Ficha Técnica Amulet Innovality
Ficha Técnica Amulet Innovality
Ficha Técnica Amulet Innovality
November 2014
Fujifilm Digital Mammography System AMULET Innovality Product Specifications
Contents
1. Outline.................................................................................................................................................... 1
2. Features ................................................................................................................................................. 1
4. Configuration.......................................................................................................................................... 6
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
5. 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
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! 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.
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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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(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.
(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.
(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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(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.
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3. System Configuration
Workstation
(AWS) FDR-3000AWS
Exposure Unit
FDR-3500DRLH <Optional>
Tomosynthesis exposure
<Components> software kit
Stereo exposure software
Exposure Unit
FDR-3500H <Accessory Sold Separately>
Flat detector Biopsy Positioner
FDR-3000DRL 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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Cable lengths
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4. Configuration
(1) Exposure stand, control cabinet, flat panel sensor, control pad, foot
4.1 FDR-3500DRLH
switch, generator 1 set
Standard configuration
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・Axilla pad L 3
・Axilla pad R 3
・Stereo up-grade kit 1
・Tomosynthesis exposure software kit 1
・S-View key software for tomosynthesis exposure 1
・Stereo exposure software 1
・Shielding plate 1
・Under armlest 1
・Face guard T 1
・Power cable (15 m) (590.6 in) (Japan only) 1
・Power cable (25 m) (984.3 in) (Japan only) 1
・Power cable 11 m (433.1 in) (Transformer - Generator
(X-ray high voltage unit)) 1*1
・Power cable 6 m (236.2 in) (Transformer - Generator
(X-ray high voltage unit), Japan only) 1*1
・Foot switch array modification kit Flip Type 1*2
・Foot switch array modification kit Cross Type 1*2
・Compression plate storage holder 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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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 Emergency shut-down button: 3 places (left/right of stand, control pad)
Mechanisms Emergency decompression switch: 3 places (left/right of foot switch, control pad)
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6. Power Conditions
(1) Ratings
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7. Environmental Conditions
State Temperature Humidity
Operating 20C to 30C 30% to 75%RH (no condensation)
FDR-3500DRLH
Not operating 15C to 35C 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 10C to 30C 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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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
(X-ray high voltage unit)
Control cabinet
Positioner control cabinet
(Accessory sold separately)
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787(30.9)
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180(7.08)
420(16.54) 50(1.96)
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180(7.09) *
183(7.20)
90(3.54)
65(2.56) *
70(2.76)
341(13.43) 312(12.3)
350(13.78) * 310(12.2) *
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Fujifilm Digital Mammography System AMULET Innovality Product Specifications
604(23.8)
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Fujifilm Digital Mammography System AMULET Innovality Product Specifications
604(23.8)
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Fujifilm Digital Mammography System AMULET Innovality Product Specifications
310(12.2)
609(23.98) 23(0.91)
2140(84.25)
1900(74.8)
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341(13.4)
183(7.20)
180(7.09) *
45(1.77)
341(13.4)
183(7.20)
180(7.09) *
45(1.77)
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Fujifilm Digital Mammography System AMULET Innovality Product Specifications
341(13.4)
183(7.20)
90
(3.54) 40
(1.58)
341(13.4) 313(12.3)
200
(7.87)
90 70
(3.54) (2.76)
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341(13.4) 310(12.2)
215
(8.46)
90 70
(3.54) (2.76)
312(12.3)
183(7.20)
180(7.09) *
45
(1.77)
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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) *
276(10.9)
285(11.2) *
311(12.2)
183(7.20)
180(7.09) *
60
(2.36) 40
(1.58)
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276(10.9)
200
(7.87)
45
(1.77)
276(10.9)
310(12.2)
215
(8.46)
45
(1.77)
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123(4.84)
183
(7.20)
40
(1.58)
264 264
(10.4) 313 (12.3)
308
183
(7.20)
90 90
(3.54)
208 85
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251(9.88) 311(12.2)
40
(1.58)
126
(4.96)
311(12.2)
123(4.84)
40
(1.58)
126
(4.96)
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186
(7.3)
40 (1.6)
146 40 (1.6)
(5.7)
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251(9.88)
183(7.20)
40(1.58)
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110(4.33)
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(6) Under-armrest
Units: mm (in.) Tolerance:±10%
Installed
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(2.25)
57
* Can be attached to the wall surface from either the lateral or vertical direction.
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230(9.05) 309(12.17)
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309(12.17)
358(14.09)
30(1.18)
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594(23.39)
1670
(65.75)
Decoration label
attachment surface
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0
R .87
20 )
(7
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● Height dimension
Units: mm (in.) Tolerance:±10%
(10.43)
265
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581(22.87) 70(2.75)
281(11.06)
■ Control cabinet
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