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

1
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
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
For Safe Operation
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.

3
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
1
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
For Safe Operation
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.

5
FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N
For Safe Operation
1
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
For Safe Operation
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.