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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
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

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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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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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.

(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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(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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3. System Configuration

Digital Mammography System FDR MS-3500 (AMULET Innovality)

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

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


Standard configuration Specifications"

4.3 FDR MS-3500 ・Stationary Digital Mammography System (FDR-3500DRLH) 1


Standard components ・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 ・24x30 compression plate (Low) 1


Options ・24x30 compression plate (Shift) 1
・24x30 compression plate (Shift Small) 1
・24x30H compression plate (Flex) 1
・24x30H compression plate (FS) 1
・18x24 compression plate (Low) 1
・18x24 compression plate (High) 1
・18x24 compression plate (Small) 1
・18x24L compression plate (Flex) 1
・18x24L compression plate (FS) 1
・Rectangular spot compression plate 1
・Compression plate for axilla radiography 1
・Compression plate for magnifications 1
・Rectangle spot magnification compression plate 1
・Round spot compression plate 1
・Round spot magnification compression plate 1
・2D biopsy compression plate 1
・Magnification table 1
・Remote exposure hand switch 1
・Remote exposure foot switch 1
・Protective shield (0.5 mm Pb lead equivalent) 1
・Protective shield cover (0.5 mm Pb lead equivalent) 1 (excludes Japan)
・Monitor arm 1
・Chest wall pad 3

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


Specifications"
Options

4.6 Accessories Sold ・Biopsy positioner (FDR-2000BPY) (*1) 1


Separately (Components)
Positioner 1
Positioner control cabinet 1
Control panel 1
Biopsy compression plate 1
Needle holder (C, M, V) 1 each
Needle holder (M8) 1 *Optional
Needle holder (E) 1 *Optional
Needle guide (MV) 1
Needle guide (C-L, C-S) 1 each
10 types in total (5 types (14, 16, 18, 20, 22G) for C-L and C-S)
Needle guide (E) 1 *Optional
Protection sheet 1
Phantom to check position accuracy 1
Needle to check position accuracy 1
BIOPSY software key 1
Biopsy spacer 1
Needle guide cover 2
Needle holder (H EV) 1 *Optional
Mammotome Revolve Kit 1 *Optional
・Biopsy power cable 20 m (787.4 in) 1 (Japan only)
・Slip-proof conversion kit for biopsy spacer 1 *Optional
・Lateral approach kit 1
(Components)
Lateral adapter 1
Lateral biopsy compression plate 1
Lateral position accuracy check phantom 1
Slide stopper (TEST) 1
Slide stopper (M) 1 *Optional
Slide stopper (V) 1 *Optional
Slide stopper (E) 1 *Optional
Slide stopper (C) 1 *Optional
Needle guide cover 2
Needle guide (TEST) 1
Mammotome Revolve Lateral Kit 1 *Optional
・Equipment rack 1
・Anchor plate 1
・FCR 1shot Phantom M Plus 1
・Decoration label (GREEN LINE) 1*1
・Decoration label (DARK CIRCLE) 1*1
・Decoration label (LINE CIRCLE) 1*1
・Decoration label (LIGHT CIRCLE) 1*1
・Decoration label (LEAF) 1*1
*1: only 1 type can be selected

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5. Specifications (1) X-ray conversion method


Direct-conversion
5.1 High
(2) X-ray comversion material
Performance
a-Se
X-ray
(3) Effective image area (on the flat panel sensor)
Detection
236.4 mm (vertical) x 296.4 mm (horizontal) (9.31 in. x 11.7 in.)
Sensor
(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”.)

5.2 Exposure Unit 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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(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 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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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


Exposure ST mode : ±7.5°
Function HR mode : ±20°
(Optional) (2) Number of exposures
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 (1) Exposure angle


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

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5.8 Biopsy (1) Image size


Positioner 70 mm x 60 mm (2.75 in. x 2.36 in.) (Detector top surface)
Function (2) Needle attachment, needle guide
(Accessory sold Mammotome (Model number : STHC1) ( 8/11/14G)
separately) Mammotome Revolve (Model number : MSTH1) (8/10G)
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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6. Power Conditions
(1) Ratings

Voltage Ratings Note


Single-phase two-wire or
16.5A
AC 200/208/220/ three-wire 200 to 240 V ±10%
FDR-3500DRLH (steady)
230/240V 50/60 Hz
90A (peak)
Breaker: 50 A
Refer to "FUJIFILM Mammography Workstation
AWS
FDR-3000AWS-d Product Specifications"

(2) Power consumption

FDR-3500DRLH 1.2 kVA


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

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7. Environmental Conditions
State Temperature Humidity
Operating 20C to 30C 30% to 75%RH (no condensation)
FDR-3500DRLH
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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8. External Dimensions and Weight


[External dimensions and weight]
Width Depth Height Weight
Exposure stand Approx. Approx. Approx. Approx.
624 mm 1270 mm 1,974 mm 370 kg
(24.57 in.) (50 in.) 2285 mm (815.7 lb.)
(Base plate approx. (77.72 in. to
787 mm (30.98 in.)) 89.96)
Control cabinet Approx. Approx. Approx. Approx.
205 mm 503 mm 530 mm 20 kg
(8.07 in.) (19.8 in.) (20.87 in.) (44.09 lb)
Generator Approx. Approx. Approx. Approx.
(X-ray high voltage unit) 445 mm 315 mm 825 mm 70 kg
(17.52 in.) (12.4 in.) (32.48 in.) (154.3 lb)
Positioner control cabinet Approx. Approx. Approx. Approx.
160 mm 350 mm 473 mm 17 kg
(6.3 in.) (13.78 in.) (18.62 in.) (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
(X-ray high voltage unit)
Control cabinet
Positioner control cabinet
(Accessory sold separately)

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8.2 Exposure Stand


Units: mm (in.) Tolerance:±10%

787(30.9)

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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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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)


Units: mm (in.) Tolerance:±10%
825(32.48)

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8.7 24x30 compression plate (High)


Units: mm (in.) Tolerance:±10%

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) *

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

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8.8 Operation Table


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

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[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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[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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[Protective shield cover (0.5 mm Pb lead equivalent) (Optional) (excludes Japan)]


Units: mm (in.) Tolerance:±10%

310(12.2)
609(23.98) 23(0.91)

2140(84.25)
1900(74.8)

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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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(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%

341(13.4) 313(12.3)

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) 310(12.2)

215
(8.46)
90 70
(3.54) (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%

264 264
(10.4) 313 (12.3)
308

183
(7.20)
90 90
(3.54)

208 85

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

(1)-13 Compression plate for magnifications


Units: mm (in.) Tolerance:±10%

251(9.88) 311(12.2)

40
(1.58)
126
(4.96)

(1)-14 Rectangle spot magnification compression plate


Units: mm (in.) Tolerance:±10%

311(12.2)

123(4.84)

40
(1.58)
126
(4.96)

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

(1)-15 Round spot compression plate


Units: mm (in.) Tolerance:±10%

100 (3.9) 310 (12.2)

186
(7.3)

40 (1.6)

(1)-16 Round spot magnification compression plate


Units: mm (in.) Tolerance:±10%

100 (3.9) 310 (12.2)

146 40 (1.6)
(5.7)

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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)

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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%

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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


Units: mm (in.) Tolerance:±10%
(0.9)
23
90(3.54)

110(4.33)

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

(6) Under-armrest
Units: mm (in.) Tolerance:±10%

Installed

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

(7) Compression plate storage holder


Units: mm (in.) Tolerance:±10%

(2.25)
57
* Can be attached to the wall surface from either the lateral or vertical direction.

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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%

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

(1) -3 control panel


Units: mm (in.) Tolerance:±10%

(1)-4 Biopsy compression plate


Units: mm (in.) Tolerance:±10%
358(14.09)

230(9.05) 309(12.17)
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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%

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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%

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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%

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

(7) Needle guide cover


Units: mm (in.) Tolerance:±10%

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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%

309(12.17)
358(14.09)
30(1.18)

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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

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

9. Installation Space Drawing


■ Exposure stand/Control cabinet
● Front/rear direction
Units: mm (in.) Tolerance:±10%
R 7.6
70 )
(2

0
R .87
20 )
(7

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

● Height dimension
Units: mm (in.) Tolerance:±10%

(10.43)
265

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

■ Anchor position for exposure stand


Units: mm (in.) Tolerance:±10%

581(22.87) 70(2.75)

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

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Fujifilm Digital Mammography System AMULET Innovality Product Specifications

■ Anchor position for operation desk and equipment rack


Units: mm (in.) Tolerance:±10%

Z30N0958D

48
Z30N0958D

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