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Product Specifications November 2014



Fujifilm Digital Mammography System AMULET Innovality Product Specifications



Contents 1.



Outline.................................................................................................................................................... 1



2.



Features ................................................................................................................................................. 1



3.



System Configuration ............................................................................................................................ 4



4.



Configuration.......................................................................................................................................... 6



5.



4.1



FDR-3500DRLH ............................................................................................................................ 6



4.2



FDR-3000AWS ............................................................................................................................. 6



4.3



FDR MS-3500 ............................................................................................................................... 6



4.4



FDR MS-3500 Options .................................................................................................................. 6



4.5



FDR-3000AWS Options ................................................................................................................ 8



4.6



Accessories Sold Separately ........................................................................................................ 8



Specifications ......................................................................................................................................... 9 5.1



High Performance X-ray Detection Sensor ................................................................................... 9



5.2



Exposure Unit................................................................................................................................ 9



5.3



Safety Mechanisms ..................................................................................................................... 10



5.4



Throughput .................................................................................................................................. 11



5.5



Startup Time ................................................................................................................................ 11



5.6



Tomosynthesis Exposure Function ............................................................................................. 11



5.7



Stereo Exposure Function........................................................................................................... 11



5.8



Biopsy Positioner Function ......................................................................................................... 12



6.



Power Conditions ................................................................................................................................. 13



7.



Environmental Conditions .................................................................................................................... 14



8.



External Dimensions and Weight ......................................................................................................... 15 8.1



External View .............................................................................................................................. 15



8.2



Exposure Stand ........................................................................................................................... 16



8.3



Control Cabinet ........................................................................................................................... 17



8.4



Control Pad ................................................................................................................................. 17



8.5



Foot Switch ................................................................................................................................. 18



8.6



Generator (X-ray High Voltage Device) ...................................................................................... 18



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.7



24x30 compression plate (High) ................................................................................................ 19



8.8



Operation Table .......................................................................................................................... 20



8.9



FDR MS-3500 Options ............................................................................................................... 24



8.10 Dimensional Drawing of Accessories Sold Separately .............................................................. 37 9.



Installation Space Drawing .................................................................................................................. 45



! 



Caution The copyright of the application software included in this device belongs to FUJIFILM Corporation and is protected by the Copyright Act of Japan and international treaties.Users must not copy or distribute any part or whole of the application software of this device without authorization. AWS is a product (software/hardware) used to display medical images.FUJIFILM Corporation and product suppliers assume no responsibility/compensation for any consequences arising if this product is used for purposes other than those designated in its scope of functionality (such as the use of other application software or remodeling).



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



1. Outline



The FDR MS-3500 consists of a digital mammography device (referred to as the mammography exposure unit hereafter) and FDR-3000AWS workstation (referred to as the AWS hereafter), and is a device that is used to perform mammography exposures, print image processed data, send data to PACS, and provide diagnosis images. The image detector section of the exposure unit is equipped with an a-Se direct-conversion flat panel detector (FPD) and uses proprietary FUJIFILM HCP panel to acquire high-quality images with a high resolution and low level of noise. The device features a short examination cycle and image display time, and the various compression plates and positioning support functions (including various pads, patient information check function and prior image reference function) for performing optimum mammography examinations to suit a range of study situations. The FDR MS-3500 also comes with a range of optional extras, and can be combined with an optional tomosynthesis function, allowing projection images from multiple angles to be acquired, with those images re-organized and slice images displayed (provided). By combining the FDR MS-3500 with the separately sold biopsy positioner FDR-2000BPY, the system is able to acquire positional information from image information acquired from stereo exposure, allowing biopsy studies to be performed. Digital Mammography FDR MS-3500 System Digital Mammography FDR-3500DRLH Equipment* Features: Performing mammography X-ray exposures and acquiring digital mammography images. Workstation FDR-3000AWS Features: Setting X-ray exposure conditions and providing acquired images for diagnosis. Tomosynthesis Allowing projection images from multiple angles to be exposure software kit acquired and slice images to be re-organized from the (optional) acquired images. Biopsy Positioner FDR-2000BPY (accessory sold Features: Providing functions to calculate the necessary separately) coordinates of the sample for performing a biopsy study and to move the needle to the calculated position accurately. *A W (tungsten) X-ray tube is installed in digital mammography equipment.



2. Features



(1)



The use of a high-performance flat panel sensor allows exposure to acquire high-quality mammography images at the optimal X-ray dose.



(2)



A short interval between the completion of one exposure and the start of the next one ensures optimal processing speed for the workflow of mass screening, etc.



(3)



Three different exposure modes (full-auto, semi-auto and manual) are available for a wide range of dose settings.



(4)



In full-auto and semi-auto exposure modes, Automatic Exposure Control (AEC) accurately detects the mammary region and controls the tube voltage, mAs value and other variables automatically to calculate the optimal X-ray radiation dose. At this time, a function in the system analyzes X-ray transmission in the mammary region and automatically changes the tube voltage from preliminary exposure to full exposure according to the analysis result.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (5)



The intelligent AEC with the pre-exposure image analysis function is installed. This function enables AEC exposure, expanding the AEC exposure range for a breast with foreign substances such as an implant, and adjusting the beam quality and dose according to the breast state in addition to the thickness information.



(6)



A two-stage automatic compression stop function is available to prevent excessive breast compression by setting the standard and maximum values depending on the intended use.



(7)



An automatic decompression function is available, and when enabled, compression of the breast is automatically released when exposure is complete to reduce the compression time that the patient is subjected to.



(8)



The included foot switch allows the operator to raise/lower the swivel arm or to compress/decompress the patient’s breast with the compression plate, even if the patient is being supported with both hands. Optionally, the layout of the foot switches can be changed.



(9)



The system comes with features to increase comfort during studies, with armrests, an exposure unit lower handle (optional), chest wall pad and axillary pad mounted to help reduce patient pain during positioning.



(10)



An automatic positioning function is available which, with a touch of a button, allows the swivel arm to rotate and stop automatically at a specific angle and to return to 0º after a series of exposures is completed.



(11)



The AWS X-ray control panel can be used to configure exposure conditions and check radiation conditions on single screen.



(12)



Projection images are acquired at multiple angles with the tomosynthesis exposure software kit (optional), a high-resolution LCD monitor (optional: the precise enlargement function software and referral viewing function software are also used on this monitor) and tomosynthesis face guard (optional), and slice images can be re-organized from the acquired images.



(13)



The tomosynthesis exposure software kit (optional) has two types of modes to suit different clinical purposes: ST mode with a focus on exposure speed; and high-definition HR mode that allows a greater deflection angle and better depth resolution.



(14)



The tomosynthesis exposure software kit (optional) includes a mode for tomosynthesis exposure only and another mode which allows a combination of 2D (conventional) and tomosynthesis exposures for increased efficiency.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (15)



S-View (optional) is a 2D image that consists of synthesized several sliced images; and S-View is a type of 2D images that supports the interpretation of sliced images . When a Tomosynthesis mammography is implemented, sliced images at 1mm thick interval and a S-View image are automatically created. The additional information of whole by S-View, in addition to the detailed information by sliced images, allows the entire exposed images easier to be comprehended than diagnoses with Tomosynthesis images only.



(16)



The stereo exposure software (optional) enables exposure from two directions. The information on the inner breast can be recognized in three dimensions by viewing the acquired image stereoscopically on the dedicated viewer (Amulet Bellus (SMV 658)).



(17)



Biopsy study positioning is determined with a stereotactic exposure image using high-resolution images with a biopsy positioner (optional) high-resolution LCD monitor (optional: can also be used as detailed image display software and prior image reference software).



(18)



A compression plate is available with the system to suit smaller breast positioning in relation to the detector size. A function that automatically shifts the exposure field is available to drastically improve position during MLO exposure.



(19)



A function is available that allows the user to switch the exposure field size when using a spot or a 24x30 size compression plate.



(20)



The compression plate mounting area features a swivel arm control panel (rotation, elevation, exposure field light, and switching foot monitor display) and information display (compression force, compression thickness, and angle) functions that allow the operator to control the system without having to take their eyes off of the patient.



(21)



The exposure stand features a patient information display function that displays the ID, name and date of birth of the patient registered in the AWS, allowing the operator to check patient information properly immediately before positioning them.



(22)



An automatic startup function allows the system to start up automatically at a specified time and to complete calibration. This reduces a considerable amount of time required for starting up the system. If the system is not used for a certain period of time by the sleep mode function, power to the flat panel sensor will be cut and the load on it and power consumption can be reduced.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



3. System Configuration



Digital Mammography System FDR MS-3500 (AMULET Innovality) Workstation (AWS) FDR-3000AWS Exposure Unit FDR-3500DRLH



Tomosynthesis exposure software kit



Stereo exposure software



    







Exposure Unit FDR-3500H



Flat detector FDR-3000DRL



Biopsy Positioner FDR-2000BPY



The FDR MS-3500 consists of the FDR-3500DRLH and the FDR-3000AWS, and does not include peripheral devices such as servers or image viewers. The FDR-3500DRLH consists of an exposure stand, control cabinet, control pad, foot switch, and generator. The FDR-3000AWS consists of a PC, monitor, keyboard, mouse, and HUB unit. The FDR-3500DRLH can be used in a patient environment. The FDR-3000AWS is not designed to be used in a patient environment. To use the FDR-3000AWS in a patient environment, connect an additional protective grounding cable (optional for the AWS), and connect the power to a medical power outlet via an insulating transformer (optional for the AWS). When installing the FDR-3000AWS within the study room, the protective plate (optional) protects doctors or the operator from X-ray radiation.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications Cable lengths



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



4. Configuration 4.1 FDR-3500DRLH Standard configuration



(1) Exposure stand, control cabinet, flat panel sensor, control pad, foot switch, generator 1 set



4.2 FDR-3000AWS Standard configuration



Refer to "FUJIFILM Mammography Workstation FDR-3000AWS-d Product Specifications"



4.3 FDR MS-3500 Standard components



・Stationary Digital Mammography System (FDR-3500DRLH) ・AWS (FDR-3000AWS) 1 ・Face guard 1 ・24x30 compression plate (High) 1 ・X-ray power radiation cable 1 ・Chest wall pad 2 ・Axillary pad L 2 ・Axillary pad R 2 ・Fuse 1 set ・Operation desk 1 ・Operation manual, supplied documentation 1 set ・Standard anchor 1



4.4 FDR MS-3500 Options



・24x30 compression plate (Low) ・24x30 compression plate (Shift) ・24x30 compression plate (Shift Small) ・24x30H compression plate (Flex) ・24x30H compression plate (FS) ・18x24 compression plate (Low) ・18x24 compression plate (High) ・18x24 compression plate (Small) ・18x24L compression plate (Flex) ・18x24L compression plate (FS) ・Rectangular spot compression plate ・Compression plate for axilla radiography ・Compression plate for magnifications ・Rectangle spot magnification compression plate ・Round spot compression plate ・Round spot magnification compression plate ・2D biopsy compression plate ・Magnification table ・Remote exposure hand switch ・Remote exposure foot switch ・Protective shield (0.5 mm Pb lead equivalent) ・Protective shield cover (0.5 mm Pb lead equivalent) ・Monitor arm ・Chest wall pad



1



1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (excludes Japan) 1 3 Z30N0958D



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications ・Axilla pad L ・Axilla pad R ・Stereo up-grade kit ・Tomosynthesis exposure software kit ・S-View key software for tomosynthesis exposure ・Stereo exposure software ・Shielding plate ・Under armlest ・Face guard T ・Power cable (15 m) (590.6 in) (Japan only) ・Power cable (25 m) (984.3 in) (Japan only) ・Power cable 11 m (433.1 in) (Transformer - Generator (X-ray high voltage unit)) ・Power cable 6 m (236.2 in) (Transformer - Generator (X-ray high voltage unit), Japan only) ・Foot switch array modification kit Flip Type ・Foot switch array modification kit Cross Type ・Compression plate storage holder



3 3 1 1 1 1 1 1 1 1 1 1*1 1*1 1*2 1*2 1



*1: 2 m (78.74 in) is supplied as standard, however more can be purchased separately if required to suit a particular layout. *2: Foot switch array



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications 4.5



FDR-3000AWS Options



Refer to "FUJIFILM Mammography Workstation FDR-3000AWS-d Product Specifications"



4.6



Accessories Sold Separately



・Biopsy positioner (FDR-2000BPY) (*1) (Components) Positioner Positioner control cabinet Control panel Biopsy compression plate Needle holder (C, M, V) Needle holder (M8) Needle holder (E) Needle guide (MV) Needle guide (C-L, C-S)



1 1 1 1 1 1 each 1 *Optional 1 *Optional 1 1 each



10 types in total (5 types (14, 16, 18, 20, 22G) for C-L and C-S)



Needle guide (E) Protection sheet Phantom to check position accuracy Needle to check position accuracy BIOPSY software key Biopsy spacer Needle guide cover Needle holder (H EV) Mammotome Revolve Kit ・Biopsy power cable 20 m (787.4 in) ・Slip-proof conversion kit for biopsy spacer ・Lateral approach kit (Components) Lateral adapter Lateral biopsy compression plate Lateral position accuracy check phantom Slide stopper (TEST) Slide stopper (M) Slide stopper (V) Slide stopper (E) Slide stopper (C) Needle guide cover Needle guide (TEST) Mammotome Revolve Lateral Kit ・Equipment rack ・Anchor plate ・FCR 1shot Phantom M Plus ・Decoration label (GREEN LINE) ・Decoration label (DARK CIRCLE) ・Decoration label (LINE CIRCLE) ・Decoration label (LIGHT CIRCLE) ・Decoration label (LEAF)



1 *Optional 1 1 1 1 1 2 1 *Optional 1 *Optional 1 (Japan only) 1 *Optional 1 1 1 1 1 1 *Optional 1 *Optional 1 *Optional 1 *Optional 2 1 1 *Optional 1 1 1 1*1 1*1 1*1 1*1 1*1



*1: only 1 type can be selected



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



5. Specifications 5.1 High Performance X-ray Detection Sensor



5.2 Exposure Unit



(1) X-ray conversion method Direct-conversion (2) X-ray comversion material a-Se (3) Effective image area (on the flat panel sensor) 236.4 mm (vertical) x 296.4 mm (horizontal) (9.31 in. x 11.7 in.) (4) Pixel resolution 50 x 50 μm/pix (5) Number of Output Pixels 4728 (vertical) x 5928 (horizontal) = 28,027,584 pixels (6) Output graduation (1) FDR-3000DRL 16bit (2) FDR-3000AWS 10bit to 14bit (For details, see “FUJIFILM Mammography Workstation FDR-3000AWS-d Product Specifications”.) Generator X-ray tube (1) Tube voltage range 22 kV to 49 kV (1 kV intervals) (2) Tube voltage accuracy ±1 kV (3) mAs setting range Large focus: 2 mAs to 600 mAs Small focus: 2 mAs to 300 mAs (4) mAs setting precision ±10% ＋0.2 mAs (5) Focal spot size Large focus: 0.3 Small focus: 0.1 * According to IEC 60336: 1995 (6) Nominal maximum power Large focus: 7 kW Small focus: 2 kW (7) Maximum tube current Large focus: 200mA Small focus: 61mA (8) Anode angle Large focus: 16° Small focus: 10° (9) Anode material Tungsten (W/Re) (10) Anode heat storage capacity 300,000 HU (≒222,000 J)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (11) Max. dissipation rate of anode 60,000 HU/min (≒ 44, 000 J/min) (12) Anode speed 180 Hz (13) Filter 50 um ±5 um Rhodium 700 um ±70 um Aluminum (14) Tube assembly heat storage capacity 500,000 HU (≒370,000 J) (15) X-ray leakage radiation < 100 mR/h (49 kV at a distance of 1 m (39.4 in)) (16) Total filtration of X-ray generator 0.7 mmAl (17) Total filtration of tube assembly 0.63 mm Be Swivel arm (18) Vertical travel 690 mm to 1,500 mm (27.2 in. to 59.1 in.) (height of photography platform when at 0°) (19) Rotation +190° to -190° (20) SID 650 mm (25.6 in.) Compression modes (21) Auto Compression 0 N to 200 N (22) Manual Compression 0 N to 230 N (＋50° to －50°) 0 N to 200 N (+190° to ＋50°, －50° to －190°) Magnification (23) Magnification factor 1.8x Grid (24) Grid Aspect ratio 6:1 41 lines/cm Film material: Pb, intermediate material: fiber 5.3 Safety Mechanisms



Emergency shut-down button: 3 places (left/right of stand, control pad) Emergency decompression switch: 3 places (left/right of foot switch, control pad)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications 5.4 Throughput



(1) Image display time for AWS AWS preview image display



5 seconds or less (2) Exposure interval Time from completion of exposure to availability of next exposure 15 seconds or less 5.5 Startup Time



15 minutes or less



5.6 Tomosynthesis (1) Exposure angle ST mode : ±7.5° Exposure HR mode : ±20° Function (2) Number of exposures (Optional) ST mode: 15 images HR mode: 15 images (3) Output pixel size ST mode: 150 um x 150 um (100 um x 100 um can also be set) HR mode: 100 um x 100 um (50 um x 50 um can also be set) (4) Exposure time ST mode: Approx. 4 seconds HR mode: Approx. 9 seconds (5) Re-organized thickness increment/decrementl ST mode: 1 mm (0.04 in.) HR mode: 1 mm (0.04 in.) 5.7 Stereo Exposure Function (Optional)



(1) Exposure angle 0° and 4° (2) Exposure time 13 seconds or less (press compression SW to release of compression plate)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1) Image size 5.8 Biopsy 70 mm x 60 mm (2.75 in. x 2.36 in.) (Detector top surface) Positioner (2) Needle attachment, needle guide Function Mammotome (Model number : STHC1) ( 8/11/14G) (Accessory sold Mammotome Revolve (Model number : MSTH1) (8/10G) separately) VACORA (Model number for holder part : VA1LO) (10/14G) EnCor (Model number : ECP01) (7G/10G/12GV) ATEC (Model number for holder part : STX-2) (9G/12G) Eviva (Model number for holder part : Eviva Adapter) (9G/12G) Other biopsy guides (needle guides) between 14G and 22G are available (3) Positioner drive system Electric (AUTO, Manual) and Manual (electric touch panel operation 0.5 mm (0.02 in.)) (4) Coordinate display 0.1mm (0.004in.) (5) Positioner precision for positioner ±1 mm (0.004 in.) or less (IEC compliant) (6) Positioner weight 5.5 kg (12.13 lb) or less (7) Stereo angle ±15º (8) Image display time for BIOPSY software Normal mode (100 μm pixel): 13 seconds or less Magnification mode (50 μm pixel): 45 seconds or less



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



6. Power Conditions (1) Ratings Voltage



FDR-3500DRLH



AWS



Ratings



16.5A AC 200/208/220/ (steady) 230/240V 90A (peak)



Note Single-phase two-wire or three-wire 200 to 240 V ±10% 50/60 Hz Breaker: 50 A



Refer to "FUJIFILM Mammography Workstation FDR-3000AWS-d Product Specifications"



(2) Power consumption



During normal use



FDR-3500DRLH 1.2 kVA AWS+LCD 1.0 kVA



During standby



FDR-3500DRLH 0.3 kVA AWS+LCD 1.0 kVA Specifications are subject to change without notice.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



7. Environmental Conditions



FDR-3500DRLH



State



Temperature



Humidity



Operating



20C to 30C



30% to 75%RH (no condensation)



Not operating 15C to 35C



10% to 80%RH (no condensation)



Air-conditioning is required in the room where the device is installed in for temperature control when the device is operating or not operating. Temperature control from 10C to 30C is required during transportation of the detector unit. A special case with heat storage material is required for transportation of only the exposure unit. Use a heat storage case for point to point transportation to maintain the appropriate temperature. When the device is stored at the point of destination for a long period of time, or if it is stored without a heat storage case, the surrounding temperature must be maintained from 10 to 30ºC.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8. External Dimensions and Weight [External dimensions and weight] Exposure stand



Width



Depth



Height



Weight



Approx. 624 mm (24.57 in.)



Approx. 1270 mm (50 in.)



Approx. 1,974 mm 2285 mm (77.72 in. to 89.96) Approx. 530 mm (20.87 in.) Approx. 825 mm (32.48 in.) Approx. 473 mm (18.62 in.)



Approx. 370 kg (815.7 lb.)



(Base plate approx. 787 mm (30.98 in.))



Control cabinet



Generator (X-ray high voltage unit) Positioner control cabinet



Approx. 205 mm (8.07 in.) Approx. 445 mm (17.52 in.) Approx. 160 mm (6.3 in.)



Approx. 503 mm (19.8 in.) Approx. 315 mm (12.4 in.) Approx. 350 mm (13.78 in.)



Approx. 20 kg (44.09 lb) Approx. 70 kg (154.3 lb) Approx. 17 kg (37.48 lb)



Hardware specification, dimensions and weight are subject to change without notice.



8.1 External View Exposure stand



Install the control cabinet and generator within 5 m (196.9 in.) of the exposure stand. Install the positioner control cabinet within 3 m (118.1 in.) of the exposure stand.



Generator Control cabinet



(X-ray high voltage unit) Positioner control cabinet (Accessory sold separately)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.2



Exposure Stand Units: mm (in.) Tolerance:±10％



787(30.9)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.3 Control Cabinet Units: mm (in.) Tolerance:±10％



8.4 Control Pad



118(4.64)



Units: mm (in.) Tolerance:±10％



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.5 Foot Switch Units: mm (in.) Tolerance:±10％



180(7.08)



420(16.54)



50(1.96)



8.6 Generator (X-ray High Voltage Device)



825(32.48)



Units: mm (in.) Tolerance:±10％



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.7 24x30 compression plate (High)



183(7.20) 180(7.09) *



70(2.76) 65(2.56) *



90(3.54)



Units: mm (in.) Tolerance:±10％



312(12.3) 310(12.2) *



341(13.43) 350(13.78) *



* For the model that complies only with IEC 60601-1:2005.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.8 Operation Table Characteristics ・ Can store the AWS PC. Units: mm (in.) Tolerance:±10％



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications [with protective shield (optional)] Characteristics ・Comes with protective glass (equivalent to 0.5 mm Pb), and can be used in the study room. ・Can store the AWS PC. Units: mm (in.) Tolerance:±10％



604(23.8)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications [with protective shield (optional), equipment rack (accessory sold separately)] Characteristics ・Comes with protective glass (equivalent to 0.5 mm Pb), and can be used in the study room. ・Can store the AWS PC. ・Can store each compression plate or accessories during exposure. Units: mm (in.) Tolerance:±10％



604(23.8)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



310(12.2)



[Protective shield cover (0.5 mm Pb lead equivalent) (Optional) (excludes Japan)] Units: mm (in.) Tolerance:±10％



23(0.91)



1900(74.8)



2140(84.25)



609(23.98)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.9 FDR MS-3500 Options (1) Compression plate (1)-1 24x30 compression plate (Low) Units: mm (in.) Tolerance:±10％



341(13.4)



183(7.20) 180(7.09) * 45(1.77)



* For the model that complies only with IEC 60601-1:2005.



(1)-2 24x30 compression plate (Shift) Units: mm (in.) Tolerance:±10％



341(13.4)



183(7.20) 180(7.09) * 45(1.77)



* For the model that complies only with IEC 60601-1:2005.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-3 24x30 compression plate (Shift Small) Units: mm (in.) Tolerance:±10％



341(13.4)



183(7.20) 90 (3.54)



40 (1.58)



(1)-4 24x30H compression plate (Flex) Units: mm (in.) Tolerance:±10％



313(12.3)



341(13.4)



200 (7.87)



90 70 (3.54) (2.76)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-5 24x30H compression plate (FS) Units: mm (in.) Tolerance:±10％



341(13.4)



215 (8.46)



90 (3.54)



310(12.2)



70 (2.76)



(1)-6 18x24 compression plate (Low) Units: mm (in.) Tolerance:±10％



312(12.3)



183(7.20) 180(7.09) * 45 (1.77)



* For the model that complies only with IEC 60601-1:2005.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-7 18x24 compression plate (High) Units: mm (in.) Tolerance:±10％



276(10.9) 285(11.2) *



312(12.3) 310(12.2) *



183(7.20) 180(7.09) * 90 (3.54) 70(2.76) 65(2.56) *



* For the model that complies only with IEC 60601-1:2005.



(1)-8 18x24 compression plate (Small) Units: mm (in.) Tolerance:±10％



276(10.9) 285(11.2) * 311(12.2)



183(7.20) 180(7.09) * 60 (2.36)



40 (1.58)



* For the model that complies only with IEC 60601-1:2005.



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-9 18x24L compression plate (Flex) Units: mm (in.) Tolerance:±10％



276(10.9)



200 (7.87) 45 (1.77)



(1)-10 18x24L compression plate (FS) Units: mm (in.) Tolerance:±10％



276(10.9)



310(12.2)



215 (8.46) 45 (1.77)



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Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-11 Rectangular spot compression plate Units: mm (in.) Tolerance:±10％



123(4.84)



183 (7.20) 40 (1.58)



(1)-12 Compression plate for axilla radiography Units: mm (in.) Tolerance:±10％



313 (12.3) 308



264 264 (10.4)



183 (7.20) 90 (3.54)



90



208



85



Z30N0958D



29



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-13 Compression plate for magnifications Units: mm (in.) Tolerance:±10％



311(12.2)



251(9.88)



40 (1.58) 126 (4.96)



(1)-14 Rectangle spot magnification compression plate Units: mm (in.) Tolerance:±10％



311(12.2)



123(4.84)



126 (4.96)



40 (1.58)



Z30N0958D



30



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-15 Round spot compression plate Units: mm (in.) Tolerance:±10％



310 (12.2)



100 (3.9)



186 (7.3) 40 (1.6)



(1)-16 Round spot magnification compression plate Units: mm (in.) Tolerance:±10％



100 (3.9)



146 (5.7)



310 (12.2)



40 (1.6)



Z30N0958D



31



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-17 2D biopsy compression plate Units: mm (in.) Tolerance:±10％



251(9.88)



183(7.20)



40(1.58)



Z30N0958D



32



Fujifilm Digital Mammography System AMULET Innovality Product Specifications



(2) Magnification table Units: mm (in.) Tolerance:±10％



Magnification table (when stored) Units: mm (in.) Tolerance:±10％



Z30N0958D



33



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (3) Remote exposure hand switch Units: mm (in.) Tolerance:±10％



(4) Remote exposure foot switch Units: mm (in.) Tolerance:±10％



(5) Shielding plate



90(3.54)



23 (0.9)



Units: mm (in.) Tolerance:±10％



110(4.33)



Z30N0958D



34



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (6) Under-armrest Units: mm (in.) Tolerance:±10％



Installed



Z30N0958D



35



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (7) Compression plate storage holder



57 (2.25)



Units: mm (in.) Tolerance:±10％



* Can be attached to the wall surface from either the lateral or vertical direction.



Z30N0958D



36



Fujifilm Digital Mammography System AMULET Innovality Product Specifications



8.10 Dimensional Drawing of Accessories Sold Separately (1) Biopsy Positioner (1)-1 Positioner Units: mm (in.) Tolerance:±10％



(1)-2 Positioner Control Cabinet Units: mm (in.) Tolerance:±10％



Z30N0958D



37



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1) -3 control panel Units: mm (in.) Tolerance:±10％



(1)-4 Biopsy compression plate



358(14.09)



Units: mm (in.) Tolerance:±10％



230(9.05)



309(12.17) Z30N0958D



38



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (1)-5 Biopsy spacer Units: mm (in.) Tolerance:±10％



(2) Needle holder C Units: mm (in.) Tolerance:±10％



Z30N0958D



39



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (3) Needle holder M Units: mm (in.) Tolerance:±10％



(4) Needle holder V Units: mm (in.) Tolerance:±10％



Z30N0958D



40



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (5) Needle holder M8 Units: mm (in.) Tolerance:±10％



(6) Needle holder E Units: mm (in.) Tolerance:±10％



Z30N0958D



41



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (7) Needle guide cover Units: mm (in.) Tolerance:±10％



Z30N0958D



42



Fujifilm Digital Mammography System AMULET Innovality Product Specifications (2) Lateral approach kit (2)-1 Lateral approach kit Units: mm (in.) Tolerance:±10％



(2)-2 Lateral biopsy compression plate Units: mm (in.) Tolerance:±10％



30(1.18)



358(14.09)



309(12.17)



Z30N0958D



43



Fujifilm Digital Mammography System AMULET Innovality Product Specifications



(3) Decoration label Units: mm (in.) Tolerance:±10％ 594（23.39）



1670 (65.75)



Decoration label attachment surface



Z30N0958D



44



Fujifilm Digital Mammography System AMULET Innovality Product Specifications



9. Installation Space Drawing ■ Exposure stand/Control cabinet ● Front/rear direction Units: mm (in.) Tolerance:±10％



0 70 ) R 7.6 (2 0 20 ) R .87 (7 Z30N0958D



45



Fujifilm Digital Mammography System AMULET Innovality Product Specifications ● Height dimension



265 (10.43)



Units: mm (in.) Tolerance:±10％



Z30N0958D



46



Fujifilm Digital Mammography System AMULET Innovality Product Specifications



■ Anchor position for exposure stand Units: mm (in.) Tolerance:±10％



70(2.75)



581(22.87)



281(11.06)



■ Control cabinet Units: mm (in.) Tolerance:±10％



■ Generator (X-ray high voltage unit) Units: mm (in.) Tolerance:±10％ 300(11.81) recommended (Min. 200(7.87))



Z30N0958D



47



Fujifilm Digital Mammography System AMULET Innovality Product Specifications ■ Anchor position for operation desk and equipment rack Units: mm (in.) Tolerance:±10％



Z30N0958D



48



Z30N0958D