Amulet Innovality Operation Manual

For Safe Operation
FDR MS-3500 (FDR-3500DRLH)
Operation Manual Product Overview
23rd Edition : November 2020
Operations
Troubleshooting
Daily Inspection and

Maintenance
Appendices
Original Instructions
When the manual is provided in languages other This Operation Manual describes details on basic operations of the FUJIFILM
than English, it is considered to be a “Translation Digital Mammography System FDR MS-3500 and cautions to be observed when
of the original instructions”.
operating it. Please read the Operation Manual thoroughly before actually
In this case, it must bear the words “Translation of
the original instructions” in place of “Original operating the FDR MS-3500 system.
Instructions” above. After reading this manual, store it nearby the FDR MS-3500 system so that you
can see it whenever necessary.
Refer to the reference guide for more details of operation methods and functions
(including options).
897N102525X
Introduction
FUJIFILM Digital Mammography System FDR MS-3500 is a system designed for obtaining digital
mammographic images and providing the obtained images for diagnosis.
This Operation Manual provides necessary information for using the FUJIFILM Digital Mammography
System FDR MS-3500 system (referred to as the system hereafter), such as the overview of the
system, system operation procedures and precautions to observe, as well as daily system inspections
and maintenance.
The FDR MS-3500 consists of the FDR-3500DRLH and FDR-3000AWS workstation.
The FDR-3500DRLH is hereinafter referred to as the exposure unit.
The FDR-3000AWS is hereinafter referred to as AWS.
This Operation Manual applies to the following software.
• FDR-3500H Application Software V5.7 or later
• FDR-3000DRL Application Software V3.8 or later
• AWS Application Software V9.2 or later
Installation may only be conducted by authorized service personal.
CAUTIONS
1 No part or all of this manual may be reproduced in any form without prior permission.
2 The information contained in this manual may be subject to change without prior notice.
3 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
installation, relocation, remodeling, maintenance, and repair performed by dealers other than
those specified by FUJIFILM Corporation.
4 FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM
Corporation products due to products of other manufacturers not supplied by FUJIFILM
Corporation.
remodeling, maintenance, and repair using repair parts other than those specified by
FUJIFILM Corporation.
negligence of the precautions and operating methods contained in this manual.
7 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use
under environment conditions outside the range specified for this product, such as the
power supply, installation environment, etc., as described in this manual.
natural disasters, such as fires, earthquakes, floods, lightning, etc.
Part of the components contains harmful substances which may pollute the ambient
environment if disposed carelessly. In particular, lead is contained in concentrations > 0.1 wt%
in X-ray tube. For details on product disposal, contact our official dealer or FUJIFILM
Representative.
Regulation (EU) 2017/745 requires that any serious incident that has occurred in relation to the
device should be reported to the manufacturer or European Authorized Representative, and the
competent authority of your country. In case you become aware of any serious incident, please
report immediately to our official dealer and the competent authority of your country.
This system is classified as a medical device under EC Directive 93/42/EEC.

It has been designed for operation by medical personnel who have undergone the proper
training and under whose direction patients will come in contact with it.
Process waste correctly, as stipulated by local law or any regulations that apply. Improper
disposal of the system units may cause land pollution and/or generation of toxic gas.
Caution: ‌Rx Only in the United States (Federal law restricts this device to sale by or on the order of a
physician.)
ii FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X

Open-Source Software Used in This Product
This product uses third party’s software that is made available as open source software or free software.
This software is provided “as is” with no warranty of any kind as to its merchantability or fitness for any
particular purpose.
For information on open source software used in this product, please see the attached CD and DVD.
Source codes for certain type of open source software used in this product are available at delivery
cost.
If you would like to receive such source codes, please contact FUJIFILM dealer or the service
representatives at the agency from which you purchased this product. (Please be noted that any
inquiries concerning the contents of source codes should be directed to original licensers of open
source software.)
Note: FUJIFILM
‌ has successfully performed verification and validation testing on all third party software
and has confirmed its suitability to be used in this system.
Trademarks
FDR is a trademark or a registered trademark of FUJIFILM Corporation.
Other holders’ trademarks
Windows is the registered trademark of US Microsoft Corporation in the U. S. A. and other countries.
All other company names and product names described in this manual are the trademarks or registered
trademarks of their respective holders.
Copyright © 2012-2020 FUJIFILM Corporation. All rights reserved.
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X iii
FUJIFILM Digital Mammography System
Operation Manuals
Manage and store all the Operation Manuals of the devices constituting the system together as a set.
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual
Biopsy Connection FDR-2000BPY Operation Manual
FDR-2000BPY Option Lateral Approach Kit Operation Manual
FDR MS-3500 Option Tomosynthesis Exposure Tomosynthesis Exposure Software Operation Manual
FDR MS-3500 Option Tomosynthesis BiopsySoftware Operation Manual
FDR MS-3500 Option CEDM Software Operation Manual
FUJIFILM Mammography Workstation FDR-3000AWS Operation Manual

See “Workstation FDR-3000AWS Operation Manual” for optional items for the AWS.
The following FDR MS-2500 options are usable.
Biopsy Connection FDR-2000BPY Operation Manual
FDR-2000BPY Option Lateral Approach Kit Operation Manual
How to Read This Manual

Marks
Information items to be observed when you are operating this system and the supplementary
remarks are described in this manual with the respective marks. For the safe system operation, be
sure to observe Warning/Caution.
Indicates hazardous situations that may lead to serious injuries or even death
WARNING if the precaution is not or cannot be followed.
Indicates a potentially hazardous situation which may result in slight or

CAUTIONS moderate degree of injury or property damage if the CAUTION is ignored or
could not be followed.
Indicates procedures requiring special attention, instructions that must be followed,

supplementary explanations, etc.
HINT Shows an item helpful for further effective system operation.
Shows a more detailed operation method or an item that describes additional

information.
iv FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X

Contents
Introduction............................................................................................................................... ii
FUJIFILM Digital Mammography System Operation Manuals................................................. iv
How to Read This Manual........................................................................................................ iv
Chapter 1 For Safe Operation

1.1 Precautions Before Operating This Equipment........................................................... 1
1.2 Precautions to be Observed When Using the Electric Medical Equipment................. 2
1.3 Safety........................................................................................................................... 3
1.4 Electromagnetic Compatibility (EMC).......................................................................... 9
1.5 Precautions in Using FDR MS-3500.......................................................................... 15
1.6 Location of Each Label.............................................................................................. 19
1.7 Diagnosis System Safety Standard Requirements.................................................... 28
Chapter 2 Product Overview

2.1 Features of the Diagnosis System............................................................................. 29
2.2 Diagnosis System Configuration................................................................................ 30
2.3 Part Names and Functions ....................................................................................... 32
Chapter 3 Operations
3.1 System Basic Operation Procedures......................................................................... 36
3.2 Changing the Compression Plate.............................................................................. 39
3.3 Emergency Stop........................................................................................................ 41
3.4 Sleep Mode................................................................................................................ 42
Chapter 4 Troubleshooting
4.1 Diagnosis System Troubleshooting and Solutions.................................................... 43
4.2 Example of Diagnosis System messages.................................................................. 43
Chapter 5 Daily Inspection and Maintenance

5.1 Daily Inspection and Maintenance............................................................................. 44
5.2 Periodical Inspections of the Exposure Unit.............................................................. 48
Appendix A Main Specifications

A.1 Specifications............................................................................................................. 50
A.2 Checking Radiation Field Sizes with Each Compression Plate................................. 53
A.3 Automatic Exposure Control (AEC)........................................................................... 56
A.4 AGD measurement.................................................................................................... 58
A.5 Storage environment label......................................................................................... 60
Appendix B Test Report

B.1 Physical Laboratory Testing Data.............................................................................. 61
B.2 Clinical Image Evaluation.......................................................................................... 70
Appendix O Using Exposure Unit Optional Items

O.1 Using the Magnification Table.................................................................................... 72
O.2 Attaching the Chest Wall Pad.................................................................................... 74
O.3 Attaching the Axilla Pads........................................................................................... 74
O.4 Connecting the Remote Exposure Switch................................................................. 75
O.5 How to Use the Shielding Plate................................................................................. 75
O.6 How to Use the Face Guard T................................................................................... 76
O.7 How to Use the Face Guard T Comfort..................................................................... 77
O.8 How to Use the Compression Plates with the Shift Function..................................... 79
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X v

vi FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X
Chapter 1 For Safe Operation
1.1 Precautions Before Operating This
Equipment 1
Before using this equipment, please read “Precautions Before Operating This Equipment” carefully so
that you can operate it correctly.
For Safe Operation

Whenever you operate this equipment, be sure to observe those precautions. Failure to do so may
cause you to subject to injuries or property damage to occur.
The institution where the equipment is installed is responsible for its use and
maintenance.
In addition, this equipment should not be used by persons other than doctors or
suitably trained staff.
Process waste correctly, as stipulated by local law or any regulations that apply.
The correlation applicable between related devices and their constituent

subassemblies and components does no affect the safety of the operation of this
equipment.
• ‌You shall not modify the System and/or its components, and shall not disassemble,
decompile, or in any other way reverse engineer the System and/or its components.
FUJIFILM shall not be liable to you for any defects caused by such modification,
disassembly, decompilation or reverse enginerring, and shall not liable to you for
any damages caused by said defetcs.
• ‌You shall not alter, remove, or obscure any patent markings, copyright notices,
trademark notices, or other proprietary or confidentiality notices that are (i) placed
or embedded in the System and/or its components, (ii) displayed when the System
and/or its components are run, or (iii) applied to the System and/or its components,
their packaging, and labels.
• ‌You shall comply with the applicable U.S. and foreign export laws and regulations
and shall not export, re-export or otherwise transfer the System and/or its
components in violation of the applicable export laws and regulations.
• ‌The System and its components may include parts and/or software supplied by
thrid parties. Any inquiries on the third-party parts and/or software in the System
shall be forwarded to FUJIFILM. Unless explicitly provided otherwise, the third-party
suppliers shall not be liable to end-users of the Systems for their parts and/or
software.
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X 1

1.2 Precautions to be Observed When
Using the Electric Medical Equipment
We ask that you heed these usage precautions and use the equipment correctly.
1. This equipment should be used only by people who have the proper skills.
1 2. Observe the following precautions before beginning to use the device.
2-1. Inspect the switch contacts, polarities, dial settings and meters and confirm that the
equipment is functioning properly.
For Safe Operation
2-2. Confirm that the ground wire has been completely connected.
2-3. Make sure that all cords have been connected properly and safely.
2-4. Be aware that correct diagnosis can be hindered and danger can result from using different
pieces of equipment together.
3. Heed the following precautions after using the equipment.
3-1. Using the established procedure, restore the operation switches, dials, etc., to what they
were prior to use and then turn the power off.
3-2. When unplugging cords, do not pull on the body of the cord itself or apply unnecessary
force.
3-3. After using the accessories, recollect them and put them back in order.
4. If there is trouble with the equipment, do not attempt to fix it randomly. Instead, do what is
indicated and entrust repairs to a professional.
5. Do not remodel the equipment.
6. Maintenance and Inspection
6-1. Inspect the equipment and parts periodically.
6-2. If the equipment has not been used for a long time, make sure that it operates normally and
safely prior to using it again.
7. Other Items
7-1. When subjecting patients (particularly infants and pregnant women) to radiation, make sure
not to exceed the necessary time and dose. Also, ensure that radiation is contained within
the region for exposure.
7-2. For cleaning and disinfecting the parts that patients come in contact with in a normal usage
environment, slightly moisten a soft cloth (non-woven cloth: Kimwipe®) in neutral detergent
or ethanol for disinfection and wipe away any dirt. If neutral detergent is used, please also
wipe with disinfectant ethanol. Do not use any other cleansers or disinfectants.
Also, do not scrub the equipment’s surface vigorously.
7-3. Follow the Operation Manual and operate the equipment correctly.
2 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X

1.3 Safety
Read this section before using the equipment to ensure proper handling.
1.3.1 Exposure Unit

Preventing explosion 1
WARNING
For Safe Operation

• ‌Because this equipment is not explosion-proof, do not use combustible and explosive gases
near the equipment.
• ‌Flammable gasses may stay in the study room after disinfection. Ventilate the room well
before powering on the system following disinfection.
Preventing electrical shock

WARNING
• ‌To prevent electrical shock, observe the following cautions.
• ‌Never open any covers of the equipment. Do not touch a high-voltage unit of the equipment
with your hand, otherwise you may receive an electrical shock.
• ‌Do not install the equipment in a location where the equipment might be exposed to water.
• ‌Ensure that the equipment is fully grounded.
• ‌Ensure that all cables are connected correctly and safely.
• ‌If you find an incorrect connection, stop using the system and contact a designated contractor.
• ‌Do not use the equipment where the equipment may be exposed to any liquids. Never allow
any liquid to spill on over or into the equipment. Otherwise, electrical shock may occur.
Should you suspect any liquid has penetrated into the equipment, immediately stop using it
and contact our official dealer.
• ‌Do not use the equipment in a location where metal particles could come into the equipment.
This may cause an electrical shock.
• ‌Make sure to turn off the equipment before cleaning or disinfecting parts other than the
compression plate, exposure table, armrests, and face guard. Otherwise, you may receive an
electrical shock.
• ‌During cleaning or disinfecting of the equipment, keep the temperature of the study room
15°C to 35°C to ensure proper performance of the exposure unit.
CAUTIONS
• ‌Follow the specified procedure when turning off the equipment. Otherwise, the flat panel
sensor could be damaged by thermal shock.
• ‌Do not store magnetic media near the exposure stand or control cabinet of the exposure unit.
Otherwise, magnetism generated by the equipment may cause the data to be lost.
Preventing radiation damage

CAUTIONS
When breast thickness is 45mm, if 20 exposures or more are made in total or if an exposure is
continued for one minute or more*, the health of the patient may be compromised.
* When breast thickness is 100mm : 8 exposures or more in total or an exposure continued for 20 seconds or more.
US (Type B), EU (Type C)
* When breast thickness is 75mm : 14 exposures or more in total or an exposure continued for 40 seconds or more.
Japan (Type A)
Connection instructions
WARNING
Make sure that the devices to be connected to the equipment are authorized for connection.

Technologist’s and patient’s safety instructions
WARNING
• ‌Make sure that no patient is around the equipment before powering on it after an electrical
outage.
• ‌Inspect the equipment before leading a patient to the equipment. Should you find any failure,
contact our official dealer.
• ‌B efore exposure with X-ray, check that the patient has been positioned appropriately.
1 Technologists or patients must operate the exposure equipment from a safe position. Check
that there are no other people within the exposure area or around the device.
• ‌Before leading a patient to the equipment, make sure that the foot switch is away from the
path to the equipment and outside of the movable region of the swivel arm. Otherwise, the
patient or technologists may accidentally touch the foot switch in the way to the equipment,
For Safe Operation
resulting in an unintended operation.

• ‌Make sure to keep observing movements of both equipment and patient while positioning the
movable parts at the patient’s body.
• ‌When the patient is inspected, sitting on a chair, use a height-adjustable chair and set it to the
lowest position so that the patient is not caught in the exposure unit.
• ‌Make sure that a patient’s hand or foot does not touch the swivel arm control panel, control
pad or foot switch.
• ‌Exposure should be made in an environment where the technologist can visually and aurally
determine the patient’ s condition.
• ‌If the equipment malfunctions while adjusting the movable parts or performing a study,
immediately press the emergency stop button and contact our official dealer.
System isolation instructions

WARNING
• ‌To ensure complete system isolation, never install any unauthorized accessories or other
such items. When it is necessary to install authorized accessories or optional items, contact
our official dealer.
• ‌Keep equipment other than the exposure stand out of reach of patients to ensure appropriate
system isolation.
• ‌To prevent the system from colliding with other equipment and getting faulty, do not change
the location of the installation of the system and do not place any other equipment or article
within the range of the motions of the system.
Radiation safety instructions

X-ray exposure time in a study is controlled as follows.
• In auto mode
The auto-specified exposure conditions control the maximum exposure dose (time).
• In manual mode
The manual mAs setting controls the X-ray exposure time.
X-ray exposure time in an abnormal situation can be controlled by the following.
• Early release of the exposure switch
• Hardware backup timer of the high voltage generator
• Detection of abnormality in the generator
WARNING
• ‌Operate the device by following the instructions given in the Operation Manual and supplied
documentation. Wrong operations could expose a technologist or patient to unnecessary
X-ray exposure.
• ‌Make sure that no one other than a technologist or patient is in the study room when making
X-ray exposures. If it is necessary for a care assistant or other person to remain in the room,
provide sufficient radiation protection when using the remote exposure switch or remote
exposure foot switch.
• Use the longest possible focal spot to skin distance to minimize the absorbed dose.
• ‌Reduce the radiation field size to the minimum necessary size for the exposure. If X-rays are
unavoidably radiated to areas outside of the subject region, take other protective measures
such as readjusting the collimator or wearing a Pb apron.

Radiation protection area
The manager of the facility must specify the radiation protection Low level radiation area
area, in which minimum radiation is present, where a doctor or
5
mm
11..5
technologist can make an exposure safely, using the figure below Patient
as a guide.
45°
Protective shield
1
(optional)
Radiation protection area
WARNING
For Safe Operation

• ‌Only qualified technologists are allowed to make X-ray exposures.
• ‌Before making an X-ray exposure in the study room, the technologist must retreat to the
radiation protection area secured by the protective shield (optional).
• ‌When making an X-ray exposure remotely from a room next to the study room, install the
protective shield (optional) or protective window, or take other measures to protect the
adjacent room from radiation.
• ‌When making an X-ray exposure in the study room with the remote exposure switch or remote
exposure foot switch but without using the protective shield (optional), wear protective
clothing. If not wearing protective clothing, make an X-ray exposure while staying in the low
level radiation area 1.5 m or more away at the rear of the patient back.
• ‌Technologists must wear a film badge or pen dosimeter to monitor exposure doses they
receive.
Mechanical safety instructions

Danger of hitting or being caught between the parts
The technologist or patient can only come into contact with the armrests when the patient is being
positioned.
Do not grab the armrests, but place the hands lightly on them.
The technologist must remove all the dangers that could harm the patient or third party before operating
the system. Potentially dangerous parts are indicated by arrows in the figure below.
WARNING
Dangerous parts on the exposure stand
• ‌A patient’s or technologist’s hand, foot or other body (Movable parts)
parts may hit or be caught by the potentially dangerous
parts. Eliminate all dangers completely. Swivel arm
This part rotates.
• ‌When operating the equipment by the foot switch, swivel Face guard
arm control panel or control pad, make sure that no Space between the compression
hand, foot, or other part of the technologist’ s or patient’ plate and face guard or swivel arm
(when the face guard is not installed)
s body is caught between the movable parts. Compression plate
Exposure table
This part moves up/down.
Emergency stop button

WARNING
Press the emergency stop button to immediately turn off the equipment in an emergency. This
cuts off the power to the exposure stand and stop it forcibly.
The equipment has the three buttons: two on the exposure stand and one on the control pad.
Software use instructions

CAUTIONS
Do not install any software in addition to the preinstalled software. Do not uninstall the
preinstalled software. The system is preinstalled with the appropriate software. If it is deleted
or other software is added, various operational errors may result.

Mammography-specific instructions
Only qualified technologists are allowed to operate the equipment. The technologists are required to fully
understand the principles of mammography in advance to perform operations described in this Operation
Manual.
Protective shield
The protective shield (optional) protects the technologist from exposure to X-rays.
This is designed in compliance with the relevant requirements in 21CFR 1020, IEC 60601-2-45:2011 and
1 IEC 60601-2-45:2011/A1:2015. The shield is 0.5 mm Pb equivalent.
WARNING
When making an exposure by the AWS installed in the study room, the technologist should be
For Safe Operation
where the protective shield (optional) covers and protects all of his/her body from exposure to
X-rays.
Inspect the protective shield (optional) before making X-ray exposures.
Face guard
The face guard is designed to prevent the patient’s head from entering the radiation field. It is not X-ray
proof.
WARNING
When making an X-ray exposure without using the face guard, make sure that the patient’s
head is physically positioned outside of the X-ray path.
Disinfection instructions
WARNING
• ‌Confirm that the respiratory density of disinfectant including solvent is under legal regulation.
Certain disinfectants may damage health. When using a disinfectant, follow instructions
supplied by the manufacturers.
• ‌Do not use any of the disinfectants described below as damage to the equipment may result.
Quality, performance and safety of the equipment cannot be assured.
• Chloric disinfectant which is strongly corrosive to metals and rubber parts.
• ‌Disinfectant whose uses on metals, plastics, and coating are forbidden according to the
instructions supplied with the disinfectant.
• Formalin gas and disinfectant sprays that may get inside the equipment.
Disinfectant ethanol is recommended for disinfection.
Carefully read the instructions and cautions supplied with the disinfectant before use.
Disinfectant ethanol is ethanol of 76.9 to 81.4 vol% without other additives.
Characteristics of the Network

WARNING
Connect to the Ethernet Network of 1000BASE-T, 100BASE-TX, or 10BASE-T prescribed in the
IEEE standard 802.3.
Do not connect telephone lines to LAN connector. Only UTP-type straight LAN cables of 4-pair
Category 5 cable(CAT 5E) or higher are appropriate for connection to this connector.
Cautions on Network
CAUTIONS
After connecting this system to the network with other systems, confirm that the other systems
are not affected. If they are affected, take countermeasures such as network separation.

Precaution on External Netowork Connection
CAUTIONS
When a setting of the network to which the equipment is connected has been changed, check
that the change does not affect the system operation and take measures if necessary.
- Change of connection destination
- Addition of devices
- Removal of devices
- Update of devices 1
- Upgrade of devices
For Safe Operation

Other precautions
WARNING
• ‌Be sure to inspect the system periodically. To assure optimum performance of the equipment,
it is necessary to systematically perform maintenance and inspection. For information on
maintenance and inspection, contact our official dealer.
• ‌Disinfection may be required for the optional items of the system. See the related Operation
Manuals for details.
• ‌C lean/disinfect the compression plate using the specified method. Do not sterilize the
compression plate. Doing so may cause the compression plate to become deformed or
damaged.

1.3.2 Diagnosis System
Preventing electrical shock
WARNING
• ‌Do not use a multiple tap connector or extension cable for powering the equipment
constituting the AWS. Otherwise, fire or electrical shock may occur due to the electrical load
1 exceeding the allowable limit.
• ‌Always use optional items and supplied items recommended by FujiFilm. Using optional
items and supplied items other than those recommended by FujiFilm may cause electrical
shock or damage to occur.
For Safe Operation
Connection instructions
WARNING
Make sure that the devices to be connected to the equipment are authorized for connection.
Technologist’s and patient’s safety instructions

WARNING
Do not operate the AWS installed in a study room while touching the patient’s body. Otherwise,
the patient may receive an electrical shock.
System isolation instructions

WARNING
• ‌To ensure complete system isolation, never install any unauthorized accessories or other
such items. When it is necessary to install authorized accessories or optional items, contact
our official dealer.
• ‌Keep equipment other than the exposure stand out of reach of patients to ensure appropriate
system isolation.
• Do not move the AWS from where it is installed.
Classification
1) According to the type of protection against electrical shock
CLASS 1 EQUIPMENT
2) According to the degree of protection against electrical shock
Type B applied part
3) According to the degree of protection against harmful ingress of water
Main Unit : IPX0
Foot switch (optional) : IPX1
Remote exposure foot switch (optional) : IPX8
4) According to the degree of safety of application in the presence of a flammable anesthetics mixture
with air or with oxygen or nitrous oxide.
Equipment not suitable for use in the presence of a flammable anesthetics mixture with air or with
oxygen or nitrous oxide.
5) According to the mode of operation
Continuous operation with intermittent loading

1.4 Electromagnetic Compatibility (EMC)
In order to prevent the occurrence of problems caused by electromagnetic wave in the operating
environment, read carefully this section and operate the equipment and other devices in the vicinity
properly.
1.4.1 Exposure Unit 1

The equipment can be used in general X-ray rooms in medical facilities and examination vehicles.
The FDR MS-3500 consists of the FDR-3500DRLH and FDR-3000AWS workstation.
For Safe Operation

Electromagnetic Compatibility (EMC) Standards
This system has been tested and found to comply with the limits for medical devices to the IEC
60601-1-2 (EN 60601-1-2).
These limits are designed to provide reasonable protection against harmful interference in a typical
medical installation, as this equipment is suitable for use in a professional healthcare facility
environment.
These limits are designed to provide reasonable protection against harmful interference in a typical
medical installation.
Each device generates, uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to each device or other devices
in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
If each device does cause harmful interference to other devices, which can be determined by tuning
the equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the devices.
• Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
If the problem cannot be solved with the above measures, stop using this equipment and consult
the manufacturer, our official dealer or FUJIFILM Representative for help.
WARNING
● Do not place devices generating electromagnetic wave near this equipment.
● If a device(s) other than those specified is connected, predetermined EMC performance
cannot be guaranteed.
● Do not use mobile RF communications equipment within 30cm (11.8 in.) of this equipment.
● The product may be interfered with by other equipment, even if that other equipment
complies with CISPR EMISSION requirements.
● Do not use this equipment near devices that generate strong electromagnetic waves, such
as thermotherapy devices or HF surgical equipment.
● If this equipment is used near commercially available electronic devices, such as mobile
phones, laptop computers or home appliances, which generate electromagnetic waves, this
equipment may malfunction due to electromagnetic interference.

● The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment, this equipment
might not offer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the equipment.
● Do not use this equipment near X-ray units other than the designated mobile X-ray units or
near large medical devices, such as MRI scanners or X-ray CT scanners.
● The AWS PC cover is required if the operation desk is not equipped with a built-in personal
1 computer. The AWS PC cover is for preventing contact with the metal parts on the back of the
personal computer.
For Safe Operation
Further Information for IEC 60601-1-2 (EN 60601-1-2)

1. The FDR MS-3500 complies with IEC 60601-1-2:2014 (EN 60601-1-2:2015).
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 Tables 1 to 5.
3. Portable and mobile RF communications equipment and other devices, which cause
electromagnetic interference, can affect medical electrical equipment, resulting in image data
communication failure or artifacts.
4. Information regarding the cable affecting EMC is as follows.
Cable Maximum Length Specification
Network Cable (AWS) 20m (65.62ft) Cat5e or more, UTP and Straight
Network Cable (Exposure Unit) 20m (65.62ft) Cat5e or more, UTP and Straight
5. The use of optional items, transducers and cables other than those specified, with the exception
of transducers and cables sold by FUJIFILM Corporation as replacement parts for internal
components, may result in increased emissions or decreased immunity of the FDR MS-3500.
6. The equipment should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the equipment should be observed to verify normal
operation in the configuration in which it will be used.
7. Essential performance of the equipment and the system
There is no unacceptable harm caused by artifacts occurring on output images.
X-ray irradiation is accurate.
The equipment has the reproducibility of the X-ray output.
The automatic exposure control (AEC) is accurate.
Compression force for breast compression is accurate.
The equipment has the linearity of output X-ray dose irrespective of exposure condition.
The equipment receives images from the flat panel sensor and records them.
8. Test items (Tables 1 to 5)

Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
The FDR MS-3500 is intended for use in the electromagnetic environment specified below.
The customer or the user of the FDR MS-3500 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
The FDR MS-3500 uses RF energy only for their internal function.
RF emissions
CISPR 11
Group 1 Therefore, their RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
1
RF emissions
Class A
CISPR 11
For Safe Operation

Harmonic emissions The FDR MS-3500 is suitable for use in all establishments other than domestic
N/A
IEC 61000-3-2 establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions N/A
IEC 61000-3-3
Table 2
Guidance and manufacturer’s declaration - electromagnetic immunity
IEC 60601-1-2 Electromagnetic environment -

Immunity test Compliance level
test level guidance
Electrostatic Floors should be wood, concrete or
discharge ±8kV contact ±8kV contact ceramic tile. If floors are covered with
(ESD) ±15kV air ±15kV air synthetic material, the relative humidity
IEC61000-4-2 should be at least 30%.
±2kV for power supply ±2kV for power supply
Electrical fast Mains power quality should be that of a
lines lines
transient/burst typical commercial or hospital
±1kV for input/output ±1kV for input/output
IEC61000-4-4 environment.
lines lines
Mains power quality should be that of a
Surge ±1kV line(s) to line(s) ±1kV line(s) to line(s)
typical commercial or hospital
IEC61000-4-5 ±2kV line(s) to earth ±2kV line(s) to earth
environment.
0% UT 0% UT
for 0.5 cycle for 0.5 cycle Mains power quality should be that of a
Voltage dips, short and 1 cycle and 1 cycle typical commercial or hospital
interruptions and environment. If the user of the FDR MS-
voltage variations on 70% UT 70% UT 3500 requires continued operation during
power supply input (30% dip in UT) (30% dip in UT) power mains interruptions, it is
lines for 25 cycles for 25 cycles recommended that the FDR MS-3500 be
IEC61000-4-11 powered from an uninterruptible power
0% UT 0% UT supply or a battery.
for 5 s for 5 s
Power frequency Power frequency magnetic fields should
(50/60Hz) magnetic be at levels characteristic of a typical
30 A/m 30 A/m
field location in a typical commercial or
IEC61000-4-8 hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

Table 3
Guidance and manufacturer’s declaration - electromagnetic immunity
IEC 60601-1-2
Immunity test Compliance level Electromagnetic environment - guidance
test level
1 Conducted RF
IEC61000-4-6
3V
150 kHz to 80 MHz
3V Portable and mobile RF communications equipment
should be used no closer to any part of the FDR
MS-3500, including cables, than the recommended
I S M F r e q e n c y b a n d * See Table 5. separation distance calculated from the equation
Amateur radio band applicable to the frequency of the transmitter.
For Safe Operation
Recommended separation distance

Radiated RF 10 V/m 10 V/m
IEC61000-4-3 80 MHz to 2.7 GHz d = 1.2 150 kHz to 80 MHz
d = 1.2 80 MHz to 800 MHz
Proximity fields from RF * See Table 5.
d = 2.3 800 MHz to 2.7 GHz
where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the FDR MS-3500 is used exceeds the applicable
RF compliance, the FDR MS-3500 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the FDR MS-3500.
b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

Table 4
Recommended separation distances between
Portable and mobile RF communications equipment and the FDR MS-3500
The FDR MS-3500 is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled.
The customer or the user of the FDR MS-3500 can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the FDR MS-3500
as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter

1
Rated maximum output m
power of transmitter
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
For Safe Operation

d = 1.2 d = 1.2 d = 2.3
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 metres
(m) can be estimated using 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.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Table 5
Test compliance levels between portable and mobile RF communications equipment and the FDR MS-3500
ISM (Industrial, Scientific and Medical) frequency band compliance level
Frequency Test level Frequency Test level

MHz V MHz V
6.765 6 13.553 6
1 26.957 6 40.66 6
Amateur radio band compliance level
Frequency Test Level Frequency Test Level

For Safe Operation
MHz V MHz V
1.8 6 3.5 6
5.3 6 7 6
10.1 6 14 6
18.07 6 21 6
24.89 6 28 6
50 6
Proximity fields from RF compliance level
Frequency Test level Frequency Test level

MHz V/m MHz V/m
385 27 450 28
710 9 745 9
780 9 810 28
870 28 930 28
1462 10 1720 28
1845 28 1970 28
2450 28 3540 10
5240 9 5500 9
5785 9

1.5 Precautions in Using FDR MS-3500
1.5.1 Exposure Unit
Minimizing exposure
• ‌Use this equipment only for breasts. If used for other body parts, the patient may be subject to an
unnecessary X-ray dose or be injured. 1
• ‌Before making an X-ray exposure, check if the patient has breast (mammary) implants. Inform the patient
of risks in an X-ray exposure of the breasts implants. Breast (mammary) implants affect the AEC function
by blocking X-rays or shifting breast tissues. For an exposure of the patient with breast (mammary)
For Safe Operation

implants, use manual mode. Take great care while compressing the patient’s breasts because the bag(s)
used for implants may break when compressed.
• ‌Stand at the rear of the protective shield (optional) while making X-ray exposures. When making an X-ray
exposure without using the protective shield (optional), install the protective window or take other
measures to protect the room adjacent to the study room.
• ‌If not using the protective shield (optional), wear protective clothing (0.5 mm Pb equivalent) or stay in the
low level radiation area 1.5 m or more away at the rear of the patient back.
• ‌Wear a film badge or pen dosimeter to monitor exposure doses you receive.
• ‌Make sure that the X-ray radiation field is appropriate before making an X-ray exposure. Otherwise, a
misdiagnosis or an unnecessary increase in X-ray radiation dose may result.
• ‌Make sure that no body part other than the breast to be exposed is in the radiation field. Adjust the
equipment if necessary so that the radiation field covers only the breast to be exposed, using the light
field lamp as a guide. Otherwise, the patient may subject to unnecessary X-ray exposure.
• ‌Specify the correct compression force for an exposure. Otherwise, image quality degrades, resulting in a
misdiagnosis or an unnecessary increase in X-ray radiation dose.
• ‌Before making an X-ray exposure, make sure that the exposure orientation of the patient (right-left CC,
right-left MLO, etc.) is correct both in an actual orientation and in the setting for the exposure menu
selected in the AWS. Otherwise, image quality degrades, resulting in a misdiagnosis or an unnecessary
increase in X-ray radiation dose.
• ‌The damaged equipment should be ensured that the damaged equipment has no adverse effect on X-ray
exposures. Otherwise, a misdiagnosis or an unnecessary increase in X-ray radiation dose may result.
• ‌Never apply a strong impact to the exposure table. Otherwise, a misdiagnosis or an unnecessary
increase in X-ray radiation dose may result.
• ‌Only qualified technologists are allowed to make X-ray exposures.
Preventing accidents
• ‌Keep the exposure table, compression plate or other parts touched by patients or technologists clean. If
the parts are soiled with the blood, etc. of an injured patient, infection may result. Disinfect the soiled
parts immediately with a disinfectant or other cleaning solution.
• ‌Before making an X-ray exposure, make sure that there is no sign of abnormality on the exposure table.
A flaked or scratched surface could injure the patient.
• ‌Before using the compression plate, make sure that it is not worn out. If the plate has any crack, replace
it with the new one. Otherwise, the plate may break while it is used and the sharp edges could injure the
patient.
• ‌Before adjusting the compression force on breasts, make sure that no part or all of the patient’s body is
at the risk of hitting the equipment or being caught by the equipment.
• ‌Pay attention to the patient’s behavior to prevent the patient from hanging onto or leaning against the
swivel arm. Otherwise, the patient may be injured or the arm may be deformed.
• ‌Before adjusting the angle or height of the swivel arm, make sure that a part or all of the patient’s body is
not at the risk of hitting the arm or being caught by the part.
• ‌Before rotating the swivel arm, make sure that the patient is away from the exposure stand.
• ‌Check the conditions of the patient (whether she has an implanted pacemaker/defibrillator or breast
implants, etc.) before executing a study.
• ‌When compression of the breast is completed, the foot switch should be moved away from the patient
and technologist. If the foot switch is accidentally operated, it may endanger the patient or technologist.
• ‌During an X-ray exposure, a technologist or doctor should be where the emergency stop button is within
their reach.
• ‌Install the magnification table horizontally. If slanted, the stainless stay will fall down under its own weight

and could cause injury to the patient or technologist.
• ‌Make sure that the compression plate, face guard, magnification table, etc. is securely installed. If it is
not correctly locked, it could drop off and cause injury to the patient or technologist.
• ‌Do not remove the plastic plate portion of a compression plate from its frame. Otherwise, the
compression plate may break.
If the compression plate is broken or damaged, contact our official dealer to have it replaced with a new
one. Using a broken or damaged compression plate is highly dangerous.
• ‌When using the magnification table, instruct the patient to put her arms on the armrests.
If the patient accidentally touches the operation buttons on the swivel arm control panel, the arm may
1 rotate, move up or down, possibly causing injury to the technologist or patient.
• ‌Do not apply force of 200N or greater on the armrests. Otherwise, they may break.
• ‌During a magnification exposure (with the face guard removed), make sure that the patient’s head or
other body part cannot be caught between the compression plate and collimator when decompressing.
For Safe Operation
• ‌When installing or removing the magnification table, tightly hold the bottom part with both hands. If not,
the table might fall and cause an injury.
• ‌When cleaning the magnification table, make sure that it is correctly installed. Do not apply excessive
force to the table, otherwise it may break and cause an injury.
• ‌Do not lean against or sit on the operation desk. The operation desk may break or topple over, possibly
causing an injury.
• ‌Do not apply a strong impact to the protective shield on the operation desk.
As the protective shield is made of X-ray-proof glass, it may be cracked if a strong impact is applied. If
cracked, contact our official dealer to have a protective shield replaced with a new one. Though highly
safe laminated glass or shatterproof film is adopted, using a cracked shield is highly dangerous.
• ‌When making an exposure of a patient in a wheelchair, the swivel arm or exposure table may hit the
patient’s foot and cause injury at the time of rotating or moving up/down the swivel arm. Be careful of
themoving parts.
• ‌When installing the under-armrest (optional) and conducting an exposure of a patient in a wheelchair,
there is the risk that the under-armrest may hit the patient’s foot and cause injury when the swivel arm is
rotating or moving up or down. Take care of moving parts.
Preventing malfunctions
• ‌Do not use inappropriate detergent or disinfectant. Otherwise, it may cause cracks on the surface or
inside of the covers. Such detergent or disinfectant penetrates into the equipment and could cause fire.
• ‌Use a disinfectant that will cause no damage to the equipment or harm to the human body when
disinfecting the equipment.
Maintaining image quality

• ‌Do not specify the incorrect exposure parameters. Otherwise, insufficient image quality may result and
affect image interpretation. Read the Operation Manual thoroughly and specify the optimum exposure
parameters.
• ‌During exposure, be sure to keep the patient from moving. If the patient moves, image abnormality may
occur and the required image quality may not be obtained.
• ‌Pay attention to the patient’s behavior and prevent the patient from hitting or leaning against the
exposure stand or swivel arm during image reading. Otherwise, image quality may be degraded, affecting
image interpretation.
• ‌Do not calibrate the equipment with any objects left on the exposure table. The calibration may fail and
artifacts may appear on images. If artifacts appear, redo the calibration.
• ‌Clean the exposure table, compression plate and other parts before making an exposure. Dirt or dust
adhering to the parts may produce abnormal images, resulting in insufficient image quality.
• ‌Read the Operation Manual thoroughly and specify the optimum image processing parameters. Image
processing with the incorrect parameters may result in insufficient image quality, affecting image
interpretation.
• ‌When using Blackening Processing, make sure that the effective image area is not missing on the AWS
monitor. If necessary, clear the blackened area by using Manual Blackening Processing and redo the
processing.
• ‌Check the information attached to radiographic images before using it for image interpretation. Make
sure that the patient information is correct.
• ‌When making an exposure with the compression plate removed, make sure to use manual mode. Using
full auto or semi auto mode may result in insufficient image quality.

• ‌After inputting a marker, make sure that it is correctly displayed on the monitor.
The marker frame is displayed only on the monitor, not on the image output on film. Note that the marker
may become invisible depending on the color of its letter or frame background color.
• ‌Do not use the S value (system sensitivity) to determine the exposure dose or adjust the automatic
exposure control (AEC), since the value may change as time elapses or due to a malfunction.
• ‌If there is a wire hook, marker, pacemaker, or similar in the range of exposure, AEC exposure may be
incorrectly conducted.
• ‌Before conducting exposures, make sure that the breast and the X-ray exposure field are appropriately
positioned.
• ‌If unusual dots, lines (black or white), or density unevenness is observed on images, perform calibration. 1
Managing data
For Safe Operation

• ‌The system identifies and manages images by the date and time they were read.
Read images with the wrong date and time may be rewritten in their storage destination.
Make sure to specify correct date and time.
Other limitations
• ‌Minimum necessary interval between successive exposures
When making X-ray exposures one after another, allow a longer interval between exposures than that
indicated in the graph “Minimum exposure interval for energy input to X-ray tube”. Do not make
exposures more than 60 times in an hour. Otherwise, X-ray exposure may be disabled for a long time
due to heat generated from the X-ray tube.
‌See the graph “Minimum exposure interval for energy input to X-ray system (tube)” in “A.1
Specifications”.
When operating parts of the equipment successively, observe the following operation time limit and
operation interval for safety.
Part Operation time limit Operation interval
Swivel arm up/down movement 16 seconds 60 seconds or more
Swivel arm rotation 24 seconds 23 seconds or more
Compression plate *1 30 seconds 120 seconds or more
Grid mounting/dismounting *2 90 seconds or more
*1: ‌Successive compression plate operation without making X-ray exposures
*2: ‌The operation interval is the time period that should be left between a grid dismounting and the next mounting.

Preventing accidents
• ‌When opening or closing the door on the operation table to start up the AWS, be careful not to catch your
fingers or hands.
• ‌Be careful not to get your fingers or hands caught between the monitor arm and other parts.
• ‌Install the AWS on the operation desk. If the AWS is installed in a dusty environment, dust accumulating
1 in the power supply unit or other components could result in smoke or fire.
• ‌Before starting the AWS, make sure that the circuit breaker of the control cabinet is on, and then turn on
the exposure stand.
• ‌Do not press the power switch on the front of the AWS to power off the equipment. Make sure to perform
For Safe Operation
the system shutdown procedure, and wait until the equipment is automatically powered off.
• ‌When the monitor arm is not in use, fix the monitor to prevent it from falling off the operation table.
Preventing malfunctions
• ‌Do not install any software or hardware in addition to the preinstalled one. Do not uninstall the
preinstalled software or hardware.
The AWS is preinstalled with the appropriate software or hardware. If other software or hardware is
added, various operational errors may result.
• ‌Before operating the AWS, make sure that the monitor has appropriate brightness (light intensity). If not,
contact our official dealer. Regularly adjust the monitor settings to keep optimum display of images read
by the AWS. Apart from regular adjustments, do not change the settings.
If a fluorescent tube for the monitor backlight is used for over a prolonged period, brightness (light
intensity) of the monitor decreases because the lifetime of the fluorescent tube is running out.
In this case, use of the monitor adjustment tool or service by our official dealer is recommended.
Maintaining image quality

• ‌Do not operate the AWS during an exposure. Otherwise, images may not be read correctly or the read
images may be processed based on incorrect exposure menu data.
• ‌When the AWS disk space is running low, images will be automatically deleted from the oldest.
The auto-deletion of images can be avoided by locking studies.
The system identifies and manages images by the date and time they were read. Make sure that the
correct date and time are displayed when the AWS has started.
Managing data
• ‌When disposing of the AWS, completely delete all personal information.

1.6 Location of Each Label
The positions where the labels are affixed on the exposure unit are shown below. The relevant safety
signs are also described.
1.6.1 Location of Labels on the Exposure Unit

1
n Exposure stand
For Safe Operation

Stamped number (350N101885)
5 5
3 3
1
2
: Type B applied part
1. Sub-circuit ON 2. Sub-circuit OFF 3. Stop Label 4. Caution Label

(Regarding Physical
Contact)
5. Type B applied
part label
Do not touch the biopsy positioner
connector. Touching it may cause a
system failure.

Foot switch
Left-hand side Right-hand side 1. Foot Switch Label
1 2 (Left-hand Side)
1
2. Foot Switch Label
(Right-hand Side)
For Safe Operation
Remote exposure foot switch

Front Back
2. Remote Exposure Foot Switch
Model Number Label
1 2
リモート撮影フットスイッチ 128Y100145
3
4
XXXXXXX
Minimum necessary interval between successive exposures

When making X-ray exposures one after another, allow a longer interval between exposures 3. Identification Label
than that indicated in the graph “Minimum exposure interval for energy input to X-ray tube”.
Do not make exposures more than 60 times in an hour. Otherwise, X-ray exposure may be
disabled for a long time due to heat generated from the X-ray tube.
See the graph “Minimum exposure interval for energy input to X-ray system (tube)” in
“A.1 Specifications”.
1. Successive Operation Condition Label 4. Remote Exposure Foot Switch Label
or
n Generator
1. High voltage warning label
2
3 2. System Label 3. Rating Label

n Compression plate
• 24×30 (Low) 1. Identification Label 2. Model Number Label
1 401Y120024
• 24×30 (High) 1. Identification Label 2. Model Number Label

1
2
For Safe Operation

1
401Y120004
• 24×30 (Shift) 1. Identification Label 2. Model Number Label
1 401Y120025
• 24×30 (Shift Small) 1. Identification Label 2. Model Number Label
1
401Y100124
• 24×30H (Flex) 1. Identification Label 2. Model Number Label
2
1
401Y100121
• 24×30H (FS) 1. Identification Label 2. Model Number Label
2
1
401Y100131
• 18×24 (Low) 1. Identification Label 2. Model Number Label
1 401Y120026
• 18×24 (High) 1. Identification Label 2. Model Number Label
2
1
401Y120005

• 18×24 (Small) 1. Identification Label 2. Model Number Label
1
401Y120006
• 18×24L (Flex) 1. Identification Label 2. Model Number Label

1
2
1 401Y100122
For Safe Operation
• 18×24L (FS) 1. Identification Label 2. Model Number Label
1 401Y100130
• 18×24 (FS Small) 1. Identification Label 2. Model Number Label
2
401Y120033
1
• 18×24 (Shift P) 1. Identification Label 2. Model Number Label
2
1
401Y120038
• 18×24 (Shift P Smal) 1. Identification Label 2. Model Number Label
1 401Y120046
• 18×24 (FS Shift P) 1. Identification Label 2. Model Number Label
401Y200001
1

• Rectangle spot 1. Identification Label 2. Model Number Label
2
1
401Y100118
• For axilla radiography 1. Identification Label 2. Model Number Label

1
2
1 401Y100115
For Safe Operation

• For magnification 1. Identification Label 2. Model Number Label
2
401Y100116
• Rectangle spot magnification 1. Identification Label 2. Model Number Label

2
401Y100119
• Round spot 1. Identification Label 2. Model Number Label
401Y120009
1
• Round spot magnification 1. Identification Label 2. Model Number Label

2
1
401Y120011
• 2D biopsy 1. Identification Label 2. Model Number Label
1 401Y100114

n Operation desk (optional)
1. Caution Label (Potential Finger Pinching Points)
1 1
When changing the position of the monitor, be careful
so that your fingers are not caught between the
monitors or between the monitor and the monitor arm.
2. Protective Shield Attenuation Equivalent Label

For Safe Operation
or
n Control pad
1 1. Warning Label 2. Stop Label
4
2 3. Caution Label (for Connection) 4. Successive Operation Condition Label
3 See “O.4 Connecting the Remote

Exposure Switch” for how to
connect the remote exposure switch.
Minimum necessary interval between successive exposures

When making X-ray exposures one after another, allow a longer interval between
exposures than that indicated in the graph “Minimum exposure interval for energy
4 input to X-ray tube”. Do not make exposures more than 60 times in an hour.
Otherwise, X-ray exposure may be disabled for a long time due to heat generated
from the X-ray tube.
See the graph “Minimum exposure interval for energy input to X-ray system
(tube)” in “A.1 Specifications”.
n Magnification table (optional)

1. Magnification Table 3. Identification Label
Model Number Label
1.8倍拡大撮影台S 357Y100432
XXXXXXX
4. Type B applied part label
2. Magnification Table
1 23 4
Name Plate
: Type B applied part
XXXXXXXX

n Remote exposure switch (optional)
1. Remote exposure switch Model Number Label
リモート撮影スイッチ 128Y100144
1 XXXXXXX
The following information is shown on the packaging box. 1

• FUJIFILM Corporation
• EXPOSURE SWITCH REMOTE AR E
For Safe Operation

• Serial No.
n Shielding Plate (optional)

1. Shielding Plate Model Number Label
遮蔽板キット 898Y101477
1
XXXXXXX
n Face Guard T (optional)

2 1
1. Identification Label 2. Identification Label
n Face Guard T Comfort (optional)

1. Face Guard T Comfort 2. Identification Label
Model Number Label
1
2
3. Maximum Load Capacity Label

3
n 1 Shot Phantom M Plus 24x30 (optional)

1 2
1. Identification Label 2. Identification Label

1.6.2 Position of Labels on the Diagnosis System
n FDR-3000AWS
1
For Safe Operation
Identification Label
n Software product for FDR-3000AWS
Identification Label
• The month and year of actual manufacture are printed on the label.
• Store the CD case with care.

1.6.3 Safety and Other Signs
The following safety signs are used in the FDR MS-3500 labels or on its body.
Sign Description Sign Description
Attention, consult ACCOMPANYING
Manufacturer
DOCUMENTS.
Stop Year of manufacture

1
ON/OFF (power supply: only part of the Environmentally Friendly Use Period
equipment) (EFUP)
For Safe Operation

Connection point for the neutral
Sub-circuit ON N conductor on permanently installed
equipment
Sub-circuit OFF Light field lamp button icon
Protective grounding (to the earth) Single-touch button icon
Alternating current Exposure unit height adjustment icon
This symbol indicates that the

equipment is a Type B Applied Part.
Compression/decompression icon
High voltage
This symbol indicates compliance of the

Exposure icon
equipment with Directive 93/42/EEC.
This symbol indicates that this product is not to
Exposure stand display panel switching
be disposed of with your household waste,
icon
according to the WEEE Directive and your
national law. This product should be handed
over to a designated collection point. Refer to instruction manual/booklet
Improper handling of this type of waste could
have a possible negative impact on the
environment and human health due to
potentially hazardous substances that are
generally associated with EEE.
At the same time, your cooperation in the
correct disposal of this product will contribute
to the effective usage of natural resources.
For more information about waste, please
contact FUJIFILM dealers.

1.7 Diagnosis System Safety Standard
Requirements
The safety standard requirements for the system are shown below.
1 1.7.1 Diagnosis System

• ‌For the AWS Application Software, see “Introduction” (Page ii).
• ‌For safety, “Preventing electrical shock” (Page 8), “Technologist’s and patient’s safety instructions” (Page
8), “System isolation instructions” (Page 8), “Software use instructions” (Page 5), “Mammography-specific
For Safe Operation
instructions” (Page 6) in “1.3 Safety”.

• ‌For precautions, see “Minimizing exposure” (Page 15), “Preventing accidents” (Page 18)”, “Preventing
malfunctions” (Page 18), “Maintaining image quality” (Page 18), “Managing data” (Page 18) in “1.5
Precautions in Using FDR MS-3500”.
• ‌For the location of each label, see “n Operation desk” (Page 24), and “n Magnification table (optional)”
(Page 24) in “1.6.1 Location of Labels on the Exposure Unit” and “1.6.2 Position of Labels on the
Diagnosis System” (Page 26).
• ‌For the features of this system, see “2.1 Features of the Diagnosis System” (Page 29).
• ‌For the system configuration, see “2.2.1 Basic Configuration of the Diagnosis System” (Pages 30 to 31).
• ‌For the name of each part, see “n Operation desk” (Page 34) in “2.3.1 Part Names and Functions of the
Exposure Unit” and “2.3.2 Part Names and Functions of the Diagnosis System” (Page 35).
• ‌For the name of the AWS windows, see “Workstation FDR-3000AWS Operation Manual”.
• ‌For the basic operations, see “Reference Guide 3.2.3 Starting a Study” (Pages 3-4 to 3-5), “Reference
Guide 3.2.4 Selecting Exposure Menu Items” (Pages 3-5 to 3-6), “Reference Guide 3.2.6 Single-Touch”
(Pages 3-8 to 3-9), “Reference Guide 3.2.7 Positioning” (Pages 3-10 to 3-11) “Reference Guide 3.2.8
X-ray Exposure” (Pages 3-12 to 3-13) and “Reference Guide 3.2.9 Completing Studies” (Page 3-13).
• ‌For the errors displayed on the monitor, see “Reference Guide 4.2.1 List of Error Messages” (Pages 4-2).
• ‌For daily inspection, see “5.1.2 Diagnosis System” (Page 47).
• ‌For the main specifications, see “A.1.2 AWS” (Page 52).
• ‌For the external view and weight, see “Reference Guide A.2.2 AWS” (Page A-4).
1.7.2 Exposure Unit Operation Procedures

1 Start up the exposure unit and system
F
‌ or details, see “3.1.1 Starting up the Exposure Unit” and “3.1.2 Starting up the Diagnosis
System”.
2 Start the study

Enter patient information into the exposure menu. Install a compression plate to suit the purpose
of the study.
3 Conduct exposures
Change the compression plate as needed.
F
‌ or details, see “3.2 Changing the Compression Plate”.
Adjust the height and angle of the swivel arm to suit the patient. Use Single-Touch if required.
Position the patient.
Apply compression if required. Check the exposure field.
Set the exposure mode with AWS.
F
‌ or details, see “A.3 Automatic Exposure Control (AEC)”.
Press the exposure button to conduct an exposure. Release the compression plate.
Optimize the image with AWS.
4 Shutting down the Exposure Unit and the System

F
‌ or details, see “3.1.5 Shutting Down the Exposure Unit” and “3.1.6 Shutting down the
Diagnosis System”.
5 Stopping the System in Emergency

F
‌ or details, see “3.3.1 Exposure Unit Emergency Stop Button”, “3.3.2 Exposure Unit
Emergency Stop Operation” and “3.3.3 Exposure Unit Restoration”.
Chapter 2 Product Overview
2.1 Features of the Diagnosis System
Features of the system are described below.
• ‌Owing to the high-performance flat panel sensor, high quality mammographic images can be obtained
with less X-ray exposure.
• ‌Short intervals between exposures enable processing speed fast enough to maintain smooth work flows
including mass screening. 2
• ‌Three exposure modes (auto, semi auto, and manual) are available to cover various exposure conditions.
• ‌In full-auto and semi-auto modes, the optimal X-ray radiation dose is calculated automatically based on
Product Overview
the breast thickness and compression force that have been automatically measured by the system.
• ‌The automatic exposure control (AEC) enables to accurately detect the mammary region and
automatically controls the mAs value and others.
• ‌This equipment is provided with the two-step automatic decompression function of compression plate.
When this function is enabled, compression of the breast is automatically released at the end of exposure
to shorten patient’s pain.
• ‌A compression plate automatic release function is included. When this function is enabled, compression
of the breast is automatically released at the end of exposure to shorten patient’s pain.
• ‌This equipment is provided with the foot switch (optional) so that raising/lowering operations of the swivel
arm and compression/decompression operations of compression plate are possible even when both
hands are used to support a patient.
• ‌This equipment is provided with the armrests as well as optional chest wall pad and axilla pads. These
items help relieve discomfort of the patient when she is positioned for exposure.
• ‌The AWS includes the X-ray control panel, which allows a doctor or technologist to set and check the
exposure conditions in the same window.
• ‌The automatic positioning function allows the swivel arm to automatically rotate to and stop at a desired
angle with a single touch of a button.
• ‌The exposure stand is provided with the patient information display function, which displays patient ID,
patient name, and date of birth registered on the AWS. With this function, a doctor or technologist can
have accurate information on the patient before positioning.
• ‌Using the optional tomosynthesis exposure software allows exposure images to be acquired from several
angles, and a 3D slice image to be re-organized from those images.
• ‌When the optional tomosynthesis exposure software and the optional tomosynthesis biopsysoftware are
used together, targeting is possible for positioning on slice images. This enables the user to perform
highly accurate studies easily.
• ‌With the use of the biopsy positioner, the three-dimensional coordinates of an object are calculated
based on the image obtained from a stereotactic exposure in order to support positioning of the needle.
• ‌CEDM (Optional) can capture images consecutively under two different tube voltage conditions during
one compression, and then create and display a subtraction image of the two acquired images. A
subtraction image of the acquired images is created from a low tube-voltage (low energy) exposure taken
under conditions similar to standard mammography exposure and a high tube-voltage (high energy)
exposure that applies a Cu filter.

2.2 Diagnosis System Configuration
Configuration of the system is described below.
2.2.1 Basic Configuration of the Diagnosis System

The diagnosis system consists of the exposure unit which is used to obtain mammographic X-ray
exposures and digital mammographic X-ray images, and the AWS which provides the obtained
images for diagnosis. The system is equipped with functions to obtain digital images by using the
FPD, process, record and output the obtained images.
Server Image viewer
Diagnosis System (FDR MS-3500)

2 Exposure Unit (FDR-3500DRLH) AWS
Flat panel sensor Control cabinet Hub Personal computer

Product Overview
Generator Exposure stand Monitor
Control pad
• ‌The FDR MS-3500 consists of the exposure unit and the AWS. Peripheral devices such as a server and an
image viewer are not included.
• ‌The FDR-3500DRLH consists of the exposure stand, control cabinet, flat panel sensor, control pad and
generator.
• ‌The AWS consists of a personal computer, monitor (optional), keyboard, mouse and hub.
‌ ee “Workstation FDR-3000AWS Operation Manual” for optional items for the AWS.
S
‌See “Biopsy Connection FDR-2000BPY Operation Manual”, “FDR MS-3500 Option Tomosynthesis
Exposure Software Operation Manual” and “FDR MS-3500 Option Tomosynthesis BiopsySoftware
Operation Manual” for details on the biopsy positioner, tomosynthesis exposure software and
tomosynthesis biopsysoftware
WARNING
• ‌The exposure unit can be used in an environment where a patient comes in contact with the equipment.
• ‌When installing the AWS in the study room, the technologist should be where the protective shield
(optional) covers and protects all of his/her body from exposure to X-rays.
• ‌When installing the AWS in a study room, use the protective shield (optional) to protect the technologist
from exposure to X-rays.
CAUTIONS
Handle and keep all the Operation Manuals for each component of FDR MS-3500 as a whole.

Components
n Diagnosis System
Exposure unit and AWS are included.
n Exposure Unit
Exposure stand, control cabinet, flat panel sensor, control pad and generator are included.
n AWS
Personal computer, keyboard, mouse and hub are included.
Standard attachment
n Exposure Unit 2
• Face guard • Axillary pad R
• 24×30 compression plate (High) (401Y120004) *2 • Fuse
Product Overview
• X-ray power radiation cable • Operation manual, supplied documentation
• Chest wall pad *1 • CD-ROM (Reference Guide)
• Axillary pad L • Stand anchor
*1 Replacement parts for a chest wall pad and axilla pads are optional.
*2 Accessories: Extra facilities to the FDR MS-3500 which easily can be mounted by the user.
Optional items
n Exposure Unit
• 24×30 compression plate (Low) (401Y120024)*2 • Remote exposure foot switch
• 24×30 compression plate (Shift) (401Y120025)*2 • Protective shield
• 24×30 compression plate (Shift Small) (401Y100124)*2 • Protective shield cover
• 24×30H compression plate (Flex) (401Y100122)*2 • Monitor arm
• 24×30H compression plate (FS) (401Y100130)*2 • Chest wall pad *1
• 18×24 compression plate (Low) (401Y120026)*2 • Axillary pad L *1
• 18×24 compression plate (High) (401Y120005)*2 • Axillary pad R *1
• 18×24 compression plate (Small) (401Y120006)*2 • Operation desk
• 18×24L compression plate (Flex) (401Y100121)*2 • Biopsy positioner (FDR-2000BPY) *2
• 18×24L compression plate (FS) (401Y100131)*2 • Lateral approach kit (898Y101490)*2
• 18×24 compression plate (FS Small) (401Y120033)*2 • Stereo up-grade kit
• 18×24 compression plate (Shift P) (401Y120038)*2 • Tomosynthesis exposure software
• 18×24 compression plate (Shift P Small) (401Y120046)*2 • Tomosynthesis exposure software Excellent
• 18×24 compression plate (FS Shift P) (401Y200001)*2 • Tomosynthesis biopsysoftware
• Rectangle spot compression plate (401Y100118)*2 • Shielding Plate
• Compression plate for axilla radiography (401Y100115)*2 • Under armlest
• Compression plate for magnifications (401Y100116)*2 • Face guard T (898Y101468)*2
• Rectangle spot magnification compression plate (401Y100119)*2 • Face guard T Comfort (898Y200541)*2
• Round spot compression plate (401Y120009)*2 • Foot switch array modification kit Frip Type
• Round spot magnification compression plate (401Y120011)*2 • Foot switch array modification kit Cross Type
• 2D biopsy compression plate (401Y100114)*2 • Compression plate storage holder
• Foot switch • 1 Shot Phantom M Plus 24x30
• Magnification table (898Y101487)*2 • CEDM Software
• Remote exposure hand switch • Comfort Comp
*1 For replacement.
*2 Accessories: Extra facilities to the FDR MS-3500 which easily can be mounted by the user.
n AWS
Refer to “FUJIFILM Mammography Workstation FDR-3000AWS Operation Manual”.
Separately-sold items
n Exposure Unit
• Biopsy positioner (FDR-2000BPY) • Anchor plate • Decoration seal
• Lateral approach kit
Contact a designated contractor to purchase optional items and separately-sold items.

2.3 Part Names and Functions
Part names and functions of the FDR MS-3500 is described below.
2.3.1 Part Names and Functions of the Exposure Unit

n Exposure stand
Emergency stop button <Exposure stand display panel>
(Located at the left- and This displays the angle of
Single-touch angle
right-hand sides of the column) Stereo angle swivel arm, compressed
breast thickness and
2 Angle of swivel arm compression force. The
Compression force
progress bar indicates
the image reading status
Column after the exposure. The
Compressed breast
The swivel arm moves up or time remaining until
thickness
down his column.
Product Overview
reading completion is
Intermediate compression force also displayed on the
progress bar.
Progress bar
• Patient information display

Swivel arm Patient information can be displayed.
Mammography exposure unit
equipped with swivel function. S
ee “Workstation FDR-3000AWS Operation Manual”
for the display specifications.
Patient information is
Patient ID
Exposure stand displayed while executing
a study on the AWS. The
display panel Fuji Momoko Patient name
patient information
display changes to the
: These areas come in 1973.02.22 Date of birth and
progress bar after the
age
exposure. Patient
contact with the patient
Implant icon information is also
displayed if changes are
made to it on the AWS
during a study.
CAUTIONS
• ‌The 24 x 30H compression plate (Flex), 18 x 24L compression plate (Flex), 24 x 30H
compression plate (FS), 18 x 24L compression plate (FS), 18 x 24 compression plate (FS
Small) and 18x24 compression plate (FS Shift P) are designed to properly distribute the
compression force over the breast.
With this feature, the compression plate tilts according to the consistency and/or size of the
breast. The compressed breast thickness is properly adjusted by the compression force of
approximately 80N or more along the tilt of the compression plate.
The thickness of the thickest part on the chest wall side of the compressed breast is
displayed on the exposure stand display panel.
• ‌Patient information is displayed on the panel according to the character size setting of the
exposure stand. For setting, contact our official dealer.
• ‌T he compression pressure configurable maximum is 200N. Even after the maximum
compression pressure is set, additional compression of about 200 to 230N is possible with
the manual compression dial.
Left-hand side Right-hand side 1 Swivel arm up foot Step on this switch to raise the
switch swivel arm.
3 6 6 3
2 Swivel arm down Step on this switch to lower the
foot switch swivel arm.
3 Swivel arm control Use this to raise or lower the

foot switch swivel arm.
4 Decompression Step on this switch to move the
foot switch compression plate of the swivel arm
to release breast compression.
1 2 4 5 5 4 2 1
5 Compression foot Step on this switch to move the
switch*1 compression plate of the swivel arm
The foot switch consists of two sets, one each for right-
to strengthen breast compression.
and left-hand sides.
*The position of each switch can be changed (option). 6 Compression/ Use this to start compression or
decompression decompression of the compression
Contact a designated contractor for details.
switch plate of the swivel arm.
*1 Lightly stepping on the switch turns on the light field lamp,
indicating the radiation field.
n Swivel arm
Emergency stop button (Located at the left- and
right-hand sides of the column)
Stop button in case of emergency. Press this once to cut off
the power to the exposure stand and stop it forcibly.
Swivel arm control panel

This control panel is equipped with buttons to raise,
lower, and rotate the swivel arm.
Swivel arm clockwise/counterclockwise rotation button

Press this to rotate the swivel arm clockwise (+)/counterclockwise Face guard
(-).
This keeps the face of a
patient away from the path
Single-touch button
Press this to automatically
of X-ray exposure. 2
rotate and stop the swivel
Swivel arm up/down button arm at the set angle.
Compression
Press this to raise/lower the swivel arm. adjustment knob
Product Overview
Use this to fine-adjust
the compression force.
Compression force
Rotation angle display Compression plate
display Compressed breast This compresses breast
thickness display during exposure.
Bottom LCD
switching button
Manual Flat panel sensor
Light field on/off
compression Flat panel detector which
button Exposure table
dial converts X-ray images
Press this to turn on
or off the light field Set breast on this table directly into electric signals.
lamp and switch the during exposure.
exposure field size.
Swivel arm
counterclock- Swivel arm
wise rotation clockwise
button Swivel arm up/down rotation button
Press this to rotate the button Press this to
swivel arm Press this to raise/lower rotate the swivel
counterclockwise (-). the swivel arm. arm clockwise (+).
CAUTIONS
The swivel arm cannot be raised, lowered, or rotated when the compression force is more than
30N. In this case, unless the compression force is set to 0N, the swivel arm operations cannot
be performed.
n Control cabinet n Generator

Principally no user operation is required.
Breaker ON
Breaker OFF
Circuit breaker
CAUTIONS
Do not turn off the power to the control cabinet.

n Control pad
Emergency stop button System power LED
Stop button in case of emergency. Press This LED turns on at the time of system
this once to cut off the power to the startup.
exposure stand and stop it forcibly.
System power switch

Press this slide switch to turn on/off the
exposure stand.
Exposure lamp button Exposure switch

Press this to start radiation of the
exposure stand.
Decompression button
2
Press this to release the compression plate
when it is in the compressing position.
n Operation desk
Product Overview
Protective shield (optional)

 Protective shield for protecting technologists from exposure to X-rays.
 Made of X-ray-proof glass.
The shield is 0.5 mm Pb equivalent.
 Designed to meet the relevant requirements of 21CFR 1020, IEC
60601-2-45:2011 and IEC 60601-2-45:2011/A1:2015.
Monitor arm (optional)

Use this to install and secure the AWS monitor.
Operation desk
Place the AWS on this.

2.3.2 Part Names and Functions of the Diagnosis System
Personal computer
Monitor (Optional)
Mouse
Hub
Monitor Keyboard 2
‌See “Workstation FDR-3000AWS Operation Manual” for optional items for the AWS.
Product Overview
n X-ray Control Panel
This panel displays the status of the exposure stand connected to the AWS and allows the various
settings to be made. During a study, the actual radiation parameter information is displayed in real time
on the X-ray control panel in the “Study window”.
‌See “Workstation FDR-3000AWS Operation Manual” for optional items for the AWS.
(4) Exposure unit setting button
(1) ‌Exposure parameters (2) ‌Exposure parameters (3) ‌Calibration menu

setting section display section button
(5) ‌Flat panel detector (6) ‌Exposure stand status (7) ‌Exposure (9) Time display
(FPD) status display display message display
(8) Exposure status indicator

Chapter 3 Operations
3.1 System Basic Operation Procedures

Basic operation procedures of the FDR MS-3500 are described below.
3.1.1 Starting up the Exposure Unit

1 Confirm the power circuit breaker of the control cabinet.
Confirm that the power circuit breaker of the control cabinet is on.
3 2 Turn on the power of the control pad.

Sliding the system power switch on the control pad to the right-hand side turns the power to the
exposure stand on. Check the following to confirm that the exposure stand is on, and then release
system power switch.
Operations
• The system power LED turns on.

• A short beep sounds from the buzzer.
• The exposure button turns on briefly.
Calibration starts automatically after powering on the exposure stand.
After the exposure stand power is turned on, the buzzer sounds and the exposure button turns on
until system startup is complete, however there is no X-ray exposure in this state.
3.1.2 Starting up the Diagnosis System

It takes around 8 minutes (including automatic calibration) until you can make an exposure after
pressing the system power switch.
1 Start up the exposure unit.

Start it up with the procedure described in “3.1.1 Starting up the Exposure Unit”.
2 Turn on the monitor.

Turn on the monitor by pressing the power switch.
3 Check for the personal computer power.

As the system starts up, the personal computer is automatically powered on.
4 Confirm that the calibration is finished.

When the message “Daily Calibration” disappears and “Daily Calibration PASS” appears instead
on the monitor, calibration is finished.
• When it passes 1:00 a.m. without shutting down the system, calibration starts automatically.
• ‌If the system is restarted within 30 minutes after shutdown, an exposure can be made after
approximately 3 minutes, as automatic calibration is skipped.
• ‌In an emergency, X-ray exposure can be made without performing daily calibration. Select “Abort”
from the calibration menu, while “Initializing” is displayed in the flat panel detector (FPD) status
display of the AWS. However, daily calibration must be performed every day to keep the flat panel
sensor in optimal conditions. If daily calibration is cancelled or aborted, artifacts may appear in the
image.

3.1.3 Starting the Study
1 Enter patient information into the exposure menu.
Install a compression plate to suit the purpose of the study.
3.1.4 Conducting Exposures

1 Change the compression plate as needed.
‌For details, see “3.2 Changing the Compression Plate”.
2 Position the patient.

Adjust the height and angle of the swivel arm to suit the patient. Use Single-Touch if required.
Position the patient.
Apply compression if required. Check the exposure field.
Set the exposure mode with AWS.
3
‌For details, see “A.3 Automatic Exposure Control (AEC)”.
Operations
Conduct exposures
Press the exposure switch to conduct an exposure. Release the compression plate.
Optimize the image with AWS.
CAUTIONS
• D uring exposure, the buzzer sounds and the exposure switch lights yellow.
Exposure ends automatically.
• If the buzzer sound or the yellow illumination of the exposure switch continues for
more than 15 seconds, release your hand from the exposure switch.The buzzer
sound and the yellow illumination of the exposure switch stop.
• If the buzzer sound or the yellow illumination of the exposure switch does not stop
even after releasing the exposure switch, press the emergency stop button.
Exposure is forcibly stopped.
3.1.5 Shutting down the Exposure Unit

1 The exposure unit automatically shuts down as the system is shut down.
No operation is required to turn the exposure unit off.
3.1.6 Shutting down the Diagnosis System

1 Shut down the system on the AWS.
2 Select in the “Patient Information Input window”, and then select

from the displayed menu.
3 A confirmation box is displayed.
Select . The application software of the AWS ends, and the power of the personal computer
is automatically turned off.
Select to cancel the operation.

4 Turn off the monitor by pressing the power switch.
• Before shutting down the system, make sure that no compression is still being applied.
• ‌When it passes 0:00 a.m. with the exposure stand turned on, calibration automatically starts at 1:00
a.m. Since the system cannot be operated during calibration, wait until it finishes before starting
operation.
• ‌As the AWS is not supposed to operate continuously all day long, turn the personal computer off
once a day by performing shutting down operation.
Do not press the power switch when turning off the personal computer.
• ‌To deactivate AWS, select .
3
Operations

3.2 Changing the Compression Plate
Change the compression plate to the compression plate suitable for the exposure menu item selected.
1 Remove the compression plate.

Hold the compression plate, and press either of
the unlock levers (2) while pressing the unlock
lever (1) to unlock the compression plate, and
then remove it from the compression plate
socket.
Unlock lever (2)
3
Unlock lever (1)
Operations
When replacing the compression plate,
raise it to 100 mm (3.93 in.) or more above
the exposure table.
2 Attach the compression plate.

Align the projection of the compression plate
to the projection of the compression plate
mounting slot, and then set the compression
plate to the direction of the arrow.
If the compression plate is not mounted

correctly, the digits on the swivel arm
operation panel display blink.
Projection of the
compression plate
Display on the
operation panel
Projection of the
compression plate
mounting slot
3 Check the compression plate mounting

slot.
Make sure that the compression plate is
correctly locked.

4 Confirm the name of the attached Name Display on the AWS
compression plate. 24 x 30 compression plate (High) 24 × 30 HIGH

24 x 30 compression plate (Low) 24 × 30 LOW
Confirm that the name of the attached 24 x 30 compression plate (Shift) 24 × 30 S

24 x 30 compression plate (Shift Small) 24 × 30 SS
compression plate is displayed in the 24 x 30H compression plate (Flex) 24 × 30 FLEX
exposure parameters display section of the 24 x 30H compression plate (FS) 24 × 30H FS
AWS. 18 x 24 compression plate (High) 18 × 24 HIGH
If the name is not displayed, check if the 18 x 24 compression plate (Small) 18 × 24 Small
18 x 24L compression plate (Flex) 18 × 24 FLEX
compression plate is attached correctly. 18 x 24L compression plate (FS) 18 × 24L FS
The types of compression plates, their 18 x 24 compression plate (FS Small) 18 × 24 FS Small
names displayed in the exposure parameters 18 x 24 compression plate (Shift P) 18 × 24 SP
18 x 24 compression plate (Shift P Small) 18 × 24 SP Small
display section and output image sizes are 18 x 24 compression plate (FS Shift P) 18 × 24 FS SP
shown in the righthand table. Rectangle spot compression plate SPOT
Compression plate for axilla radiography AXILLA
Compression plate for magnification MAG 1.8
Rectangle spot magnification compression plate MAG 1.8 SPOT
Round spot compression plate SPOT R
Round spot magnification compression plate MAG 1.8 SPOT R
2D biopsy compression plate 2D-BIOPSY
3 CAUTIONS
• ‌Be careful not to pinch your fingers when attaching and removing the compression
plate.
Operations
• ‌Make sure that the compression plate is securely attached. If it is not correctly
locked, it could drop off and cause injury to the patient or technologist.
• ‌Hold the compression plate to prevent it from falling when removing it with the
swivel arm rotated.
• ‌When using the compression plate for rectangle spot magnification, round spot
magnification or magnification, be sure to use the magnification table (optional).
Otherwise, radiation may not be delivered properly.
• ‌When the compression plate is correctly attached, the collimator automatically adjusts itself to
produce the radiation field of the plate and the light field lamp lights on the exposure table
approximately 20 seconds.
• ‌The compressed breast thickness display may change when the compression plate is attached;
however, the height between the exposure table and the compression table is accurate.
• ‌If using the optional magnification table, attach it in this step.
‌See “O.1 Using the Magnification Table” for details.

3.3 Emergency Stop
When the equipment abnormally operates or in case of emergency, press the emergency stop button to
forcibly stop the equipment.
3.3.1 Exposure Unit Emergency Stop Button

Emergency stop buttons (1) are at left- and right-hand sides of column, and on the control pad. All
the buttons are same function to stop the exposure stand.
(1)
(1)
Operations
3.3.2 Exposure Unit Emergency Stop Operation
1 Press one of the emergency stop buttons (1).
The exposure stand operation (swivel arm movement, compression plate operation or X-ray
radiation) stops.
2 Lead the patient to a safe place outside the study room.
3.3.3 Exposure Unit Restoration

1 Release the locked state.
The emergency stop button will be depressed, so pull it to release its
locked state.
3.3.4 Diagnosis System Restoration

1 Release the locked state.
Pull the depressed emergency stop button to release its locked state.
2 Start restore processing.

Select [OK] in the displayed error message window to restore the system.
CAUTIONS
• ‌If the system is not restored properly, shut it down, and then restart it after more
than 30 seconds have elapsed.
S
‌ ee “3.1.6 Shutting Down the Diagnosis System” for how to shut down the system.
‌See “3.1.2 Starting up the Diagnosis System” for how to start up the system.
• ‌Before restoring the system, make sure that the patient is away from the exposure
stand.
Information during an exposure or being input cannot be restored.

3.4 Sleep Mode
To reduce the load on the flat panel sensor, the device will automatically switch to Sleep Mode if there is
no exposure conducted for one hour or more after starting up, and the power to the flat panel sensor will
be cut.
3.4.1 Switching to Sleep Mode

Sleep Mode will be displayed on the monitor when switching to Sleep Mode, and exposures cannot
be conducted while this is displayed. Sleep Mode will be released by starting a study and selecting
the unexposed menu.
‌For details, see “3.4.2 Releasing from Sleep Mode”.
3
Operations
Sleep Mode settings can be disabled in the service settings, however leaving it enabled is
recommended, as it reduces the load on the flat panel sensor.
3.4.2 Releasing from Sleep Mode

Sleep Mode will be released by selecting the unexposed menu from the AWS study screen after the
device switches to Sleep Mode. The status bar in the image below will be displayed when releasing
Sleep Mode, and exposures can be conducted after the status bar disappears.

Chapter 4 Troubleshooting
4.1 Diagnosis System Troubleshooting

and Solutions
In the majority of cases where there is a problem with the equipment, the solution will be displayed as a
message on the AWS screen. Conduct the steps outlined in the displayed solution.
If a message is displayed recommending that you contact a designated contractor for the solution,
or if you conduct the steps in the displayed solution and the problem is not resolved, contact a
designated contractor.
Contact a designated contractor if the Exposure Unit does not start up, or if there is a problem that
does not have a solution displayed in the AWS screen.
4.2 Example of Diagnosis System 4

messages
Troubleshooting
This section displays several messages that are often displayed by the system. Conducting the steps in
the displayed solutions resolves the majority of problems.
‌See “Reference Guide 4.2 When an Error Message Appears” for details of other messages.
Message/Cause Remedy
The door is open. Close the door before exposure.
The position of the tube is incorrect. Return the tube back to 0° before exposure.
The compression plate has not been set correctly. Reinstall the compression plate.
Images may not be obtained correctly due to a high temperature. Lower the temperature of the room.
A calibration error has occurred. Conduct the daily calibration again.
1 If “The position of X-ray tube is invalid” (Display example)

is displayed on the lower right side of
the AWS screen, return the position of
the tube to 0° with the following
operation.
2 By pressing the single-touch button Swivel arm clockwise/counterclockwise rotation button

and the swivel arm clockwise/
counterclockwise rotation button at
the same time, only the tube of the Single-touch button
swivel arm can be rotated. Operate the

buttons until the position of the tube
returns to 0°. 2 1
* Press 1 and then 2.

Chapter 5 Daily Inspection and Maintenance
5.1 Daily Inspection and Maintenance
Information on daily inspection and maintenance of the FDR MS-3500.
5.1.1 Exposure Unit

Daily inspection and maintenance of the exposure unit are described below. Daily inspection
consists of “inspection before studies”, “inspection during studies”, and “AEC (Automatic Exposure
Control) inspection”. Also clean and disinfect the equipment during daily inspection.
n Inspection before studies
No. Items to be inspected Details of inspection
1 Correct system startup, shutting • ‌Make sure that the system power LED is on.
down, and correct • ‌If there is any abnormality in the system, the system power LED is off. In
communication with the this case, contact our official dealer.
connected units
2 Visual inspection of the •M‌ ake sure that the compression plate has not suffered from excessive
compression plate abrasion and/or cracks. Stroke and check the plate, especially the surface
which touches breast to make sure that it is smooth and has no prickly feel.
• ‌If anything is wrong with the plate, replace it with new one. For
replacement of the compression plate, contact a designated contractor.
5 CAUTIONS
If plates with a prickly feel or cracks are used, they may
break during compression and cause serious injury to
patients. Make sure to replace them.
Daily Inspection and Maintenance
3 Check of the motions Motor condition

• ‌Make sure that the motor works smoothly by operating the swivel arm
control panel and foot switches.
• ‌If the motor does not work smoothly, turn off the exposure stand and
Height and angle adjustment of the swivel arm
• ‌Make sure that you cannot raise, lower, or rotate the swivel arm when the
compression force is set to more than 30N.
• ‌If the swivel arm operates in the above mentioned condition, turn off the
exposure stand and contact our official dealer.
Confirmation of compression operation
• ‌Make sure that the compression force display changes when the
compression force is adjusted. If any abnormality is found, turn off the
4 Check of image quality Make an exposure under the following conditions and ensure that no spots,
streaks and/or density unevenness are found on the image.
• Subject : 40-mm acrylic board
• Compression height : 45 mm (1.77 in.)
* Do not attach the compression plate.
• Exposure menu : ACR Phantom
• Exposure conditions : ‌Exposure mode [Auto], i-AEC [OFF] and dose level
[H-mode].
n Inspection during studies

No. Items to be inspected Details of inspection
1 Exposure switch • ‌The exposure switch on the control pad lights up green when ready for
radiation.
• ‌When the exposure switch is pressed, it turns yellow.
• ‌If the exposure switch lights up yellow even though it has not been
pressed, turn off the exposure stand and contact our official dealer.
During the startup of the exposure unit, the exposure switch briefly
turns on yellow.

n AEC inspection
Perform AEC inspection in the following procedures.
1 Put an ACR phantom or 40-mm acrylic board on the exposure table. Attach the
compression board to the exposure stand, and set the height of compression to 45 mm.
2 Select [Auto] (auto mode) by using the (Set Exposure Mode button).
i-Choose AEC (provisional) OFF.
3 Make an exposure.
The exposure switch lights for a while (approximately one second).
X-ray radiation finishes and the image is output.
‌ 4 Remove the phantom, and enclose the exposure table with the lead cover.
A Pb apron, etc. can be used.
5 Make an exposure under the same conditions as before.

The exposure switch lights for a while (approximately one second).
When an error message is displayed, it indicates the correct operation of AEC.
CAUTIONS
If the error message does not appear, shut down the exposure stand and contact our
official dealer.
6 Remove the Pb cover.
7 Follow the message and select [OK] to start the restore processing. 5
When the restore processing finishes, the AEC normally operates.

n Warming Up the Exposure Stand
When the exposure stand has not been used for more than a week, perform the warm-up operation
to prevent the X-ray tube from deterioration.
1 Protect the exposure table by using the Pb protective apron, etc.
Make sure to protect the exposure table by using any Pb protector to prevent the FPD from
deterioration due to a test exposure.
2 Set the exposure menu items. Enter any information for making a test exposure.
‌See “Reference Guide 3.2.4 Selecting Exposure Menu Items” for details.
3 Press (exposure mode setting button) to select [Manu] .
4 Set the exposure parameters.

When making an X-ray exposure, first use the low tube voltage and mAs, then gradually use the
higher ones as the number of exposures increases.
The recommended exposure conditions are as follows.
23kV, 20mAs Making an exposure 3 times
5 Make an X-ray exposure.

Perform X-ray exposures the specified number of times for each exposure condition to complete
the warming up.
‌For the daily inspection and periodic maintenance of the system, refer to “Chapter 5 Daily
Inspection and Maintenance”.

n Cleaning/Disinfection
Turn off the exposure stand before cleaning or disinfection.
Note that there is no need to turn off the exposure stand before cleaning the following items that
touch patients during studies.
• Compression plate • Armrests • Compression plate socket
• Exposure table/Magnification table • Face guard • Face Guard T
• Face Guard T Comfort
Cleaning
Before studies, make sure to clean parts that touch the patient. Cleaning is necessary for all the parts
other than those that only require disinfection.
For cleaning, use a cloth slightly moistened with neutral detergent diluted with cold water or lukewarm
water and tightly wrung out. Use a lint-free non-woven or 100 % cotton cloth.
Disinfectant ethanol is ethanol of 70 to 75 wt% or 76.9 to 81.4 vol% without other additives.
Clean according to the following procedure.
1 Wipe all patient contact surfaces with a lint-free non-woven or 100 % cotton cloth
dampened with commercially available disinfectant ethanol (wet but not dripping) for a
minimum of 5 minutes and until visibly clean. Replace soiled wipes as needed.
2 Use a small sterile swab for hard to clean locations (i.e. needle guard lumen) for a
minimum of 30 seconds. Replace soiled swabs as needed.
3 Allow the device to air dry.

5
4 Visually inspect the device for remaining soil in a well-lit area; no visible soil should be
left on the device. If visual soil remains. Repeat above steps as necessary.
CAUTIONS
• ‌Make sure to use a recommended detergent to clean the equipment. Improper detergent may
damage the equipment.
• ‌Make sure not to let detergent or disinfectant ethanol get inside the equipment during
cleaning.
• ‌Clean the magnification plate under stable conditions. In addition, do not apply load to it while
cleaning. The magnification may be broken, causing an injury.
Disinfection
Disinfectant ethanol is recommended for disinfection.
Carefully read the instructions and cautions supplied with the disinfectant before use.
Disinfectant ethanol is ethanol of 70 to 75 wt% or 76.9 to 81.4 vol% without other additives.
Using lint-free non-wovens or 100 % cotton cloths dampened with commercially available disinfectant
ethanol (wet but not dripping), wipe all surfaces of the device paying close attention to seams and
recessed areas. Maintain contact of the disinfectant on all surfaces of the device per the manufacturer’s
recommended minimum contact time (i.e. a minimum of 10 minutes).
• Compression plate • Exposure table/Magnification table • Face guard
• Face Guard T • Face Guard T Comfort
WARNING
Confirm that the respiratory density of disinfectant is under legal regulation.
Certain disinfectants may damage health. When using a disinfectant, follow instructions
supplied by the manufacturers.

CAUTIONS
• ‌Do not use any of the disinfectants described below as damage to the equipment may result.
Quality, performance and safety of the equipment cannot be assured.
• Chloric disinfectant which is strongly corrosive to metals and rubber parts.
• ‌Disinfectant whose uses on metals, plastics, and coating are forbidden according to the
instructions supplied with the disinfectant.
• Formalin gas and disinfectant sprays that may get inside the equipment.
• ‌The compression plates and face guard gradually wear out due to disinfectant. Make sure to
perform daily inspection. Do not use these parts if any defects are found. Otherwise, the
patient may be injured.

Perform daily inspection and maintenance to use the AWS under optimal conditions.
n Personal computer
• ‌Checking for normal startup and shutdown of the AWS as well as the establishment of proper
communication with the connected devices
• Checking the fan for its operation
Check if strange noise or odor is not perceived.
• ‌Checking the built-in clock for the time and adjustment
The AWS identifies and manages images based on time information. Make sure that the time of
the clock is always set correctly.
• Cleaning the color LCD monitor 5
• Cleaning the keyboard and mouse
n Hub

• Checking if the power lamp is on
• Checking if the link lamp/activity (operational) lamp is on or blinking

5.2 Periodical Inspections of the Exposure Unit
Periodical inspection of the system is described below.
5.2.1 Weekly Inspection

Restart the system once a week.
Wait more than 30 seconds after shutting down the system, and then start up the system.
5.2.2 Monthly Inspection

n Emergency stop button
1 Press the emergency stop button and confirm that operations through the swivel arm
control panel and foot switches are disabled.
CAUTIONS
If the swivel arm still operates, turn off the breaker that supplies power to the
n Checking the compression motor brake

1 Place a phantom (40-mm acrylic board, ACR phantom) on the exposure table, and
compress it by the compression plate until the compression force reaches 150N.
5
2 After a minute, confirm that changes of the value are within the range of ±20N.
CAUTIONS
If the compression force changed more than ± 20N, turn off the exposure stand and

5.2.3 Maintenance and Inspection Items Assigned to
Specified Dealer
For safety of patients, users and third parties, have periodical inspection performed once a year and
in two years mainly to replace consumable parts. Periodical inspection is performed by our official
dealer.
Periodical Maintenance
Make sure that the periodical maintenance and inspection assigned to our official dealer are
performed as specified.
Maintenance and Inspection Items Assigned to Specified Dealer

Periodical Periodical Periodical
Maintenance and Period Maintenance and Period Maintenance and Period
Inspection Items Inspection Items Inspection Items
Check of error logs
Every half Exposed radiation
and the number of Greasing Every year Every year
a year recognition check
exposures
Every half Micro-switch check/
Imaging check Every year AEC inspection Every year
a year adjustment
Every half Swivel arm operation X-ray output check/
AWS inspection Every year Every year
a year check adjustment
Tomosynthesis Every half Emergency stop Tomosynthesis
Every year Every year
imaging check a year switch inspection adjustment
Visual system
Every half Compression unit
inspection and Collimator inspection Every year Every year
a year inspection
cleaning
Elevation stand and
operation console Every year
Generator check/
Every year
Air filter cleaning/
Every year
5
adjustment replacement
inspection
Tube inspection Every year FPD calibration Every year Grid check/adjustment Every year

Main Periodical Replacement Parts
Name of Periodical Replacement Parts Period
Air filter Every 2 years
18 x 24L compression plate (FS), 24 x 30H compression plate (FS),
Every 1 year *1
18 x 24 compression plate (FS Small), 18 x 24 compression plate (FS Shift P)
18 x 24 compression plate (Low), 18 x 24 compression plate (High),
18 x 24 compression plate (Small), 18 x 24L compression plate (Flex),
18 x 24 compression plate (Shift P), 18 x 24 compression plate (Shift P 180,000 times *2
Small), 24 x 30 compression plate (High), 24 x 30 compression plate (Number of X-ray exposures)
(Low), 24 x 30 compression plate (Shift), 24 x 30 compression plate
(Shift Small), 24 x 30H compression plate (Flex)
Rectangle spot compression plate, Compression plate for axilla
radiography, Compression plate for magnifications, Rectangle spot 180,000 times *3
magnification compression plate, Round spot compression plate, Round (Number of X-ray exposures)
spot magnification compression plate, 2D biopsy compression plate
*1 : ‌Equal to 60,000 times. However, this number is based on FUJIFILM’s evaluation conditions.
*2 : ‌Equal to 900 days if exposures are made 200 times per day (four exposures (in two directions for each breast) for 50 patients).
*3 : ‌Equal to 1,800 days if exposures are made 100 times per day (four exposures (in two directions for each breast) for 25 patients).
The cycles of periodical maintenance and inspection and of parts replacement differ depending on
the usage and the daily operation time.
For details, contact us directly or our official dealer.
“FDR Mammography QC Program” (optional) is available for you to easily perform quality control of
multiple items, especially those related to image quality.
Contact our official dealer for details.

Appendix A Main Specifications
A.1 Specifications
Specifications of the FDR MS-3500 including processing capabilities are described below.
They are subject to change without prior notice.
A.1.1 Exposure Unit Specifications

Power Requirements
Input voltage Input current (standby) Input current (normal) Input current (peak) Frequency
AC200V (Single phase) 2.4A
AC220V (Single phase) 2.18A 16.5A 90A 50 Hz/60 Hz
Requirements for Maximum Allowable Impedance between Substation Equipment and

Circuit Breaker
Maximum allowable Maximum allowable
Input voltage Input voltage
impedance impedance
AC200V (Single phase) 0.143Ω AC230V (Single phase) 0.165Ω
AC208V (Single phase) 0.150Ω AC240V (Single phase) 0.172Ω
AC220V (Single phase) 0.158Ω
Requirements for Circuit Breaker Connected to Insulation Distance between L and N

Equipment Creepage 3mm (0.11 in.) or longer
Number of electrodes 2 Clearance 1.6mm (0.06 in.) or longer
Rated insulation voltage Ui (V) 600 (V) or more
Rated current (A) 50 (A) (AC240V)
* Install a breaker upstream of the device that does not trip
when 500A flows continuously for 0 . 02 seconds , 200A
flows for 1 second, or 130A flows for 10 seconds, and that
trips when 1500A flows continuously for 0.1 seconds.
Operating Characteristic Curves Temperature Characteristic Curve

temperature
Reference ambient
time variation (%)
Percentage of
Operating characteristic curves

operation
Maximum (60A~63A)
Reference ambient temperature (40°C)
Maximum (40A~50A) Reference ambient temperature (45°C)
Ambient temperature (°C)
Operation time
Minimum
A Maximum
Main Specifications
Current (Percentage of rated current)

* Recommended product : NF63-CV (50A) (Mitsubishi)

Environmental Requirements
(1) Operating conditions
Temperature : 20 °C to 30 °C
Humidity : 30% RH to 75% RH (No dew condensation)
Air pressure : 750 hPa to 1060 hPa
(2) Non-operating conditions
Temperature : 15 °C to 35 °C
Humidity : 10% RH to 80% RH (No dew condensation)
Air pressure : 750 hPa to 1060 hPa
* This equipment cannot be used at an altitude of over 3000 m (9842 ft).
Attenuation Equivalent
• Collimator : At least 0.4 mmAl (to the conditions of 49kV radiation)
• Exposure table : 0.1 mmAl (to the conditions of 30kV radiation)
• Magnification table : 0.21 mmAl (to the conditions of 30kV radiation)
• Biopsy protection cover : 0.18 mmAl (to the conditions of 30kV radiation)
Operating Mode
Continuous operation with intermittent loading
Continuous Operation
60 shots/hour (28kV, W/Rh, 71mA, 4 consecutive hours)
40 shots/hour (28kV, W/Rh, 71mA, 8 consecutive hours)
However, maintain the interval shown in the Minimum exposure interval for energy
input to X-ray tube graph at least.
SID (Focal Spot to Image Receptor Distance)
65 cm (25.59 in.)
Characteristics of X-ray Exposure
Tube voltage range 22kV to 49kV (at 1kV increments)
Tube voltage accuracy ±1kV
mAs setting range Large focal spot: 2mAs to 600mAs
Tomosynthesis:
(HR mode) 16mAs to 125mAs
(ST mode) 16mAs to 90mAs
Small focal spot: 2mAs to 300mAs
(Depending on load conditions such as tube voltage)
mAs setting accuracy ±10%+0.2mAs
Tube current Large focal spot: 20mA to 200mA
Small focal spot: 20mA to 61mA
Nominal maximum output power 7kW (35kV x 200mA) * Load time: 40ms
Nominal maximum output power (at 30kV, 40ms) 5kW (168mA)
Maximum output power for making exposures at 2.8kW (28kV x 100mA)
1-minute intervals Load time 1s
Total allowable mAs per hour 7,560mAs (35kV), 5,400mAs (49kV)
Anode material 10%Re/Tungsten face on molly alloy
Large focal spot: 0.3
X-ray tube focal spot size Small focal spot: 0.1
* Per IEC 60336, determined with the slit camera method.
Specific filter 0.63mm Be
Anode and filter combination W/50μmRh, W/700μmAl, W/(250μmCu+700μmAl) A
Main Specifications

Cooling curve of the X-ray system (tube) Minimum exposure interval for energy input
----- Tube [°C]
----- Ambient temperature
to X-ray system (tube)
Min. exposure interval [sec]

Temperature [°C)]
■ : 2D imaging
● : Tomosynthesis imaging
Input for exposure [kV x mA x sec]
Time [min]
Condition: 25°C, large focal spot
X-ray Conversion Method

Direct conversion
X-ray Conversion Material
a-Se
Effective Image Area (on the flat panel sensor)
236.4 mm (9.31 in.) (vertical) x 296.4 mm (11.7 in.) (horizontal)
Pixel Resolution
50 x 50 μ m/pix
Number of Output Pixels
4728 (vertical) x 5928 (horizontal) = 28,027,584 pixels
Output gradation
(1) FDR-3000DRL
16bit
(2) FDR-3000AWS
10bit to 14bit (For details, contact our official dealer.)
Characteristics of Tomosynthesis exposure (Option)
Configuration for the acquisition Center of rotation : Approx. 47 mm above the center of the image
of the projection image receptor
Number of images : 15
Rotation angle : ±7.5° (ST mode)
±20° (HR mode)
Direct focal distance *1 -20° -7.5° 0° +7.5° +20°
Approx. Approx. Approx. Approx. Approx.
616 mm 645 mm 650 mm 645 mm 616 mm
*1 The shortest distance between focus and image receptor
+ : Clockwise direction - : Counterclockwise direction
Intersection position of reference -20° -7.5° 0° +7.5° +20°
axis and image receptor *2 Approx. 17 mm Approx. 6 mm Approx. 6 mm Approx. 17
Center
to the right to the right to the left mm to the left
*2 The position of the intersection of the reference axis and the
receptor with respect to the center of the receptor
X-ray loading factors for the kV : 22 kV to 49 kV
A acquisition of the projection mAs : 16 mAs to 125 mAs (HR mode)
image 16 mAs to 90 mAs (ST mode)
The mAs value of each projection image is 1/15 of the value shown
above.
Main Specifications
A.1.2 AWS
Refer to “FUJIFILM Mammography Workstation FDR-3000AWS Operation Manual”

A.2 Checking Radiation Field Sizes with
Each Compression Plate
This section describes radiation field sizes available with each compression plate as well as how to
check the sizes.
A.2.1 Radiation Field Sizes

Size of radiation field is automatically set depending on the compression plate attached. It also
varies depending on whether a grid is used or not. The following table shows radiation field sizes
available with each compression plate. The radiation field size is the smallest when using the
compression plate for rectangle spot magnification.
Compression plate Radiation field sizes

24 × 30 compression plate (High) 18 × 24 cm radiation field
24 × 30 compression plate (Low) 36.5˚ to 146.5˚ ±36.4˚ or less/±146.6˚ or more -36.5˚ to -146.5˚
24 × 30H compression plate 24 cm (9.44 in.) 24 cm (9.44 in.) 24 cm (9.44 in.)
(Flex)
18 cm (7.08 in.)
18 cm (7.08 in.)
18 cm (7.08 in.)
24 × 30H compression plate (FS)
(Hold the light exposure field ON/
OFF button to switch the radiation
(0.19 in.)
(0.19 in.)
(0.19 in.)
0.5 cm
0.5 cm
0.5 cm
Chest wall edge Chest wall edge
field sizes between 18 × 24 cm Chest wall edge
and 24 × 30 cm. Position of the

18 × 24 cm radiation field varies
24 × 30 cm radiation field
depending on the angle of the 30 cm (11.81 in.)
swivel arm.)
24 cm (9.44 in.)
(0.19 in.)
0.5 cm
Chest wall edge
24 × 30 compression plate (Shift) 36.5˚ to 146.5˚ ±36.4˚ or less/±146.6˚ or more -36.5˚ to -146.5˚
24 × 30 compression plate (Shift 24 cm (9.44 in.) 24 cm (9.44 in.) 24 cm (9.44 in.)
Small)
18 cm (7.08 in.)
18 cm (7.08 in.)
18c m (7.08 in.)

(Position of the radiation field varies
depending on the angle of the
swivel arm.)
(0.19 in.)
(0.19 in.)
(0.19 in.)
0.5 cm
0.5 cm
0.5 cm
Chest wall edge Chest wall edge Chest wall edge
18 × 24 compression plate (Shift Compression plate position: Left Compression plate position: Center Compression plate position:
P) Right
18 24 compression plate (Shift P
× 24 cm (9.44 in.) 24 cm (9.44 in.) 24 cm (9.44 in.)
Small)
18 cm (7.08 in.)
18 cm (7.08 in.)
18 cm (7.08 in.)
18 × 24 compression plate (FS Shift P)

(Position of the radiation field varies
depending on that of the
(0.19 in.)
(0.19 in.)
(0.19 in.)
compression plate.)
0.5 cm
0.5 cm
0.5 cm
Chest wall edge Chest wall edge Chest wall edge
A
18 × 24 compression plate (High)
18 × 24 compression plate (Low) 24 cm (9.44 in.)
18 × 24 compression plate
(Small)
0.5 cm 18 cm (7.08 in.)
18 × 24L compression plate

Main Specifications
(Flex)
(0.19 In.)
18 × 24L compression plate (FS) Chest wall edge
18 × 24 compression plate (FS

Small)

Compression plate Radiation field sizes
Rectangle spot compression 9.2 × 9 cm radiation field 18 × 24 cm radiation field
plate
24 cm (9.44 in.)
(Hold the light exposure field ON/
18 cm (7.08 in.)
9 cm
field sizes between 9.2 × 9 cm

(3.54 in.)
and 18 × 24 cm.)
(0.19 in.) (3.62 in.)

0.5 cm 9.2 cm
(0.19 in.)
0.5 cm
Compression plate for axilla

radiography
20 cm (7.87 in.)
(0.19 in.) (3.15 in.)

0.5 cm 8 cm
Chest wall edge
Compression plate for

magnification 23.7 cm (9.33 in.)
(7.24 in.)
18.4 cm
(0.19 in.)
0.5 cm
Chest wall edge
Rectangle spot magnification 14.5 × 14.5 cm radiation field 18 × 24 cm radiation field

compression plate
24 cm (9.44 in.)
(Hold the light exposure field ON/ 14.5 cm

OFF button to switch the radiation (5.7 in.)
18 cm (7.08 in.)
field sizes between 14.5 × 14.5
14.5 cm
(5.7in.)
cm and 18 × 24 cm.)
(0.19 in.)
(0.19 in.)
0.5 cm
0.5 cm
Round spot compression plate 8.1 × 11.6 cm radiation field 18 × 24 cm radiation field
(Hold the light exposure field ON/ 24 cm (9.44 in.)
field sizes between 8.1 × 11.6 cm
0.5 cm 18 cm (7.08 in.)

11.6 cm
and 18 × 24 cm.) (4.6 in.)

0.5 cm 8.1 cm
(0.19 in.) (3.2in.)
(0.19 In.)
Round spot magnification 14 × 23.7 cm radiation field 18 × 24 cm radiation field

compression plate
24 cm (9.44 in.)
(Hold the light exposure field ON/ 23.7 cm

0.5 cm 18 cm (7.08 in.)
(9.3 in.)
field sizes between 14 × 23.7 cm

(5.5in.)
14 cm
and 18 × 24 cm.)
(0.19 in.)
(0.19 In.)
0.5 cm
2D biopsy compression plate 22.4 cm (8.81 in.)

0.5 cm 17.4 cm (6.85 in.)
(0.19 In.)
A
Chest wall edge
Main Specifications

A.2.2 Checking Radiation Field Size
The radiation field size can be indicated by the light field lamp lit on the exposure table and the
indication on the monitor.
1 Confirm the radiation field size.
When the compression plate is correctly

attached, the collimator automatically adjusts
itself to produce the radiation field of the plate Radiation
and the light field lamp lights on the exposure field size
table approximately 20 seconds. Check that
the light field size corresponds to the radiation
field size of the compression plate.
2 Confirm the compression plate name.
Check the compression plate name displayed

in the exposure parameters display section.
Check that the attached compression

plate is displayed.
Name Display on the AWS

24 x 30 compression plate (High) 24 × 30 HIGH
24 x 30 compression plate (Shift) 24 × 30 S
24 x 30 compression plate (Shift Small) 24 × 30 SS
24 x 30H compression plate (Flex) 24 × 30 FLEX
24 x 30H compression plate (FS) 24 × 30H FS
18 x 24 compression plate (High) 18 × 24 HIGH
18 x 24 compression plate (Small) 18 × 24 Small
18 x 24L compression plate (Flex) 18 × 24 FLEX
18 x 24L compression plate (FS) 18 × 24L FS
18 x 24 compression plate (FS Small) 18 × 24 FS Small
18 x 24 compression plate (Shift P) 18 × 24 SP
18 x 24 compression plate (Shift P Small) 18 × 24 SP Small
18 x 24 compression plate (FS Shift P) 18×24 FS SP
Rectangle spot compression plate SPOT
Compression plate for axilla radiography AXILLA
Compression plate for magnification MAG 1.8
Rectangle spot magnification compression plate MAG 1.8 SPOT
Round spot compression plate SPOT R
Round spot magnification compression plate MAG 1.8 SPOT R
2D biopsy compression plate 2D-BIOPSY
A
Main Specifications

A.3 Automatic Exposure Control (AEC)
This section describes the coverage of the automatic exposure control (AEC) as well as how to check if
the AEC is on/off and the absorbed dose.
A.3.1 Coverage
■ Description
AEC operates in i-AEC mode or regular mode (i-AEC OFF).
In i-AEC mode, the x-ray exposure image acquired by preliminary exposure is analyzed to
implement optimum dose control.
i-AEC
[ON] : Used to take images of the breast. Dose control is performed through image analysis.
[OFF] : Used to take images of the phantom and other matters than the breast.
■ Subjects
[AUTO] : Automatically controls the target/filter, X-ray tube voltage and mAs.
[Semi] : Automatically controls the mAs.
Manually select the target/filter and X-ray tube voltage.
[Manu] : The automatic control is not executed.
Manually select the above parameters.
■ Controlling conditions
In [Auto] mode, exposure is automatically controlled as follows.
Tube voltage (kV)
Compressed breast
Target/Filter Preliminary
thickness (mm (in.)) L-mode N-mode H-mode
exposure
6 (0.23) ~ 10 (0.39) W/Rh 24 26 26 26
11 (0.43) ~ 15 (0.59) W/Rh 25 26 26 26
16 (0.62) ~ 20 (0.78) W/Rh 26 26 26 26
21 (0.82) ~ 25 (0.98) W/Rh 27 26 26 26
26 (1.02) ~ 30 (1.18) W/Rh 28 26 26 26
31 (1.22) ~ 35 (1.37) W/Rh 28 27 27 27
36 (1.41) ~ 40 (1.57) W/Rh 28 28 28 28
41 (1.61) ~ 45 (1.77) W/Rh 28 28 28 28
46 (1.81) ~ 50 (1.96) W/Rh 28 28 28 28
51 (2.00) ~ 55 (2.16) W/Rh 29 29 29 29
56 (2.20) ~ 60 (2.36) W/Rh 30 30 30 30
61 (2.40) ~ 65 (2.55) W/Rh 30 30 30 30
66 (2.59) ~ 70 (2.75) W/Rh 31 30 30 30
A 71 (2.79) ~ 75 (2.95)
76 (2.99) ~ 80 (3.15)
W/Rh
W/Rh
31
32
31
32
31
32
31
32
81 (3.18) ~ 85 (3.34) W/Rh 32 32 32 32
86 (3.38) ~ 90 (3.57) W/Rh 33 33 33 33
Main Specifications
91 (3.58) ~ 95 (3.74) W/Rh 34 33 33 33

96 (3.78) ~ 100 (3.93) W/Rh 35 34 34 34

In [Manu] mode, specify the exposure conditions using the following table as a guide since the
exposure is not controlled automatically.
Compressed breast
Target/Filter KV mAs
thickness (mm (in.))
10 (0.39) W/Rh 26 25
20 (0.78) W/Rh 26 32
30 (1.18) W/Rh 26 56
40 (1.57) W/Rh 28 63
45 (1.77) W/Rh 28 71
50 (1.96) W/Rh 28 80
60 (2.36) W/Rh 30 90
70 (2.75) W/Rh 30 110
80 (3.15) W/Rh 32 125
90 (3.57) W/Rh 33 160
100 (3.93) W/Rh 34 180
* The above values are the recommended parameters for exposures in N-mode.
* ‌First select an appropriate target/filter for the thickness and density of the breast to be examined, and then
select the suitable tube voltage (kV) and mAs.
A.3.2 Confirming the AEC ON/OFF

Whether the AEC is being used or not can be checked on the X-ray control panel.
When exposure mode is set to [Auto] or [Semi], the AEC is being applied.
i-AEC is ON when its indication is green. i-AEC is turned on/off whenever the i-AEC indication is
pressed.
However, when the 2D biopsy or biopsy compression plate is used, i-AEC is turned off regardless of
whether the indication is ON or OFF.
i-AEC [ON] i-AEC [OFF]
‌See “Workstation FDR-3000AWS Operation Manual” for details.
A
Main Specifications

A.4 AGD measurement
This chapter explains how to measure the AGD value using an acrylic-board phantom.
■ REFERENCE
The followings are the causes of variations in AGD value and the variation range.
- Different dosimeter and PMMA thickness were used. Variation range: ±20% approx
- The measurement was made without a compression plate. Variation range: ±10% approx
- The performance
■ INSTRUCTION
The AGD value for check is the total value of pre-exposure and real exposure.
- Add the value of [Pre exposure average glandular dose (mGy)] shown in the exposure result list
to the AGD value displayed on the AWS screen. (Because, the AGD value only for real exposure
is displayed on the AWS screen.)
(1) Install the 24x30 compression plate (High) to the compression unit.
(2) Place the 20mm-thick acrylic board (for 24x30 size) on the exposure stand.
(3) Set the compression plate to 21mm above the exposure plane.
(4) Set the exposure conditions on the AWS.
Exposure Menu: RCC
AEC: Auto
Dose Level: N-mode
D-Tap: 0 or hide (Display preference of D-Tap can be selected at “IIP ServiceUtility” > [Image
Modality] > [94 Enable D-Tap].)
iAEC: OFF
(5) Press the exposure button on the control pad to make an exposure.
(6) Calculate the AGD value, and check that the calculated AGD value is within the allowable
range.
(6-1) Take a note of the AGD value for the real exposure shown on the AWS screen.
(6-2) Take a note of the AGD value for the pre-exposure shown on the list of exposure
results.
(6-3) Check that the AGD value, obtained by adding the value for the real exposure in Step
(6-1) and the value for the pre-exposure in (6-2), is within the range below.
- Japan (Type A) : 0.99mGy ± 22%
- US (Type B) : 0.52mGy ± 22%
- EU (Type C) : 0.52mGy ± 22%
(7) Refer to the table of the AGD target values, and repeat Steps (2) to (6).
[JAPAN(Type A)]
Breast Thickness PMMA Thickness
L-mode (mGy) N-mode (mGy) H-mode (mGy)
(mm) (mm)
21 20 0.32 0.76 1.08
32 30 0.42 0.76 1.09
45 40 0.55 1.00 1.43
60 50 0.75 1.14 1.73
75 60 1.00 1.44 2.34
A
[US(Type B)/EU(Type C)]
Breast Thickness PMMA Thickness
L-mode (mGy) N-mode (mGy) H-mode (mGy)
(mm) (mm)
Main Specifications
21 20 0.32 0.52 0.75

32 30 0.42 0.69 0.99
45 40 0.55 0.92 1.32
60 50 0.75 1.24 1.79
75 60 1.00 1.66 2.40
90 70 1.36 2.25 3.24
103 80 1.79 2.79 4.27
116 90 2.39 3.96 5.71

■ REFERENCE
To adjust X-ray dose, use a D-tap (with which X-ray dose changes by 10% at one step).
■ REFERENCE
X-ray dose can be calculated with the following formula.
AGD = E • g • c • s
E: Entrance surface dose
g and s: Factor dependent on radiation quality and object’s thickness
c: Factor dependent upon radiation quality, object’s thickness and mammary gland density
For details on g, c, and s values, refer to “European guidelines for quality assurance in breast
cancer screening and diagnosis”.
Example of surface dose and average entrance dose calculated with the formula above
PMMA: 40mm (breast thickness of 45mm)
N-mode
Surface Dose AGD
(mGy) (mGy)
JAPAN (Type A) 3.2 1.00
US (Type B)
2.9 0.92
EU (Type C)
A
Main Specifications

A.5 Storage environment label
n FPD, Controller Unit, Generator and Accessories
n Mammographic stand
A
Main Specifications

Appendix B Test Report
B.1 Physical Laboratory Testing Data
B.1.1 Sensitometric Response
The sensitometric response of the AMULET Innovality system is shown in Figure 18-1, plotted as a
function of the radiation exposure level versus the digital value. As can be seen, the output signal
level is linear relative to the logarithmic exposure scale. The exposure conditions to measure
sensitometric response were 28kVp, W/Rh beam, with 2 mm of added Al filtration.
Figure 18-1: Sensitometric Response of AMULET Innovality
B.1.2 Spatial Resolution

Figure 18-2 provides a quantitative measure of the spatial resolution properties of the AMULET
Innovality system plotted by its pre-sampled Modulation Transfer Function (MTF).
The AMULET Innovality system has a pixel pitch of 50µm, producing a Nyquist frequency of 10
cycles/mm.
Measurements were conducted in accordance with IEC 62220-1-2.
B
Test Report
Figure 18-2: Spatial Resolution of AMULET Innovality

B.1.3 Noise Analysis
Figure 18-3 provides a quantitative measure of the noise properties of the AMULET Innovality
system, as described by a 2-dimensional Noise Power Spectrum (NPS) as a function of spatial
frequency and exposure level. Measurements are provided at the eight exposure levels listed in the
graph’s key. These measurements were performed in accordance with IEC 62220-1-2, W/Rh Target/
Filter combination, 28KVp, with 2.0mm Al.
Figure 18-3: Noise Analysis of AMULET Innovality
B.1.4 Signal-to-Noise Ratio Transfer – DQE

Figure 18-4 provides a quantitative measure of the efficiency of the Signal-to-Noise Ratio (SNR)
transfer of the AMULET Innovality system, as a measure of the Detective Quantum Efficiency (DQE)
as a function of spatial frequency. All DQE calculations were made using the NPS results that were
provided in this section under “Noise Analysis” and performed in accordance with IEC 62220-1-2,
W/Rh Target/Filter combination, 28KVp, with 2.0mm Al.
B
Test Report
Figure 18-4: Signal-to-Noise Transfer for AMULET Innovality

B.1.5 Dynamic Range
The dynamic range of the AMULET Innovality system is shown as measures of Noise Equivalent
Quanta (NEQ) and Detective Quantum Efficiency (DQE) in Figures 18-5 and 18-6, respectively.
These measurements are presented at the exposure levels specified in this section under “Signal-
to-Noise Transfer – DQE”, i.e., W/Rh Target/Filter combination, 28KVp, with 2.0mm Al., and at a
very low spatial frequency (1.0 cycle/mm) and a frequency that is 1/2 of the Nyquist frequency (5.0
cycle/mm) of the AMULET Innovality detector.
Figure 18-5: Dynamic Range-NEQ
Figure 18-6: Dynamic Range-DQE
B.1.6 Image Erasure and Fading B

The AMULET Innovality image readout is accomplished immediately after x-ray exposure, therefore,
image erasure and fading testing is not applicable.
Test Report
B.1.7 Repeated Exposure Test

Because AMULET Innovality utilizes a detector erasing process after each exposure, its Ghost
Image factor is negligible, measured as 0.088, well below the acceptable limiting value of 0.3. Ghost
image testing was performed in accordance with The Addendum on Digital Mammography: The
European Protocol for the Quality Control of the physical and technical aspects of mammography
screening, version 1.0, November 2003.
B.1.8 Automatic Exposure Control Performance
Contrast-to-Noise Ratio (CNR) results for each of the AEC modes available in the AMULET
Innovality system are provided in Figure 18-7. These values were measured using homogeneous
material (PMMA) at thicknesses of 20mm to 70mm. The corresponding exposure conditions
selected by the AEC system are listed in Table 18-1.
Figure 18-7: AEC Performance – CNR
H MODE
PMMA thickness Target Filter Tube Voltage [kV] mAs AGD CNR
20mm WRｈ 26kVp 47 0.7mGy 9.3
30mm WRｈ 27kVp 69 0.9mGy 8.2
40mm WRｈ 28kVp 98 1.2mGy 7.2
50mm WRｈ 30kVp 124 1.7mGy 6.2
60mm WRｈ 31kVp 160 2.1mGy 5.2
70mm WRｈ 33kVp 194 2.7mGy 4.4
Table 18-1: AEC Performance – H Mode Exposure Conditions
N MODE
20mm WRｈ 26kVp 32 0.5mGy 7.9
30mm WRｈ 27kVp 47 0.6mGy 6.9
40mm WRｈ 28kVp 68 0.9mGy 6.1
50mm WRｈ 30kVp 85 1.2mGy 5.1
60mm WRｈ 31kVp 108 1.4mGy 4.3
70mm WRｈ 33kVp 133 1.9mGy 3.6
Table 18-2: AEC Performance – N Mode Exposure Conditions
L MODE
20mm WRｈ 26kVp 18 0.3mGy 6.0
B 30mm
40mm
WRｈ
WRｈ
27kVp
28kVp
28
39
0.4mGy
0.5mGy
5.4
4.7
50mm WRｈ 30kVp 49 0.7mGy 3.9
60mm WRｈ 31kVp 63 0.8mGy 3.2
Test Report
70mm WRｈ 33kVp 77 1.1mGy 2.8

Table 18-3: AEC Performance – L Mode Exposure Conditions

B.1.9 Phantom Testing – ACR MAP
Soft-copy display evaluation results of the ACR MAP phantom at thicknesses of 2cm, 4.2cm, and
6cm with corresponding exposure conditions are provided in Figures 18-8 through 18-10,
respectively. The Nuclear Associates NA18-220 Phantom (MAP) was used for these
measurements. Three observers, engineers at Fujifilm’s Research and Development Center, all with
significant mammography-specific imaging experience, including special training in ACR MAP
phantom evaluation, provided the scoring.
Soft-copy evaluation was performed using a GSDF-calibrated EIZO RadiForceG51 display on a
workstation with ApolloView Lite (Ver.1.3.3.6) DICOM Viewing software.
The MAP Phantom images used for scoring in this Section are included on a CD which is included
in a sleeve at the beginning of the paper copy of this submission.
H-MODE N-MODE
ACR Phantom
20 mm L-MODE
0
Fibers Specks Masses
Figure 18-8: ACR Phantom (2cm) Scoring
H-MODE N-MODE
ACR Phantom
42 mm L-MODE
0
Fibers Specks Masses
B
Figure 18-9: ACR Phantom (4.2cm) Scoring
Test Report

Figure 18-10: ACR Phantom (6cm) Scoring
Table 18-4 provides the relevant exposure information for each ACR MAP image included on the
ACR MAP Phantom Images CD in the media sleeve at the beginning of this submission.
PMMA20mm Hmode Nmode Lmode
AGD 0.86 mGy 0.59 mGy 0.33 mGy
Target/Filter W/Rh W/Rh W/Rh
Tube Voltage 26 kV 26 kV 26 kV
25312 25315 25318
25313 25316 25319
File Name 25314 25317 25320
25321 25334 25337
25322 25335 25338
File Name 25323 25336 25339
File Name 25340 25343 25346
25341 25344 25347
25342 25345 25348
Table 18-4: ACR MAP Phantom Images - Exposure Conditions.
B
Test Report

B.1.10 Phantom Testing – CD MAM
Evaluation results of the CD MAM are shown in Figure 18-11. Tests were performed at multiple
exposure levels that are typically used for mammography with phantom scoring conducted using the
EUREF-recommended “Automated Readout” software, CDCOM Version 1.5.2. Tests were
performed with a beam quality of 30 kVp, W/Rh at the mAs values indicated on the graph. Eight
images were produced at each mAs setting. Each image was scanned and the average plotted.
Error bars represent 2 SEM (standard error on the mean).
Figure 18-11: CD MAM Phantom Scoring
B.1.11 Patient Radiation Dose

Quantitative estimates of patient radiation dose, for AMULET Innovality’s three AEC modes
(H-Mode, N-Mode, L-Mode) at the required thicknesses and simulated breast compositions are
shown in Tables 18-5 through 18-7, respectively. As can be seen by the resultant data and in
compliance with MQSA 21 CFR 900.12(e)(5)(vi), the average glandular dose delivered during s
single craniocaudal view of a phantom simulating a standard breast does not exceed 3.0 mGy per
exposure.
H-MODE
Percent Simulated Breast Thickness (㎝)
Glandular/Adipose
Tissue 2.0 4.2 6.0
30/70 ｋVp 26 28 29
(BR3070) mAs 38 70.8 89
Anode material/x-ray filtration W/Rh W/Rh W/Rh
Entrance Surface Exposure level (mGy) 1.21 3.03 4.39
Average Glandular Dose (mGy) 0.58 0.95 1.16
50/50 ｋVp 26 28 30
(BR12) mAs
Anode material/x-ray filtration
41.7
W/Rh
81.3
W/Rh
95
W/Rh
B
Test Report
70/30 ｋVp 26 28 30
(PMMA) mAs 48.2 103.8 125.7
Table 18-5: Patient Radiation Dose – H Mode

N-MODE
Glandular/Adipose
Tissue 2.0 4.2 6.0
30/70 ｋVp 26 28 29
(BR3070) mAs 25.6 48.3 61.6
50/50 ｋVp 26 28 30
(BR12) mAs 28.2 55.8 65.6
70/30 ｋVp 26 28 30
(PMMA) mAs 32.8 71.9 79.3
Table 18-6: Patient Radiation Dose – N Mode
L-MODE
Glandular/Adipose
Tissue 2.0 4.2 6.0
30/70 ｋVp 26 28 29
(BR3070) mAs 14.7 27.7 35.6
50/50 ｋVp 26 28 30
(BR12) mAs 16 31.9 37.9
70/30 ｋVp 26 28 30
(PMMA) mAs 18.6 41.1 50.0
Table 18-7: Patient Radiation Dose – L Mode
B
Test Report

B.1.12 Breast Compression System
Maximum Compression Force = 200 N
Minimum Compression Force = 0 N
The reason for selecting these levels: IEC60601-2-45
Device: TANITA, HA-622
The breast compression system provides the minimum and maximum powered compression
pressures as shown in Table 18-8 for automatic compression, and Table 18-9 for manual
compression.
These values were measured using the TANITA, HA-622. The HA-622 is placed between the
compression plate and the AMULET Innovality detector.
Testing for Automatic Compression in Table 18-8 was performed by compressing the Test Device by
automatic operation until the compression display of the AMULET Innovality System showed the
force value in the “Display” row. Testing for Manual Compression in Table 18-9 was performed by
manually dialing the force value in the “Display” row. In both case the corresponding indicated value
displayed on the Test Device was read and entered in the measurement row in the tables.
Display (N) 0 44 77 118 154 193

Measurement value (N) 0 44.1 78.4 120.5 157.8 196
Table 18-8: Compression force measurement (Automatic)
Display (N) 0 44 79 115 153 194 203

Measurement value (N) 0 39.2 74 117.6 156 196 205.8
Table 18-9: Compression force measurement (Manual)
Note: The maximum compression force in Automatic mode is 200 N.
B
Test Report

B.2 Clinical Image Evaluation
B.2.1 Clinical Image Evaluation
The study objective was to have expert mammographic radiologists evaluate mammographic
attributes for each case, in order to provide an overall assessment of whether the presented image
sets collectively were of sufficiently acceptable quality for mammographic usage to allow
determination of substantial equivalence to a predicate device.
B.2.2 Study Design, Patient Population and Variables

The Clinical Image Evaluation of the AMULET Innovality was conducted in accordance with Section
9 of the FDA’s Class II Special Controls Guidance Document: Full-Field Digital Mammography
System, dated March 27, 2013, in order to provide the clinical components of a 510(k) premarket
notification submission to the United States Food and Drug Administration.
For this study, subjects whose images were selected contributed an image set (a total of four
images: CC and MLO views of each breast, plus any additional views if a diagnostic case) from the
AMULET Innovality System. The Principal Investigator for this study selected six (6) cases for each
of the three exposure modes (High, Normal, and Low) which were reviewed.
All eighteen (18) cases met the image quality evaluation criteria specified in the Class II Special
Controls Guidance Document: Full-Field Digital Mammography System, Section 9.
This study encompassed a review of the image sets and associated information of screening and
diagnostic subjects with the following criteria:
• Breast Densities as described in the BI-RADS® Atlas;
For the Normal mode, three image sets were of subjects having fatty breasts and three
image sets were from subjects having dense breasts;
For the Low mode, three image sets were of subjects having fatty breasts and three image
sets were from subjects having dense;
For the High mode, three image sets were of subjects having fatty breasts and three image
sets were from subjects having dense breasts;
• The screening image sets consisted of four images: cranio-caudal (CC) and mediolateral
oblique (MLO) views of each breast;
• Three of the image sets for each exposure mode were from diagnostic subjects and in addition
to the four screening views also included additional images such as spot and/or magnification
views.
• The image sets were reviewed in the same manner as clinical images submitted by a
mammography facility for MQSA accreditation;
• The image sets were reviewed by two expert mammographic radiologists, with a third to
resolve disagreements (although the third was unnecessary because there were no
disagreements.
B These radiologists met the radiologists’ qualifications as required by the guidance document.
An overall assessment was made by the two independent reviewers that image sets exposed by the
Fujifilm AMULET Innovality FFDM system collectively are of sufficiently acceptable quality for
Test Report
mammographic usage. No image evaluation issues were raised.

B.2.3 Methodology used in gathering clinical information
The Image acquisition protocol governing collection of the AMULET Innovality cases was approved
by an Investigational Review Board. Per this Protocol:
• The study was conducted in accordance with the ethical principles that have their origins in
the Declaration of Helsinki.
• The IRB, in accordance with 21CFR812 Subpart D and International Conference of
Harmonization (ICH) guidelines for GCP (ICH E6 GCP), provided continuing review of the
study.
• IRB approval of the protocol, the informed consent form, and any other written materials
supplied to the subjects, including any advertisements for subject recruitment, was obtained
and provided prior to enrollment of study subjects.
• Fuji provided each participating image-acquisition site with a model informed consent template
compliant with 21CFR Parts 50 and 56. The consent form was approved by the IRB and
contains all elements required by federal, state, local, and institutional regulations or
requirements.
• The study principal investigator(s), participating radiologist, and staff were responsible for
maintaining accurate, complete, and up-to-date records of each subject. The investigator is
also responsible for maintaining any source documentation related to the study, including any
image data, tracings, computer equipment, pathology reports, or worksheets.
• The privacy of participating subjects was maintained in accordance with the HIPAA privacy
ruling and disclosed per 24CFR50.
• A study monitor representing Fuji retrieved the Case Report Forms (CRF) after validating the
information recorded for accuracy and completeness. The investigator must retain a copy of
all CRFs.
• International Health, LLC served as the Data Management Corporation (DMC). The DMC
responsibilities included oversight of the data collection efforts (excluding image data collected
by Fuji designees), facilitation of data entry into the computerized database, all final data
cleaning, and performance of a final data quality-control audit prior to database lock.
• CRFs were logged and tracked when received by the DMC. CRFs were entered and stored in
a 21CFR11 compliant clinical database.
• To maintain subject confidentiality, an authorized designee at each image-acquisition site
assigned each consented subject a 4-digit subject ID number in consecutive and ascending
order. The site ID number and the subject ID number serve as the subject’s only identifier on
all study-related documentation.
• Fuji or its authorized representative(s) monitored the study. Study monitors visited sites
routinely throughout the study. The monitors confirmed that the study was conducted
according to the protocol.
B
Test Report

Appendix O Using Exposure Unit
Optional Items
O.1 Using the Magnification Table
How to use the magnification table is explained below.
O.1.1 Purpose and preparation of the Magnification Table

Using the magnification table enables 1.8 times magnified mammographic images to be obtained.
The subject’s cross section 30 mm (1.18 in.) above

the top surface of the magnification table is
magnified 1.8 times.
Focal spot
(14.21 in.)
361 mm
650 mm (25.5 in.)
Subject
(1.18 in.)
30 mm
Magnification table
Flat panel sensor
1 Unfold the right- and left-hand side

stays (1) and push the hinge locks all
Unfold the right-hand side stay first.
the way in (2).
Hinge lock
Stay
(1)
(2)
(1) (2)
Stay
Hinge lock
2 Pull the right- and left-hand side hinge

locks forward (3) and fold the stays (4)
Unfold the reft-hand side stay first.
O after using the magnification table.
Hinge lock
Stay
Use of Optional Items
(3) (4)
(4)
(3)
Stay
Hinge lock

3 Scratch-proof sheets are affixed behind Scratch-proof sheet (small)
the magnification table to avoid

Scratch-proof sheet (large)
scratches on the exposure table.
Replace these sheets if they are dirty.
The exposure table may be scratched
when using the magnification table. A
slip-proof sheet is also affixed, so that Slip-proof sheet
the magnification table does not slip off
the exposure table. If the adhesive
strength of the slip-proof sheet is
weakened, replace it with a new one.
CAUTIONS
Be careful not to pinch your hand when using the hinge lock and stay.
O.1.2 Installing the Magnification Table

1 Insert the right- and left-hand side stays 2 When removing the magnification
of the magnification table into the slots table, unlock the guide pins while
on the exposure stand (1). pulling the right- and left-hand side
unlock knobs (2), and then pull the
table until the stays come out of the
Slot
slots (3).
Stay (1)
(1) Slot
Unlock knob Stay
(2)
(2)
Unlock knob
Slip-proof sheet
Exposure table
Magnification table
(3)
CAUTIONS
• ‌When the magnification table is in use, the face guard comes in contact with the
compression plate. Remove the face guard before use.
• ‌Install the magnification table horizontally. If slanted, the stay will fall down under
its own weight and could cause injury to the patient or technologist.
• ‌Make sure that the magnification table is securely installed. If it is not correctly
locked, it could drop off and cause injury to the patient or technologist.
• Be careful not to pinch your fingers when installing the magnification table.
• Be careful not to pinch your fingers when removing the magnification table.
O.1.3 Confirming the Magnification Table Installation

Whether the magnification table is installed or not n Example of display
can be confirmed in the exposure parameters
display section.
Indicates that the magnification table and O
compression plate for magnification are
Exposure table Use/Non-use of Magnification installed.
type Table
NORMAL Not used

MAG Used
The grid is automatically set to “OUT”.
CAUTIONS
Make sure that the magnification table is securely installed. If it is not correctly locked,
the patient may be subject to an unnecessary X-ray dose.

O.2 Attaching the Chest Wall Pad
How to attach the chest wall pad is explained below.
1 Confirm the mark positions (1) on the

chest wall side-edge of the exposure Exposure table
table.
2 Peel the covering off of the double-sided

tape on the rear of the chest wall pad.
(1)
3 Align the marks (1) on the exposure table (1)

with the marks (2) on the chest wall pad,
and then affix the pad to the table.
Chest wall pad

(2)
CAUTIONS
Do not use tape other than the supplied double-sided tape.
O.3 Attaching the Axilla Pads

How to attach the axilla pads are explained below.
1 Peel the covering off of the double-sided

tape on the rear of the axilla pads.
2 Align the marks on the axilla pads and

exposure table, and then affix the pads
(1) to the table.
(1)
O
Exposure table
(1)
The axilla pads are intended to be used symmetrically.
Affix them on both the right- and left-hand sides.
CAUTIONS
Do not use tape other than the supplied double-sided tape.

O.4 Connecting the Remote Exposure Switch
How to connect the remote exposure switch (remote exposure hand switch and/or remote exposure foot
switch) is described below.
1 Insert the modular plug of the remote exposure switch into the modular jack on the
rear of the control pad.
Control box Modular plug
Modular jack
Remote exposure hand switch
Modular plug
Remote exposure foot switch
2 Insert the cable of the remote exposure switch into the modular jack on the control pad.
3 After using the remote exposure switch, hang it on the hook attached to the operation table etc.
CAUTIONS
Read “Radiation safety instructions” and “Radiation protection area” in “1.3 Safety”,
before making an X-ray exposure in the study room with the remote exposure switch
and/or remote exposure foot switch.
O.5 How to Use the Shielding Plate

This section describes how to use the shielding plate.
O.5.1 Attaching the Shielding Plate

1 Slide and attach the shielding plate. Guide
Shielding Plate O
CAUTIONS
Before conducting exposures in a case where shielding is required, make sure that
the shielding plate is correctly set.
O.5.2 Detaching the Shielding Plate
1 Slide and detach the shielding plate.
O.6 How to Use the Face Guard T

This section describes how to use the Face guard T.
O.6.1 Attaching the Face Guard T

1 Attach the Face Guard T by sliding it
in.
Face guard T
O.6.2 Detaching the Face Guard T

1 Detach the Face Guard T by sliding it
out.
O

O.7 How to Use the Face Guard T Comfort
This section describes how to use the Face guard T Comfort.
CAUTIONS
• The Face guard T Comfort cannot be used in combination with the biopsy positioner,
magnification table, compression plate for magnification, rectangle spot magnification
compression plate or round spot magnification compression plate (all of them are optional).
Before attaching the Face guard T Comfort, be sure to check that these optional parts are not
attached.
• The Face guard T Comfort cannot be used simultaneously with the face guard (standard
attachment) or Face Guard T (optional).
O.7.1 Attaching the Face Guard T Comfort

1 Hold the detachable arms of the Face
guard T Comfort with both hands, and hook
them onto the shafts on both sides of the
exposure stand.
Shafts
Detachable arms
2 Attach the Face guard T Comfort by raising

it horizontally.
Ensure that the buttons are locked, which

indicates that the Face guard T Comfort is
attached securely.
<When locked properly>
Right and left buttons are locked: The right
and left buttons are projected.
<When locked improperly>

Right and left buttons are unlocked: The
right and left buttons are retracted.
O
Partially locked: The right or left button is Buttons
projected.
Locked Unlocked
If the right and left buttons are unlocked or

partially locked, detach the Face guard T
Comfort according to the instructions
described in O.7.2 Detaching the Face Button is projected Button is retracted
Guard T Comfort .
Attach the Face guard T Comfort again.
CAUTIONS
If the locks are released, the Face guard T Comfort may fall down and make contact
with the compression plate. When attaching or detaching the Face guard T Comfort,
hold the detachable arms with both hands.
O.7.2 Detaching the Face Guard T Comfort

1 While holding the detachable arms of the
Face guard T Comfort with both hands ,
release the locks by pressing the right and
left buttons, and detach the Face guard T
Comfort.
<When unlocked properly>

Right and left buttons are unlocked: The
right and left buttons are retracted.
CAUTIONS
If the locks are released, the Face guard T Comfort may fall down and make contact
with the compression plate. When attaching or detaching the Face guard T Comfort,
hold the detachable arms with both hands.
O

O.8 How to Use the Compression Plates
with the Shift Function
This section describes how to use the compression plates with the shift function.
The 18 x 24 compression plate (FS Shift P) is used as an example in the procedure below. However,
the same method is applied to other compression plates with the shift function.
The compression plates with the shift function allow exposures in the 18 x 24 cm radiation field at the
central, rightmost, or leftmost position of the exposure table. If the compression part is not set to one of
these positions, the digits on the swivel arm operation panel display will blink to indicate that exposures
cannot be conducted in the correct radiation field.
1 Pull up the lever (1).
2 Slide the compression part in the desired direction while the lever is held up (2).
3 Make sure that the radiation field also shifts in the same direction.
4 Make sure that the lever returns to its original position and that the digits on the swivel arm
operation panel display are not blinking.
Shifting to the left Center Shifting to the right

Swivel arm operation panel display
Lever
(1) (1)
(2) (2)
CAUTIONS
Be careful not to pinch your fingers when sliding the compression part.
O

O

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For Safe Operation

FDR MS-3500 (FDR-3500DRLH)

Operation Manual Product Overview

23rd Edition : November 2020

Daily Inspection and

This system is classified as a medical device under EC Directive 93/42/EEC.

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HINT Shows an item helpful for further effective system operation.

Shows a more detailed operation method or an item that describes additional

iv FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X

Chapter 1 For Safe Operation

Chapter 2 Product Overview

Chapter 5 Daily Inspection and Maintenance

Appendix A Main Specifications

Appendix B Test Report

Appendix O Using Exposure Unit Optional Items

FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X v

For Safe Operation

The correlation applicable between related devices and their constituent

FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X 1

2 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X

1.3.1 Exposure Unit

For Safe Operation

Preventing electrical shock

Preventing radiation damage

FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X 3

resulting in an unintended operation.

System isolation instructions

Radiation safety instructions

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area, in which minimum radiation is present, where a doctor or

Radiation protection area

For Safe Operation

Mechanical safety instructions

s body is caught between the movable parts. Compression plate

Emergency stop button

Software use instructions

FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X 5

Inspect the protective shield (optional) before making X-ray exposures.

Characteristics of the Network

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For Safe Operation

FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525X 7

Technologist’s and patient’s safety instructions

System isolation instructions

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1.4.1 Exposure Unit 1

For Safe Operation

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Further Information for IEC 60601-1-2 (EN 60601-1-2)

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Emissions test Compliance Electromagnetic environment - guidance