FujiFilm AMULET Innovality FDR MS-3500 User manual

This Operation Manual describes details on basic operations of the FUJIFILM
Digital Mammography System FDR MS-3500 and cautions to be observed when
operating it. Please read the Operation Manual thoroughly before actually
operating the FDR MS-3500 system.
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).
For Safe Operation
Product Overview
Operations
Troubleshooting
Daily Inspection and
Maintenance
Appendices
897N102525N
FDR MS-3500 (FDR-3500DRLH)
Operation Manual
14th Edition : March 2017
Original Instructions
When the manual is provided in languages other
than English, it is considered to be a “Translation
of the original instructions”.
In this case, it must bear the words “Translation of
the original instructions” in place of “Original
Instructions” above.

ii FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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 V5.0 or later
• FDR-3000DRL Application Software V3.0 or later
• AWS Application Software V8.0 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 specied 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.
5 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
remodeling, maintenance, and repair using repair parts other than those specified by
FUJIFILM Corporation.
6 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
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.
8 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
natural disasters, such as res, earthquakes, oods, lightning, etc.
This system is classied 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.)
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.
For information on open source software used in this product, please see the attached CD. 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 conrmed 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 © 2012-2017 FUJIFILM Corporation. All rights reserved.

iii
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
FUJIFILM Digital Mammography System
Operation Manuals
Manage and store all the Operation Manuals of the devices constituting the system together as a set.
See “Workstation FDR-3000AWS Operation Manual” for optional items for the AWS.
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual
FDR MS-3500 Option Tomosynthesis BiopsySoftware Operation Manual
FUJIFILM Mammography Workstation FDR-3000AWS Operation Manual
FDR MS-3500 Option CEDM Software Operation Manual
FDR MS-3500 Option Tomosynthesis Exposure Tomosynthesis Exposure Software Operation Manual
FDR-2000BPY Option Lateral Approach Kit Operation Manual
Biopsy Connection FDR-2000BPY Operation Manual
The following FDR MS-2500 options are usable.
FDR-2000BPY Option Lateral Approach Kit Operation Manual
Biopsy Connection FDR-2000BPY 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.
WARNING
Indicates hazardous situations that may lead to serious injuries or even death
if the precaution is not or cannot be followed.
CAUTIONS
Indicates a potentially hazardous situation which may result in slight or
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 897N102525N
Contents
Introduction ..............................................................................................................................ii
FUJIFILM Digital Mammography System Operation Manuals................................................ iii
How to Read This Manual....................................................................................................... iii
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......................................................................... 12
1.6 Location of Each Label .............................................................................................16
1.7 Diagnosis System Safety Standard Requirements................................................... 24
Chapter 2 Product Overview
2.1 Features of the Diagnosis System............................................................................ 25
2.2 Diagnosis System Conguration............................................................................... 26
2.3 Part Names and Functions ......................................................................................28
Chapter 3 Operations
3.1 System Basic Operation Procedures........................................................................ 32
3.2 Changing the Compression Plate............................................................................. 34
3.3 Emergency Stop ....................................................................................................... 36
3.4 Sleep Mode............................................................................................................... 37
Chapter 4 Troubleshooting
4.1 Diagnosis System Troubleshooting and Solutions.................................................... 38
4.2 Example of Diagnosis System messages................................................................. 38
Chapter 5 Daily Inspection and Maintenance
5.1 Daily Inspection and Maintenance............................................................................ 39
5.2
Periodical Inspections of the Exposure Unit .....................................................................................42
Appendix A Main Specications
A.1 Specications............................................................................................................ 44
A.2 Checking Radiation Field Sizes with Each Compression Plate................................ 47
A.3 Automatic Exposure Control (AEC) .................................................................................. 50
A.4 AGD measurement ................................................................................................... 52
A.5 Storage environment label........................................................................................54
Appendix B Test Report
B.1 Physical Laboratory Testing Data ............................................................................. 55
B.2 Clinical Image Evaluation ......................................................................................... 64
Appendix O Using Exposure Unit Optional Items
O.1 Using the Magnication Table................................................................................... 66
O.2 Attaching the Chest Wall Pad ...................................................................................68
O.3 Attaching the Axilla Pads ..........................................................................................68
O.4
Connecting the Remote Exposure Switch............................................................................... 69
O.5 How to Use the Shielding Plate ................................................................................69
O.6 How to Use the Face Guard T.................................................................................. 70

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FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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1
Chapter 1 For Safe Operation
1.1 Precautions Before Operating This
Equipment
Before using this equipment, please read “Precautions Before Operating This Equipment” carefully so
that you can operate it correctly.
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 modication,
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 condentiality 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.

2FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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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.
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.
2-2. Conrm 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. 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.

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FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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1.3 Safety
Read this section before using the equipment to ensure proper handling.
1.3.1 Exposure Unit
Preventing explosion
WARNING
• 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 nd 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 ofcial 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.

4FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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1
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 nd any failure,
contact our ofcial dealer.
•Before exposure with X-ray, check that the patient has been positioned appropriately.
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,
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 ofcial 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 ofcial 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-specied 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 eld 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.

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FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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Radiation protection area
The manager of the facility must specify the radiation protection
area, in which minimum radiation is present, where a doctor or
technologist can make an exposure safely, using the gure below
as a guide.
1.5 m
45°
Low level radiation area
Radiation protection area
Patient
Protective shield
(optional)
1.5 m
WARNING
• Only qualied 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 gure below.
WARNING
• A patient’s or technologist’s hand, foot or other body
parts may hit or be caught by the potentially dangerous
parts. Eliminate all dangers completely.
• When operating the equipment by the foot switch, swivel
arm control panel or control pad, make sure that no
hand, foot, or other part of the technologist’ s or patient’
s body is caught between the movable parts.
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.
Dangerous parts on the exposure stand
(Movable parts)
Swivel arm
This part rotates.
Exposure table
This part moves up/down.
Space between the compression
plate and face guard or swivel arm
(when the face guard is not installed)
Face guard
Compression plate

6FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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1
Mammography-specic instructions
Only qualied 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 and IEC60601-2-45:2011.
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
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 eld. 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
•Conrm 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, conrm that the other systems
are not affected. If they are affected, take countermeasures such as network separation.

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FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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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
- Upgrade of devices
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 ofcial dealer.
•Disinfection may be required for the optional items of the system. See the related Operation
Manuals for details.
•Clean/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.

8FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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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, re or electrical shock may occur due to the electrical load
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.
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 ofcial 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.
Classication
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: IPX1
Remote exposure foot switch (optional): IPX8
4) According to the degree of safety of application in the presence of a ammable anesthetics mixture
with air or with oxygen or nitrous oxide.
Equipment not suitable for use in the presence of a ammable anesthetics mixture with air or with
oxygen or nitrous oxide.
5) According to the mode of operation
Continuous operation with intermittent loading

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FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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1.4 Electromagnetic Compatibility (EMC)
1.4.1 Exposure Unit
This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-
2:2007(EN 60601-1-2:2007/AC:2010).
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment 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 equipment.
•Connect the equipment into an outlet on a circuit different from that to which the other device(s) are
connected.Consult a FUJIFILM dealer for help as necessary.
This Operation Manual contains the names of standards applied in IEC 60601-1-2.
The names of standards applied in EN 60601-1-2 are replaced as follows.
IEC 60601-1-2
(descriptions in this Operation Manual) Standards applied in EN 60601-1-2
CISPR 11:1997+A1:1999+A2:2002 EN 55011
IEC 61000-3-2:2000+A1:2001+A2:2004 EN 61000-3-2
IEC 61000-3-3:1994+A1:2001+A2:2005 EN 61000-3-3
IEC 61000-4-2:1995+A1:1998+A2:2000 EN 61000-4-2
IEC 61000-4-3:2006 EN 61000-4-3
IEC 61000-4-4:2004 EN 61000-4-4
IEC 61000-4-5:2005 EN 61000-4-5
IEC 61000-4-6:2003+A1:2004+A2:2006 EN 61000-4-6
IEC 61000-4-8:1993+A1:2000 EN 61000-4-8
IEC 61000-4-11:2004 EN 61000-4-11
Further information for IEC 60601-1-2 (EN 60601-1-2)
Model name FUJIFILM Digital Mammography System FDR MS-3500 is referred to as FDR MS-3500 in this
section.
• Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the accompanying documents.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• Information regarding the cable affecting EMC is as follows.
Name General Specication
Network Cable (AWS) Cat5e or more,UTP type and straight cable
Network Cable (Exposure unit) Cat5e or more, UTP type and straight cable
• The use of accessories, 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 .
• The FDR MS-3500 should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the FDR MS-3500 should be observed to verify normal operation
in the conguration in which it will be used.
• Basic performance of equipment and system
Obtains digital images by using the at panel sensor, and processes, records and outputs the obtained
images.
• Test items (Tables 1 to 4)

10 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
The FDR MS-3500 is intended for use in the electromagnetic environment specied 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
RF emissions
CISPR 11 Group 1
The FDR MS-3500 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11 Class A
FDR MS-3500 is suitable for use in all establishments other than domestic and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 N/A
Voltage uctuations/
icker emissions
IEC 61000-3-3
N/A
Table 2
Guidance and manufacturer’s declaration - electromagnetic immunity
The FDR MS-3500 is intended for use in the electromagnetic environment specied below.
The customer or the user of the FDR MS-3500 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
±2kV for power supply
lines
±1kV for input/output lines
±2kV for power supply
lines
±1kV for input/output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV differential mode
±2kV common mode
±1kV differential mode
±2kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<5%
UT
(>95% dip in UT )
for 0.5 cycle
<5%
UT
(>95% dip in UT )
for 0.5 cycle
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the FDR
MS-3500 requires continued operation
during power mains interruptions, it is
recommended that the FDR MS-3500 be
powered from an uninterruptible power
supply or a battery.
40% UT
(60% dip in UT )
for 5 cycles
40%
UT
(60% dip in UT )
for 5 cycles
70%
UT
(30% dip in UT )
for 25 cycles
70%
UT
(30% dip in UT )
for 25 cycles
<5%
UT
(>95% dip in UT )
for 5 s
<5%
UT
(>95% dip in UT )
for 5 s
The nominal input current of the FDR
MS-3500 exceeds 16A by phase.
Power frequency
(50/60Hz) magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE:
UT is the a.c. mains voltage prior to application of the test level.

11
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
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Table 3
Guidance and manufacturer’s declaration - electromagnetic immunity
The FDR MS-3500 is intended for use in the electromagnetic environment specied below.
The customer or the user of the FDR MS-3500 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the FDR MS-3500, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
d
= 1.2 P 80 MHz to 800 MHz
d = 2.3 P 800 MHz to 2.5 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 xed RF transmitters, as determined by an
electromagnetic site survey,ashould 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 higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
a Field strength from xed 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 xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld 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, eld 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.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.2 P
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2.5 GHz
d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in 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 reection from structures, objects and people.

12 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
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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.
• 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)
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 lm badge or pen dosimeter to monitor exposure doses you receive.
• Make sure that the X-ray radiation eld 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 eld covers only the breast to be exposed, using the light
eld 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 qualied 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 aked 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 magnication table horizontally. If slanted, the stainless stay will fall down under its own weight
and could cause injury to the patient or technologist.

13
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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• Make sure that the compression plate, face guard, magnication 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 ofcial dealer to have it replaced with a new
one. Using a broken or damaged compression plate is highly dangerous.
• When using the magnication 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
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 magnication 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.
• When installing or removing the magnication table, tightly hold the bottom part with both hands. If not,
the table might fall and cause an injury.
• When cleaning the magnication 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 laminated 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 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 re.
• 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, insufcient 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 insufcient 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 insufcient image quality.

14 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
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• 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 lm. 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 eld are appropriately
positioned.
• If unusual dots, lines (black or white), or density unevenness is observed on images, perform calibration.
Managing data
• The system identies 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
Specications”.
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.

15
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
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1.5.2 Diagnosis System
Preventing accidents
• When opening or closing the door on the operation table to start up the AWS, be careful not to catch your
ngers or hands.
• Be careful not to get your ngers 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
in the power supply unit or other components could result in smoke or re.
• 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
the system shutdown procedure, and wait until the equipment is automatically powered off.
• When the monitor arm is not in use, x 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 ofcial 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 uorescent tube is running out.
In this case, use of the monitor adjustment tool or service by our ofcial 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 identies 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.

16 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
1
1.6 Location of Each Label
The positions where the labels are afxed on the exposure unit are shown below. The relevant safety
signs are also described.
1.6.1 Location of Labels on the Exposure Unit
n Exposure stand
3. Stop Label
1. Sub-circuit ON 2. Sub-circuit OFF 4. Caution Label
(Regarding Physical
Contact)
Do not touch the biopsy positioner
connector. Touching it may cause a
system failure.
3
4
3
1
2
5
: Type B applied part
5. Type B applied
part label
5
Stamped number (350N101885)