For Safe

Operation

Product
Overview

Basic
Operation

FDR-1000DRLZ/FDR-1000DRSZ
Operation Manual Troubleshooting
3rd Edition May 2009
Daily Inspection
and
Maintenance

Appendix

Maintenance
and Inspection

This Operation Manual describes details on how to operate

FUJIFILM Digital Mammography FDR-1000DRLZ and FDR-
1000DRSZ and cautions to be observed when operating it. Please
read the Operation Manual thoroughly before actually operating
the FDR-1000DRLZ or FDR-1000DRSZ.
After reading this manual, store it nearby the FDR-1000DRLZ or
897N100873B FDR-1000DRSZ so that you can see it whenever necessary.
 FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B
ii
 Introduction
FUJIFILM Digital Mammography FDR-1000DRLZ and FDR-1000DRSZ are designed
exclusively for the FDR MS-1000 to obtain digital mammographic images.

This Operation Manual provides necessary information for using the FUJIFILM Digital
Mammography FDR-1000DRLZ and FDR-1000DRSZ (hereinafter collectively referred to as
“exposure unit”), such as the equipment overview, operation procedures and precautions to
observe, as well as daily inspections and maintenance.
This Operation Manual contains descriptions of both types of the exposure units. Read this
manual after confirming the type of your exposure unit.

This Operation Manual is applicable to the following software version.

• DRLZ application software V1.0
• DRSZ application software V1.2

Accompanying documents were originally drafted in the English language.

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.
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 fires, earthquakes, floods, lightning, etc.

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.
Caution: R
 x Only in the United States (Federal law restricts this device to sale by or on
the order of a physician.)

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 © 2008-2009 FUJIFILM Corporation. All rights reserved.

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

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 FUJIFILM Digital Mammography System
Operation Manuals

FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ

Operation Manual

FUJIFILM Mammography Workstation FDR-1000AWS Operation Manual

See “FUJIFILM Mammography Workstation FDR-1000AWS Operation Manual”

for optional items for the AWS.

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

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 Contents at a Glance

Chapter 1 For Safe Operation

This chapter describes the warnings and cautions for safe
operation of the exposure unit.

Chapter 2 Product Overview

This chapter gives the names of various units and describes their
functions and the features of the exposure unit.

Chapter 3 Basic Operation

This chapter describes an operational sequence of the system
startup through study execution to system shutdown.

Chapter 4 Troubleshooting
This chapter describes actions should be taken if problems occur
in the the exposure unit.

Chapter 5 Daily Inspection and Maintenance

This chapter describes daily care and maintenance for keeping the
exposure unit in optimum working condition.

Appendix A Main Specifications

Maintenance and Inspection

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 How to Read This Manual
The page configuration, marks and notations used in this Operation Manual are explained below.

Basic page configuration

The pages of this Operation Manual basically consist of the following elements:

Section title Lead

Indicates the operation that is Describes information that is about to be
covered in the section. explained in this section together with
supplementary information.

3.2 Basic Operation Procedures

Basic operation procedures of the exposure unit are described below.

Item title When using the FDR MS-1000 system, operations are required on the AWS. See “FUJIFILM Digital
Mammography System FDR MS-1000 Operation Manual” and “FUJIFILM Mammography Workstation
Index
FDR-1000AWS Operation Manual” for details.
Indicates the operation that is Allows you to open a
covered under the item. desired chapter
3.2.1 Starting Up the System
It takes approximately 30 minutes (including automatic calibration) until you can make an exposure after
quickly.
pressing the System On button.

NOTE
Before starting up the system, make sure to release compression by using the decompression button.
Otherwise, an error occurs.

1 Confirm that the circuit breaker of the control cabinet is ON.

Operation procedure

Basic Operation
A sequence of numbered
Breaker ON
operational steps to guide the
user through an operation.

Breaker OFF

Circuit breaker

2 Press the System On button of the control pad to turn the exposure stand on.
Calibration starts automatically after powering on the exposure stand.

System On button

NOTE
When it passes 1:00 a.m. without shutting down the system, calibration starts automatically.

3 Turn on the monitor by pressing the power switch.

Monitor

Power switch

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

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Page number
Indicates the order of a particular
page in a chapter.

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 Marks
Marks are used in the descriptions to mark supplementary information and information that
must be observed while using the exposure unit. For your safety and correct use, always
observe a Warning or Caution.

Indicates a dangerous situation which, if ignored or

cannot be followed for some reason, could result in death
or serious injury.

Indicates a hazardous situation which, if ignored or

cannot be followed for some reason, could result in a
slight or moderate degree of personal injury or material
damage.

NOTE Indicates information that should be noted.

TIP Indicates information that may be helpful.

Indicates an item that provides details of the procedure or
related information.

★ Indicates a procedure that is dependent on the situation.

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 Contents

Chapter 1 For Safe Operation

1.1 Precautions Before Operating This Equipment...................... 1-2
1.2 Precautions to be Observed When Using the Electric Medical
Equipment.............................................................................. 1-3
1.3 Safety..................................................................................... 1-4
1.4 Electromagnetic Compatibility (EMC).................................... 1-10
1.5 Precautions in Using the Exposure Unit................................. 1-14
1.6 Location of Each Label........................................................... 1-16
1.6.1 Location of Labels on the Exposure Unit....................... 1-16
1.6.2 Safety and Other Signs................................................. 1-22
1.7 Dimensions and Installation Requirements............................ 1-23
1.7.1 External Dimensions of the Exposure Stand.................. 1-23
1.7.2 External Dimensions of the Control Cabinet.................. 1-24
1.7.3 Necessary Space for Installing the Exposure Stand and
Control Cabinet............................................................ 1-24

Chapter 2 Product Overview

2.1 Part Names and Functions . .................................................. 2-2
2.1.1 Part Names and Functions of the Exposure Unit........... 2-2

Chapter 3 Basic Operation

3.1 Flow Chart of Basic Operations of the System...................... 3-2
3.2 Basic Operation Procedures ................................................. 3-3
3.2.1 Starting Up the System................................................. 3-3
3.2.2 Replacing the Compression Plate................................. 3-5
3.2.3 Shutting Down the System........................................... 3-8
3.3 Emergency Shutdown............................................................ 3-9
3.3.1 Emergency Shut-down Button...................................... 3-9
3.3.2 Emergency Shutdown Operation.................................. 3-9
3.3.3 Restoration from Emergency Shutdown........................ 3-10

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 Chapter 4 Troubleshooting
4.1 Troubleshooting..................................................................... 4-2
4.2 When an Error Message Appears.......................................... 4-3
4.2.1 Error Messages Appearing Without Error Code............. 4-3
4.2.2 Errors in the Exposure Unit........................................... 4-4
4.3 When an X-ray Image is Defective......................................... 4-6
4.3.1 Types of Calibration...................................................... 4-6
4.3.2 Panel Check................................................................. 4-7
4.3.3 Field Calibration............................................................ 4-7

Chapter 5 Daily Inspection and Maintenance

5.1 Daily Inspection and Maintenance ............................................. 5-2
5.1.1 Exposure Unit............................................................... 5-2
5.2 Periodical Inspection . ........................................................... 5-5
5.2.1 Weekly Inspection . ...................................................... 5-5
5.2.2 Monthly Inspection . ..................................................... 5-5
5.2.3 Yearly and Biyearly Inspection....................................... 5-5
5.2.4 Warming Up the Exposure Stand.................................. 5-6

Appendix A Main Specifications

A.1 Specifications......................................................................... A-2
A.1.1 Exposure Unit................................................................ A-2
A.2 External View and Weight...................................................... A-7
A.2.1 Exposure Unit............................................................... A-7
A.3 Checking Radiation Field Sizes with Each Compression Plate... A-8
A.3.1 Radiation Field Sizes..................................................... A-8
A.3.2 Checking Radiation Field Size....................................... A-9
A.4 Automatic Exposure Control (AEC)............................................. A-11
A.4.1 Coverage...................................................................... A-11
A.4.2 Confirming the AEC ON/OFF........................................ A-13
A.4.3 Checking the Absorbed Dose ...................................... A-13

Maintenance and Inspection

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 FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B
x
 Chapter 1
For Safe Operation

Page

1.1 Precautions Before Operating This Equipment________ 1-2

1.2 Precautions to be Observed When Using the Electric
Medical Equipment_________________________________ 1-3
1.3 Safety_____________________________________________ 1-4
1.4 Electromagnetic Compatibility (EMC)_________________ 1-10
1.5 Precautions in Using the Exposure Unit______________ 1-14
1.6 Location of Each Label_ ____________________________ 1-16
1.7 Dimensions and Installation Requirements____________ 1-22

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

1-1
 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.
For Safe Operation

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.

This system is classified as a medical device under EC Direc-

tive 93/42/EEC.
This equipment has been designed on the assumption that
the patient would not come into direct contact with it or for
operation by appropriately trained operator.

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.

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

1-2
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.

For Safe Operation

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. 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. 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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 1.3 Safety
Read this section before using the equipment to ensure proper handling.
See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details.

Preventing explosion

WARNING
For Safe Operation

Because this equipment is not explosion-proof, do not use combustible and explosive
gases near the equipment.

WARNING

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

The input voltage for the exposure unit is AC208/230/240V～.

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.

WARNING

Do not use the equipment in a location where the equipment may be exposed to any
liquids. Never allow any liquid to spill on 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.

WARNING

Do not use the equipment in a location where metal particles could come into the
equipment. This may cause an electrical shock.

WARNING

• 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.

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

1-4
 CAUTION

Follow the specified procedure when turning off the equipment. Otherwise, the flat panel
sensor could be damaged by thermal shock.

CAUTION

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.

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

Make sure that no patient is around the equipment before powering on it after an electrical
outage.

WARNING

Inspect the equipment before leading a patient to the equipment. Should you find any
failure, contact our official dealer.

WARNING

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.

WARNING

• Make sure to keep observing movements of both equipment and patient while
positioning the movable parts at the patient's body.
• When making an exposure of a seated patient, prepare a height-adjustable chair and
lower the seat to the end.

WARNING

Make sure that a patient’s hand or foot does not touch the swivel arm control panel,
control pad or foot switch.

WARNING

Exposure should be made in an environment where the technologist can visually and
aurally determine the patient’ s condition.

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

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 WARNING

If the equipment malfunctions while adjusting the movable parts or performing a study
immediately press the emergency shut-down button and contact our official dealer.

System isolation instructions

WARNING

To ensure complete system isolation, never install any unauthorized accessories or other
For Safe Operation

such items.
When it is necessary to install authorized accessories or optional items, contact our
official dealer.

WARNING

Keep equipment other than the exposure stand out of reach of patients to ensure
appropriate system isolation.

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 is controlled by the following.

• Early release of the release radiation switch
• X-ray tube unit hardware backup timer
• Detection of abnormality in the generator

WARNING
• Operate the equipment by following the instructions given in the Operation Manual.
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.

WARNING

Use the longest possible focal spot to skin distance to minimize the absorbed dose.

WARNING

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.

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 Radiation protection area
The manager of the facility must specify the area where patients may enter considering the radiation
protection area shown below.

Low level radiation area

m
5
1.
Patient

For Safe Operation

Protective shield
(optional)

Radiation protection area

WARNING

• 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 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.

See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details on the
protective shield (optional).

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
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.

Dangerous parts on the exposure stand (Movable parts)

Swivel arm
This part rotates.
Face guard
Space between the
compression plate and
face guard or swivel
arm (when the face
guard is not installed)
Compression plate
Exposure table
This part moves up/down.

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 WARNING

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 shut-down button

WARNING
For Safe Operation

Press the emergency shut-down button to immediately turn off the equipment in an
emergency. This cuts off the power to the exposure stand, forcibly shutting down the
system.
The equipment has the three buttons: two on the exposure stand and one on the control pad.

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.

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.

WARNING

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.

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B

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 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.

Conformance to standards

For Safe Operation

This equipment conforms to the following:
• IEC 60601-1:1988 Ed.2+A1:1991+A2:1995
• IEC 60601-1-4:1996 Ed.1.0+A1:1999
• EN 980:2003
• EN 1041:1998

Laser notice

This equipment is the Class 1 laser product which conforms to IEC 60825-1:1993+A1:1997+A2:2001.

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: IPX1
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

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 1.4 Electromagnetic Compatibility (EMC)

This equipment complies with the following standard regarding Electromagnetic Compatibility (EMC).
EMC standard : IEC 60601-1-2:2001+A1:2004 (EN 60601-1-2:2001+A1:2006)
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation.
For Safe Operation

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
Standards applied in EN 60601-1-2
(descriptions in this Operation Manual)
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 FDR-1000DRLZ/FDR-1000DRSZ is referred to as FDR-
1000DRLZ/FDR-1000DRSZ 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 Specification

Network Cable Cat5e or more,
STP type and straight cable

• T he 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-1000DRLZ/FDR-1000DRSZ.
• The FDR-1000DRLZ/FDR-1000DRSZ should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the FDR-1000DRLZ/FDR-1000DRSZ should be observed to verify
normal operation in the configuration in which it will be used.

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 Guidance and manufacturer’s declaration - electromagnetic emissions
The FDR-1000DRLZ/FDR-1000DRSZ is intended for use in the electromagnetic environment specified below.
The customer or the user of the FDR-1000DRLZ/FDR-1000DRSZ should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
The FDR MS-1000 uses RF energy only for its internal function. Therefore,
RF emissions
Group 1 its RF emissions are very low and are not likely to cause any interference in
CISPR 11
nearby electronic equipment.
RF emissions
Class A
CISPR 11

For Safe Operation

Harmonic emissions The FDR MS-1000 is suitable for use in all establishments other than
N/A
IEC 61000-3-2 domestic and those directly connected to the public low-voltage power
Voltage fluctuations/ supply network that supplies buildings used for domestic purposes.
flicker emissions N/A
IEC 61000-3-3

Guidance and manufacturer’s declaration - electromagnetic immunity

The FDR-1000DRLZ/FDR-1000DRSZ is intended for use in the electromagnetic environment specified below.
The customer or the user of the FDR-1000DRLZ/FDR-1000DRSZ should assure that it is used in such an
environment.
Electromagnetic environment - guid-
Immunity test IEC 60601 test level Compliance level
ance
Electrostatic discharge ±6kV contact ±6kV contact Floors should be wood, concrete or
(ESD) ±8kV air ±8kV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/ ±2kV for power supply ±2kV for power supply Mains power quality should be that
burst lines lines of a typical commercial or hospital
IEC 61000-4-4 ±1kV for input/output ±1kV for input/output environment.
lines lines
Surge ±1kV differential mode ±1kV differential mode Mains power quality should be that
IEC 61000-4-5 ±2kV common mode ±2kV common mode of a typical commercial or hospital
environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be that
interruptions and (>95% dip in UT) (>95% dip in UT) of a typical commercial or hospital
voltage variations on for 0.5 cycle for 0.5 cycle environment. If the user of the
power supply input 40% UT 40% UT FDR-1000DRLZ/FDR-1000DRSZ
lines (60% dip in UT) (60% dip in UT) requires continued operation during
IEC 61000-4-11 for 5 cycles for 5 cycles power mains interruptions, it is
70% UT 70% UT recommended that the FDR-
(30% dip in UT) (30% dip in UT) 1000DRLZ/FDR-1000DRSZ be
for 25 cycles for 25 cycles powered from an uninterruptible
<5% UT <5% UT power supply or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s

Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60Hz) magnetic should be at levels characteristic of
field a typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

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 Guidance and manufacturer’s declaration - electromagnetic immunity
The FDR-1000DRLZ/FDR-1000DRSZ is intended for use in the electromagnetic environment specified below.
The customer or the user of the FDR-1000DRLZ/FDR-1000DRSZ should assure that it is used in such an
environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
IEC 61000-4-6 150 kHz to 80 MHz equipment should be used no closer to any part of
the FDR-1000DRLZ/FDR-1000DRSZ, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.
For Safe Operation

Recommended separation distance

Radiated RF 3 V/m 3 V/m d = 1.2 P
IEC 61000-4-3 80 MHz to 2.5 GHz 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 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 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-1000DRLZ/FDR-
1000DRSZ is used exceeds the applicable RF compliance, the FDR-1000DRLZ/FDR-1000DRSZ should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the FDR-1000DRLZ/FDR-1000DRSZ.
b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

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 Recommended separation distances between
Portable and mobile RF communications equipment and the FDR-1000DRLZ/FDR-1000DRSZ
The FDR-1000DRLZ/FDR-1000DRSZ is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled.
The customer or the user of the FDR-1000DRLZ/FDR-1000DRSZ can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the FDR-1000DRLZ/FDR-1000DRSZ as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power m
of transmitter

For Safe Operation

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
d = 1.2 P d = 1.2 P 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 reflection from structures, objects and
people.

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 1.5 Precautions in Using the Exposure Unit

See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for other related
precautions.

Minimizing exposure
For Safe Operation

• 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 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.
• 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 patient's blood or other infectious material, disinfect the parts immediately with a
disinfectant, etc.
• 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.

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• Before rotating the swivel arm, make sure that the patient is away from the exposure stand.
• 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 shut-down button is
within their reach.
• 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.
• Do not apply force of 135 kg or greater on the armrests. Otherwise, they may break.

For Safe Operation

• Check the conditions of the patient (whether she has an implanted pacemaker/defibrillator or breast implants,
etc.) before executing a study.

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.
• Install a cover on the collimator when using the X-ray tube unit rotated ± 180°. If blood or other material
penetrates into the collimator, the equipment may malfunction.

Maintaining image quality

• 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.

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 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.

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 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

For Safe Operation

■ Exposure stand
3 1. System Label

4 4

1
2

2. Rating Label
3. Stop Label

4. Successive Operation Condition Label

Sign Meaning
Caution

When moving the swivel arm up/down time after time, allow a
60-second or longer interval between 16-second movements.

When rotating the swivel arm time after time, allow a

23-second or longer interval between 24-second movements.
When performing compressions one after another without
making X-ray exposures, allow a 120-second or longer
interval between 30-second compressions.
When mounting/dismounting a grid time after time, allow a
90-second or longer interval between the operations.

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 5. Second Set of Labels

For Safe Operation

FPD

XXXXXXX

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 Foot switch

Right-hand side Left-hand side

Foot switch label

For Safe Operation

Foot Switch Label Foot Switch Label

Remote exposure foot switch

Remote exposure foot switch model number label

Model number label
Remote exposure foot switch label

Remote Exposure Foot Switch Label Model Number Label

10139752

Remote Exposure Foot Switch Model Number Label

ExposureSW(フットタイプ) 126Y100016

XXXXXXX

See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details of optional
items.

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■ Compression plate
• 24×30 (Low) Model Number Label

14404867

• 24×30 (High) Model Number Label

14404866

For Safe Operation

• 18×24 (Low) Model Number Label

14404859

• 18×24 (High) Model Number Label

14404858

• Rectangle spot Model Number Label

14404862

• For axilla radiography Model Number Label

14404863

• For magnification Model Number Label

14409863

• Rectangle spot magnification Model Number Label

14409864

• 2D biopsy Model Number Label

14409803

See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details of optional
items.

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 The following table shows compression plates available for each exposure unit.
Name FDR-1000DRLZ FDR-1000DRSZ
24 x 30 compression plate (Low) Standard —

24 x 30 compression plate (High) Standard —

18 x 24 compression plate (Low) Optional Standard

18 x 24 compression plate (High) Optional Standard

Compression plate, rectangle spot Optional

Compression plate for axilla radiography Optional

For Safe Operation

Compression plate for magnification Optional

Compression plate, rectangle spot magnification Optional

2D biopsy compression plate Optional

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■ Control pad
1. Warning Label
1

2. Stop Label

For Safe Operation

3 4 6

3. Revision Number Label

4. Model/Serial Number Label

8

9 7

8. Caution Label (for Connection) 5. DHHS Certification Label

See "FUJIFILM Digital Mammography System

FDR MS-1000 Operation Manual" for how to
connect the remote exposure switch.

9. Successive Operation Condition Label 6. Spare Part Number Label

7. Connector Number Label (X3)

Sign Meaning
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 tube” in “A.1 Specifications”.

See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details of optional
items.

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 1.6.2 Safety and Other Signs
The following safety signs are used in the labels on the exposure unit or on its body.

Sign Description

Attention, consult ACCOMPANYING DOCUMENTS.

Stop
For Safe Operation

Power-OFF (partial)

Power-ON (partial)

Protective grounding (to the earth)

Alternating current

Type B application

High voltage

Electrical or electronic equipment to be collected separately for disposal

Year of manufacture

Environmentally Friendly Use Period (EFUP)

Connection point for the neutral conductor on permanently installed

N equipment

Light field lamp button icon

This button does not function

Icon of height adjustment by the foot switch

Icon of compression/decompression by the foot switch

Swivel arm up/down movement icon

Swivel arm angle adjustment icon

Grid mounting/dismounting icon

Operation-on icon

Operation-off icon

Exposure icon

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1.7 Dimensions and Installation
Requirements

The installation requirements for the exposure unit are described below.

1.7.1 External Dimensions of the Exposure Stand

For Safe Operation

Unit: mm

Swivel arm rotation range

1580

427 1175

Maximum height of
the swivel arm 80
15
Vertical movement range
2350

of the exposure table

850

70
0

Swivel arm rotation range

650

600
920
1100

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 1.7.2 External Dimensions of the Control Cabinet

Unit: mm

565 265
For Safe Operation

570
1.7.3 Necessary Space for Installing the Exposure
Stand and Control Cabinet
The exposure stand and control cabinet should be installed in a location having the space shown in the
figures below at minimum.
Control cabinet

0（*1） Unit: mm
500
100
Cable length:
Approx. 4200

2690
Exposure stand

1500 1500

990

(*1): The control cabinet can be installed with

its back in close contact with the wall.
3000

Top view

Unit: mm

2400 (*1)

2100 (*2)

(*1): When using the exposure unit without changing the factory settings
(*2): When the upper limit of the vertical movement was reduced 300 mm
at the time of installation
Right-side view

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 Chapter 2
Product Overview

Page

2.1 Part Names and Functions __________________________ 2-2

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 2.1 Part Names and Functions

Part names and functions of the exposure unit are described below.

2.1.1 Part Names and Functions of the Exposure Unit

■ Exposure stand
Emergency shut-down button
(Located at the left- and right-hand sides of the column)
Product Overview

Column
The swivel arm moves up or down this column.

Swivel arm
Mammography exposure unit equipped
with swivel function.

Exposure stand display panel

Angle of swivel arm

Compressed breast thickness
Compression force

Progress bar

This displays the angle of swivel arm,

Right-hand Left-hand compressed breast thickness and compression
force. The progress bar indicates the image
1 2 4 5 5 4 2 1 reading status after the exposure.
The time remaining until reading completion is
also displayed on the progress bar.

6 6 The foot switch consists of two sets,

one each for right- and left-hand sides.
3 3

1 Compression foot Step on this switch to move the 4 Swivel arm down Step on this switch to lower the
switch* compression plate of the swivel arm foot switch swivel arm.
to strengthen breast compression.
5 Swivel arm up foot Step on this switch to raise the
2 Decompression Step on this switch to move the switch swivel arm.
foot switch compression plate of the swivel
arm to release breast compression. 6 Swivel arm control Use this to raise or lower the
foot switch swivel arm.
3 Compression/ Use this to start compression or
decompression decompression of the compression
switch plate of the swivel arm.

* Lightly stepping on the switch turns on the light field lamp, indicating the radiation field.

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■ Swivel arm
Emergency shut-down button (Located at the left- and
right-hand sides of the column)
Shut-down button in case of emergency. Press this once to
shut 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. Decompression button
To release the
Swivel arm Swivel arm up compression plate
counterclock- button manually.
wise rotation Press this to raise Face guard
button the swivel arm. This keeps the face of a
Press this to rotate Swivel arm clockwise patient away from the
the swivel arm path of X-ray exposure.
rotation button
counterclockwise.
Press this to rotate Compression
Swivel arm the swivel arm adjustment knob
down button clockwise. Use this to fine-adjust

Product Overview
Press this to lower This button cannot the compression
the swivel arm. pressure.
be used.
Light field lamp button Compression plate
Press this to turn on or off This compresses breast
the light field lamp. during exposure.
Flat panel sensor
Exposure table Flat panel detector which
Set breast on this table during converts X-ray images
exposure. directly into electric signals.

■ Control cabinet
Principally no user operation is required.

Breaker ON

CAUTION

Breaker OFF Do not turn off the power to the control

cabinet.
Circuit breaker

■ Control pad
Emergency shut-down button
Shut-down button in case of emergency.
Press this once to shut off the power to the
exposure stand and stop it forcibly.

System Off button

Press this to turn off the
exposure stand.
Not in use

Decompression button System On button

Press this to release the Press this to turn on the
compression plate when it exposure stand.
is in the compressing
position.

Release radiation switch

Press this to start radiation of the
exposure stand.

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 ■ Operation desk

Operation desk
Place the AWS on this.
Product Overview

See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for optional items.

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 Chapter 3
Basic Operation

Page

3.1 Flow Chart of Basic Operations of the System_ _______ 3-2

3.2 Basic Operation Procedures ________________________ 3-3
3.3 Emergency Shutdown_ _____________________________ 3-9

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 3.1 Flow Chart of Basic Operations
of the System
Flow of basic operations of the exposure unit is described below.
When using the FDR MS-1000 system, operations are required on the AWS. See “FUJIFILM Digital
Mammography System FDR MS-1000 Operation Manual” and “FUJIFILM Mammography Workstation
FDR-1000AWS Operation Manual” for details.

1 Start up the system.

2 Perform calibration.
Basic Operation

3 Input patient information.

4 Select exposure menu items.

5 Attach the compression plate.

6 Position the patient.

7 Perform exposures.

8 Shut down the system.

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3.2 Basic Operation Procedures
Basic operation procedures of the exposure unit are described below.
When using the FDR MS-1000 system, operations are required on the AWS. See “FUJIFILM Digital
Mammography System FDR MS-1000 Operation Manual” and “FUJIFILM Mammography Workstation
FDR-1000AWS Operation Manual” for details.

3.2.1 Starting Up the System

It takes approximately 30 minutes (including automatic calibration) until you can make an exposure after
pressing the System On button.

NOTE
Before starting up the system, make sure to release compression by using the decompression button.
Otherwise, an error occurs.

1 Confirm that the circuit breaker of the control cabinet is ON.

Basic Operation
Breaker ON

Breaker OFF

Circuit breaker

2 Press the System On button of the control pad to turn the exposure stand on.
Calibration starts automatically after powering on the exposure stand.

System On button

NOTE
When it passes 1:00 a.m. without shutting down the system, calibration starts automatically.

3 Turn on the monitor by pressing the power switch.

Monitor

Power switch

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 4 Turn on the personal computer by pressing the power switch.

Power switch

Personal computer

5 When a completion message appears, the calibration is finished.

Automatic calibration takes approximately 15 minutes. Do not operate the AWS or exposure unit
during the calibration.
NOTE
If the system is restarted within 30 minutes after shutdown, an exposure can be made after approximately
15 minutes, as automatic calibration is skipped.
NOTE
Basic Operation

If the exposure unit has not been used for a week or more, warm up the equipment after startup.
See “5.2.4 Warming Up the Exposure Stand” for details.

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3.2.2 Replacing the Compression Plate
Replace with an appropriate compression plate according to the exposure menu item.

1 Confirm that the face guard is attached.

NOTE
If the face guard is not attached, attach it by pushing it in the mounting part of the swivel arm.

Swivel arm

Face guard

Basic Operation
2 Press the lock release in the left-hand arrow direction in the figure below to unlock the
compression plate.
NOTE
When the peripheral area of the compression plate socket is visible, the lock is released.
Peripheral area of the compression plate socket
Lock release

Compression plate

3 Pull the compression plate out of the compression plate socket.

CAUTION

Be careful not to pinch your fingers when uninstalling the compression plates.

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 4 Insert the pole of the compression plate into the compression plate socket on the swivel arm
until you hear a locking sound.

Lock release

Compression plate socket

Compression plate

NOTE
When the compression plate is correctly installed, 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.
Basic Operation

5 Confirm that the peripheral area of the compression plate socket is hidden under the lock
release.
NOTE
If the peripheral area is visible, the compression plate is not locked. Insert it further.
Lock release
Pole Peripheral area of the compression plate socket

CAUTION

• Make sure that the compression plate 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 compression plates.

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 6 Confirm that the name of the attached compression plate is displayed on the monitor.
If the name is not displayed, check if the compression plate is attached correctly.
The types of compression plates and their names displayed in the exposure parameters display
section are as shown in the table below.

Remark
Name Type
FDR-1000DRLZ FDR-1000DRSZ
Not used. — —

24 x 30 compression plate (High) 24 × 30 HIGH Standard —

24 x 30 compression plate (Low) 24 × 30 LOW Standard —

18 x 24 compression plate (High) 18 × 24 HIGH Optional Standard

18 x 24 compression plate (Low) 18 × 24 LOW Optional Standard

Compression plate, rectangle spot RECTANGULAR SPOT Optional

Compression plate, rectangle spot

RECTANGULAR SPOT MAG Optional
magnification

Basic Operation
Compression plate for magnification MAG Optional

Compression plate for axilla

AXILLA 18 x 24 Optional
radiography

2D biopsy compression plate 2D-BIOPSY Optional

NOTE
• If using the optional magnification table, attach it in this step.
See “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details on
the magnification table.
• W
 hen using the compression plate for rectangle spot magnification or for magnification, be sure to use
the magnification table (optional).

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 3.2.3 Shutting Down the System
NOTE
Before shutting down the system, make sure that no compression is still being applied.

1 Press the System Off button of the control pad to turn the exposure stand off.

System Off button

2 Confirm that the message “The line is being disconnected.” is displayed on the monitor,
and then shut down the system on the AWS.
Basic Operation

NOTE
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.

3 Select in the “Patient Information Input window”, and then select from
the displayed menu.

4 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.

NOTE
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.

5 Turn off the monitor by pressing the power switch.

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3.3 Emergency Shutdown
When the equipment abnormally operates or in case of emergency, press the emergency shut-down
button to forcibly stop the equipment.
When restoring the exposure unit, operations are required on the AWS. See “FUJIFILM Digital
Mammography System FDR MS-1000 Operation Manual” and “FUJIFILM Mammography Workstation
FDR-1000AWS Operation Manual” for details.

3.3.1 Emergency Shut-down Button

Emergency shut-down buttons 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.
Emergency
shut-down
button Emergency shut-down
button

Basic Operation
3.3.2 Emergency Shutdown Operation
1 Press one of the emergency shut-down buttons.
The exposure stand operation (swivel arm movement or X-ray radiation) stops.
The compression plate moves to the decompression position and stops.
If the compression plate is not released, rotate the compression adjustment knob to manually release it.

2 Lead the patient to a safe place outside the study room.

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 3.3.3 Restoration from Emergency Shutdown
CAUTION

Before restoring the system, make sure that the patient is away from the exposure stand.

1 Turn the depressed emergency shut-down button clockwise to release its locked state.

2 Select [OK] in the displayed error message window to restore the system.
For example, the following message appears: “Emergency stop operation[00015] :
Pressing the button below will start restore processing on the exposure unit.”
NOTE
Information in an exposure or input in progress at the time of the shutdown cannot be restored.
Basic Operation

3 When the system is restored, the “Patient Information Input window” appears. Retry
operations from the patient information input.

4 If the system is not restored, shut down the system.

See “3.2.3 Shutting Down the System” for details.

5 Make sure that the system is shut down completely, wait 5 seconds and restart the system.
See “3.2.1 Starting Up the System” for details.

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 Chapter 4
Troubleshooting

Page

4.1 Troubleshooting____________________________________ 4-2

4.2 When an Error Message Appears____________________ 4-3
4.3 When an X-ray Image is Defective_ __________________ 4-6

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 4.1 Troubleshooting
The troubleshooting information is given below.
When using the FDR MS-1000 system, operations are required on the AWS. See “FUJIFILM Digital
Mammography System FDR MS-1000 Operation Manual” and “FUJIFILM Mammography Workstation
FDR-1000AWS Operation Manual” for details.

When the exposure unit does not operate normally, see the relevant pages to take necessary actions
according to the symptom shown below.
Should you encounter any trouble you cannot handle, contact our official dealer.

Possible problems

The exposure unit does not start up.

Contact our official dealer.

An X-ray exposure cannot be made.

Contact our official dealer.

An error message appears.

Troubleshooting

See “4.2 When an Error Messages Appears”.

An X-ray image has streaks/dots or density uneveness.

See “4.3 When an X-ray Image is Defective”.

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4.2 When an Error Message Appears

This section describes necessary actions to clear error messages that may appear on the AWS monitor.

4.2.1 Error Messages Appearing Without Error Code

When the following errors occur, only the error messages appear on the AWS monitor. Perform the
relevant remedial actions. If the equipment does not operate normally despite taking the remedy,
contact our official dealer.

Message Cause Remedy

The exposure device is adjusting its The temperature of the X-ray tube Wait until the temperature
temperature. is too high. decreases.
The door is open. The door switch is activated. Close the door of the study room.
The exposure device is in • The collimator is operating. Wait until the operation stops.
preparation. • A grid is being mounted or
dismounted.
Check the combination of the table The compression plate cannot be Install the correct compression

Troubleshooting
and the paddle. used with the exposure table. plate or exposure table.
The compression paddle is not set An incorrect compression plate is Install the correct compression
up correctly. installed or no compression plate plate.
is installed. This message is displayed while
no compression plate is installed.

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 4.2.2 Errors in the Exposure Unit
When an error occurs in the exposure unit, the error code and message appear as shown in the table
below. If an error not listed below occurs, restart the system. If the error keeps on recurring after the
system restart, contact our official dealer.

Error
Message Cause Remedy
code
50950 Hardware error[50950] : Pressing the button Hardware error Restart the system.
below will start restore processing on the
exposure unit.
50951 Firmware error[50951] : Pressing the button Firmware error
below will start restore processing on the
exposure unit.
50952 Power Supply error[50952] : Pressing the Power Supply error
button below will start restore processing on
the exposure unit.
50953 Door switch error[50953] : Pressing the button Door switch error
below will start restore processing on the
exposure unit.
50954 Emergency stop operation[50954] : Pressing Emergency stop
the button below will start restore processing operation
on the exposure unit.
Troubleshooting

50955 User operation error[50955] : Pressing the User operation

button below will start restore processing on error
the exposure unit.
50956 Environment setting error[50956] : Pressing the Environment setting
button below will start restore processing on error
the exposure unit.
50957 Error with compression paddle[50957] : Error with
Pressing the button below will start restore compression
processing on the exposure unit. paddle
50958 Exposure unit operational error[50958] : Exposure unit
Pressing the button below will start restore operational error
processing on the exposure unit.
50959 Exposure unit error[50959] : Pressing the Exposure unit error
button below will start restore processing on
the exposure unit.
50960 AEC error[50960] : Pressing the button below AEC error
will start restore processing on the exposure
unit.
50961 Communication error[50961] : Pressing the Communication
button below will start restore processing on error
the exposure unit.
50962 Temperature-control error[50962] : Pressing Temperature-
the button below will start restore processing control error
on the exposure unit.
50963 Compression unit error[50963] : Pressing the Compression unit
button below will start restore processing on error
the exposure unit.
50964 General error[50964] : Pressing the button General error
below will start restore processing on the
exposure unit.

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 Error
Message Cause Remedy
code
51950 [51950] An unknown error occurred. Console Error [Unit Restart the system.
Control]
54950 Perform exposure for calibration. System requires Perform operations following
exposure operation the displayed messages.
for Field Calibration. See “4.3.3 Field Calibration”
for details.
54951 When performing exposure for calibration, System finds Remove the compression plate
remove the compression paddle and set a unexpected objects and magnification table and
regular object table. between X-ray press [OK] button.
source and FPD.

Troubleshooting

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 4.3 When an X-ray Image is Defective
When an X-ray image has streaks (black/white) or dots, or the density is uneven, perform a
calibration.

4.3.1 Types of Calibration

There are two types of calibration: Panel Check and Field Calibration.
In the Panel Check, the flat panel detector (FPD) is calibrated in the same manner as in the calibration
automatically performed at the time of system startup.
In the Field Calibration, the FPD is more precisely calibrated by making an exposure.

Type Panel Check Field Calibration

Display in the message Display Calib
—
display
Main processing • Erasure • Erasure
The FPD is initialized • Defect data creation
• Defect data creation • Offset and shading correction data creation
Defects on the FPD are Image correction data, based on information
located and memorized. obtained by X-ray radiation, is memorized.
Troubleshooting

X-ray radiation Not required Required

Timing of calibration When streaks/dots appear on When the image density is uneven or streaks/
an image. dots on an image persist after the Panel Check.
Required time* Approx. 15 min. Approx. 30 min.
Abortion/Switch • Either type can be aborted within 20 seconds after the calibration start by
selecting [Abort]. After this, calibration cannot be aborted.
• The Field Calibration can be switched to the Panel Check within 20 seconds after
the calibration start. Once switched, it cannot be aborted.
*: The required times in the table above are mere indications. They may be more or less depending on the system status.

Selecting (calibration menu button) displays menus associated with calibration.

: Aborts calibration.

: Aborts field calibration and performs panel check.

: Performs panel check.

: Performs field calibration. Follow the displayed message to make an exposure.

: Cancels the menu display.

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4.3.2 Panel Check
The Panel Check requires approximately 15 minutes.

1 Select and then [Panel Check] in the menu.

The Panel Check starts.
To abort it, select [Abort] within 20 seconds.
If the calibration is aborted, redo it from the start.

2 When a completion message appears, the calibration is finished.

4.3.3 Field Calibration

The Field Calibration requires approximately 30 minutes.
Follow the displayed message to make an exposure.

1 Remove the compression plate, and magnification table if installed, from the exposure stand
and confirm that there is no object on the exposure table.
See “3.2.2 Replacing the Compression Plate” and “FUJIFILM Digital Mammography System
FDR MS-1000 Operation Manual” for how to remove the compression plate and magnification table.

Troubleshooting
2 Select and then [Field Calibration] in the menu.
To abort it, select [Abort] within 20 seconds.
To switch the type to the Panel Check, select [Switch] within 20 seconds.
When 20 seconds have passed after selecting [Field Calibration], the calibration can no longer be
aborted or switched.
If the calibration is aborted, redo it from the start.

3 When the message requesting an X-ray radiation appears, press the release radiation switch.
The exposure conditions are automatically set to the following values.

•Mo/Mo, 30kV, and 75mAs

•Mo/Mo, 23kV, and 11.7mAs

4 When a completion message appears, the calibration is finished.

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Troubleshooting

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 Chapter 5
Daily Inspection and
Maintenance
Page
5.1 Daily Inspection and Maintenance _____________________ 5-2
5.2 Periodical Inspection _______________________________ 5-5

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 5.1 Daily Inspection and Maintenance

Information on daily inspection and maintenance of the exposure unit.

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.

■ Inspection before studies

No. Items to be inspected Details of inspection
1 Status indicator Make sure that the status indicator shows no error.
2 Compression plate • Check the compression plate before starting up the system.
If the system starts up with a phantom compressed, an error occurs.
Before starting up the system, make sure to release compression by
using the decompression button.
• Make sure that the compression plate has not suffered from
excessive 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.
Daily Inspection and Maintenance

• If anything is wrong with the plate, replace it with new one.

CAUTION

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.
3 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
contact our official dealer.
4 Height and angle adjustment • Make sure that you cannot raise, lower, or rotate the swivel arm when
of the swivel arm the compression force is set to 30N or more.
• If the swivel arm operates in the above mentioned condition, turn off
the exposure stand and contact our official dealer.

■ Inspection during studies

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

TIP
During starting up of the exposure stand, the release radiation switch
briefly turns yellow to inspect LED.

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■ AEC inspection
Perform AEC inspection in the following procedures that require the operations on the AWS.
See “FUJIFILM Mammography Workstation FDR-1000AWS Operation Manual” for details.

1 Remove the compression plate and magnification table from the exposure stand to clear
the space between the radiation source and exposure table.

2 Press (exposure mode setting button) and select [Semi] (semi auto).

3 Specify the tube voltage with (tube voltage setting button) and the target/filter with
(target/filter setting button).
The recommended settings are as follows:
•23 kV and Mo/Mo

4 Make an exposure.
The release radiation switch lights for a while (approximately one second).
The displayed mAs is under 20 mAs.

5 Place a Pb cover over the exposure table.

A Pb apron, etc. can be used.

6 Make an exposure under the same conditions as before.

The release radiation switch lights for a while (approximately one second).

Daily Inspection and Maintenance

If the error message (“AEC error[50960]: Pressing the button below will start restore processing on the
exposure unit.”) appears, the AEC is normally functioning.

CAUTION

If the error message does not appear, shut down the exposure stand and contact our official
dealer.

7 Remove the Pb cover.

8 Follow the message and select [OK] to start the restore processing.
When the restore processing finishes, the AEC normally operates.

■ 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
• Exposure table/Magnification table
• Armrests
• Face guard

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 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.

CAUTION

Make sure to use a recommended detergent to clean the equipment. Improper detergent may
damage the equipment.

CAUTION

Make sure not to let detergent get inside the equipment during cleaning.

Disinfection
Ethanol for disinfection is recommended.
Parts to be disinfected:
• Compression plate
• Exposure table/Magnification table
• Face guard

WARNING

Confirm that the respiratory density of disinfectant is under legal regulation.

Daily Inspection and Maintenance

Certain disinfectants may damage health. When using a disinfectant, follow instructions
supplied by the manufacturers.

CAUTION

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.

CAUTION

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.

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5.2 Periodical Inspection

Periodical inspection of the exposure unit is described below.

5.2.1 Weekly Inspection

Restart the system once a week.
Wait more than 5 seconds after shutting down the system, and then start up the system.

5.2.2 Monthly Inspection

■ Emergency shut-down button
1 Press the emergency shut-down button and confirm that operations through the swivel arm
control panel and foot switches are disabled.

WARNING

If the swivel arm still operates, turn off the breaker that supplies power to the exposure
stand and contact our official dealer.

■ Brake mechanism of the compression motor

Daily Inspection and Maintenance

1 Place a phantom (45 mm PMMA Plexiglas, RM156) on the exposure table, and compress it by
the compression plate until the compression force reaches 150N.

2 After a minute, confirm that changes of the value are within the range of ±20N.

WARNING

If the compression force changed more than ± 20N, turn off the exposure stand and contact
our official dealer.

5.2.3 Yearly and Biyearly Inspection

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.
Inspection items are the same in a yearly and biyearly inspection.
Inspection items are as follows.
• Swivel arm up/down movement and rotation
• Compression plate movement
• Emergency shut-down button
• Collimator
• Exposure table
• Coolant

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 Part to be replaced once in two years is as follows.
(Clean the part in the year when replacement is not performed.)
• Air filter

“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.

5.2.4 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.
The following procedure requires the operations on the AWS.
See “FUJIFILM Mammography Workstation FDR-1000AWS Operation Manual” for details.

1 Protect the exposure table by using the Pb protective apron, etc.

NOTE
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 “FUJIFILM Digital Mammography System FDR MS-1000 Operation Manual” for details.
Daily Inspection and Maintenance

3 Press (exposure mode setting button) to select [Manu] (manual mode) .

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.
23 kV 80 mAs Making an exposure 3 times
23 kV 120 mAs Making an exposure 3 times
25 kV 150 mAs Making an exposure 3 times
28 kV 250 mAs Making an exposure 2 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.

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 Appendix A
Main Specifications

Page

A.1 Specifications______________________________________ A-2

A.2 External View and Weight___________________________ A-7
A.3 Checking Radiation Field Sizes with Each Compression
Plate______________________________________________ A-8
A.4 Automatic Exposure Control (AEC)___________________ A-11

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 A.1 Specifications
Specifications of the exposure unit including processing capabilities are described below.
They are subject to change without prior notice.

A.1.1 Exposure Unit

Power Requirements
Input voltage Input current Frequency
AC208V~
13.5 A
(Single phase)
AC230V~
12.2 A 50 Hz/60 Hz
(Single phase)
AC240V~
11.7 A
(Single phase)

Maximum Allowable Impedance

208 V 0.25Ω
230 V 0.30Ω
240 V 0.35Ω

Characteristics of Circuit Breaker

Number of electrodes 2
Rated Rated insulation voltage
500
breaking Ui V
capacity (kA) AC 230 V 32A or less

Max. Insulation Distance

Creepage 3 mm
Clearance 3 mm
Operating Characteristic Curves
Main Specifications

Operating characteristic curves

NF50-SR

Maximum
Operation time

Minimum

Current (Percentage of rated current)

Temperature Characteristic Curves

time variation (%)
Percentage of operation

temperature
ambient
Reference

Ambient temperature (°C)

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 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

Attenuation Equivalent
• Exposure table : 0.1 mmAl
• Magnification table: 0.15 mmAl
• Inner cover: 0.01 mmAl

Operating Mode
Continuous operation with intermittent loading
Continuous Operation
60 exposures/hour (28 kV/100 mAs)

SID (Focal Spot to Image Receptor Distance)

65 cm

Main Specifications

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 Heating and cooling curves of the X-ray tube assembly

Room temperature 20 °C
Average rotor power 124 W

Anode heating and cooling curves

P 40 Mo W

Minimum exposure interval for energy input to X-ray tube

450
Main Specifications

400

350
Min. exposure interval [s]

300

250

200

150

100

50

0
0 2000 4000 6000 8000 10000 12000 14000 16000 18000 20000
Input for exposure [kV * mA * s]

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 Tube load curves

Focus 0.1 Mo Focus 0.1 W

Focus 0.3 Mo Focus 0.3 W

Main Specifications

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 X-ray Tube (Mo/W)
Type: P40 Mo/W
Molybdenum or tungsten/molybdenum rotating anode with a beryllium window.
Focal Spot Size
Large focal spot : 0.3 mm Small focal spot : 0.1 mm
(Determined with the star pattern test.)
X-ray Tube Current (Mo/W)
Maximum tube current at a focal spot on a molybdenum target
Large focal spot : 150 mA at 25 kV
Small focal spot : 28 mA at 25 kV
Maximum tube current at a focal spot on a tungsten target
Large focal spot : 188 mA at 25 kV
Small focal spot : 34 mA at 25 kV
Nominal Maximum Tube Voltage
40 kV
Anode and Filter Combination Mo/W Tube
Mo/30 μm Mo
Mo/25 μm Rh
W/50 μm Rh

High Voltage Generator

Tube Voltage Waveform
Multi-pulse (500 kHz high-frequency)
Tube Voltage Range
23 kV to 35 kV (at 1 kV increments)
mAs Setting Range (28 kV, Mo Target)
Large focal spot : 2 mAs to 500 mAs (±10%, +0.2 mAs)
Small focal spot : 2 mAs to 140 mAs (±10%, +0.2 mAs)
Exposure Time
Large focal spot : 10 ms to 4 s
Small focal spot : 60 ms to 4 s
Voltage setting accuracy: ±5% (measured in the high-voltage circuit)
mAs setting accuracy: ±5% (measured in the high-voltage rectifier circuit)
Nominal Maximum Power (25 kV to 35 kV)
Molybdenum anode: large focal spot: 3.75 kW / small focal spot: 0.7 kW
Tungsten anode: large focal spot: 4.7 kW / small focal spot: 0.85 kW
X-ray Conversion Method
Main Specifications

Direct conversion
X-ray Conversion Material
a-Se
Effective Image Area
(1) FDR-1000DRSZ
177 mm (vertical) x 237 mm (horizontal)
(2) FDR-1000DRLZ
236.4 mm (vertical) x 296.4 mm (horizontal)
Pixel Resolution
50 x 50 μm/pix
Number of Pixels
(1) FDR-1000DRSZ
3540 (vertical) x 4740 (horizontal) = 16,779,600 pixels
(1) FDR-1000DRLZ
4728 (vertical) x 5928 (horizontal) = 28,027,584 pixels
Density Resolution
16 bit
Spatial Frequency Limit
10.0 lp/mm
Calibration Frequency
At least 1 time/day

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A.2 External View and Weight

The external view and weight of the exposure unit are described below.

A.2.1 Exposure Unit

Width (mm) Depth (mm) Height (mm) Weight (kg)

Exposure stand Approx. 920-1,580 Approx. 1,175 Approx. 1,930-2,350 Approx. 345

Control cabinet Approx. 265 Approx. 565 Approx. 570 Approx. 21.5

NOTE
Dimensions and weight are subject to change due to the specification change, etc.

Main Specifications

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 A.3 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.
When using the FDR MS-1000 system, operations are required on the AWS. See “FUJIFILM Digital
Mammography System FDR MS-1000 Operation Manual” and “FUJIFILM Mammography Workstation
FDR-1000AWS Operation Manual” for details.

A.3.1 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

With a grid Without a grid
24 x 30 compression 30 cm
30 cm
plate (High)
24 x 30 compression
24 cm

16.5 cm
plate (Low)
0.5 cm

0.5 cm
Chest wall edge Chest wall edge

18 x 24 compression 24 cm
24 cm
plate (High)
18 x 24 compression
18 cm

16.5 cm
plate (Low)
0.5 cm

0.5 cm
Chest wall edge Chest wall edge
Main Specifications

2D biopsy compression 24 cm
24 cm
plate
18 cm

16.5 cm
0.5 cm

0.5 cm

Chest wall edge Chest wall edge

Compression plate,
rectangle spot
9 cm
9 cm
0.5 cm

Chest wall edge

Compression plate,
rectangle spot
12.4cm
magnification
12.4cm
0.5cm

Chest wall edge

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 Compression plate Radiation field sizes
Mo target W target
Compression plate for
24 cm 20cm
magnification

16.5 cm

16.5cm
0.5 cm

0.5cm
Chest wall edge Chest wall edge

Compression plate for

axilla radiography
20 cm

8 cm
0.5 cm
Chest wall edge

A.3.2 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 When the compression plate is correctly installed, 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. Check that the light field size corresponds to the radiation field size
of the compression plate.

Radiation field size

Main Specifications

NOTE
If the compression plate is not correctly installed, the light filed lamp does not light. In this case, check and
correct the compression plate installation.

See “3.2.2 Replacing the Compression Plate” for how to replace the compression plate.

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 2 Check the compression plate name displayed on the monitor.

NOTE
Check that the installed compression plate is displayed.

Remark
Name Type
FDR-1000DRLZ FDR-1000DRSZ
Not used. — —

24 x 30 compression plate (High) 24 × 30 HIGH Standard —

24 x 30 compression plate (Low) 24 × 30 LOW Standard —

18 x 24 compression plate (High) 18 × 24 HIGH Optional Standard

18 x 24 compression plate (Low) 18 × 24 LOW Optional Standard

Compression plate, rectangle spot RECTANGULAR SPOT Optional

Compression plate, rectangle spot

RECTANGULAR SPOT MAG Optional
magnification

Compression plate for magnification MAG Optional

Compression plate for axilla

AXILLA 18 x 24 Optional
radiography

2D biopsy compression plate 2D-BIOPSY Optional

Main Specifications

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A.4 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.4.1 Coverage
■ 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.
See “FUJIFILM Mammography Workstation FDR-1000AWS Operation Manual”for details on the
exposure modes.

• X-ray tube voltage

23 kV - 35 kV

• X-ray tube current

Maximum tube current on a molybdenum target

Large focal spot: 20 mA - 150 mA

Small focal spot: 10 mA - 28 mA

Maximum tube current on a tungsten target

Large focal spot: 20 mA - 188 mA

Small focal spot: 10 mA - 34 mA

• AEC area

Main Specifications
The AEC detects X-rays in the shadowed area shown in the figure below.

11cm

9.8cm

2.5cm
0.5cm

Chest wall edge

NOTE
To detect X-rays properly, object must cover AEC area at least 2.5cm from chest wall side.

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 ■ Controlling conditions
In [Auto] (full auto mode), exposure is automatically controlled as follows.

Dose level
Compressed
breast H-mode L-mode W-mode
thickness
(mm) Tube Tube Tube
Target/Filter Target/Filter Target/Filter
voltage voltage voltage
20 Mo/Mo 26 Mo/Mo 26 W/Rh 26

30 Mo/Mo 27 Mo/Mo 27 W/Rh 26

40 Mo/Rh 28 Mo/Mo 28 W/Rh 28

50 Mo/Rh 28 Mo/Rh 28 W/Rh 28

60 Mo/Rh 30 Mo/Rh 30 W/Rh 29

70 W/Rh 29 W/Rh 29 W/Rh 29

80 W/Rh 30 W/Rh 30 W/Rh 30

90 W/Rh 30 W/Rh 30 W/Rh 30

In [Manu] (manual mode), specify the exposure conditions using the following table as a guide since the
exposure is not controlled automatically.

Compressed breast
Tube voltage (kV) Target/Filter mAs
thickness (mm)
20 26 Mo/Mo 22

30 27 Mo/Mo 28

40 28 Mo/Rh 45

45 28 Mo/Rh 56

50 28 Mo/Rh 63
Main Specifications

60 30 Mo/Rh 80

70 29 W/Rh 220

* The above values are the recommended parameters for exposures in L-mode (low dose).
* 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.

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A.4.2 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] (full auto) or [Semi] (semi auto), the AEC is being applied.
For details, see “FUJIFILM Mammography Workstation FDR-1000AWS Operation Manual”.

A.4.3 Checking the Absorbed Dose

The absorbed dose in an exposure can be checked on the X-ray control panel.
When a patient's breast positioned on the exposure table is compressed, the type of compression plate
and exposure table, and compression force are displayed on the X-ray control panel.
The exposure unit and AWS automatically* calculate the absorbed dose based on these and related
information and an exposure is made.

(*) First the incident dose is estimated from the exposure conditions (target/filter) and actual dose (mAs/kV) of an
exposure. Then the absorbed dose is calculated from the incident dose and compressed breast thickness by
following the EUREF guidelines.
The absorbed dose can be automatically calculated only when compressed breast thickness is between 20 to
100 mm.

Main Specifications

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Main Specifications

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Maintenance and Inspection
1 Maintenance and Inspection Items Assigned to Specified
Dealer
For periodical inspection of the equipment and necessary arrangements, consult our official dealer.

Maintenance and Inspection

FUJIFILM Digital Mammography FDR-1000DRLZ/FDR-1000DRSZ Operation Manual 897N100873B