................................................... 25  ACQUISITION WORKSTATION: DIMENSIONS AND WEIGHT (OPTIONAL) ................................................................................ 26  SECTION 2: CONFIGURATIONS ....................................................................................................................................... 28  “FULL DICOM” CONFIGURATION ......................................................................................................................................... 30  “FULL DICOM” CONFIGURATION + DIAGNOSTIC STATION .................................................................................................. 31  “MINI‐PACS” CONFIGURATION ............................................................................................................................................. 32  SECTION 3: MAIN PARTS DESCRIPTION .......................................................................................................................... 33  MELODY III D C MAIN PARTS ................................................................................................................................................ 34  MELODY III D C MAIN PARTS ................................................................................................................................................ 36  ACQUISITION WORK STATION MAIN PARTS ........................................................................................................................ 38  ANTI‐X PROTECTIVE BARRIER WITH OPTIONAL MONITOR AND KEYBOARD  (ACQUISITION WORKSTATION) .............................. 39  C‐ARM MOVEMENTS KEYBOARDS....................................................................................................................................... 41  CONTROL PANEL (ACQUISITION SOFTWARE) ...................................................................................................................... 42  KNOB FOR FINE MANUAL COMPRESSION ........................................................................................................................... 44  FOOT‐CONTROLS ................................................................................................................................................................. 45  CONNECTOR PANEL ............................................................................................................................................................. 45  SECTION 4: GENERAL OPERATIONS ................................................................................................................................ 46  EXAMINATION ROOM ......................................................................................................................................................... 47  RELEVANT INSTRUCTIONS BEFORE INITIAL START‐UP ......................................................................................................... 47  SWITCHING ON.................................................................................................................................................................... 47  BLACK OUT .......................................................................................................................................................................... 51  SWITCHING OFF .................................................................................................................................................................. 53  EMERGENCY PUSHBUTTONS ............................................................................................................................................... 54  C‐ARM MOVEMENTS ........................................................................................................................................................... 55  C‐ARM VERTICAL TRASLATION ............................................................................................................................................ 55  THE OPERATOR CAN MOVE VERTICALLY THE C‐ARM  BY MEANS OF THE BUTTONS N° 13 (PARAGRAPH “MAIN PARTS”). ................................ 55  C‐ARM ROTATION ............................................................................................................................................................... 55  OPTIONAL MOTORIZED ROTATION ................................................................................................................................ 55  C‐ARM ROTATION FOR STEREO BIOPSY (ONLY FOR MELODY III D C EQUIPPED WITH SBD FFDM) ............................................... 57  COMPRESSION PADDLES INSERTION AND REMOVAL .......................................................................................................... 60  BREAST COMPRESSION SYSTEM .......................................................................................................................................... 62  Motor driven compression ............................................................................................................................................. 62  Manual compression with fine adjustment .................................................................................................................... 64  Compression release ...................................................................................................................................................... 64  LIGHT BEAM INDICATOR ..................................................................................................................................................... 66  AUTOMATIC COLLIMATION DEVICE .................................................................................................................................... 67  MODM10C-U02



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DEVICE FOR GEOMETRIC MAGNIFICATION (VARIABLE 1.5X/2X) .......................................................................................... 67  PROTECTIVE SCREEN ........................................................................................................................................................... 68  FOCAL SPOT SELECTION ...................................................................................................................................................... 69  RADIOGRAPHIC EXPOSURE ................................................................................................................................................. 69  DOSE CALCULATOR ............................................................................................................................................................. 70  OPERATING AND ERROR MESSAGES ................................................................................................................................... 70  OPERATING ERRORS ............................................................................................................................................................ 70  ERROR MESSAGES ............................................................................................................................................................... 72  SECTION 5: EXPOSURE TECHNIQUES .............................................................................................................................. 74  MANUAL MODE .................................................................................................................................................................. 76  AUTOMATIC EXPOSURE MODE ........................................................................................................................................... 77  AUTOMATIC FILTER DEVICE RH/AG ...................................................................................................................................... 79  SECTION 6: TYPICAL OPERATING CONFIGURATIONS ...................................................................................................... 81  MELODY III D C 24X30CM FORMAT ....................................................................................................................................... 83  CONFIGURATION FOR STANDARD EXAMINATION (LARGE  BREAST) .............................................................................................. 83  CONFIGURATION FOR STANDARD EXAMINATION (NORMAL BREAST) .............................................................................................. 84  CONFIGURATION FOR SPOT CONTACT EXAMINATION .................................................................................................................. 84  CONFIGURATION FOR GEOMETRIC MAGNIFICATION ................................................................................................................... 86   CONFIGURATION FOR BIDIMENSIONAL BIOPSY .......................................................................................................................... 86  MELODY III D C 24X30 CM FORMAT ...................................................................................................................................... 88  CONFIGURATION FOR STEREOTACTIC BIOPSY ............................................................................................................................. 88  SECTION 7: ACQUISITION SOFTWARE OPERATING INSTRUCTIONS ................................................................................. 89  1. STARTING THE ACQUISITION SOFTWARE ........................................................................................................................ 91  2. USER INTERFACE DESCRIPTION ....................................................................................................................................... 92  2.1. Status Bar ................................................................................................................................................................ 93  2.2. Operation Bar .......................................................................................................................................................... 95  2.3. Menu Panel ............................................................................................................................................................. 96  3. OPENING STUDY ............................................................................................................................................................ 102  3.1 Opening study from Worklist ................................................................................................................................. 103  3.1.1 Remote Worklist ................................................................................................................................................................ 103  3.1.2 Local Worklist .................................................................................................................................................................... 108 



3.2 Opening local study ................................................................................................................................................ 111  4. RADIOGRAPHIC EXPOSURE ............................................................................................................................................ 112  4.1 Setting the exposure parameters ........................................................................................................................... 115  4.2 Setting the ACR code .............................................................................................................................................. 116  5. IMAGE TOOLS ................................................................................................................................................................ 123  5.1 Display & Images .................................................................................................................................................... 124  5.2 Fit to Window, Pan/Scroll, 1:1, Effective size, Lens ................................................................................................ 126  5.3 Set anchor point ..................................................................................................................................................... 127  5.4 Window/Level, Contrast, Histo, Restore original ................................................................................................... 128  5.5 Process, Info, Change ACR settings ........................................................................................................................ 130  5.6 Downsize to 18x24, Delete, Recover 24x30, Measure, Plot Line, Alt Images ......................................................... 133  6. CLOSING STUDY ............................................................................................................................................................. 138  7. LOADING STUDY FROM PC ............................................................................................................................................. 139  8. DICOM FUNCTIONS ....................................................................................................................................................... 141  9. DAILY CHECK .................................................................................................................................................................. 154  SECTION 8: MAINTENANCE ......................................................................................................................................... 164  GENERAL CONCEPTS ......................................................................................................................................................... 165  GRID MOVEMENT TEST ..................................................................................................................................................... 166  CLEANING AND DISINFECTION .......................................................................................................................................... 167  DETECTOR FANS FILTERS CHECK AND REPLACEMENT ....................................................................................................... 169  MOVING THE UNIT TO ANOTHER PLACE ........................................................................................................................... 170 



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SECTION 9: ACCESSORIES & OPTIONAL PARTS ............................................................................................................. 171  LIST OF PARTS .................................................................................................................................................................... 172  LIST OF OPTIONS ............................................................................................................................................................... 172  CONFIGURATIONS AVAILABLE ........................................................................................................................................... 174  COMPRESSION PADDLES ................................................................................................................................................... 177  DEVICE FOR GEOMETRIC MAGNIFICATION WITH VARIABLE (1,5X/2X) .............................................................................. 178  FOOT‐CONTROLS ............................................................................................................................................................... 178  PHANTOM FOR PERIODICAL SYSTEM CALIBRATION .......................................................................................................... 179  PHANTOM FOR DAILY CHECK WITH COMPRESSION .......................................................................................................... 180  STEREOTACTIC BIOPSY DEVICE .......................................................................................................................................... 180  ANTI‐X PROTECTIVE BARRIER ............................................................................................................................................ 181  ACQUISITION WORKSTATION ............................................................................................................................................ 181  SECTION 10: SPECIAL HINTS – IMAGE RECOVERY STRATEGY – TROUBLESHOOTING ...................................................... 182  PATIENT POSITIONING ...................................................................................................................................................... 183  IMAGE RECOVERY STRATEGY – TROUBLESHOOTING ........................................................................................................ 192  Incorrectly sized images acquired with 18x24 compression paddle ............................................................................. 192  Incorrectly sized images acquired with 24x30 compression paddle ............................................................................. 193  Images with metallic clips, surgical marker and cluster of micro calcification ............................................................ 194  Images with surgical anatomical parts ........................................................................................................................ 195  Images with breast specimen ....................................................................................................................................... 196  Wrong ACR setting ....................................................................................................................................................... 197  Spot compression device (if available) ......................................................................................................................... 198  SECTION 11: TECHNICAL SPECIFICATIONS .................................................................................................................... 201  TECHNICAL SPECIFICATIONS .............................................................................................................................................. 202  ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 60601‐1‐2 ............................................................................... 214  WEEE INFORMATIONS ACCORDING TO DIRECTIVES 2012/19/EU AND 2002/96/EC ........................................................... 218  (WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT) ..................................................................................................................... 218  SECTION 12: WARRANTY CONDITIONS ........................................................................................................................ 219  WARRANTY CONDITIONS .................................................................................................................................................. 220  FAILURE REPORT ............................................................................................................................................................... 222  SAFETY FEEDBACK ............................................................................................................................................................. 224 



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SECTION 1: GENERAL INFORMATION



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INTRODUCTION Proper use of this equipment presupposes that the operating personnel is thoroughly familiar with the operating instruction, in particular the sections Safety, Function and Safety Check, and Protective Measures and able to use Personal Computers and their applications. If legally-binding regulations govern the installation and/or the operation of the above equipment, it is responsibility of the installer or the operator to observe these regulations.



INTENDED USE The MELODY III D C is a system indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer or for needle localization in case of stereotactic biopsy. The MELODY III D C is intended to be used in the same clinical applications as traditional film/screen systems. This Operator’s Manual is intended to give a detailed overview on Functions, Specifications, Safety and all other important issues to know to get maximum utilization of mammography system.



CONTRAINDICATIONS No absolute contraindications are given for mammography. Due to the nature of X-ray procedures the patient is exposed to radiation and adverse health effects exist and are known.



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



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GENERAL DESCRIPTION The FFDM DIGITAL MELODY III D C is complete mammography solutions optimized for digital imaging. They are composed of: 



Mammography Unit with X-Ray tube and Indirect Conversion Amorphous Silicon detector 24x30 cm format or Direct Conversion Amorphous Selenium 24x30 cm format with not Isocentric (MELODY III D C) or Isocentric C-Arm (MELODY III D C) usable for Stereo biopsy in combination with SBD FFDM Stereo biopsy device;







Integrated X-Ray control and image Acquisition Software (AS);



Although not as a part of the FFDM MELODY III D C and systems (which are just complete mammography solutions when composed by components described above), an optional acquisition station (Anti-x protective barrier equipped with devices for remote control of the unit) may be provided on request. Indirect Conversion Amorphous Silicon Detector is recommended for installation in mobile environment (E.g. Truck, Van, etc) or critical installation in general.



The Mammography Unit is inclusive of: • high voltage X-Ray generator: -



100 kHz ripple – 5 kW power



-



20 ÷ 35 kV (0,5 kV step) (20 ÷ 40 kV optional)



-



1 ÷ 640 mAs



• MELODY III D C: not isocentric C-Arm with motorized vertical movement and manual rotation (motorized rotation optional). Fixed focus-detector distance of 66 cm • MELODY III D C: isocentric C-Arm with motorized vertical movement and manual rotation (motorized rotation optional). 24x30 cm format upgradeable with motorized rotation for biopsy projections +/-15° (only with SBD FFDM). Fixed focus-detector distance of 66 cm • X-Ray tube with tungsten biangular anode: -



0,1 and 0,3 mm focal spots



-



300 kHU maximum anode heat content



-



3.000 rpm (10.000 optional)



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-



Automatic Filter (50 μm Rhodium/50 μm Silver)



-



Automatic collimation device from standard examination to geometric magnification



• Indirect Conversion Detector - 24x30 cm format - Technology: Amorphous Silicon (a-Si) - Depth: 16 bit - Pixel Pitch: 85x85 µm - Resolution: 2816x3584 pixels (24x30 cm format) - Active Area: 23.9x30.5 cm (24x30 cm format) - Read time: 75% @ 1 lp/mm (typical 85%); >10% @ 5 lp/mm (typical 20%) - DQE (Detector Quantum Efficiency): >45% @ 1 lp/mm (typical 50%); >10% @ 5 lp/mm (typical 20%) for exposure of 28 kV Direct Conversion Full Field Flat Panel Detector: -



Format: 24x30 cm



-



Active Area: 23.9x30.5 cm



-



Technology: Amorphous Selenium (a-Se)



-



Depth: 16 bit



-



Pixel Pitch: 85x85 μm



-



Pixel Pitch in tomosynthesis: 85x85 μm (full resolution)



-



Pixel Pitch in reconstructed slices: 85x85 μm



-



Resolution: 2816x3584 pixels



-



MTF (Modulation Transfer Function): > 90 % a 1 lp/mm; > 40 % a 5.8 lp/mm



-



DQE (Detector Quantum Efficiency): > 50 % (@ 1 lp/mm for exposure of 28 kV); > 20 % (@ 5.8 lp/mm for exposure of 28 kV)



• Automatic Exposure Control (AEC) with full automatic kV/mAs, manual kV/auto mAs in function of effective Breast Density evaluated by pre-exposure X-Ray pulse or breast thickness for fast operation and/or special cases with silicone prosthesis. Dose limits according to European Protocol for Dosimetry and EUREF protocol MODM10C-U02



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• AGD (Average Glandular Dose) calculator •Smart µPress (microPress) compression device: -



Motor-driven adjustable force and manual compression with safety release



-



Force really exerted on the breast shown on double displays



-



Breast thickness shown on four display



-



Descending paddle speed proportionally reduced with increasing compression force



-



Compression paddles with softly curved and smooth lines for higher patient comfort



• Potter-Bucky with removable anti-scatter grid (Ratio 6:1, 36 lp/cm) • Device for geometric magnification (1,5x/ 2x factor) without anti-scatter grid and with automatic selection of small focal spot (optional) • Keyboard over the detector for automatic image tagging plus manual prefix/suffix according to ACR protocol. Integrated display with “C” arm inclination, projections, compression force selected/applied, breast thickness and laterality selection • Two emergency push-buttons • Acquisition Software complete of: -



Capability to display and viewing Off-line images



-



Local operational mode



-



Patient information local DataBase



-



PC tools to make operations on the local PC:



-







Local opening of new studies (i.e. not from the worklist)







Local studies storing (i.e. in the internal computer memory)







Local studies reloading (i.e. from the internal computer memory)







Local DataBase managing



Graphic tools to manipulate images: 



Selection and positioning of images to display







Display protocol with ACR predefined views







Current session loaded images







Post-processing algorithm specific for mammography to enhance the quality of



the acquired images 



Fit to window, Zoom, Pan, Magnification lens







1:1, Effective size







DICOM W/L, High/Very High/Skin contrast



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



Histograms







Override ACR settings







Mirroring operations on ACR standard views (CC, MLO)







Post-processing filters dedicated to detection of metallic clips, specimens and



surgical breast parts -



DICOM tools: 



Worklist studies opening and closing







Sending of locally stored studies to the appropriate RIS server







Studies printing







Studies recording on CD/DVD







QC tools based on EUREF protocol







Storage commitment (SC)







Modality Performed Procedure Step (MPPS)



 2 MPixel Color LCD Display System (21.3” viewable size)  Wireless Keyboard with touch pad  Integrated UPS - UPS 180 / 266 Vac, 650 VA (230 Vac) or 700 VA (115 Vac), 10 minutes (typically) - Intelligent power management system with safe automatic shutdown  HIS-RIS-PACS Interface  Conformities: - FULL DICOM 3.0 MG: - IHE (PIR-Patient Information Reconciliation, SWF-Scheduled Workflow, MIMammography Image)



A Viewing/Reporting Station is available in option (not part of this Medical Device)



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SAFETY SYMBOLS



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



physical injury.



Indicates a risk of danger that if disregarded leads to slight CAUTION



or moderate physical injury and/ or property damage.



Should be understood as a tip. The user does not NOTE



absolutely have to observe these instructions. However, there will be advantages if he does.



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SAFETY INFORMATION CAUTION



Please pay attention to the following cautions!



1.



MELODY III D C has not to be used by unskilled or untrained personnel. The manufacturer does not accept responsibility for injury or damage associated with improper or unsafe system operation. the user should refer to this operator manual for directions on how to use the MELODY III D C.



2.



A correct use of this Mammographic Unit assumes that operators (technicians and radiologists) hold the necessary technical and specialist knowledge and they have been properly trained for Good Clinical Practice.



3.



It is supposed that the reader of this manual is used to the general operations of the windows® operating system, it is also assumed that the concepts of PACS, RIS, DICOM, server etc. are well-known.



4.



This machine must be used only for mammography.



5.



This machine must be used only in a controlled area inside a dedicated room provided with x-ray protection that meets local standards and regulation.



6.



This equipment used in the presence of flammable anesthetic or oxygen may cause an explosion



7.



The mammography unit is classified as permanently installed according to IEC 60601-1 international standard. This means that it must be electrically connected by means of permanent connections. In particular, for the maximum electrical safety, the protective earth conductor must be fixed and permanently installed.



8.



To guarantee the isolation of the mammo unit circuits from supply mains, a locking mechanism has to be provided by the responsible organization (e.g. a padlock) capable of being locked in the off position.



9.



MELODY III D C can be used by all categories of patient. For disable patients (on wheel chair) be always careful to all automatic movements of c-arm (especially up/down movement).



10.



Patients with disabilities or temporary disablement must remain seated during the positioning and the mammographic examination.



11.



Keep away foot controls from the patient’s feet and/or exam chair, especially for disable patient on wheel chair and with disability in general. The manufacturer recommends to keep foot controls in a safe area outside the patient ambient (approximately 1,5 m, as defined by IEC 60601-1 ).



12.



Before using, check the state of all parts of mammo unit: they have to be perfect.



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13.



Frequently verify the wear of the compression paddles to prevent damages as cracks and tears, and consequent risks for the patient.



14.



Do not modify this equipment without authorization of the manufacturer



15.



Use only original accessories and spare parts.



16.



Do not remove plastic coverings of mammography unit that give a protection against the electrical, thermal and mechanical hazards.



17.



Do not insert in the x-ray beam devices other than compression paddles or magnification device.



18.



Use lead apron for patient protection.



19.



During x-ray emission, operator must be behind anti-X protective barrier and in a position where it is possible to watch patient and unit.



20.



Respect the storage conditions.



21.



Pay attention to video monitor of mammography unit that: it is the most fragile part of the system.



22.



Use the mammography unit and its software according to the instruction given in this manual. Do not try to install unauthorized software, access to operating system configuration or perform other potentially dangerous operations.



23.



Do not use other equipment or network/data couplings (to which a signal input/output part may be connected), other than those forming part of MELODY III D C.



24.



This is a medical equipment and it should not be considered to be a generalpurpose computer: when operating the system, do not attempt to make any change to system software and do not use it as a personal internal PC. Any modification or attempt to modify the operating system software will make the unit unsuitable for its intended use.



25.



No computer virus protection or network security is provided. anti-virus protection and network security are the ongoing responsibility of the user.



26.



When Mammography System Is Installed In Mobile Environment (E.G. Van, Truck), It’s Necessary Before Cruise Remove Any Accessory From Unit, Move The C-Arm To The Bottom Position And Lock It By Means Of Its Special Support.



27.



The device incorporates a low risk LED (risk group 1) for light beam centering device (according to CEI EN 62741).



28.



Never Leave Unsolved Problems That May Affect The Safety Of The Product.



29.



The pictures present in this manual are only indicative and may be subjected to changes (for example the background color) which are not significant for the procedure described



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INTERNATIONAL SYMBOLS The meaning of symbols appearing on the plate and on some components of the machine is specified in the following table. SYMBOLS



CEI–IECSTANDARD DEFINITION ISO 7000-0434A Caution IEC 60417-5008 “OFF” Power



IEC 60417-5010 “ON” Power



IEC 60417-5840 Type B Applied Part



IEC 60417-5032 Alternating Current IEC 60417-5019 Protective Earth (ground)



IEC 60417-5017 Earth (ground)



ISO 15223-1 Manufacturer ISO 15223-1 Date of Manufacture ISO 15223-1 Serial Number ISO 7010-M002 Refer to instruction manual/booklet NOTE On ME EQUIPMENT “Follow instructions for use” MODM10C-U02



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SYMBOLS



CEI–IECSTANDARD DEFINITION IEC 60417-5036 Dangerous Voltage



WEEE (Waste Electrical and Electronic Equipment)



IEC 60417-5367 C-ARM POSITION



IEC 60417-5638 Emergency Stop



IEC 60417-5326 Large Focus



IEC 60417-5325 Small Focus



IEC 60417-5384 Indication of radiation field by light



IEC 60417-5349 Radiodiagnostic compression device, movement



IEC 60417-5350 Radiodiagnostic compression device, pressure applied IEC 60417-5351 AUTOMATIC COMPRESSION RELEASE



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SYMBOLS



CEI–IECSTANDARD DEFINITION IEC 60417-5381 FILTER DEVICE MODE



IEC 60417-5353 Grid movement



IEC 60417-5339 X-ray source assembly, emitting



IEC 60417-5172 Class II equipment (according to IEC 60536) C-arm rotation angle



Breast THICKNESS



Automatic Modality SELECTION



ERROR MESSAGE



x-RAY EMISSION CONTROL LAMP



EXPOSURE TECHNIQUE SELECTION



Focal Spot



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ACRONYMS ACR:



American College of Radiology



AEC:



Automatic Exposure Control



AGD



Average Glandular Dose



AOI:



Area Of Interest



AS:



Acquisition Software



DICOM: DME



Digital Imaging and Communications in Medicine Digital Mammography Equipment



FFDM:



Full Field Digital Mammography



FTSE:



Function of tissue strenght evaluation



GUI:



Graphical User Interface



MMI:



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



OD PACS:



Optical density Picture Archiving and Communications Systems



RIS:



Radiology Information System



ROI:



Region Of Interest



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DEVICE CLASSIFICATION The identification label is placed on the back of the device and a true copy of it is also placed inside.



220/230/240 Vac MAINS (STANDARD)



MELODY III D C



MELODY III D C (isocentric)



115 Vac MAINS (OPTIONAL)



MELODY III D C



MELODY III D C (isocentric)



IEC 60601-1 Standard MELODY III D C belongs to Class I type B applied parts.



Directive 93/42/EEC for Medical Devices MELODY III D C belongs to Class IIb.



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MELODY III D C IDENTIFICATION LABELS



X-RAY TUBE (alternative labels are provided in case of optional tube chosen)



X-RAY tube



H.S. STARTER (optional)



COLLIMATION DEVICE



C-ARM COMPRESSION SYSTEM



MOTORIZED ROTATION OF C-ARM (optional)



POTTER-BUCKY



INVERTER



UNIFIED FRAME



HIGH VOLTAGE GENERATOR



Z150-dwg050-00



DETECTOR



MAGNIFICATION DEVICE



INTERNAL LABELS NOTE



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MELODY III D C (isocentric) IDENTIFICATION LABELS X-RAY TUBE (alternative labels are provided in case of optional tube chosen)



X-RAY tube



H.S. STARTER (optional)



COLLIMATION DEVICE



C-ARM COMPRESSION SYSTEM



MOTORIZED ROTATION OF C-ARM (optional)



INVERTER



POTTER-BUCKY



UNIFIED FRAME



H.IGH VOLTAGE GENERATOR



INTERNAL LABELS



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Z150-dwg051-00



DETECTOR



MAGNIFICATION DEVICE



NOTE



Identification labels are important for a safe use of the mammographic unit.



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ANTI-X BARRIER/AWS IDENTIFICATION LABELS



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MELODY III D C DIMENSIONAL DRAWINGS When carrying out the necessary support calculation, weight of patient and operator must be taken into CAUTION



consideration.



Weight: 315 Kg



The mechanical indication given in drawings above are nominal, they have a tolerance of ±10% (depth) and ±1 NOTE



mm (wide) due to the sum of overall tolerance during assembling



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MELODY III D C DIMENSIONAL DRAWINGS



Weight: 360 Kg When the stereotactic biopsy device SBD FFDM is installed on MELODY III D C the C-Arm maximum rotation is limited to ± 90° NOTE



During normal operations C-arm maximum rotation is always limited to ± 130°.



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The mechanical indication given in drawings above correspond to nominal values, they have a tolerance of NOTE



±10% (depth) and ±1 mm (wide) due to the sum of overall tolerance during assembling.



ANTI-X PROTECTIVE BARRIERS: DIMENSIONS AND WEIGHT (optional)



DIMENSIONS IN mm Weight: 77 kg



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Weight: 105 kg



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ACQUISITION WORKSTATION: DIMENSIONS AND WEIGHT (optional)



 



DIMENSIONS IN mm



Weight: 85 kg



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PROTECTION AGAINST STRAY RADIATION If examination room is not already provided with operator protection barrier, standalone protective glass is available as accessory.



According to local regulation for radiological protection, the access to the equipment and to the protected area must be restricted to the authorized personnel only.



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SECTION 2: CONFIGURATIONS



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



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“FULL DICOM” CONFIGURATION



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



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“FULL DICOM” CONFIGURATION + DIAGNOSTIC STATION



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



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“mini-PACS” CONFIGURATION



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



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SECTION 3: MAIN PARTS DESCRIPTION



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MELODY III D C MAIN PARTS



1



12



2



5



3



8



18 4 14 13 7 15



10



16 17



6 11



9



MAMMOGRAPHY UNIT



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



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MELODY III D C MAIN PARTS 2 3



12



1 5



8 18 4



13 10 14



7



15



16 6



17



11



9



MAMMOGRAPHY UNIT



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



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ACQUISITION WORK STATION MAIN PARTS



22



21 20



19



   



 



19. X-RAY PUSH-BUTTON 20. WIRELESS KEYBOARD 21. LCD COLOR MONITOR 22. ANTI-X BARRIER



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ANTI-X PROTECTIVE BARRIER WITH OPTIONAL MONITOR AND KEYBOARD (Acquisition workstation) The unit configuration available depends on the option NOTE



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



Mammo unit



Acquisition work station



Double configuration



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AUXILIARY DISPLAY



1



2



deg



6



3



cm



CC



MLO



ML



N



LM



LMO



FB



SIO



M



L



R XCC



CV



AT



ID



TAN



S



5



RL



RM



4



1. C-ARM INCLINATION 2. COMPRESSED BREAST THICKNESS (mm) 3. SELECTED COMPRESSION FORCE (less bright) REALLY EXERTED COMPRESSION FORCE (most bright) 4. LATERALITY L/R SELECTION 5. PROJECTIONS, PREFIXES AND SUFFIXES (ACR protocol) 6. COMPRESSION FORCE ADJUSTMENT



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C-ARM MOVEMENTS KEYBOARDS



 



A



FOR MANUAL ROTATION VERSION



A



Z150-dwg055-00



FOR MOTORIZED ROTATION VERSION A



A



1 ON BOTH SIDES



Z150-dwg056-00



1. UP/DOWN VERTICAL MOVEMENT



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CONTROL PANEL (ACQUISITION SOFTWARE)



10



11



1 2 13



3 4 5 6 MODM10C-U02



7



8



9



12 Page 42 of 226



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1. SELECTED TECHNIQUE (MANUAL, FULL AUTO, AUTO mAs) 2. FILTER DEVICE MODE AND ANODE/FILTER COMBINATION 3. SPECIAL PROJECTION SELECTION 4. PROJECTION (ACR protocol) 5. MAGNIFICATION RATIO 6. INCLINATION OF THE C-ARM (degrees) 7. COMPRESSED BREAST TICHKNESS (mm) 8. COMPRESSION FORCE (N) 9. DOSE INDICATION ( Average Glandular Dose) 10.



kV VALUE



11.



mAs VALUE



12.



SELECTED FOCAL SPOT (AUTOMATIC)



13.



COMPRESSION AUTOMATIC RELEASE ENABLE/DISABLE



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KNOB FOR FINE MANUAL COMPRESSION



1



2



ON BOTH SIDES 1. ROTATING CONTROLLER (TO SELECT COMPRESSION FORCE OR TO ALLOW FINE MANUAL COMPRESSION) 2. PUSH-BUTTON TO ACTIVATE THE FUNCTION:



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



COMPRESSION FORCE TARGET SELECTION (ON)







FINE MANUAL COMPRESSION (OFF)



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FOOT-CONTROLS 3



1



2



1. COMPRESSION PADDLE DOWN 2. COMPRESSION PADDLE UP 3. FAST RELEASE



CONNECTOR PANEL 1 1. UPS SWITCH ON



2



2. RX PUSHBUTTON CONNECTOR 3. LAN



3



4. USB 5. FOOT-CONTROLS CONNECTORS



4



(one for standard configuration)



5



OPTIONAL



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SECTION 4: GENERAL OPERATIONS



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EXAMINATION ROOM X-Ray units can only be operated inside dedicated room provided with X-ray protection that meets local standards and regulations.



RELEVANT INSTRUCTIONS BEFORE INITIAL START-UP The initial start-up must be performed only the Technical Service or by a person authorized by the manufacturer. In case of first installation, the Technical Service or the person authorized has to follow the specific instructions contained in the Service Manual.



SWITCHING ON



Before switching ON the unit, check that all emergency WARNING



push buttons are unlocked.



Verify that switch on the wall is ON. Switch ON the Wireless keyboard. 1. Switch ON internal UPS by means back side push button n°1 on connector panel (see



the dedicated paragraph) with integrated lamp, lamp is bright when UPS is ON. 2. Switch ON the unit by means of push button n°7 (see paragraph “main parts”), system



initialization procedure is performed automatically. The procedure is detailed in chapters 3-5 of technical manual.



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The software runs automatically. At the beginning, it shows a thermo graph with temperature room trend in the time. If room temperature exceeded upper or lower limits, according to the range fixed with detector on board, an error message appears (refer to Section 7: Maintenance).



Lens buttons let to the user to zoom in or zoom out the NOTE



thermo graph. The two red lines in the thermo graph window indicate the acceptable temperature range of FFDM unit



The thermo graph window disappears in few second, then the home page of DME (Digital Mammography Equipment) launcher is shown.



The DME Acquisition Software start automatically (after 10 seconds). MODM10C-U02



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The operator can select the fast launch of DME Acquisition software clicking on icon at the middle of display.



DME Acquisition



DME Toolkit



Do not click on the icon located on the lower left corner of the display (crossed tools), this is a service function only for technicians. If the operator wrongly clicks on the icon DME Toolkit, he can easily return on the main menu clicking on the following icon, located in the upper right corner of the next window:



During system initialization, after the DME Acquisition software launch, the unit checks the presence and the functionality of all devices and components to which is connected.



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If one of the following warning icons appears, start sequence will proceed after clicking “OK” on both icons.



If both icons are displayed, switch off the unit and restart it again. The unit will not be usable for normal use e.g. image acquisition as evident by the lower bar shown below:



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After about 5 minutes, the User Interface is shown on display of acquisition Software and a green message on the down bar reveals that mammography system is “ready” to use.



BLACK OUT The unit is provided of Intelligent Power Management (IPM) with Automatic shutdown capability. During a black out, the operator is advised by an audible sizzle noise and by a series of four short beeps emitted by UPS every 30 seconds. Beeps become continuous when the battery is low and it is about to switch off. In case of intermittent or permanent black out there is no need of closing the study in progress and manually shutting down the unit, it will be done automatically on low battery condition (manufacturer set 50% percentage of battery charge as lower limit for automatic shutdown) .



If blackout persist, please switch off the UPS for saving the NOTE



MODM10C-U02



remaining battery charge after automatic shutdown.



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If necessary, percentage of available battery charge (%) can be read by clicking on the specific icon of Windows OS



During black out no C-arm movements, compression and exposure are possible. Emergency patient release is possible by means of fast unlock of compression paddle holder as described in section 4: General operation - “Emergency patient release”



When the emitted beeps become continuous, the UPS has WARNING



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only one minute of autonomy.



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SWITCHING OFF Verify that any study, open locally or from worklist (see Section 7 of this manual), is closed. Switch OFF takes place in two steps: 1. Close DME Acquisition software clicking on red icon located on the upper right corner of the display.



1



2



2. Switch OFF the mammography system by clicking again on the upper right corner of the display.



WARNING



Never switch OFF the UPS system while mammography unit is switched ON.



Periodically, do not switch OFF the UPS to recharge internal NOTE



battery. Typical charging time is 8 hours. Do not leave the system permanently ON to avoid an useless dust collection on fans filters and a shortening of detector life (see



NOTE



also Section 8: Maintenance). Switch OFF the keyboard to preserve battery life.



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EMERGENCY PUSHBUTTONS There are two emergency push-buttons on the MELODY III D C, one on each side of the Mammography Unit (n° 14 – paragraph “Main Parts”). In case of emergency, to immediately stop any movement and disable HV generator, press one of the emergency push buttons. The following message appears immediately when the emergency pushbutton is pressed:



Once the emergency has been solved, before to re-use the mammography system, it’s necessary to follow these steps:  turn the Emergency push-button (one-quarter rotation) to restore it;



wait 30 seconds until power to motors and HV generator is restored. If the above error message is not due to emergency pushbutton call for service. NOTE



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



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



C-ARM VERTICAL TRASLATION The operator can move vertically the C-Arm by means of the buttons n° 13 (paragraph “main parts”).



“ ” = UP



“ ” = DOWN



C-ARM ROTATION Manual rotation is available operated by means of push button n°12 (see paragraph “main parts”). The mammography unit has a safety system with a sliding clutch calibrated on a limited force to avoid any lesion or damage if C-Arm during rotation runs into a person or an object. MELODY III D C version has limited rotation +/-130°.



OPTIONAL MOTORIZED ROTATION The rotation is available operated by means of push button n°12 (see paragraph “main parts”) PRE-SELECTABLE ANGLES (buttons n° 2 - paragraph “C-Arm Movements Keyboard”) With a single pressure on “CC” button the C-Arm rotates automatically to “0°” angular position (factory default). With a single pressure on “LAT” or “ OBL” button the C-Arm rotates automatically at preselected angular positions.



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The default angular position settings are:



“CC” = 0°



“OBL CCW” = - 45°



“OBL CW” = + 45°



“LAT CCW” = - 90°



“LAT CW” = + 90° When the C-Arm is being automatically rotated, the



NOTE



movement may be immediately stopped by pressing any “LAT”, “ OBL”, “CC” button.



Pre-selectable angles can be modified by a procedure described in Technical Manual. FINE ADJUSTMENT ANGLE (buttons n° 3 - paragraph “C-Arm Movements Keyboards” and buttons n°12 – paragraph “Main parts”) A continuous pressure of “CW” or “CCW” buttons rotates the C-arm in ±180° (±130° for isocentric C-arm) range respect to 0° position.



“



” = CW



(continuous rotation)



“



” = CCW



(continuous rotation)



After a rotation movement on a pre-selected angle (“LAT” or “OBL”) the operator can adjust the C-Arm inclination pressing the Fine Adjustment angle buttons”. In this case, the pressure of opposite “OBL” button activates the C-Arm rotation at the opposite position respect to Fine Adjusted angle. The rotation angle and the standard code of mammography view (according to ACR standard) are shown on all displays.



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deg



cm



CC



MLO



ML



N



LM



LMO



FB



SIO



M



L



R XCC



CV



AT



ID



TAN



S



RL



RM



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



MODM10C-U02



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



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RIGHT



SCOUT



LEFT



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



When the stereotactic biopsy device BYM-3D FFDM is installed on Helianthus C Bym the C-Arm maximum NOTE



MODM10C-U02



rotation is limited to ± 90°, as shown in the following figure.



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“S” = SCOUT



“L” = LEFT



“R” = RIGHT



Three pushbuttons are provided: SCOUT, RIGHT, LEFT. When SBD FFDM is inserted, C-Arm vertical movement and rotation are disabled and only +/-15° rotation for stereo views is possible. If C-Arm position has to be changed, safety interlock switch on board of SBD FFDM NPU has to be activated (for further details see Operator’s Manual MO_SBD-FFDM-UXX). At Power ON C-Arm returns automatically at SCOUT position. After Bym-3D FFDM removing the C-Arm returns WARNING



MODM10C-U02



automatically at SCOUT position.



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COMPRESSION PADDLES INSERTION AND REMOVAL To insert a compression paddle tighten the internal knobs of locking system in order to retract the four pins.



Place the compression paddle on locking system and release the knobs to lock it.



To remove compression paddle tighten the internal knobs of locking system and pull it.



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In order to examine a small/medium breast in lateral projections is available a 18x24 cm compression paddle with lateral shifting.



TO LEFT



TO RIGHT



To move the compression paddle with lateral shifting from middle to right or to left push it towards desired direction. The paddle stops into place with an audible click.



Using the 18x24 cm compression paddle with lateral shifting, NOTE



the acquired image is conveniently resized and displayed in 18x24 cm format Using a 24x30 cm compression paddle to examine a



NOTE



small/medium breast, the acquired image isn’t resized and is displayed in 24x30 cm format



The above described removal of compression paddle allows also a fast mechanical unlock and then an emergency NOTE



decompression of breast in case of power failure or in case of patient physical discomfort, to guarantee her maximum safety.



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BREAST COMPRESSION SYSTEM The mammographic unit is equipped with an advanced compression system. The breast compression can be motor driven or manual with fine adjustment. In case of motor driven compression, function of tissue strength evaluation (FTSE) allows to modulate the force depending on breast density.



Motor driven compression The compression force can be set by Control Panel by means of buttons n° 8 (see the paragraph “Control Panel”) or rotating the encoder for fine manual compression (see the paragraph “controller for fine manual compression”) after having activated the function by means of push-button n° 2. The selected value (in N) is shown on all displays:



deg



cm



CC



MLO



ML



N



LM



LMO



FB



SIO



M



L



R XCC



CV



AT



ID



TAN



S



RL



RM



The range of compression can be set from 70 to 200 N by means of internal setting. Motorized compression is operated by the foot –controls n°9 (see the paragraph “Main Parts”).



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1



3



2



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



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Manual compression with fine adjustment Manual compression is possible acting on the controllers placed on both sides of C-arm.



The continuous rotation of the controller n° 1 in a direction (see the paragraph “Controller for fine manual compression”) allows to bring down the paddle, touch the breast and press it until to reach the desired force value. The compression force can increase up to maximum value set (200 N). The continuous rotation of the controller n° 1 in the other direction (see the paragraph “controller for fine manual compression”) allows to rise the paddle reducing the force. In any time, the operator can pass from motor driven to manual compression and vice versa. The force really exerted on the breast at the end of compression is shown both on the display of control panel and on the auxiliary display.



Compression release There are two different operating modes for compression release at the end of the exposure: -



AUTO SOFT RELEASE (normal mode)



-



MANUAL RELEASE (for 2D breast biopsy)



The operator can choose the release mode on control monitor by means of button n° 7 (see the paragraph “Control Panel”). The selected mode is shown on the area n° 6 of the display.



Auto release enabled MODM10C-U02



Auto release disabled Page 64 of 226



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



3



In case of power failure: backup battery is provided to maintain the compression of the patient’s breast. The compression release is NOTE



possible by pushing the n°3 of foot-control. This operation will move upwards the compression paddle. In case of emergency stop or black out with breast under



NOTE



compression to operate a fast release of breast, push the button n.3 of the foot-control



In case of power failure of mammography system with breast under compression, the operator may get free the patient using the fast mechanical unlock.



To remove compression paddle tighten the internal knobs of locking system and pull it. MODM10C-U02



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LIGHT BEAM INDICATOR



CAUTION



Don’t watch directly the collimation lamp



Every time the compression down pedal is used, the luminous field indicator light switches on for about 20 seconds. The compressor paddle goes down with a little delay, so that if the breast is already compressed the operator can switch on the light, avoiding additional pressing. The compression movement is immediate when the light beam is already on.



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AUTOMATIC COLLIMATION DEVICE The unit is provided with an automatic collimation device. With 24x30 cm detector, inserting device for geometric magnification, system automatically selects the suitable collimation field (10x14 cm). With 24x30 cm detector, using the 18x24 cm compression paddle with lateral shifting, the acquired image is conveniently resized and displayed in 18x24 cm format.



DEVICE FOR GEOMETRIC MAGNIFICATION (VARIABLE 1.5x/2x) Magnification ratio 1,5x or 2x is selected by pulling the two lateral spring-loaded plungers at the same time, and fix table height at requested position. Release the plungers and verify that locator pins lock the device for geometric magnification.



Inserting the device for geometric magnification, small focus NOTE



MODM10C-U02



and collimation field are automatically selected.



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PROTECTIVE SCREEN Mammography unit is provided of a protective screen to keep patient’s face and extraneous parts (i.e. shoulder, earring, hairs, etc.) out of X-Ray beam. The presence of extraneous parts in the image filed negatively affects the functioning of presentation algorithm, with impact on breast border recognition, worse contrast and dynamic range. In order to fix the protective screen, insert the rear side of his frame in the guide ways under the X-Ray window and push the protective screen reward to lock it.



To remove the protective screen pull it frontward to unlock.



NOTE



MODM10C-U02



The protective screen is not intended for magnification techniques.



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FOCAL SPOT SELECTION On MELODY III D C the selection of focal spot is automatic; large focus with Potter-Bucky and small focus with device for geometric magnification. No manual selection allowed. The selected focal spot is shown on control panel.



Large Focus



Small Focus



RADIOGRAPHIC EXPOSURE Radiographic exposure is allowed only when study is open from Acquisition Software and breast



is compressed. Otherwise error messages like “Open study first” or “Apply



compression force” alarm will appear. In semi-automatic and fully automatic exposure technique (see Section 5 of this Manual), the pre-exposure pulse is announced by a short sound signal and by a bright signal (see paragraph “Control Panel”). Exposure is announced by a long sound signal and by a bright signal on control panel (see paragraph “Control Panel”). After X-ray pushbutton is pressed there’s a few delay, depending on the detector synchronization, before the tube starts running. If the X-ray pushbutton is released, the X-ray emission stops immediately. At the end of exposure, the compression is released (with the function “Auto release” enabled) and the paddle rises automatically.



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DOSE CALCULATOR The MELODY III D C mammography unit automatically provides calculated values of the Average Glandular Dose (AGD). After each exposure, the dose in mGy is stored in the DICOM header and total dose is displayed in real time after any exposure on the Operation Bar (Menu Panel of Acquisition Software).



For proper dose calculator operation, it’s necessary to use the appropriate compression paddle as described in the chapter “Typical Configurations”. Shifted paddles have to be used with large focus and straight paddles with small focus because focal spot to skin distance measurement depend on it and dose calculation too.



OPERATING AND ERROR MESSAGES All the functions of MELODY III D C Mammography System are controlled by microprocessor with unique safety features. The monitor shows textual error messages (in several languages selectable in installation phase) related to an acoustic signal.



OPERATING ERRORS APPLY COMPRESSION FORCE Before making exposure breast must be compressed and compression force must be higher than 0



BREAST THICKNESS OUT OF RANGE Compressed Breast Thickness is more than 15 cm. It could depend by patient selection (out of intended use) or compression procedure. In that case, refer to technical service.



DOOR OPEN Close the door of diagnostic room.



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EARLY PUSH BUTTON RELEASE X-ray pushbutton button has been released before the exposure has been terminated by CPU. kV and mAs released will be displayed



OPEN STUDY FIRST Before making exposure open patient study from Acquisition Software.



TECHNIQUE NOT ALLOWED Compression without Potter-Bucky(study open)



TUBE THERMAL LIMIT REACHED 90% of the maximum thermal capacity of the X-ray tube has been reached: exposure not allowed until said value is sufficiently reduced through dissipation.



C-ARM SAFETY ENGAGED



Switch off Mammo unit and call technical Assistance. MOVE C-ARM UP



Only for ISO C_ARM move UP to avoid collision with floor when rotating more than 130 degrees to Caudo Cranial position. REMOVE COLLIMATOR



Additional magnetic collimation plate must be removed for a proper operation of current operating configuration



EMERGENCY PUSHBUTTON ACTIVATED



Emergency RED pushbutton/s has been activated; C-arm movements, compression and exposure are disabled. Emergency pushbutton/s require a manual action for restoring normal position and normal operation will be available after 30 seconds delay.



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MAINS UNSTABLE



Mains unstable message appears when the supply conditions are not satisfactory because supply voltage is low or supply voltage is unstable. The operative conditions are not guaranteed with this error message.



ERROR MESSAGES DMELauncher Thermo Alert (optional) In case of this kind of warning message please follow the instruction shown and turn off the unit. Numbers and message shown are purely illustrative



In case of this kind of warning message please follow the instruction. Numbers and message shown are purely illustrative



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All other messages are technical errors, for which operator can only restart the machine, and if the problem persist, NOTE



technical support must be called.



Click “OK” to reset error if the reason for it has been removed. If not, after few seconds, it will show up again except for messages related to power problems or black out for which error messages, if persistent, will not show up again after first reset but only when attempting to star x-ray exposure.



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SECTION 5: EXPOSURE TECHNIQUES



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MELODY III D C has three different Exposure Techniques:



EXPOSURE TECHNIQUE



ADJUSTABLE PARAMETERS



 20-35 kV std. or 20-40 kV (optional) Manual



 mAs (1-640)  Filter: FIX Rh FIX Ag



 Mode: PRE (based on breast density) FAST (based on breast thickness) Fully Automatic (Full Auto)



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



Semi-Automatic (Auto mAs)



 20-35 kV std. or 20-40 kV (optional)  Filter: AUTO (Rh/Ag) FIX Rh FIX Ag



To select the Exposure Technique, press repeatedly the button n° 5 (paragraph “Control Panel”) on mammography unit or click on the button n°1 (paragraph “Remote Control Panel”) on Acquisition Software.



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MANUAL MODE In manual mode the operator can select kV and mAs in the appropriate range allowed. The unit takes care automatically of max tube loading conditions. Manual mode selected is shown by small round hand-shape icon, as shown below:



In manual mode the exposure parameters (kV and mAs) can be selected on the control panel of the Acquisition Software, clicking on the arrow icons shown below:



The kV values change through 0.5 kV steps. The selectable standard range is 20 ÷ 35 kV (20-40 kV optional). The mAs values change in log scale. A Fast selection of mAs and Kv can be used in manual mode holding down the left button of keypad or the button



on arrow icons shown below:



Fast increase of kV or mAs Fast decrease of kV or mAs



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Manual mode is not recommended for normal use. Patient dose is not guaranteed within recommended dose NOTE



limits as is for the following AEC mode. Use it only for special applications, under operator’s control.



AUTOMATIC EXPOSURE MODE The Automatic Exposure mode (AEC) is the normal operating mode of the unit, having Full Auto (kV, mAs) and Auto mAs (manual kV and automatic mAs) modes. Exposure parameters are defined by two different techniques as follows:  PRE-exposure technique is based on breast density identified by means of a short Xray pre-exposure. Breast density is averaged over a mosaic of 96 sensitive areas and exposure parameters (kV, mAs) are selected accordingly.



 FAST exposure technique is based on compressed breast thickness and kV, mAs are selected accordingly. Manual, Auto mAs, Full Auto, Pre/Fast are selected by means of pushbuttons below, modes and techniques currently selected are shown by means of small round hand-shape icon: MODM10C-U02



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



AGD in mGy and W/Rh Anode/filter combination: W/Ag



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Pre and Fast techniques are provided to manage specific conditions as follows:  Pre is the standard technique for screening and is also recommended for post surgical intervention examination for which compression force could be painy or dangerous.  Fast is highly recommended for breast inplant being kV and mAs, thickness related.



Do not use Pre with breast inplant. Do not use Fast with light compression force. WARNING



In both cases, Dose released will be too high and resulting image most probably unusable.



AUTOMATIC FILTER DEVICE Rh/Ag The automatic filter Rh/Ag provides the most appropriate ANODE/FILTER (W/Rh-W/Ag) to guarantee the lowest Dose to the patient. W/Rh anode/filter combination is the standard for small and medium breasts. W/Ag anode/filter combination is provided for large or dense breast. Trip point after which W/Ag combination is selected, corresponds to combination of thickness and density corresponding to about 6 cm of RMI Tissue Equivalent phantom.



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Anode/filter combinations Anode/Filter combinations are selected automatically and combination used for the last exposure will be shown at the right side of the icon of Control Panel. Manual selection is possible by means of below pushbutton of Control Panel:



Selected mode will be shown at the right side of the icon of Control Panel:



Manual mode can be used to fix Anode/Filter combination in order to guarantee the same for all the images of the NOTE



study in case after the first image a condition close to the trip point Rh/Ag is identified by the operator.



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SECTION 6: TYPICAL OPERATING CONFIGURATIONS



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The different exposure techniques available with mammography unit MELODY III D C are shown in the next six pictures.



Each exposure technique has a unique combination of table, collimation device, compression paddle, focal NOTE



spot, magnification device etc.



Use of different configuration can result in operating error messages, bad images with unwanted artifacts due to compression paddle arms in the picture, wrong WARNING



x-ray field coverage, wrong dose measurement and others.



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MELODY III D C 24x30cm FORMAT CONFIGURATION FOR STANDARD EXAMINATION (LARGE BREAST)



 



LARGE FOCUS



PROTECTIVE SCREEN



24x30 cm FORMAT SHIFTED COMPRESSION PADDLE



24X30 cm FORMAT POTTER-BUCKY



NOTE



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CONFIGURATION FOR STANDARD EXAMINATION (NORMAL BREAST)



LARGE FOCUS



PROTECTIVE SCREEN



18x24 cm FORMAT SHIFTED COMPRESSION PADDLE



24x30 cm FORMAT POTTER-BUCKY



NOTE



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



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CONFIGURATION FOR SPOT CONTACT EXAMINATION



PROTECTIVE SCREEN



18X24 cm FORMAT SPOT COMPRESSION PADDLE



24X30 cm FORMAT POTTER-BUCKY



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CONFIGURATION FOR GEOMETRIC MAGNIFICATION



 



SMALL FOCUS



9X21 cm FORMAT STRAIGHT COMPRESSION PADDLE



24x30 cm GEOMETRIC MAGNIFICATION DEVICE



Protective screen can’t be used with magnification techniques not NOTE



NOTE



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having room enough to be fitted.



10x14 cm FORMAT collimation and selection of small focus are automatic with the insertion of geometric magnification device..



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CONFIGURATION FOR BIDIMENSIONAL BIOPSY



0,3 mm



LARGE FOCUS



PROTECTIVEE SCREEN



18x24 cm FORMAT SHIFTED COMPRESSION PADDLE FOR 2D BIOPSY



24X30 cm FORMAT POTTER-BUCKY



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MELODY III D C 24x30 cm FORMAT



CONFIGURATION FOR STEREOTACTIC BIOPSY



STEREOTACTIC BIOPSY DEVICE SBD FFDM 24X30



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SECTION 7: ACQUISITION SOFTWARE OPERATING INSTRUCTIONS



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The MELODY III D C mammography system is a medical equipment and PC of Acquisition Station should not be used WARNING



as a general purpose computer. Do not attempt to make any change to system software and do not try to install unauthorized software



The installation of a specific software (under the user responsibility) to protect the Acquisition Software from virus and spywares coming from the servers or external devices WARNING



connected by USB ports (i.e. portable Hard Disks, flash drives, etc.) is highly recommended. Antivirus exception list must be used during configuration, refer to specific technical note.



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



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



Operation Bar



Menu Panel



Status Bar







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2.1. Status Bar The Status Bar is divided in five sections and includes a calendar with local time. The first section indicates the “Status” of the device. The possible states are: Message



Meaning



Operational



Normal condition. The system is ready and able to make exposures.



Emission unavailable



The mammography unit does not respond to the signals of the Acquisition Software. The cause can be that the connection with the mammography unit is down, or simply the mammography unit is switched off, or technical problems. If this message appears in the Status Bar, the “Mammo tool” menu in the Main Menu is not selectable. In this case the “Mammo tool” menu should be not available and grey-colored. And/or The detector does not respond to the signals of the mammography unit. The reasons can be that the connection with the detector unit is down, or simply the detector is switched off, or technical problems.



The second section indicates the operating state of the device. The possible states are: Message



Meaning



DICOM



Normal operating mode; the connection of the mammography unit from and towards the outside (DICOM net or Diagnostic Subsystem, depending on the configuration) is working correctly.



Local



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



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The messages of this section define the different and successive phases corresponding to the Study recording on a CD/DVD disk. They automatically follow one other until the end of the process. In this last phase, the indication “Completed” will be displayed on the status bar together with the message “Media can be safely removed”.



The third section indicates if the mammography system is sending a study to a DICOM server. The possible states are: Message



Meaning First phase of building of the DICOM file.



Successive and progressive phases of sending to the server.



The fourth section indicates the temperature of the detector:



The fifth section indicates the status of the detector. The possible states are: Message



Meaning



ready



The detector is ready to receive the X-rays. This is the normal condition when there is an open study (and no elaboration is going on).



not ready



The detector is not ready to receive the X-rays. After the detector receives the X-rays and acquires the image, it passes through this state before being ready for a new exposure.



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The following status diagram shows the sequence of states which the detector passes through.







2.2. Operation Bar The Operation Bar indicates data of study either current or loaded.



The Operation Bar contains also the button to log off the software.



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2.3. Menu Panel The Menu Panel includes the most important tools to operate with the Acquisition Software. It includes four submenus: “Mammo”, “PC”, “Graphic” and “DICOM”.



MELODY III D C



MELODY III D C



After switching the unit, during the initial tuning of the system, the menus are not available. Then, all the menus are available, but two exception exist:



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1. The “Mammo” menu is not available and is grey-colored This state depends on the fact that the mammography unit does not respond to the signals of the Acquisition Software. This event can occur if the connection with the mammography unit is down or for other technical problems.



In such circumstance only Load study function is available, for loading and reviewing studies from the local archive. 2. The “DICOM” menu is not available and all buttons of this menu are grey-colored The problem can be due, for example, to the PACS of the medical center that is temporarily not available, or to the connection cable that has been cut. Click on the menu to verify if the connection with the DICOM net has been restored,. If after a few seconds the question point disappears, the connection is available and it is possible to open the menu clicking on it. Otherwise the question point persists and the menu is not available. In this case it is not necessary to stop working. Anyway, it is possible to continue acquiring images and store studies locally, on the internal memory of the Computer, and when the DICOM connection is restored the studies can be sent to the PACS. A quick description of each menu follows; the functions are explained better in other sections of this manual, or other chapters of this section. MODM10C-U02



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



Mammo: it serves to set the exposure parameters, to choose the achievable dose and to check the ACR view.



Clicking on upper side of Mammo menu the Control Panel appears, and related commands are available.



Clicking on lower side of Mammo menu the operator can choose between “Low dose” and “High contrast” operating modality.



Both modalities allow to obtain dose values less then established by European Guidelines; the “High contrast” modality is preferable to view micro-calcifications, the “Low dose” modality in preferable in screening or diagnostic routine exams in order to reduce X-ray emission to the patient. MODM10C-U02



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The button “Low dose/High contrast” is ever active, but is NOTE



preferable that all projections are performed with the same operating modality to obtain the maximum omogeneity of images.







PC: it serves to make operations on the local PC of the Acquisition Software.



By means of this menu it is possible to open new studies locally (i.e. not from the worklist), save the studies locally (i.e. in the internal memory), reload the local studies (i.e. resident in the internal memory), perform three-dimensional biopsy procedures (only on MELODY III D C with isocentric arm). The functions are available depending on the status of the device. Moreover, always by means of the PC menu, it is possible to insert the following information:  Operator’s name;  Institution’s name. To allow this data integration: click on PC label (CTRL right + mouse double click), fill the corresponding fields and then click on “OK” to save them:



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The “Biopsy devices” function is available only on MELODY III D NOTE



C mammography system equipped with isocentric arm. Regarding the use of this function, refer to “SBD FFDM Operator’s Manual”.







Graphic: this menu serves to manipulate the images shown on the display.



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It is used to select the images to display, to position them in a desired layout. The functions are available only if there is a study open (from worklist or locally) or loaded, otherwise the menu is partially disabled.







DICOM:



this menu includes all the commands of the Acquisition Software that



involve DICOM functions.



It is used to open and close a study from the Worklist, send studies stored on the local PC to an appropriate server of the RIS, change the exam typology of the study, integrate a study with other images, print images and make CD of the studies according to the DICOM protocol. The menu functions are available depending on the state of the device. In particular, the menu items are available or not if there is a study presently open, or there is a study presently loaded, or nothing.



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



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3.1 Opening study from Worklist 3.1.1 Remote Worklist  To open a study from the Remote Worklist, click on the “Worklist” button and a new submenu appears.



Clicking on “Remote” button, a “Worklist Query Dialog” window will appear, the Software automatically will ask the Worklist to the configured server and it will be possible charge data.



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1 2



3



The window is subdivided in three different sections: Section



1 2



Title Remote Worklist Server Query Parameters Result



3



Function To choose the worklist server by means of a combo-box. To filter the data provided by the worklist server. It shows the results of the query. Any row represents a scheduled study and contains its main information.



To open a study from the worklist, first of all it is necessary to query the worklist server to obtain the data. For this scope, it is necessary to set the query parameters using one or more fields present in the “Query Parameters” section. It’s possible choose between: 



From/To: click on the box near the field “From”, “To” or both and change the time references in order to select the period of the acceptance date in which the results have to be researched.







Patient name: pay attention to insert the name exactly as it was inserted in the worklist.



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



Patient ID: identification number.







Issuer of Patient ID: identifier of the Assigning Authority (system, organization, agency, or department) that issued the Patient ID.







Patient sex: the possible chooses are F (female), M (male), O (other)







Patient Birth date







Scheduled Station AE Title: modality on which the Scheduled Procedure Step is scheduled to perform. This field is empty until an information will be inserted. After every data entry, the information will remain automatically saved and it will be still present at the following Worklist Query.



If you do not want set any parameters for this field, it’s NOTE



necessary, before clicking on the button “Worklist Query”, delete any information just present inside it.







Modality: the modality for mammography is MG







Scheduled Performing Physician’s Name: if the acceptance of the medical site schedules the name of the physician who will perform the exam, it is possible to filter the worklist by means of this information.







Requested Procedure ID: when the acceptance creates and inserts a new study in the worklist, this information is automatically created and associated to the study. It is possible to filter the query to the worklist server with this information.







Requested Procedure Description: this field identifies the kind of procedure (for example 4 views ACR CC…...)







Accession Number: when the acceptance creates and inserts a new study in the worklist, this information is automatically created and associated to the study. It is possible to filter the query to the worklist server with this information.



Once set the parameters, click the button “Worklist Query” and all search results will be presented.



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To open a study double click on the corresponding row or select it and press the button “Done”. If you want to exit without opening any study, do not select any row and click “Done”.



To open more studies in automatic mode, it is sufficient to select all their correspondent rows and then press the button “Done”.



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In this way, the selected studies from remote Worklist will be automatically and sequentially opened when closing the previous one.



If a query to the worklist server does not provide any result, NOTE



verify that the windows of the query parameters section are correctly filled in.



The Acquisition Software loads the data of the patient, and the Operation Bar shows the data of the currently open study.



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



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Clicking on “Local” button, a window will appear and the operator will be able to create a new study without a Worklist item and perform an unscheduled IHE operation later.



To allow that any study locally generated and stored in the local PC, later can be matched correctly to the corresponding study of the worklist, take care to identify WARNING



clearly and univocally each study locally open. The wrong association between studies stored locally and studies of the worklist can cause wrong diagnosis and loss of clinical information.



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It is possible to identify the local study by means of the Accession Number. In this case, select the related window and write the number in the box:



Additionally, it is possible to identify the local study also by means of an Other Patient ID. In this case, select the related window and write inside it the other’s identification number or code used to identify the patient univocally:



After fulfilling the form, click on OK button to open the study. The Accession Number associated to the study is saved with the study till it is present in the Acquisition Software. When the local study will be associated to a Worklist request and transferred to NOTE



the RIS, the accession number will be deleted and the data associated to the mammograms will be the ones supplied by the Worklist.







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3.2 Opening local study To open a study locally, click on the “Local Study” button of the “PC” menu.



Identify the study associating to it a unique accession number, then click on OK button. Before acquiring images, it is possible to abort the study by clicking on the “Abort Study” button of the “PC” menu. After the first image has been acquired, this button becomes disabled.



Opening a local study, at the end of the study the data and radiological images are saved only in the internal memory. The study is not yet matched with the worklist request and WARNING



the images are not yet sent to the store server of the RIS. To complete the work, making the information safe and available, it is necessary to send the study to the RIS by means of the DICOM menu, as explained in next chapters.



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



If the quality of image is good, the operator can proceed with the next exposure positioning newly the patient and setting the parameters, otherwise will be necessary repeat the exposure trying to obtain a better quality.



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The new image is displayed on the main part of screen, meantime the overall dose of the study is updated in real time on the Operation Bar. Thumbnails of acquired images are displayed on upper bar in exposure order. To change the image displayed: select another thumbnail and drag & drop it in the main part of the screen.



The orientation of the image depends on the laterality: if the laterality set in the ACR code is “R” (refer to the following paragraph 4.2), the image is shown with the nipple on the left side; if the laterality is “L”, corresponding to the left breast, the image is shown with the nipple on the right. Repeat the steps “Position the patient – set the exposure parameters – expose – evaluate the quality”, till the end of the views needed.



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NOTE



For any study the operator can acquire a maximum of ten images.



To review a previous exposure is enough to select the image clicking on its thumbnail.



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4.1 Setting the exposure parameters The exposure parameters (operating mode, kV and mAs, and anode/filter combination) can be set on the control panel of the Acquisition Software. To access the control panel of the Acquisition Software, click on the “Mammo” icon of the Menu Panel. The control panel will appear to the side.



The operator must choose the preferred operating technique (Full Auto mode, manual mode or Auto mAs mode), the operating modality (Low dose or High contrast) and choose the values of kV and mAs. To make this operation refer to the previous section 5 “Exposure Techniques”.



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4.2 Setting the ACR code The ACR code is a standard code created by the American College of Radiology (ACR) to identify the view, the operating technique and other information of the mammographic image. Any code is composed by three parts: the prefix, the name of the view, and the suffix. The complete list of codes is:



A C R PREFIX CODE R L M



MEANING Right Left Magnification



CODE CC ML MLO LM LMO FB SIO XCC CV AT



C O D E VIEW MEANING CranioCaudal MedioLateral MedioLateral Oblique LateroMedial Lateromedial Oblique From Below Superlateral to Inferomedial Oblique Exaggerated CranioCaudal Cleavage Axillary tail



SUFFIX



CODE ID S RM



MEANING Implant Displaced Spot Roll Lateral



RL TAN



Roll Medial Tangential



A complete ACR code that identifies an image contains at least the laterality (“R” or “L”) and the view, while the other information are not mandatory. For example, to identify a MedioLateral Oblique projection on the right breast, without other information, the complete ACR code is: RMLO Some codes exclude each other, for example, the prefixes of the laterality “R” and “L” can’t be present both in the same string. There are also codes that do not exclude any other code; for example the code for magnification “M” can be present or not in any view. Each code of the view exclude all the others, for example if a view is “LM”, it can’t be also “CC”, “ML”, “MLO”, “LMO” etc.



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The name of the projections can be identified by the following table:



R CC



L CC



Righ breast; Craniocaudal



Righ breast; R Exaggerated XCC Craniocaudal



Left breast Craniocaudal



Left breast; L Exaggerated XCC Craniocaudal



R SIO



Righ breast; Superolateral to Inferomedial Oblique



L SIO



Left breast; Superolateral to Inferomedial Oblique



R LM



Right breast; Lateromedial



L LM



Left breast; Lateromedial



Right breast; R Lateromedial LMO Oblique



Left breast; L Lateromedial LMO Oblique



R FB



Right breast; From Below



L FB



Left breast; From Below



R ML



Right breast; Mediolateral



L ML



Left breast; Mediolateral



Right breast; R Mediolateral MLO Oblique



Left breast; L Mediolateral MLO Oblique



R AT



Right breast; Axillary Tail



L AT



Left breast; Axillary Tail



R CV



Right breast; Cleavage



L CV



Left breast; Cleavage



The arrow represents the X-ray beam direction (from the tube NOTE



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The previous table is only a reference for the radiologist. For NOTE



the correct positioning and compression of the patient refer to the ACR protocol or other official sources of information.



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



VIEW



PREFIX



In the following list it is evidenced which codes are automatically selected and which not. CODE AUTOMATIC SELECTION L No R No M Yes, when the magnification device is inserted CC Yes, depending on inclination of C-arm ML Yes, depending on laterality and inclination of C-arm MLO Yes, depending on laterality and inclination of C-arm LM Yes, depending on laterality and inclination of C-arm LMO Yes, depending on laterality and inclination of C-arm FB Yes, depending on inclination of C-arm



SUFFIX



SIO XCC



Yes, depending on laterality and inclination of C-arm No



CV



No



AT



No



ID S



No Yes, when the magnification device is inserted No No No



RM RL TAN



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Available only for standard C-arm Manually set alternatively to CC Manually set alternatively to CC Manually set alternatively to MLO



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The following circles show the sectors of C-arm rotation in which any ACR Code is selectable:



IF THE LATERALITY IS “R” (RIGHT BREAST)



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



IF THE LATERALITY IS “L” (LEFT BREAST)



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



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After positioning the patient, the C-arm inclination and the related default ACR code are shown both on the auxiliary display and on the control panel of the Acquisition Software.



To set the laterality, click the little patient icon, highlighting the desired breast or push the button on auxiliary display. To set an alternative view (different from the default view) click on the ACR code. It changes cyclically. To set a further ACR code, select it from the list of the control panel of the Acquisition Software or from auxiliary display. After the X-ray exposure, the following message will be shown:



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



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After the confirmation, the operator will modify again the laterality of an acquired image using the pushbutton “Change ACR NOTE



settings” (for a complete description, see the paragraph “5.5 Process, Info, ACR settings” , Section 6 of this operator’s manual).



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



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



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From the “Display” submenu the operator can select the preferred number and shape of windows to divide the screen clicking on the corresponding icon. For example, clicking on “2x2”, the screen is divided as in the following picture.



Any window shows an image, otherwise is empty (black). It is also possible to insert the same image in more than one window. The operator must drag and drop the same thumbnail to several graphic windows and the same desired image will be visualized in the chosen windows. To understand how the graphic windows are engaged, suppose that they are numbered from 1 to 25 (25 is the maximum number of windows that can be shown at the same time). Any display visualizes the windows from the number 1 to the number of the displayed images. For example in the visualization “1x1” only one graphic image is visualized, and it is the number 1; in the visualization “1x2” two windows are shown, so they must be the number 1 and number 2. And so on. For example suppose that more than one graphic window is engaged, as for example six graphic windows contain images. Now if we choose to divide the screen in less graphic windows than the presently engaged, for example we choose the “2x2” visualization, the windows remaining are the number 1, 2, 3 and 4, and they remain taken by the same images that were present before. MODM10C-U02



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Now if we change again the number of windows visualized, the windows remain taken with the same concept just explained. Four further visualization exist: “ACR CC”, “ACR MLO”, “ACR x 4” and “USER”. This visualizations serve to show the images of the right and left breast having the same ACR view code. Selecting the “ACR CC” view, the screen visualizes the two images of the CranioCaudal view for the right and left breast, as shown below.



Selecting the “ACR MLO” view, the two MLO images are visualized. Selecting the “ACR x 4” view, the two CC and the two MLO images are displayed. In this window select the checkbox corresponding to the couples of images that you want see, than click OK. The couples of images selected will be visualized.



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



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The “Fit to Window” function changes the magnification of the image so that it is adapted to the graphic window in which is contained.



The “Pan/Scroll” function is active only if the image is not fitted to the window. After selecting that tool, move the mouse up and down keeping the left button pressed to scroll (i.e. move the image upward and downward), and right and left to pan (i.e. move the image rightward and leftward). The operator can use this function even during the execution of another function by pushing [Alt] and clicking on image.



The “1:1” function visualizes each pixel of the detector on one pixel of the monitor.



The “Effective size” function makes the image displayed as the same size of breast when exposed.



The “Lens” function opens a square window of 300 x 300 dpi where the image is magnified with a ratio of 3x. The window can be positioned on any side of the image according to the mouse position.



5.3 Set anchor point This function is not activated yet .



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5.4 Window/Level, Contrast, Histo, Restore original To access these functions right click with the mouse on the desired image. All the functions are active only for the window from which the pop-up menu has been activated.



The “Window/Level” function allows to modify contrast and brightness of image. Click on “Window/Level” button and, keeping the left button pressed, move the mouse up and down to increase/decrease contrast, or right and left to increase/decrease brightness.



The “Contrast” function allows to modify the contrast of image in a specific side of breast. Clicking on “Contrast” button, a submenu appears.



Click on “High” button to set high value of contrast on thorax side; click on “Very High” button to set very high value of contrast on thorax side; click on “Skin” button to set high value of contrast at skin level; click on “Flat” button to undo all contrast changes; click on “Restore original” button to go back to original image before any manipulation.



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The “Histo” function allows to display the histogram of grey level distribution of the whole image and of a selected range of the same. Click on “Histo” button to open a window with two diagrams.



The upper diagram represents the grey level distribution of the whole image. The lower diagram represents the grey level distribution of selected range in the above diagram. In order to select the range click on the left or right edge of the above histogram window to drag the rulers.



Then, click on “Apply” button to save changes or click “Cancel” button to exit.



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The modifications applied by means of all the functions above described



(“Window/Level”,



“Contrast”



and



“HIsto”),



are



permanent and they will change also the images that will be NOTE



printed. Operator is prompted to accept or not window level manual changes when closing study.



In the DICOM fields visible on the review station, Window level/width is included. In the upper left image default values of “Window level/width: 4096/8192”. In the upper right image manually modified values of “Window level/width: 6574/9781”. Images for which Window level/width has been manually modified and saved, will look different in the same study.



5.5 Process, Info, Change ACR settings To access these functions right click with the mouse on the desired image.



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The “Process” function allows to modify some parameters of reconstruction algorithm in order to enhance all structures and reducing noise to show the images on display of Acquisition Software with a reading better quality. Clicking on “Process” button, a submenu appears.



The operator can choose between five optimized algorithm for magnification, biopsy, examination of surgical anatomical parts, examination of specimen and in case of metallic clips, surgical makers or numerous clusters of micro calcifications. Clicking on “Full image” button, the original image contrast is recovered.



Clicking on “Info” button, a window appears showing all DICOM data and parameters regarding the selected image.



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The “Change ACR settings” function allows to modify the preset viewing configuration. Clicking on “Change ACR settings” button, a window appears showing the ACR settings about the image from which the Pop-up menu has been reached. .



View and laterality of image can be changed selecting new identification codes and clicking on “OK” button to accept the new configuration.



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5.6 Downsize to 18x24, Delete, Recover 24x30, Measure, Plot Line, Alt Images To access these functions right click with the mouse on the desired image.



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



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Then clicking newly, a window appears to confirm the choice.



Clicking on “Yes” button, the image is downsized permanently.



An image downsized cannot be reconverted in original WARNING



size



The “Recover 24x30” function is available only for the mammography unit with 24x30 cm detector, when an images is incorrectly downsized to 18x24 cm format. It allows to restore the original 24x30 cm format of acquired image. Clicking on “Recover 24x30” button, the image is restored at original acquisition format.



The automatic downsize malfunctioning may depend on a NOTE



misalignment of compression paddle. If necessary, please contact technical service



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The “Delete” function allows to remove the selected image from the study transfer it in a local storage. Clicking on “Delete” button a 18x24 cm a window with 16 reason codes appears.



The operator must select the reason of deletion and clicking on “OK” the image will be erased from the study. The “Measure” function allows to take some measures on selected image. Clicking on “Measure” button a Pop-up menu appears to choose between linear or area measure.



Clicking on desired kind of measure, a little hand symbol appears on the image. Click on one edge of the detail and drag the hand symbol till reaching the other edge of the object to measure. Releasing the button, a window with the measurements results appears.



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The “Plot line” and “Alt images” functions allow to make preliminary investigations on image quality. Clicking on “Plot line” button, a little hand symbol appears on the image.



Click on one edge and drag the hand symbol till draw a line. Releasing the button, a window with a profile of the gray levels on the drawn line appears.



Clicking on “Alt images” button, the unprocessed image (RAW format before the application of enhancement algorithm) is displayed.



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6. CLOSING STUDY For any study it is possible to acquire a maximum of ten images. If the maximum number of images is reached, a pop-up message appears to inform the operator.



When the images acquisition is complete the operator must close and save the study. If the study has been open locally (by means of the “Study Data” window), it is saved locally. The study can be saved also on DICOM server in a second time by “Resend” function. If the study has been open from the Worklist (by means of the “Worklist Query Dialog” window), it is saved on DICOM server. A copy of the study is also saved locally for a time configurable in installation phase.



At the end of time of local storage, all studies are erased from NOTE



the Hard Disk.



6.1 Close Study (open from Worklist) At the end of exam, clicking on “Close Study” button of “DICOM” menu a window appears to allow to send and save study with data and images into store server. However, if the connection is not available or the net is busy, data are stored locally and sent to the server when connection is newly available.



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6.2 Save Study (open locally from PC) A study open locally is saved on the internal memory of local PC clicking on the “Save Study” button of “PC” menu.



7. LOADING STUDY FROM PC It’s possible to load the studies saved into the internal memory of local PC only for reading. Clicking on the “Load Study” button of the “PC” menu a window appears with the list of studies saved locally in the local PC.



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



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



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8. DICOM FUNCTIONS By “DICOM” menu, various functions (Resend, Append, Print, Make CD and export) can be applied on the studies open from the Worklist or locally.



8.1 Resend The “Resend” function allows to send a local stored study to the DICOM server. Clicking on “Resend” button, a window appears with the list of studies saved locally in the Acquisition Software.



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Studies open from the Worklist are displayed on light green background; the studies open locally are displayed on orange background.



Select the study that has to be resend to the PACS checking the corresponding box on the left and then click on “OK”. Selecting a study open locally, the “Worklist Query Dialog” window appears; the operator can associate the study at a patient and send the images to the server.



Selecting a study open from the Worklist, it is sent directly to the server.



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8.2 Append The “Resend” function allows to recall a study earlier open from Worklist in order to integrate it with other images. In any case, the information associated to the study are not modifiable. Clicking on “Append” button, a window appears with the list of studies.



The studies open locally (by means of the “Study Data” window) are displayed on grey background and they are not selectable. The studies open from the Worklist are displayed on light green background. The operator must double click on desired study to open it. The study images are shown on display and the mammography system is already to take Xrays exposures. Once the study has been integrated, close it according to the foreseen modalities. It is always possible to iterate the “Append” function until the study remains locally stored on the local PC.



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8.3 Print The “PRINT” function allows to send to a DICOM printer the images of an open study. Pushing on the “PRINT” button the following window appears:



The thumbnail of the images, acquired in the current study, are displayed on its left side while the printer parameters are displayed on the upper side. The parameters adjustable by the operator are the following:  Printer model  Film type and size  Direction (landscape or portrait)  Resolution (DPI)



The operator can, for example, increase the number of rows and columns in which the area will be separated:



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



to inform the operator that he has to reduce the film size. The operator can also assemble the images to print in a customized layout, choosing the views and drawing their corresponding thumbnail: MODM10C-U02



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



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in which it will be possible to modify the image view features by means of the commands bar at the bottom. Clicking on “OK” it will be possible to exit and save. The images can be printed integrating them with many exposure parameters. Clicking on “Set tags” button on the bottom-left, a window appears with a list of printable parameters:



In particular, it is possible to choose, between the available tags (left column “Available”), those ones which have to be included moving them to the right column “Print” using the pushbuttons “◄” or “►”. Once selected, their order of presentation can be modified using the pushbuttons “▲” or “▼” and their dimensions clicking on “+” or “-“. It is also possible to insert a ruler of 10 cm on the image to print:



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



printed on film for mammography and with printers specific for mammography.



8.4 Make CD



All the CD/DVD functions require external driver connected to NOTE



USB back side connector (see paragraph “connector panel”)



An open study can be saved on a CD/DVD disk or on a removable drives as DICOMDIR; in both cases an essential viewer is also included. This function is typically used for delivering the images to the patient. Click on “Make CD” button:



Insert a CD/DVD or a removable drive of adequate capacity (approximately 100 Mb for each patient’s study).



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



For an anonymous recording of the study select “Anonymize”. Clicking on OK, the process starts and may take several minutes. Only when recording succeed, the following message appears and the media can be removed.



In case of CD/DVD inserted will be automatically ejected.



8.5 Export The “Export” function allows to export the DICOM studies on CD/DVD or removable drives. It drives in native format for PACS Store and is mainly used for patient studies transfer from Mobile VAN to PACS at the end of working day. Clicking on “EXPORT” button, a window appears with the list of studies saved locally in the internal memory of local PC. MODM10C-U02



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Select the study to send to the media checking the corresponding box on the left and then click on “OK”. The following message appears:



Insert a CD/DVD or a removable drive. The system automatically shows one of the following messages after finding the drive inserted:



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For an anonymous recording of the study select “Anonymize”. Clicking on OK, the process starts and may take several minutes. Only when recording succeed, the following message appears and the media can be removed.



In case of CD/DVD inserted will be automatically ejected. If the same removable support is used more and more times, it is recommended to make a copy of previous exported studies or to rename the folder containing exported CAUTION



studies. Folders will be overwritten in the following export procedure. In case of multiple selection, the exported previous studies will not be automatically overwritten.



To select all studies insert tick into virtual box “select all”, to NOTE



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unselect all studies push the tick into “unselect all”



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8.5.1 Export of “for processing images” It is highly recommended to follow the below described steps for the raw images export exclusively in particular NOTE



case like the verification of image quality. It is not a routine procedure.



To allow the export of “for processing” images, click on DICOM label (CTRL right + mouse double click) and open the DICOM server list:



Select the CDBOX Server associated to the EXPORT FUNCTION, enable the flag “send “for processing” images and click on OK to save:



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



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9. DAILY CHECK Daily, prior to start to perform the exams, the operator must verify the right operating of mammography unit, through a specific tool achievable from “Operation Bar”.



To perform the check procedure is necessary to use an optional phantom (see Section 8: accessories) to place on Potter-Bucky.



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



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



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This tool has been developed according with Euref Protocol point 2b.2.2.3.1“Image Receptor Homogeneity”. Detector health percentage is related to the number of ROI passing the test , if the value is lower than 100% call Service for periodic Detector Calibration. This tool has been developed for daily check and cannot NOTE



be used in replacement of calibration tools dedicated to quality control.



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10. EXPORT LOGS In case of occurrence of SW problems, the Technical Assistance may ask the operator to send some files which may be useful for their analysis and troubleshooting. Using the available function “Export Logs”, the operator can export the requested files on a removable drive.



NOTE



Before starting this export, it is advisable to make sure that the removable drive does not contain other files.



Click on “Export Logs” button:



Insert a removable drive. The system automatically shows the following message after finding the drive inserted:



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Clicking on “OK”, the process starts and may take several minutes. Only when recording succeed, the following message appears and the media can be removed.



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11. CALIBRATE Depending of the specific detector mounted on the Mammo Unit, the SW may automatically enables the “Calibrate” push button of the “Menu Panel” as shown in the following figure:



NOTE



The “calibrate” procedure is only for a-Si detector



In this case, daily and before starting with the exams, the operator must perform the following check through a specific tool achievable on the SW interface. To perform this procedure is necessary to use the phantom for periodical system calibration without compression (see Section 8: accessories) in place of Potter-Bucky and protective screen. Moreover, it is necessary select the anode filter/combination (W/Rh or W/Ag) and perform the calibrate procedure only with large Focus



Before to perform the procedure the operator must clean the NOTE



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The procedure to perform is the following: 1. Click on “Calibrate” button:



2. Remove Potter Bucky:



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3. Remove Protective screen:



4. Plug calibration phantom in:



5. Place it as shown in the following picture:



6. Select “Go ahead”:



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7. Press exposure button when required:



8. At the end of X-ray exposure, the following interface is displayed and the test automatically runs showing the “Wait” message:



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9. After few seconds, the message “Done” appears in place of “Wait” and the window automatically disappears at the end of the test:



NOTE



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Repeat from point 6 to 9 for other A/F combination available (W/Ag anode/filter combination in this case).



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SECTION 8: MAINTENANCE



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GENERAL CONCEPTS The expected service life of mammography unit is defined and based on Service and Maintenance Instructions contained in the Technical Manual and on applicable official QC protocols for image quality. Maintenance procedures and checklist are included in Technical Manual and can be carried out only by qualified personnel. General maintenance procedures are suggested every 6 months or recommended every 1 year as better described in Technical Manual. Image quality inspection will be established according to locally applicable standards and QA protocols but periodicity must be less than six months. User should be daily (or before every switching ON of Mammo unit) check:  External damages to shield or unit  Check of mains and earth connections, cables and corrugated tube



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



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



Do not use abrasive detergents or harsh cleaners. Do not use excess of liquid and be careful washing liquid does not drip inside Detector or mammography unit. CAUTION



Do not use steam or high temperature liquid on equipment parts. Do not use cleaning sprays directly to avoid to damage electronic components.



Wipe any parts that contact the patient using a clean lint-free or pad. To cleaning and disinfecting parts that has come in contact with blood or other potentially infectious materials follows a WARNING



protocol assigned by your Infection Control representative.



To avoid electrostatic dust collection over the plastic covers, use anti-static dashboard wetwipes.



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



screen, spray it into the cleaning cloth. Do not press hard or touch the screen with to avoid leave oily prints and smears.



KEYBOARD If wireless keyboard doesn’t work check ON/OFF switch at rear side GREEN=ON RED=OFF and internal batteries subject to periodic replacement. Use only two AA alkaline long life batteries taking care of polarity. Keyboard Switch ON



To clean the keyboard first hold it upside down to release any debris from the spaces inbetween the keys (pressing the keys is a good way to release it). Use a can of compressed air to blow any debris from around and under the keys, then use the hose of a vacuum cleaner to remove it. Finally, clean the keys surface using a wipe made humid with a neutral detergent. MODM10C-U02



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Do not use excess of detergent and be careful detergent CAUTION



liquid does not drip inside keyboard.



TRANSPARENT ANTI-X PROTECTIVE BARRIER To clean the transparent anti-X protective barrier use any specific glass cleaner and a clean soft, lint-free cloth. Then wipe carefully the surface with another dry cloth. Never spray any cleaning solutions directly onto the anti-X CAUTION



protective barrier, spray it into the cleaning cloth. Be careful detergent liquid does not drip on desk.



DETECTOR FANS FILTERS CHECK AND REPLACEMENT The air-flow for Detector cooling is protected from dust by washable and reusable Polyurethane Foam filters (1/4" Thick, 45 Pores/Inch). Dust affects reliability because a thick layer of dust can exhibit a certain amount of electrical capacitance and conductivity. Just as seriously, it will reduce the working life of fans and increase the risk of overheating. The Foam density has designed to be high enough to catch dust, but low enough not to reduce airflow. In particularly dusty places, every month, it’s advisable to verify filters cleaning to avoid a dust accretion. If filters are dirty must be replaced quickly with new others. In any case, the filters must be changed periodically with a frequency depending by the installation environment. The dirty filters can be washed (only with water) and reused totally dry in the next replacement. The filters replacement procedure is described on Technical Manual and must be carried out only by Qualified Personnel. If periodic inspection is not carried out and filters gaps are obstructed the cooling fans can periodically oscillate with a rate of about 2/3 s generating a typical audible noise that can recall the operator attention. MODM10C-U02



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Filters obstruction cause a Detector overheating. In this case the temperature can go out of calibration range and a red message is visible on Status Bar of Acquisition Software (see also the Section 5-Paragraph 2.1 of this Manual).



Detector fans filters must be replaced only by Service CAUTION



Technicians and only with original filter kit..



MOVING THE UNIT TO ANOTHER PLACE Refer to Technical Manual and use only qualified personnel.



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SECTION 9: ACCESSORIES & OPTIONAL PARTS



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LIST OF PARTS Description Standard parts 



24X30 cm format Potter-Bucky with vibrating grid







24x30 cm format shifted compression paddle







18x24 cm format shifted compression paddle with lateral shifting







Digital Flat Panel Detector (a-Si)







Fast lock and extended protective screen to keep patient’s face out of X-Ray beam







N°1 foot-controls







Full-Optional collimator device (automatic filter and collimation)







Phantom for periodical system calibration without compression







Technical manual







Operator’s manual



LIST OF OPTIONS Description Options 



VARIAN M113T biangular tube with tungsten anode (low speed only)







IAE XM12THigh speed voltage generator with wide range [20-40] Kv







Motorized rotation







High speed starter







115Vac Power Supply







Digital Flat Panel Detector (a-Se)



WARNING



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Description Optional parts 



Acquisition Workstation (Transparent Anti-X Protective Barrier with support for monitor + Keyboard supporting surface), see configurations available







24x30 cm device for geometric magnification with variable (1,5x and 2x) factor







9x21 cm format compression paddle







18x24 cm format spot compression paddle







18x24 cm format shifted compression paddle for 2D biopsy







Bearing for compression paddle (up to n°3 paddles)







Phantom for daily check with compression







SBD 3D FFDM Stereotactic biopsy device (only for MELODY III D C 24x30 cm format)







Kit for digital mammographic unit (with not isocentric C-Arm) installation on VAN







Kit for digital mammographic unit (with isocentric C-Arm) installation on VAN







Transparent Anti-X Protective Barrier







10 kVA Uninterruptible Power Supply (UPS) system







Patient chair (height adjustable)







Patient bed/chair



WARNING



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CONFIGURATIONS AVAILABLE Control monitor and wireless keyboard are provided with the unit



NOTE



and can be placed as shown in typical configurations below:



CONFIGURATION AVAILABLE BASE



DESCRIPTION



TYPICAL CONFIGURATION PROVIDED



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



2 Mpx diagnostic color monitor (21,3’’)



AA







Wireless keyboard







X-ray pushbutton



Control monitor and wireless keyboard are available on a stand-alone halftransparent anti-X barrier for operator protection. This is equipped with: 



2 Mpx diagnostic color monitor (21,3’’)



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



wireless keyboard







X-ray pushbutton



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AB



Double management configuration. Mammo unit is equipped on the stand with: 



2 Mpx diagnostic color monitor (21,3’’)







Wireless keyboard







X-ray pushbutton



Acquisition workstation for operator protection and device managing is equipped with: 



2 Mpx diagnostic color monitor (21,3’’)



AC







wireless keyboard







X-ray pushbutton



Control monitor, a wireless keyboard and an X-ray pushbutton are provided with a dedicated support to be mounted on wall as shown in typical configuration



AD



Double management configuration. Mammo unit is equipped on the stand with: 



2 Mpx diagnostic color monitor (21,3’’)







Wireless keyboard







X-ray pushbutton



Control monitor, a wireless keyboard and an X-ray pushbutton are provided with a dedicated support to be mounted on wall as shown in typical configuration workstation for MODM10C-U02



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AE



Control monitor and an X-ray pushbutton are provided with specific support for desktop placement. A wireless keyboard is provided



NOTE



The wireless keyboard is one for each configuration and can be placed as preferred.



Anti-x barrier must be supplied before use: It is mandatory use an anti-X barrier in configuration BASE, AC, AD, AE for operator’s NOTE



safety (the manufacturer does not provide protections/barrier). Do not use the mammographic unit without appropriate safety measures.



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COMPRESSION PADDLES



18x24 cm FORMAT COMPRESSION PADDLE



9x21 cm FORMAT COMPRESSION PADDLE FOR MAGNIFICATION



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24x30 cm FORMAT COMPRESSION PADDLE



18x24 cm FORMAT SPOT COMPRESSION PADDLE



18x24 cm FORMAT COMPRESSION PADDLE WITH LATERAL SHIFTING



18x24 cm FORMAT COMPRESSION PADDLE FOR 2D BIOPSY



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DEVICE FOR GEOMETRIC MAGNIFICATION WITH VARIABLE (1,5x/2x)



24x30 cm FORMAT MAGNIFICATION DEVICE



FOOT-CONTROLS



FOOT-CONTROLS FOR MOTORIZED COMPRESSION



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PROTECTIVE SCREEN



PHANTOM FOR PERIODICAL SYSTEM CALIBRATION



PHANTOM FOR PERIODICAL SYSTEM CALIBRATION



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PHANTOM FOR DAILY CHECK WITH COMPRESSION



PHANTOM FOR DAILY CHECK WITH COMPRESSION



STEREOTACTIC BIOPSY DEVICE (only for MELODY III D C equipped with isocentric arm)  24x30 cm format



SBD FFDM



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ANTI-X PROTECTIVE BARRIER Half-Transparent



Full-Transparent



ACQUISITION WORKSTATION



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SECTION 10: SPECIAL HINTS – IMAGE RECOVERY STRATEGY – TROUBLESHOOTING



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The Acquisition Software provides the customer with different strategies for images recovery which for various reasons were acquired improperly, avoiding to expose again the patient.



PATIENT POSITIONING An adequate patient positioning permits to: 



Simplify the image reading process







Use the specular systematic viewing techniques in an optimal way (binocular magnification, Tabar's masks, etc.)







Guarantee the best performances of the image presentation algorithms



From the poor care in positioning result: 



Asymmetric images







Skinfolds







Presence of extraneous parts in the image field (shoulder, hairs, earrings, etc.)



Often, to worsen the situation: 



Inadeguate breast compression



Symmetry



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Symmetry



Symmetry



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Symmetry



Symmetry



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Symmetry



Symmetry



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Skinfolds



Skinfolds



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Skinfolds



Extraneous parts in the image field



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Extraneous parts in the image field: Dynamic Range



Extraneous parts in the image field: Dynamic Range



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Extraneous parts in the image field: Border recognition



Extraneous parts in the image field: Border recognition



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Compression



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



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IMAGE RECOVERY STRATEGY – TROUBLESHOOTING Incorrectly sized images acquired with 18x24 compression paddle In case of incorrect size of images acquired with 18x24 compression paddle, it is possible downsizing to 18x24 cm format with the right click on image. Clicking on “Downsize to 18x24” button a 18x24 cm rectangle appears: moving it with the mouse select the region of image under study in order to crop it.



An image downsized cannot be reconverted in original WARNING



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size



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Incorrectly sized images acquired with 24x30 compression paddle I In case of incorrect size of images acquired with 24x30 compression paddle, it is possible



recovering 24x30 cm format with the right click on image. The “Recover 24x30” function is available only for the mammography unit with 24x30 cm detector, when an images is incorrectly downsized to 18x24 cm format. It allows to restore the original 24x30 cm format of acquired image. Clicking on “Recover 24x30” button, the image is restored at original acquisition format.



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Images with metallic clips, surgical marker and cluster of micro calcification In case of image with metallic clips, surgical marker and numerous cluster of micro calcification, in which image contrast could be not adequate for radiologist physician, you have to right click on image and select Process → OTSU → Marker, as shown in following image.



To recover the original image contrast, you have to right click on image and select Process → Marker The “marker” filter can be used also in that case in which NOTE



the patient is not properly positioned and earrings or other object are in the image plane.



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



To recover the original image contrast, you have to right click on image and select Process → Surgery



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



To recover the original image contrast, you have to right click on image and select Process→ Specimen



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



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Spot compression device (if available) In the following we are considering the use of the so called spot shifted compression paddle, shown in the following figure, designed to be used in contact mode (not for magnification).



In its current conformation, this spot compression device is made by an almost round compression plate in polycarbonate, supported by a metal structure. This structure is heavily radio-opaque and can be considered an extraneous part clearly visible in a wide standard image of which only a little ROI is usable. Furthermore, an important number of gray levels is sacrificed in favor of the metal part. See for example following figures. On the left, the image of a TOR MAM phantom is shown with its resulting histogram. On the right, you can see the same phantom imaged with the spot compression device. The large part of metal in the image field causes a loss of dynamic, noticeable as a compressed histogram of the part of the image corresponding to the phantom, highlighted in red. The blue indicates the part of dynamic stolen by the metal from the relevant object.



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



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From here, select Histo: a new window will appear, where the operator can lower the maximum displayed value (the “white point”) to increase contrast in the region of interest, as shown in following image.



New White



Click on Preview and evaluate the result. Adjust further, if needed. Please note that also the lowest displayed level can be adjusted. Once the result is satisfying, click on Apply. We must also advise you that the exposure modality “Automatic – Pre” cannot be used when imaging with the spot compression device inserted, since this AEC algorithm, due to the presence of metal parts in a relevant area of the image, will erroneously recognize a high breast density delivering too much dose to the patient. When using the spot compression device, please select Manual or Automatic – Fast mode. The Manufacturer will remain on hand in case the image quality needs further improvements. Clinical cases with comments, suggestions and eventual requests are highly welcome. Fine tunings and/or modifications are possible on the presentation algorithm and we do not exclude to design a new spot compression device with less invasive arm. MODM10C-U02



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SECTION 11: TECHNICAL SPECIFICATIONS



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TECHNICAL SPECIFICATIONS NOTE



The manufacturer reserves the right to make further improvements while keeping main features unchanged.



CLASSIFICATION (IEC 60601-1) Protection against electric shock Applied parts Protection degree according to IEC 529 Degree of safety in the presence of flammable anesthetics mixture with. air or with oxygen or with nitrous oxide Mode of operation



Class I, with type B applied parts  Potter-Bucky/Biopsy Device carbon fiber  Compression Paddles  Magnification Device IP X0 IPX1 (Foot-Controls) Not suitable for use in the presence of Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide Continuous operation with intermittent loading



POWER SUPPLY Line voltage Power Current absorption Number of phases Connection Wall connection



Mains resistance



220/230/240 Vac 10% 50/60 Hz 115 Vac 10% 50/60 Hz (optional) 6.6 kVA ( 3200 W



30 kV; 135 mA (@ 0,3 mm) ->4050 W 2,96 s loading time (400 mAs)



1 mAs (for all kV values) 8 mAs (using 20 mm PMMA phantom)



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Range of X-Ray Tube Voltage when X-Ray Tube Voltage is controlled by AEC (IEC 60601-2-45: 201.7.9.2.1.i) mAs range



X-Ray Window Housing X-Ray protection Inherent filtration HVL measured at 28 kV Total filtration



25-35 kV Optional: 25-40 kV Small focus: 1÷80 mAs (from 20 to 21 kV) 1÷140 mAs (from 22 to 30 kV) 1÷100 mAs (from 31 to 34 kV) 1÷100 mAs (from 35 to 40 kV) Large focus: 1÷320 mAs (from 20 to 24 kV) 1÷400 mAs (from 25 to 27 kV) 1÷640 mAs (from 28 to 30 kV) 1÷560 mAs (from 31 to 34 kV) 1÷320 mAs (35 kV) 1÷250 mAs (from 36 to 40 kV) 0,5 mm Beryllium >=0,5 mm Pb equivalent 0,0 mm Al IEC 60522:1999-02 >0,4 mm Al equiv. >0.5 mm Al



TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION With active temperature sensor under main CPU control



Upper limit temperature 65° outside tube assembly. HU and °C display available in technical menu.



FILTER PROPERTIES 50 m Silver 50 m Rhodium



MODM10C-U02



0.55 mm Al eq. @ 28 kV, measured with W target 0.51 mm Al eq @ 28 kV, measured with W target



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OPTIONAL X-RAY TUBE Anode rotation speed Target material Anode Heat Storage Capacity Maximum Anode Heat Dissipation Rate X-Ray Tube Assembly Heat Storage Capacity X-Ray Tube Assembly Heat Dissipation Rate Cooling method Anode Disc Target Angle Anode Disc Diameter Focal spots Focal spot size according to IEC 336, EN60336 Power (Nominal Anode Input Power) Nominal X-Ray Tube Voltage and Highest XRay Tube Current available at that voltage (IEC 60601-2-45: 201.7.9.2.1.a) Highest X-Ray Tube Current and Highest XRay Tube Voltage available at that current (IEC 60601-2-45: 201.7.9.2.1.b) Corresponding combination of X-Ray Tube Voltage and X-Ray Tube Current which results in Highest Electric Output Power (IEC 606012-45:201.7.9.2.1.c) Nominal electric power given as the highest constant electric output power in kilowatts which the X-Ray Generator can deliver at an X-Ray Tube Voltage of 30 kV, for a Loading Time of 1 s, a Cycle Time of 1,0 minute and for an indefinite number of cycles, or if these values are not selectable, at an X-Ray Tube Voltage nearest to 30 kV, for a Loading Time nearest to but not less than 1 s and a Cycle Time of 1,0 minute and for an indefinite number of cycles (IEC 60601-2-45: 201.7.9.2.1.d) Nominal electric power shall be given together with the combination of X-Ray Tube Voltage and X-Ray Tube Current and Loading Time (IEC 60601-2-45: 201.7.9.2.1.e) Lowest Current Time Product (IEC 60601-2-45: 201.7.9.2.1.f) For Mammographic X-Ray Equipment provided with automatic Exposure Control controlling Loading Time, shortest Loading Time and/or the lowest resulting Current Time Product (IEC 60601-2-45: 201.7.9.2.1.h) MODM10C-U02



VARIAN M113T



(X-RAY TUBE ASSEMBLY B 115)



3000 rpm 50 Hz Tungsten Focal track: W-Re-Mo 300 kHU (225 kJ) 60 kHU/min (750 W) 500 kHU (376 kJ) 135 HU/s (100 W) Free air convection 10° (Small focus)/16° (Large focus) 77 mm 2 0,1x0,1 mm (Small)/0,3x0,3 mm (Large) 1400 W (Small)/5900 W (Large) (3000 rpm) 35 kV; 100 mA (@ 0,3 mm) Optional: 40 kV; 80 mA (@ 0,3 mm) 34 kV; 135 mA (@ 0,3 mm) -> 4590 W Optional: 40 kV; 80 mA (@ 0,3 mm)-> 3200 W



30 kV; 135 mA (@ 0,3 mm) ->4050 W 2,96 s loading time (400 mAs)



1 mAs (for all kV values) 8 mAs (using 20 mm PMMA phantom)



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Range of X-Ray Tube Voltage when X-Ray Tube Voltage is controlled by AEC (IEC 60601-2-45: 201.7.9.2.1.i) mAs range



X-Ray Window Housing X-Ray protection Inherent filtration HVL measured at 28 kV Total filtration



25-35 kV Optional: 25-40 kV Small focus: 1÷100 mAs (from 20 to 22 kV) 1÷130 mAs (from 23 to 30 kV) 1÷100 mAs (from 31 to 35 kV) 1÷80 mAs (from 36 to 40 kV) Large focus: 1÷300 mAs (from 20 to 24 kV) 1÷640 mAs (from 25 to 35 kV) 1÷250 mAs (from 36 to 40 kV) 0,63 mm Beryllium >=0,5 mm Pb equivalent 0,0 mm Al IEC 60522:1999-02 >0,4 mm Al equiv. >0.5 mm Al



TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION With active temperature sensor under main CPU control



Upper limit temperature 65° outside tube assembly. HU and °C display available in technical menu.



FILTER PROPERTIES 50 m Silver 50 m Rhodium



0.55 mm Al eq. @ 28 kV, measured with W target 0.51 mm Al eq @ 28 kV, measured with W target



AUTOMATIC COLLIMATION DEVICE Light Source Light beam Light intensity Light beam collimation accuracy Mirror Formats (with device for geometric magnification) Protection of examination field



LED ( Risk Group 1 - Low Risk - according to IEC 62471) Switch ON by push-button or automatic when operating compression (selectable by service) Electronic timer  150 lux according to IEC 60601-2-45:203.8.5.4 with automatic out of field function 24x30 cm and 10x14 cm for magnification (Detector 24x30 cm format) Fast lock and extended protective screen to keep patient’s face out of X-ray beam



GRID Type Interspace Material Bucky factor Ratio Lines/cm Contrast factor



MODM10C-U02



Linear, Vibrating Carbon Based Polymer 2.1 (W/Rh); 1.92(W/Ag) 6:1 36 1,54



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OPTIONAL DEVICE FOR GEOMETRIC MAGNIFICATION Type Top Cover Magnification ratio Small focus selection



Gridless Interchangeable with Potter-Bucky Carbon fiber 0.1 mm Al equivalent (18x24 cm) Polycarbonate 0.2 mm Al equivalent (24x30 cm) x1,5 / x2 (variable) Automatic once fitted



DIGITAL FLAT PANEL DETECTOR Detector Tecnology Case dimensions Top Cover Chest Gap Cooling Method



Digitalization type Pixel Pitch Active Area Image Matrix Image Depth Fill factor MTF (Modulation Transfer Function)



DQE (Detector Quantum Efficiency) (for exposure of 28 kV)



Maximum Spatial Resolution Nyquist Frequency Signal to Noise Ratio (SNR) (with 45mm PMMA Phantom) Ghost Image factor (Point n°2b.2.4.5 of “European Guidelines”) Detector Read Time Image Display Time on Acquisition Software Time Between Two Images Acquisition



MODM10C-U02



a-Si TFT Array + PIN Photodiode Amorphous Selenium (a-Se) 35,9x34,6 cm (24x30 cm format) Carbon fiber 0.1 mm Al equivalent 3,9 mm Air + Fan (integrated) NOTE: The detector blowers will typically create a difference of around 4-5 degrees with respect to the ambient temperature. Logarithmic 85x85 m 23.9x30.5 cm (24x30 cm format) 2816x3584 (24x30 cm format) 16 bit 88 % geometric (for Detector a-Se) 80% geometric (for a-Si Detector) For a-Se Detector: >90% @ 1 lp/mm >40% @ 5,8 lp/mm For a-Si Detector: >75% @ 1 lp/mm (typical 85%) >10% @ 5 lp/mm for a-Si Detector (typical 20%) For a-Se Detector: >50% @ 1 lp/mm >20% @ 5,8 lp/mm) For a-Si Detector: >45% @ 1 lp/mm (typical 50%) >10% @ 5 lp/mm (typical 20%) 7 lp/mm 5,88 lp/mm 15,19 (28,5 kV-10 mAs) For a-Se Detector: 0,02 For a-Si Detector: 0,05 < 1.1 s (24x30 cm) < 15 s < 20 s Page 209 of 226



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IMAGE QUALITY Spatial resolution



Conformity with: “European Guidelines for quality assurance in mammography screening”, third edition, and with ”Recommended specifications” for Quality assurance in mammography of American College of Radiology



AUTOMATIC EXPOSURE CONTROL Controlled parameters Auto parameters selection criteria



Sensitive area (only for PRE mode)



Auto kV / Auto mAs (Full Auto Mode) Manual kV / Auto mAs (Auto mAs Mode) Dual mode: PRE and FAST PRE: tissue composition based (parameters evaluated by short X-Ray exposure) FAST: compressed breast thickness based Mosaic of 96 areas of detector automatically selected in function of brest size and projection



DOSE CALCULATOR Method of Calculation Data visualization (mGy) Method of recording AGD with a 4 cm PMMA phantom Dose Rate (28 kV-80 mAs)



Average Glandular Dose (AGD) according to: “D.R. Dance et al.” On display Image Header (DICOM) 1,216 mGy 36,63 R/min without Compression Paddle 29,80 R/min with Compression Paddle



C-ARM F.F.D. (Focus Detector Distance)/S.I.D. (Source to image receptor Distance) Motorized Movements Range of Vertical movement (from floor) Range of C-arm rotation Projection preset position Speed of C-arm Rotation Display of angle rotation



MODM10C-U02



66 cm Vertical and rotation (optional) From 43 to 128 cm (travel of 85 cm) +/-180° (CW, CCW continuous to any position) N° 5 Programmable projections (LAT, OBL, CC, OBL, LAT) 90°/7,2 s with acceleration and deceleration ramp for smooth operation On auxiliary Display (ACR) On Display of controllers for manual compression



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ISOCENTRIC C-ARM F.F.D. (Focus Detector Distance)/S.I.D. (Source to image receptor Distance) Motorized Movements Range of Vertical movement (from floor) Range of C-arm rotation



Projection preset position Speed of C-arm Rotation Display of angle rotation



66 cm Vertical and rotation +/- 15° Rotation (only with BYM 3D FFDM) From 75 to 160 cm (travel of 85 cm) +/-130° (CW, CCW continuous to any position) N° 5 Programmable projections (LAT, OBL, CC, OBL, LAT) 90°/9,6 s with acceleration and deceleration ramp for smooth operation On auxiliary Display (ACR) On Display of controllers for manual compression



AUXILIARY DISPLAY AND TAGGING KEYBOARD 3 displays (7 segments) + 18 Leds Display type Tagging Keyboard (ACR protocol) Informations



Ten pushbuttons: R/L laterality and prefixes/suffixes Compression force C-arm rotation angle Compression breast thickness Laterality, Projection, ACR prefixes and suffixes



“SMART µPRESS” COMPRESSION DEVICE Compression Paddle movement Standard Compression Paddles (for 18x24 cm format) Standard Compression Paddles (for 24x30 cm format) Optional Compression Paddles Compression Paddle Holder Maximum free space available between Compression Paddle and image receptor



Compression Force Compression Force Display Compression Paddle Descent Speed Maximum Compression Force Safety Device



Motor driven or manual with fine adjustment by double rotating controller 18x24 cm shifted for normal breasts 24x30 cm shifted for large breasts 18x24 cm with lateral shifting for normal breasts 9x21 cm straight for magnification 18x24 cm for spot contact examination 18x24 cm shifted for bidimensional biopsy Fast mechanical unlock 325 mm with shifted Compression Paddles In Magnification Mode (straight compression paddle) MAG. X 1.5 = 197,5 mm MAG. X 2 = 97,5 mm Adjustable from 70 to 200 N Effective applied force with 1 N resolution Proportionally decreasing compressing the breast Triple safety device: electronic, electro-mechanical, mechanical Selectable from Acquisition Software



Soft Compression paddle release after exposure Compression Thickness Display Displayed in mm Compression paddle aluminum equivalence Less than 0.2 mm Al (0.135 mm Al≈30 kV) Special function for 0 compression force for oncology procedures MODM10C-U02



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CONTROLLERS FOR MANUAL COMPRESSION Number and type (standard)



Two rotating wheels with central push-button on both sides of C-Arm



FOOT-CONTROLS Number and type



Control Actions



One with two pedals and one push-button for motor driven compression unlock Two with two pedals and one push-button for motor driven compression unlock (optional) Vertical movement of Compression Paddle Motor driven compression unlock



EMERGENCY STOPS Number and Type Function



MODM10C-U02



Two red push-buttons on both sides of mammography unit To Switch OFF C-Arm motors and HV generator



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PERSONAL COMPUTER Operating Systems CPU RAM HDD DVD recorder



Windows 7 Professional 64-bit Intel Core i7 2600 3,4 GHz 8 GB (optionally 16 GB available) 1 TB SATA for Operating System, Software, studies storage (~25.000 images) 48x SATA DVD +/-RW DL



Power Pack UPS (uninterruptible Power Supply) AirFlow



400 W 650 VA 178 m³/h



STANDARD COLOR MONITOR (2 MP) Technology Screen Size (diagonal) Display Resolution (pixels) Pixel pitch Viewing Angle Response Time Brightness Contrast ratio



TFT color LCD 21,3” (541 mm) 1600 x 1200 270 μm 178° horizontal and vertical 20 ms 440 cd/m² max (250 cd/m² DICOM calibrated) 1500:1 Typical



ANTI-X PROTECTIVE BARRIER (Optional) Type Pb equivalence Dimensions Glass Thickness



Stand Alone > 0.34 mm Pb @35 kV (IEC 60601-2-45) =0.26 mm @ 49 kV 773x2100x583 mm 20 mm



ANTI-X PROTECTIVE BARRIER WITH OPTIONAL MONITOR AND KEYBOARD (Acquisition Workstation) Type Pb equivalence Dimensions Glass Thickness PC monitor support Desk dimensions Features



Integrated > 0.34 mm Pb @35 kV (IEC 60601-2-45) =0.26 mm @ 49 kV 773x2100x583 mm 20 mm Fixed on glass L=580mm; H=200mm Acquisition Station X-Ray pushbutton



UPS (UNINTERRUPTIBLE POWER SUPPLY) Input voltage Output voltage Power Duration MODM10C-U02



180/266 Vac 230 Vac ± 8% 115 Vac ± 8% 650 VA 700 VA (115 V) 10 minutes (typically) Page 213 of 226



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



system as replacement parts for internal components, may result in increased emission or decreased immunity of the equipment or system.



Guidance and manufacturer’s declaration – Electromagnetic emissions The MELODY III D C is suitable for use in the specified electromagnetic environment. The purchaser or user of the MELODY III D C should assure that it is used in an electromagnetic environment as described below: Emissions test



Compliance



Electromagnetic environment – guidance



Group 1



The MELODY III D C uses RF energy only for its internal function. Therefore, its RF emission is very low and not likely to cause any interference in nearby electronic equipment.



RF emissions CISPR 11 RF emissions Class A CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions



Not applicable



The emission characteristics of MELODY III D C is suitable for use in industrial areas and hospitals (CISPR class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measured, such as relocating or reorienting the equipment.



Not applicable



IEC 61000-3-3



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The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or WARNING



stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.



Guidance and manufacturer’s declaration – Electromagnetic immunity The MELODY III D C is suitable for use in the specified electromagnetic environment. The purchaser or user of the MELODY III D C should assure that it is used in an electromagnetic environment as described below: Immunity test



IEC 60601-1-2 test level



Compliance level



Electromagnetic environment



Electrostatic discharge (ESD) IEC 61000-4-2



8 kV contact 15 kV air



IEC 60601-1-2 test level



Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.



Electrical fast transient/burst IEC 61000-4-4



2 kV for power supply lines



IEC 60601-1-2 test level



Mains power quality should be that of a typical commercial or hospital environment.



IEC 60601-1-2 test level



Mains power quality should be that of a typical commercial or hospital environment.



IEC 60601-1-2 test level



Mains power quality should be that of a typical commercial or hospital environment. If the user of the MELODY III D C requires continued operation during power mains interruptions, it is recommended that the MELODY III D C be powered from an uninterruptible power supply or battery.



IEC 60601-1-2 test level



Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.



1 kV for input/output lines>3 m Surge IEC 61000-4-5



1 kV differential mode 2 kV common mode



Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11



0% Un for 0.5 cycle( at 0°,45°,90°,135°,180°,225°,270°, and 315°) 0% Un for 1 cycle 70% Un for 25 cycle 0% Un for 5 s



Power frequency (50/60 Hz) magnetic field



30 A/m



IEC 61000-4-8



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Guidance and manufacturer’s declaration – electromagnetic immunity The MELODY III D C is intended for use in the electromagnetic environment specified below. The customer or the user of the MELODY III D C should assure that it is used in such an environment. Immunity Test



IEC 60601-1-2 Test level



Compliance level



Electromagnetic environment Portable and mobile RF communications equipment should be used no closer to any part of the MELODY III D C, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance



Radiated RF IEC 61000-4-3



3 V/m 80 MHz to 2700 MHz



3 V/m



Conducted RF IEC 61000-4-6



3V 150 kHz to 80 MHz*



3V



d  1 .2 P



80 MHz to 800 MHz



d  2 .3 P



800 MHz to 2.5 GHz



d  1 .2 P Where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:



* 6 V RMS in the ISM band (6,765 to 6,795, 13.553 to 13.567, 26.957 to 27.283 and 40.66 to 40.70 MHz)



Frequency Range and Level: RF wireless communication equipment Test Frequency (MHz)



Modulation



Immunity Level (V/m)



385



**Pulse Modulation: 18Hz



27



450



*FM + 5Hz deviation: 1kHz sine



28



710 745 780



**Pulse Modulation: 217Hz



9



810 870 930



**Pulse Modulation: 18Hz



28



1720 1845 1970



**Pulse Modulation: 217Hz



28



2450



**Pulse Modulation: 217Hz



28



5240 5500 5785



**Pulse Modulation: 217Hz



9



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



Separation distance according to frequency of transmitter m 150 kHz to 80 MHz



80 MHz to 800 MHz



800 MHz to 2.5 GHz



d  1,2 P



d  1,2 P



d  2 .3 P



0.01



0.12



0.12



0.23



0.1



0.38



0.38



0.73



1



1.2



1.2



2.3



10



3.8



3.8



7.3



100



12



12



23



For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE (1)



at 80 MHz and 800 MHz, the separation distance for the higher frequency range applies



(2)



These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.



Do not use the MELODY III D C in electromagnetic CAUTION



environments in which radiated RF disturbances are not controlled.



It is strictly recommended to keep no closer than 30 cm (12 inch) portable RF communication equipment, including CAUTION



antennas, mobile phones or other emitting EMC waves to prevent EMC interferences.



MODM10C-U02



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WEEE INFORMATIONS ACCORDING TO DIRECTIVES 2012/19/EU and 2002/96/EC (Waste Electrical and Electronic Equipment)



The following crossed-out wheeled bin symbol,



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



MODM10C-U02



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SECTION 12: WARRANTY CONDITIONS



MODM10C-U02



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WARRANTY CONDITIONS



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



MODM10C-U02



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THE MANUFACTURER RESERVES THE RIGHT TO MAKE FURTHER IMPROVEMENTS WHILE KEEPING MAIN FEATURES UNCHANGED.



MODM10C-U02



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To:



FAILURE REPORT IMPORTANT NOTICE: This report shall be submitted whenever a failure occurs. Information given through this form will expedite manufacturer’s technical assistance. In case of warranty claim this report is mandatory: warranty will not be processed without receiving this form properly filled in. DISTRIBUTOR:



NAME ADDRESS



USER:



NAME ADDRESS



X-RAY EQUIPMENT: TYPE SERIAL NUMBER DATE OF PURCHASE DATE OF INSTALLATION SOFTWARE RELEASE NUMBER OF EXPOSURES FAILURE:



MODM10C-U02



DESCRIPTION



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FAILURE:



EXPOSURE TECHNIQUE AT THE MOMENT OF THE FAILURE OCCURRENCE: MANUAL







FULL AUTO



kV



mAs







AUTO mAs







mm



EVENTUAL PREVIOUS FAILURES SIMILAR TO THE PRESENT ONE:



DETAILED DESCRIPTION OF X-RAY EQUIPMENT OPERATING CONDITIONS AT THE MOMENT OF THE FAILURE OCCURRENCE:



EVENTUAL REPAIRS TEMPORARILY CARRIED OUT:



DEFECTIVE AND/OR DAMAGED COMPONENTS: (Please specify Manufacturer code and description) MECHANICAL ELECTRICAL ELECTRONIC DATE OF FAILURE



DATE



____/____/____



____/____/____



REPORT FILLER SIGNATURE



SEAL OF THE COMPANY AND SIGNATURE OF AUTHORIZED PERSON



MODM10C-U02



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To:



SAFETY FEEDBACK In order to continuously improve quality and safety of our medical products, we kindly ask you to quickly signal us, filling in this form, any potential cause of risk bound to our medical devices. DISTRIBUTOR:



NAME ADDRESS



USER:



NAME ADDRESS



EQUIPMENT:



TYPE SERIAL NUMBER PURCHASE DATE INSTALLATION DATE SOFTWARE REVISION NUMBER OF EXPOSURES



PROVIDE US WITH A DETAILED DESCRIPTION OF THE REVEALED RISK (REAL OR POTENTIAL) HIGHLIGHTING THE RELATED OPERATING CONDITIONS. EVENTUAL SUGGESTION ARE WELL ACCEPTED.



DATE



____/____/____



MODM10C-U02



FILLER SIGNATURE



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