FDR-3000AWS Operation Manual [PDF]

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FUJIFILM FDR-3000AWS

FUJIFILM Mammography Workstation

FDR-3000AWS Operation Manual 14th Edition March 2020

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This Operation Manual describes details on how to operate the FDR3000AWS and cautions to be observed when operating it. Please read the Operation Manual thoroughly before actually operating the FDR3000AWS system. After reading this manual, store it nearby the FDR3000AWS so that you can see it whenever necessary. Please read the Reference Guide for details on how to operate and its functions (including options).

END-USER SOFTWARE LICENSE AGREEMENT FUJIFILM Corporation The license of the Software (as defined below) granted hereunder is contingent upon the Licensee’s acceptance of all the terms provided herein, and any use of the Software by the Licensee shall be deemed as such acceptance. This Product contains software ("Software") and related written materials ("Documentation"). The term "Software" shall include any updates, upgrades, modified versions, additions and copies of the Software licensed to you by FUJIFILM Corporation ("FUJI"). 1. License. Subject to the terms and conditions of this Agreement, you are granted a limited, non-exclusive, non-transferable and non-sublicensable license to use the Software and the Documentation only on a single computer until such rights are terminated according to Section 8 below. 2. Ownership. It is acknowledged and agreed that FUJI retains all title and rights to the Software the Documentation and all copies thereof, and no title or rights to the Software or the Documentation is transferred or licensed to you except as expressly set forth herein. 3. Restriction on Use. You may: (i) make and retain one extra copy of the Software for backup purposes only; and (ii) copy the Documentation only as reasonably necessary for user reference and backup purposes. Each copy of the Software and Documentation made by you shall contain the same proprietary notices, labels, and marks as the original thereof without any alteration. You shall not: (i) sell, sublicense, assign, lease, encumber or otherwise transfer the Software or the Documentation or the rights granted hereunder; (ii) reverse engineer, decompile, disassemble or create derivative works of the Software; (iii) remove or alter any proprietary notices, labels or marks on or contained in any part of the Software or the Documentation; (iv) make any copies of the Software or the Documentation except as permitted above; or (v) install the Software on any computer other than as permitted by this Agreement. As a condition of the use of the Software by you, you hereby represent and warrant that you shall not use the Software for any purpose that is unlawful or prohibited by this Agreement. You agree to abide by all applicable laws and regulations in your use of the Software. 4. Export Control. You shall comply with all export and re-export restrictions and regulations imposed by the government of the United States and other relevant countries or regions (“Export Restrictions”). You shall not knowingly transfer, directly or indirectly, any restricted software or technical data received hereunder or the direct product of such data, to any country or region identified as an embargoed destination or country in the Export Restrictions, unless prior written authorization is obtained from FUJI and each appropriate United States or other government agencies. This Section shall survive the expiration or termination of this license agreement. 5. Update and Upgrade. FUJI may, at its sole discretion, make any update or upgrade of the Software available; however, FUJI shall have no obligations to make any update or upgrade of the Software available. 6. Limited Warranty. FUJI hereby warrants that the Software shall operate in substantial conformity with the then current Documentation, when used in strict compliance with such Documentation. This warranty shall be effective only for one year following your receipt of the Software (hereinafter referred to as “Warranty Period”). This warranty is conditioned upon the installation and use of the latest version of the Software released by FUJI in strict compliance with the then current Documentation. If the Software fails to perform as warranted in the Warranty Period, FUJI shall use commercially reasonable efforts to correct such Software. THE FOREGOING STATES THE SOLE AND EXCLUSIVE REMEDIES TO WHICH YOU ARE ENTITLED FOR FUJI'S BREACH OF WARRANTY. FUJI HEREBY DISCLAIMS ANY OTHER WARRANTIES WITH RESPECT TO THE SOFTWARE AND DOCUMENTATION, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ALL WARRANTIES REGARDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. 7. Limitation of Liability. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, FUJI SHALL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND (INCLUDING WITHOUT LIMITATION, LOST PROFITS OR LOST DATA), WHETHER SUCH DAMAGES ARE BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR OTHERWISE (INCLUDING ANY DAMAGES WHICH ARE IN ANY WAY CONNECTED WITH ANY USE OF THE SOFTWARE OR DOCUMENTATION), EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 8. General Provisions. This Agreement shall be governed by and construed according to the laws of Japan, excluding its conflict of laws rules. You consent to the exclusive jurisdiction of Japanese courts and agree that the venue shall lie exclusively in Japan, in all disputes arising out of or relating to this Agreement. The use of the Software or Documentation is not authorized in any jurisdiction that does not give effect to all provisions of the terms and conditions of this Agreement, including without limitation this Section 8. 9. Termination. All the rights granted to you hereunder shall automatically terminate upon your breach of any provision herein, and you must cease the use of the Software and Documentation and destruct all copies of the Software and Documentation in your possession, including any of backup copy, upon such termination. Any provision herein that by its nature survives shall survive the termination of the rights granted to you hereunder.

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Introduction This Operation Manual includes descriptions of matters necessary when using the FDR-3000AWS (hereinafter referred to as “AWS”), such as operational procedures and precautions to observe. FDR-3000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

This Operation Manual applies to the following software. • FDR-3000AWS Application Software V9.3

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 F UJIFILM 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 F UJIFILM 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 F UJIFILM 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 F UJIFILM 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. 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. When discarding the FDR-3000AWS that incorporates the lithium battery, be sure to contact a licensed waste disposal contractor because it cannot be disposed of as a general waste. Caution : Rx Only in the United States (Federal law restricts this device to sale by or on the order of a physician.)

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 © 2013-2020 FUJIFILM Corporation. All rights reserved.

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FDR-3000AWS Operation Manuals

FDR-3000AWS Operation Manual This Operation Manual describes the basic operations of the FDR3000AWS.

FDR-3000AWS Reference Guide This Operation Manual describes how to use the FDR-3000AWS and provides the details on the User Utility.

FDR-3000AWS Options Reference Guide This Operation Manual describes how to use a suite of optional software for the FDR-3000AWS.

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Contents Introduction...........................................................................................

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FDR-3000AWS Operation Manuals......................................................

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Displaying Operation Manual or Reference Guide on AWS...............

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Chapter 1 Precautions 1.1 For Safe Operation........................................................................ 1-2 1.1.1 Warnings and Cautions Included in This Operation Manual... 1-2 1.2 Electromagnetic Compatibility (EMC).......................................... 1-4 1.3 Warnings and Cautions on Network............................................ 1-11 1.4 Precaution for Using the AWS...................................................... 1-13 1.5 Labels............................................................................................ 1-15 1.6 System Configuration................................................................... 1-17

Chapter 2 Operation Flow 2.1 Operation Window........................................................................ 2-2 2.1.1 Operation Procedures........................................................... 2-2 2.1.2 “Patient Information Input Window”....................................... 2-6 2.1.3 X-ray Control Panel............................................................... 2-11 2.1.4 “Exposure Menu Selection Window”..................................... 2-15 2.1.5 “Study Window”.................................................................... 2-17 2.1.6 “Image Edit Window”............................................................ 2-20 2.1.7 “Study List Screen”............................................................... 2-23

Chapter 3 Starting Up and Shutting Down 3.1 Starting Up and Shutting Down the AWS.................................... 3.1.1 Starting Up the AWS............................................................. 3.1.2 Performing Calibration........................................................... 3.1.3 Shutting Down the AWS........................................................

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3-2 3-2 3-7 3-9

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Chapter 4 Executing Studies 4.1 Receiving Studies......................................................................... 4-2 4.1.1 Inputting Patient Information.................................................. 4-2 4.1.2 Patient Information Database Function.................................. 4-5 4.2 Selecting Exposure Menu............................................................. 4-9 4.2.1 Modifying Exposure Menu..................................................... 4-11 4.3 Reading Images............................................................................ 4-13 4.4 Editing Images............................................................................... 4-14 4.5 Completing Studies....................................................................... 4-16

Chapter 5 Troubleshooting 5.1 Error Messages............................................................................. 5-2 5.2 How to Handle an Error................................................................ 5-4

Chapter 6 Daily Inspection and Maintenance 6.1 Performing Daily Inspection and Maintenance............................ 6-2

Appendix A Main Specifications A.1 Specifications................................................................................ A-2 A.2 External Dimensions and Weight................................................. A-4

Appendix B Optional Software B.1 Optional Software......................................................................... B-2

Maintenance and Inspection Maintenance and Inspection Items Assigned to Specified Dealer.....

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Displaying Operation Manual or Reference Guide on AWS Select

and then the desired PDF file in the GUIDE menu displayed.

To close the GUIDE menu, select To relocate

again.

, place the cursor on the button and move the cursor with the left-click button on the mouse

held down. Note that the button cannot be relocated while the GUIDE menu is displayed. By dragging

, the icon can be located anywhere in the area shown with the dotted line.



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1

Chapter 1 Precautions Page

1.1 For Safe Operation····································································· 1-2 1.2 Electromagnetic Compatibility (EMC)·········································· 1-4 1.3 Warnings and Cautions on Network··········································· 1-11 1.4 Precaution for Using the AWS···················································· 1-13 1.5 Labels························································································ 1-15 1.6 System Configuration································································· 1-17

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1.1 For Safe Operation

1

This chapter lists the precautions required to use the AWS safely. Before starting use, read this chapter very carefully and understand its operations thoroughly first.

1.1.1 Warnings and Cautions Included in This Operation Manual Safety precautions described in this manual include “WARNING ( ( CAUTION)”, which are explained as follows.

WARNING)”

and “CAUTION

WARNING Indicates hazardous situations which may lead to serious injuries or even death if the precaution is not or could not be followed.

CAUTION NOTE

Indicates hazardous situations which may lead to mild or medium injuries if the precaution is not or could not be followed. Precautions against accidents causing only physical damages. Gives procedures requiring special attention, instructions which must be followed, supplementary explanations, etc. Describes supplementary explanations for using functions of AWS other than the above “WARNING ( WARNING)” and “CAUTION ( CAUTION)” in this manual.

WARNING This system supplies high voltage to the inside of unit, etc. The following instructions must be carefully followed to prevent an electrical shock. •N  o one other than our official dealer should open the unit cover. Do not touch the high voltage portion of the above-mentioned parts with your hand, or you may get an electric shock.

WARNING •B  e careful to set each value not to excess the necessary X-ray exposure dose to patients. •P  rior to performing exposure, be sure to check exposure conditions on the X-ray control panel. •W  hen installing the FDR-3000AWS in the study room, the technologist should be where the protective shield (optional item for the FDR MS-3500) covers and protects all of his/her body from exposure to X-rays.

WARNING • Do not install the hub in the surroundings of patients. • Do not use multiple receptacles or extension cords. • Do not connect this system to devices that are not designated. Do not remove the cable currently connected and connect other cables to this system.

WARNING Do not enter the study room during calibration of the FDR MS-3500.

CAUTION The supply voltage of the units comprising this system is AC115V/230V. The instructions below must be followed to prevent an electrical shock. • While contacting the patient, do not operate the AWS. • Install the unit where no water may subject the units. • Check that the ground of each unit has been perfectly connected. • Check that all the cables have been properly and perfectly connected.

CAUTION Connect to the Ethernet Network of 1000BASE-T, 100BASE-TX, or 10BASE-T prescribed in the IEEE standard 802.3. Do not connect telephone lines to LAN connector. Only UTP-type straight LAN cables of 4-pair Category 5 cable (CAT 5E) or higher are appropriate for connection to this connector.

CAUTION Installation and relocation of this equipment must not be performed by anyone other than FUJIFILM Corporation or our official dealer.

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CAUTION • In extended uses of the unit, set aside 10 to 15 minutes after every hour to rest your eyes and hands. • ‌The image display of the unit is intended for quality check of the X-rayed image. Do not use the displayed image for diagnoses.

CAUTION

1

After connecting this system to the network with other systems, confirm that the other systems are not affected. If they are affected, take countermeasures such as network separation.

CAUTION When a setting of the network to which the equipment is connected has been changed, check that the change does not affect the system operation and take measures if necessary. - Change of connection destination - Addition of devices - Removal of devices - Update of devices - Upgrade of devices

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1.2 Electromagnetic Compatibility (EMC)

1

In order to prevent problems caused by electromagnetic wave when using this equipment, read carefully this section and operate this product and other peripheral devices properly.

Electromagnetic Compatibility (EMC) Related Standard This equipment complies with the following standard regarding Electromagnetic Compatibility (EMC). EMC standard : IEC 60601-1-2:2014 / EN 60601-1-2:2015 * ‌The AWS PC cover is required if the operation desk is not equipped with a built-in personal computer. The AWS PC cover is for preventing contact with the metal parts on the back of the personal computer. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation, as this equipment is suitable for use in a professional healthcare facility environment and in a home healthcare environment. This equipment can generate, use and radiate radio frequency energy. If the equipment is not installed and used in accordance with the instructions, or if peripheral devices that are not complied with the EMC standard, harmful interference may be generated under a particular environment causing malfunction of the equipment and other devices. If this equipment causes harmful interference to other devices, or if this equipment is affected by interference from other devices, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the 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. If the problem cannot be solved with the above measures, stop using this equipment and consult the manufacturer or our official dealer for help.

WARNING • Do not place devices generating electromagnetic wave near this equipment. • If a device(s) other than those specified is connected, predetermined EMC performance cannot be guaranteed. • Do not use mobile RF communications equipment within 30cm (11.8 in.) of this equipment. • The product may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements. • Do not use this equipment near devices that generate strong electromagnetic waves, such as thermotherapy devices or HF surgical equipment. • If this equipment is used near commercially available electronic devices, such as mobile phones, laptop computers or home appliances, which generate electromagnetic waves, this equipment may malfunction due to electromagnetic interference.

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• The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment, this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment. • Do not use this equipment near X-ray units other than the designated mobile X-ray units or near large medical devices, such as MRI scanners or X-ray CT scanners.

1

• If this equipment complies with IEC 60601-1-2, the personal computer and HUB are provided with an EMC cover. Do not remove the cover during use. If removed, the specified EMC performance cannot be guaranteed.

This Operation Manual contains the names of standards applied in IEC 60601-1-2. The names of standards applied in EN 60601-1-2 are replaced as follows. IEC 60601-1-2

(descriptions in this Operation Manual)

CISPR 11 IEC 61000-3-2 IEC 61000-3-3 IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-6 IEC 61000-4-8 IEC 61000-4-11

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Standards applied in EN 60601-1-2 EN 55011 EN 61000-3-2 EN 61000-3-3 EN 61000-4-2 EN 61000-4-3 EN 61000-4-4 EN 61000-4-5 EN 61000-4-6 EN 61000-4-8 EN 61000-4-11

1-5

Further information for IEC 60601-1-2

1

(1) ‌Medical electrical equipment is subject to special precautions regarding EMC. The equipment must be installed and put into service according to the EMC information provided in Tables 1 to 5. (2) ‌Portable and mobile RF communications equipment and other devices, which cause electromagnetic interference, can affect medical electrical equipment, resulting in image data communication failure or artifacts. (3) Information regarding the cable affecting EMC is as follows. Name

Maximum Length

General Specification

Network Cable

20m (65.62ft)

Cat5e or more, UTP type and straight cable

(4) The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by FUJIFILM Corporation as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment. (5) The equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. (6) Test items (Tables 1 to 5) (7) Essential performance FDR-3000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. Table 1

Guidance and manufacturer’s declaration - electromagnetic emissions The FDR-3000AWS is intended for use in the electromagnetic environment specified below. The customer or the user of the FDR-3000AWS should assure that it is used in such an environment. Emissions test

1-6

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Complies

Voltage fluctuations/flicker emissions IEC 61000-3-3

Does not comply

Electromagnetic environment - guidance The FDR-3000AWS uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The FDR-3000AWS is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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Table 2

Guidance and manufacturer’s declaration - electromagnetic immunity The FDR-3000AWS is intended for use in the electromagnetic environment specified below. The customer or the user of the FDR-3000AWS should assure that it is used in such an environment. Immunity test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

IEC 60601 test level

Compliance level

±8kV contact

±8kV contact

±15kV air

±15kV air

Electromagnetic environment - guidance

1

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

±2kV for power supply ±2kV for power supply lines lines Mains power quality should be that of a typical commercial or ±1kV for input/output ±1kV for input/output hospital environment. lines lines ±1kV differential mode

±1kV differential mode

±2kV common mode

±2kV common mode

0% U T for 0.5 cycle 0% U T for 1 cycle 70% U T for 25 cycles 0% U T for 250 cycles (5s)

30 A/m

Mains power quality should be that of a typical commercial or hospital environment.

0% U T for 0.5 cycle 0% U T for 1 cycle 70% U T for 25 cycles 0% U T for 250 cycles (5s)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the FDR-3000AWS requires continued operation during power mains interruptions, it is recommended that the FDR3000AWS be powered from an uninterruptible power supply or a battery.

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE : U T is the a.c. mains voltage prior to application of the test level.

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Table 3

Guidance and manufacturer’s declaration - electromagnetic immunity

1

The FDR-3000AWS is intended for use in the electromagnetic environment specified below. The customer or the user of the FDR-3000AWS should assure that it is used in such an environment. Immunity test IEC 60601 test level Conducted RF 3 V IEC 61000-4-6 150 kHz to 80 MHz ISM Frequency band Amateur radio band

Compliance level 3V 150 kHz to 80 MHz * See Table 5.

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the FDR-3000AWS, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Radiated RF 10 V/m IEC 61000-4-3 80 MHz to 2.7GHz

10 V/m 80 MHz to 2.7GHz

* See Table 5. Immunity to proximity fields from RF wireless communications equipment IEC 61000-4-3

* See Table 5.

d = 1.2 P

150 kHz to 80 MHz

d = 1.2 P

80 MHz to 800 MHz

d = 2.3 P

800MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FDR-3000AWS is used exceeds the applicable RF compliance, the FDR-3000AWS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the FDR-3000AWS. b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

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Table 4

Recommended separation distances between Portable and mobile RF communications equipment and the FDR-3000AWS The FDR-3000AWS is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FDR-3000AWS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FDR3000AWS as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

1

Separation distance according to frequency of transmitter m 150 kHz~80 MHz d = 1.2 P

80 MHz~800 MHz d = 1.2 P

800 MHz~2.7 GHz d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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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Table 5

Test compliance levels between Portable and mobile RF communications equipment and the FDR-3000AWS

1

ISM (Industrial, Scientific and Medical) Frequency Band Compliance level Frequency MHz

Test Level V

Frequency MHz

Test Level V

6.765

6

13.553

6

26.957

6

40.66

6

Amateur radio band compliance level Frequency MHz

Test Level V

Frequency MHz

Test Level V

1.8

6

3.5

6

5.3

6

7

6

10.1

6

14

6

18.07

6

21

6

24.89

6

28

6

50

6 Proximity fields from RF Compliance level

Frequency MHz

1-10

Test Level V/m

Frequency MHz

Test Level V/m

385

27

450

28

710

9

745

9

780

9

810

28

870

28

930

28

1462

10

1720

28

1845

28

1970

28

2450

2.8

3540

10

5240

9

5500

9

5785

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1.3 Warnings and Cautions on Network This device can be connected to IT-Network to perform the following functions. 1) The examination data (static images) acquired by this device can be stored in PACS (Picture Archiving and Communication System) by DICOM communication. 2) This device can receive examination orders from RIS (Radiology Information System) by DICOM communication and start them.

RIS

This device Study order Study data (DICOM MWM) (DICOM Storage) *Please refer to the DICOM Conformance Statement of this device for details.

1

PACS

CAUTION Please use an IT-Network which is isolated from external environment by Firewall and the safety is ensured.

CAUTION Connection to an IT Network may become at times unreliable, which may lead to failure to perform the functions described in section 16.1. As the result the following hazardous situations may occur:

Failure of the IT-Network

Impact on the Equipment

Hazardous Situation

Unable to transmit exam data to a PACS. Delay of transmission of exam data to a PACS. IT-Network has become unstable.

Incorrect data to a PACS. Unable to get order data from a RIS. Delay of getting order data from a RIS. Incorrect data from a RIS.

Firewall has broken down.

Delay of diagnosis.

This device has internal memory and exam data is stored in it. After IT-Network has returned to stable, This device will start to transmit exam data automatically.

Misdiagnosis

This device uses TCP/IP and DICOM Protocol. Integrity of the data is ensured by them.

Delay of exam.

This device has capability of entering order data by itself.

Incorrect exam.

This device uses TCP/IP and DICOM Protocol. Integrity of the data is ensured by them.

Attack via network.

Manipulation of exam data.

Infection by computer viruses.

Leak of exam data.

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Countermeasures of THIS DEVICE (for your reference)

This device closes unnecessary network ports. This device protects network ports for device maintenance purpose by dedicated network protocol, ID and password. This device prevents a user from loading software and executing it.

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Further Information for Network Connection 1) Hardware specification

1

Specification: 1000Base-T Connector: RJ45 Connection cable: straight LAN cable (1000Base-T) 2) Software specification • Connecting to PACS and RIS by DICOM standard. Please refer to the DICOM Conformance Statement of this device for details. 3) About the security A) This device is using the following ports in the application level (the seventh layer of OSI model). The all other ports are closed. • Port for DICOM communication It is the port number specified in the system setting by user. B) This device prevent a user from loading software and execute it. The software such as Web browser, email and software beside the specification of this device are not installed in this device. C) The anti-virus software is not installed in this device.

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1.4 Precaution for Using the AWS • ‌Breast implants may affect exposure because they block x-rays and shift breast tissue. When the exposure mode is set to Intelligent mode (iAuto or iSemi), the breast implant region is recognized automatically, and the exposure conditions are configured. However, the exposure conditions may be insufficient due to the outcome of the recognition. In such cases, use Manu (manual) mode. • ‌Read the Operation Manual thoroughly and specify the optimum exposure parameters. An exposure with the incorrect parameters may result in insufficient image quality. • ‌If the appropriate image processing parameters are not configured, the density or contrast may not be appropriate. For example, if the dynamic range (DR) compression is too strong, black and white inversion may occur, and if the frequency enhancement is too strong, noise may be noticeable. Understand the image processing and parameters properly before adjusting parameters. • ‌The image processing that calculates S/L values is performed by making analysis for each image. Therefore, the S/L values vary among the breast images for the same patient, so that, the density and contrast may differ between the left and right breasts or the CC and MLO views. • Be sure to check the image before delivering it. • ‌When making an exposure with the compression plate being removed, make sure to use “Manu (manual)” mode. Using “iAuto (intelligent full auto)”, “iSemi (intelligent semi auto)”, “Auto (full auto)” or “Semi (semi auto)” mode may result in insufficient image quality. • ‌Make sure that the AWS has enough hard disk space. The AWS hard disk is not for storing diagnostic images. When the AWS hard disk space is running low, images will be automatically deleted from the oldest. The auto-deletion of images can be avoided by locking studies and exposure menus. For details, see “FDR-3000AWS Reference Guide”. The system identifies and manages images by the date and time they were read. Make sure that the correct date and time are displayed when the AWS has started. The read images with the wrong date and time may be rewritten in their storage destination. If the date and time are wrong, set the correct information. • ‌Do not install or uninstall any of the software or hardware preinstalled in the AWS. The AWS is preinstalled with the appropriate software or hardware. If other software or hardware is added, various operational errors may result. • ‌Before operating the AWS, make sure that the monitor has appropriate brightness (light intensity). If not, contact our official dealer. Regularly adjust the monitor settings to keep optimum display of images read by the AWS. Between the regular adjustments, do not change the settings. If a fluorescent tube for monitor backlight is used for over a prolonged period, brightness (light intensity) of the monitor decreases because the lifetime of the fluorescent tube is running out. In this case, use of the monitor adjustment tool or service by our official dealer is recommended. • ‌For monitor operations (locking and unlocking the buttons, adjusting the brightness of the display, and etc.), refer to the operation manual supplied with the monitor. • ‌Do not operate the AWS during an exposure. Otherwise, images may not be read correctly or the read images may be processed based on incorrect exposure menu data. • ‌After inputting a marker, make sure that it is correctly displayed on the monitor. The marker frame is displayed only on the monitor, not on the image output on film. Note that the marker may become invisible depending on the color of its character or background. • When disposing of the AWS, completely delete all personal information. • ‌Do not connect devices other than those designated by FUJIFILM. Do not remove the cable currently connected and connect other cables to this system. • ‌Verify the overlay items for an image before output. Particular care should be taken for the patient information. • ‌If patient information is modified after an exposure, check the information on the output film or in the storage server. • Finish a study after making exposures for all exposure menus. • ‌Do not perform operations, which are not related to exposure processing or may cause system down or shutdown, until an image is displayed after an exposure. Otherwise, the exposed image will be lost. • ‌Set the exposure conditions appropriately. Be sure to check these conditions before making an exposure.

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• ‌Do not mistake the right- and left-side of the exposed image. When making an exposure, place lead characters or input a marker by using the AWS function and make sure that the direction of the image and the display on the marker are the same. Make also sure that the lead characters or the marker is correctly displayed on the monitor after setting it. • When Windows 10 is used, the hard disk can be encrypted including the areas for OS and files to prevent information leakage due to theft and loss of the personal computer. The encryption covers the C and I drives in the HDD or SSD mounted in the personal computer. For the encryption, contact our official dealer. The encryption for the HDD or SSD issues a recovery key. It is your responsibility to keep the recovery key securely. When starting up the personal computer, you may be required to enter the recovery key. • Any part of the personal computer is replaced due to failures. • Any malfunction of the computer hardware and any security event occurred on the OS due to unexpected changes in the configuration. If the recovery key is lost, the personal computer cannot be started up. ■ If you are required to enter the recovery key when starting up the personal computer If the following screen appeared to ask you to enter the recovery key when you start up the personal computer, enter the 48-digit numeric password that is written in the key and press the [Enter] key to unlock the computer.

If you are still required to enter the recovery key when starting up even after performing the operations above, contact our official dealer.

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1.5 Labels This section describes the labels placed on the AWS.

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FDR-3000AWS

Identification Label

Software product for FDR-3000AWS

Identification Label

NOTE • The month and year of actual manufacture are printed on the label. • Store the CD case with care.

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The following symbols are used on this equipment. Their meanings are described below. CE marking

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

The AWS consists of the following components: • Personal computer • Monitor • Hub A label is also placed on each component. For information related to ratings, see the label.

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1.6 System Configuration The configuration of the AWS is described in this section.

The AWS is connected to the exposure unit via a hub and is equipped with the functions to acquire digital images and to process, record, and output the acquired images. Peripheral devices such as a server and an image viewer are not included in the AWS. Server

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Image viewer

FDR MS-3500 Exposure unit

FDR-3000AWS

Exposure stand Monitor Personal computer Control cabinet

Hub Control pad

Overview of the AWS components • Personal computer: Performs various tasks such as processing and recording of image data. • Monitor: Displays the “Study window”, “Image Edit window”, etc. • Hub: Transmits signals between the personal computer and control cabinet, and between the personal computer and exposure stand. NOTE • Keep the operation manual of each device comprising the FDR MS-3500 together with this manual. • In addition to the mouse and keyboard, a barcode reader and a magnetic card reader can be connected to the AWS. • Use the operation desk of the FDR MS-3500 for storing the AWS. 897N102565N FDR-3000AWS Operation Manual

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Chapter 2

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Operation Flow Page

2.1 Operation Window····································································· 2-2

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2.1 Operation Window This section explains the operation window for the basic operations ranging from reception to completion of a study.

2.1.1 Operation Procedures

2

Receiving Studies

To “Confirming Study Details”

1. Inputting Patient Information (

“4.1.1 Inputting Patient Information” )

Select this when inputting patient information recorded in the patient information database.

“Patient Information Input window”

“Patient Information Selection box”

After inputting patient information, display the “Exposure Menu Selection window”.

2. Selecting Exposure Menu (

“4.2 Selecting Exposure Menu” )

“Patient Information Input box”

Select this when modifying patient information.

“Exposure Menu Selection window”

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After selecting an exposure menu, display the “Study window” . To “2. Confirming Study Details”

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Confirming Study Details

To “Executing Studies”

2 “Patient Information Input box”

Select this when changing exposure menus.

“Exposure Menu Change box”

Select this when modifying patient information.

“Study window”

Select this when adding exposure menus.

“Exposure Menu Addition box”

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Executing Studies 1. Starting a Study (

To “Editing Images (QA)”

“FDR-3000AWS Reference Guide”)

When executing a reserved study, select such a study in the list.

2

Select this when confirming or modifying exposure parameters.

“Study window” (before image reading)

Perform necessary operations with these icons when changing the setting for the exposure stand. (To “FDR-3000AWS Reference Guide”)

2. Reading Images (

“Exposure Parameter Selection box”

“4.3 Reading Images”)

The image sent from the exposure unit is read in the “Study window”.

“Study window” (after image reading)

Select this when finishing the study.

Select this when editing images (QA). (To “4. Editing Images (QA)”)

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Editing Images (QA) When editing the image read in the “Study window” (QA), select the QA button in the window.

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“Study window”

Select this when finishing editing images (QA).

“QA window” (by an image level)

When editing images (QA) again after finishing a study, select the appropriate study from lists such as the “All list”.

“All list”

Select this when finishing editing images (QA).

“QA window” (by a study level)

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2.1.2 “Patient Information Input Window” This is a window for inputting patient information to receive studies. By selecting the list tabs at the top of the window, various lists can be displayed. (For details on the lists, see “FDR3000AWS Reference Guide”.) The display property settings for the “Patient Information Input window” can be set in the User

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Utility. For details, see “FDR-3000AWS Reference Guide”. Explained below is how to operate the list tab, screen keyboard and other input fields in the “Patient Information Input window”. (1) List tabs

(3) Patient information input field

(4) Menu button

(5) Output error icon

(2) Screen keyboard

(1) List tabs Selecting the list tab in the window top will allow you to display various kinds of lists. : Displays the “Local WL list”. Studies that have already been received, containing yet-to-be-read images, will be added to this list. : Displays the “QA list”. Studies containing images already read (exposed), but yet-tobe-subjected to image editing (QA), will be added to this list. : Displays the “Queue list”. Studies containing images already read (exposed), but yetto-be-output (printout or delivery), will be added to this list. : Displays the “Delivered list”. Studies that contain images already read and output (printout or delivery) will be added to this list. : Displays the “All list”. All studies saved in the AWS will be displayed in this list. :  Displays the “Today list”. All studies registered today will be displayed in this list.

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(2) Screen keyboard This keyboard is used to input information in the patient information input field. :  Deletes one character to the left of the caret ( | ). :  Deletes one character to the right of the caret ( | ). Space Bar /

:  Enters one blank space. :  Moves the caret ( | ) to make space for one character to the left/right. :  Alternately switches upper- and lower-case letters of the alphabet.

2

:  Determines the input data, and moves the caret ( | ) to the next box.

(3) Patient information input field and the buttons at the right The user inputs patient information in this field using the buttons described later. Accession No.

: Input the study number. A maximum number of digits varies depending on the settings at the time of installation.

Reception #

: I nput patient’s reception number. A maximum number of digits varies depending on the settings at the time of installation.

Patient ID

: Input patient’s ID number. A maximum number of digits varies depending on the settings at the time of installation.

Patient’s Name

:  Input patient’s name (a maximum of 64 characters).

Sex

: Input patient’s sex (M (0): male, F (1): female, O (2): other). You can use the User Utility to specify which of the selections for sex is to be displayed as the default.

Date of Birth

: Input patient’s date of birth. The input format for the date is shown in the example below the input field.

Requesting :  Input requesting department code (2 characters).* Department Code Requesting department

:  Input requesting department name (a maximum of 64 characters).*

Technologist

:  Choose a technologist.

Patient comment :  Input comments on patient (a maximum of 1024 characters). Patient State

:  Input information on physical disability (a maximum of 64 characters).

Medical Alerts

:  Input information on epidemic disease (a maximum of 64 characters).

Contrast Allergies :  Input information on contraindication (a maximum of 64 characters). Pregnancy Status : Input information on pregnancy (0: Not pregnant, 1: Possible to be pregnant, 2: Pregnant, 3: Unknown). Height (cm)

:  Input height (cm).

Weight (kg)

:  Input weight (kg).

Telephone no.

:  Input phone number (a maximum of 16 characters).

Outpatient/inpatient :  Input whether outpatient or inpatient (0: Outpatient, 1: Inpatient). Blood type (ABO) :  Input blood type by ABO (0: A, 1: B, 2: AB, 3: O, 4: Unknown). Blood type (Rh)

:  Input blood type by Rh (0: Rh+, 1: Rh-, 2: Unknown).

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Implant

:  Input whether there is an implant in the patient (0: None or Unknown, 1: Left, 2: Right, 3: Both left and right). Depending on the settings at the time of installation, the information selected for the exposure menu prevails.

Study comment

:  Input comments on study (a maximum of 1024 characters). : Displays the page number of the patient information input field. turns to the next page. the previous page, and

2

turns to

: Clears patient information (except “Technologist”) input in the “Patient Information Input window”, and then returns to the top page of the patient information input field. : Enables search for necessary patient information from the database for patient information registered to the AWS main unit so that it is displayed in the “Patient Information Input window” (This is denominated the patient information database function.). : Reserves a study based on the information input in the “Patient Information Input window”. A study reserved is displayed in the “Local WL list”. : Terminates patient information input, and then displays the “Exposure Menu Selection window”. NOTE (*) Whether inputs for “Requesting Department Code” and “Requesting department” are linked with each other or not will depend on the settings at the time of installation.

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(4) Menu button (

)

will display menus associated with the AWS system. Selecting The displayed menu will differ depending on the settings at the time of installation.

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Displayed menus

Major menu items displayed are explained below. Cancel

: Closes the menu display.

Version Display

: Displays the “Version Information Confirmation box”. For details, see “FDR-3000AWS Reference Guide”.

Study List Setting

: Selectable when each of the lists is displayed. Selecting this menu displays the “Study List Setting box”. In the “Study List Setting box”, you can specify whether or not to display the information items in individual lists and change the display order of those items. For details on this study list setting, see “FDR-3000AWS Reference Guide”.

“Study List Setting box”

User Utility

: Starts up the User Utility after shutting down the AWS. After terminating the User Utility, the AWS automatically starts up.

Logoff

: Logs off the user who is logged in to the AWS. For details on logoff, see “3.1.1 (2) Logoff”.

Password change

: Displays the “Password Change window”. For details on password change, see “3.1.1 (3) Password change”.

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Shutdown of the AWS: Ends the AWS operation and shuts down the AWS. For details on AWS shutdown, see “3.1.3 Shutting Down the AWS”. Shut Down

: Ends the system operation and shuts down the AWS and the exposure unit. For details on system shutdown, see “3.1.3 Shutting Down the AWS”.

(5) Output error icon (

2

)

This icon appears when an error occurs on a device targeted by the AWS for image output or on the communication with other devices connected to the AWS. By selecting this icon, the “Error Display box” is displayed.

“Error Display box”

Check the device status, select

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, and then take an appropriate action.

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2.1.3 X-ray Control Panel In this panel, the status of exposure setting, calibration, and operation for the exposure stand and the flat panel detector (FPD) connected to the AWS are displayed. The following nine items are displayed. When executing a study, the parameters used for an exposure are displayed in real time on the X-ray control panel of the “Study window”. Different from the result data overlay display described later, you can check the result immediately after an exposure, as this function displays information in real time. Exposure unit setting button Exposure parameters setting section

Exposure parameters display section

Exposure stand status display

Exposure message display

Flat panel detector (FPD) status display

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Calibration menu button

Time display

Exposure status indicator

(1) Exposure parameters setting section The currently set exposure conditions are displayed. For operation to change the settings, see “FDR-3000AWS Reference Guide”. :  Displays the current exposure mode. After “I-AEC” is selected, intelligent mode (iAuto, iSemi) can be switched on/off. :  Displays the dose level. :  Displays the combination of the target and the filter. :  Displays dose fine adjustment level. Items to be displayed vary depending on the settings at the time of installation. : Displays the current tube voltage value. : Displays the current mAs value. : Displays the focal spot size. :  Displays the setting for grid. : Displays the average glandular dose (AGD). When the exposure mode is “Manu”, the dose value is displayed by clicking on the icon with the mouse. If positioning and compression are not completed, do not display the AGD value since the value is affected by compression breast thickness. The AGD value is just reference information, therefore make sure to check the rest of the exposure conditions. If the AGD-mAs interlock function is enabled on the settings at the time of installation, the mAs value is automatically optimized whenever the AGD value is changed. 897N102565N FDR-3000AWS Operation Manual

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(2) Exposure parameters display section The settings for the mammography exposure stand are displayed. During the exposure, the waiting time until the next exposure becomes available is indicated as a horizontal bar. : Displays the current compression force (N). : Displays the breast thickness (mm) according to the position of the compression plate. : Displays the current exposure table type.

2

: Displays the current compression plate type. NOTE Values of breast thickness and compression force may differ depending on the exposure stand display panel and swivel arm control panel and the AWS. Correct values should be confirmed on the exposure stand display and swivel arm control panels.

(3) Calibration menu button Selecting this button will display menus associated with calibration. For details, see “3.1.2 Performing Calibration”.

(4) Exposure unit setting button Selecting

will display the “Exposure unit setting menu”.

Exposure unit setting menu

Selecting “Exposure Setting” will display the “Default Exposure Setting Box”.

“Default Exposure Setting Box”

The items that can be configured are as follows. Default AEC : Set the default AEC mode to “Auto”, “Semi”, “Manu”, or “-”. This setting is automatically made at the time of AWS startup, calibration completion, and study start. When “-” is selected, “Auto” is automatically set in a study started immediately after the startup of the AWS. In the subsequent studies, the AEC mode used for the previous study is automatically set. Default Intelligent AEC

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: Switches on/off intelligent mode (iAuto, iSemi).

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Default Dose Level

: Set the default dose level to “H-mode”, “N-mode”, or “L-mode”. For details on dose level, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”. This setting is automatically made at the time of AWS startup, calibration completion, AEC mode change, recovery from an error, and study start.

Default D-Tap

: Choose dose fine adjustment level from “-3”, “-2”, “-1”, “0”, “1”, “2” and “3”. For details on fine adjustment level, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”. A

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Default D-Tap value is set automatically at the time of starting up the AWS, completing calibration, changing AEC mode, recovering from error and starting a study.

Whether this value is displayed depends on the settings at the time of installation. NOTE The “Default Dose Level”, “Default AEC” and “Default D-Tap” settings cannot be changed during a study.

Selecting “Comp. Setting” will display the “Comp.Setting Box”.

“Comp.Setting Box”

The items that can be configured are as follows. Auto Decompression

: Set the automatic decompression function to “ON” or “OFF”.

Max Compression Force

: Set the maximum compression force.

Adjusted Compression Force : Set the adjusted compression force. The adjusted compression force refers to the compression force applied when compression stops once before it reaches the maximum compression force. Lighting Upper

: Adjusts the lighting of the exposure unit. Select lighting mode from “OFF”, “Mode1”, “Mode2” and “Mode3”.



For details, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”.

Lighting Lower

: Adjusts the lighting of the exposure unit. Select lighting mode from “OFF”, “Mode1”, “Mode2” and “Mode3”.



For details, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”.

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(5) Flat panel detector (FPD) status display A message indicating the status of the flat panel detector is displayed. For details, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”.

(6) Exposure stand status display A message indicating the status of the exposure stand is displayed. For details, see “FUJIFILM

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Digital Mammography System FDR MS-3500 Operation Manual”.

(7) Exposure message display A message indicating the status of the entire exposure system is displayed. For details, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”.

(8) Exposure status indicator The current status of the mammography exposure stand is displayed. : Ready for exposure. : Exposure is being performed. : Not ready for exposure.

(9) Time display The current date and time are displayed.

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2.1.4 “Exposure Menu Selection Window” This is a window for accepting studies. You select exposure menus in this window. Display group list

Selected exposure menu list

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Patient information display field

Technologist display field

Exposure menu list registered to the display group

Patient information : Displays patient information. display field The following icon is also displayed, depending on patient information or study. /

/

: Displays breast implant information of the patient. The icon that appears varies, depending on the implant information input in the “Patient Information Input window”. No icon-0: None or unknown -1: Left -2: Right -3: Both left and right : Appears for a study which is sent from a RIS terminal for re-exposure.

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Technologist display : Displays a name of the logged-in technologist. field Whether the technologist (user) name is displayed or not in the technologist display field depends on the settings at the time of installation. Display group list

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: Select a display group. Exposure menus and study menus registered to the display group selected here will be shown in the “Exposure menu list registered to the display group”. Exposure menus registered to the “Display Group list” can be edited as necessary using the User Utility.

Exposure menu list : Displays exposure menus and study menus registered to the “Display registered to the Group list”. Exposure menus and study menus selected in this list are display group displayed in the “Selected Exposure Menu list”. Selected exposure menu list

: Displays the exposure menus and study menus selected in the “Exposure menu list registered to the display group”. Moving up and down the “Selected Exposure Menu list” with any exposure menus selected accordingly will allow you to change order of selected exposure menus. : Displays the page number of the “Exposure menu list registered to the display group”. turns to the previous page, and turns to the next page. : Displays the “Patient Information Input box” or a menu for which the patient information is modified.

/

: Scrolls the “Selected Exposure Menu list”. : Deletes an exposure menu selected in the “Exposure menu list registered to the display group”. : D eletes all exposure menus included in the “Exposure menu list registered to the display group”. : Cancels the set data in the “Patient Information Input window” and the “Exposure Menu Selection window”, and terminates the current study. Returns to the “Patient Information Input window”. : Reserves a study. The “Patient Information Input window” accepts the next study continuously. A study reserved can be selected from the “Local WL list” to restart. : Starts executing a study. When a study is started, the “Study window” is displayed. Prior to starting a study, make sure that the selected exposure menu is correct.

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2.1.5 “Study Window” This is a window for executing a study. Various settings and image reading can be operated in this window. Exposure result display field

Image display field

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Technologist display field Patient information display field

Exposure menu list Exposure menu detail display field Operation button list

Patient information : Displays patient information. display field Technologist display field : Displays a name of the logged-in technologist. Whether a technologist (user) name is displayed or not in the technologist display field depends on the settings at the time of installation. Image display field : Displays the read images. One-, two-, and four-image display modes are available in the “Study window”. In four-image display mode, four images can be displayed simultaneously. What mode is used for displaying images when starting a study depends on the settings at the time of installation and in the User Utility. In the image display field, exposure result data can be displayed in overlay mode.

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Exposure menu list

: Displays exposure menus selected in the “Exposure Menu Selection window”. Moving right or left the “Exposure Menu list” with any exposure menus selected accordingly will allow you to change order of selected exposure menus.

Exposure menu detail display field Operation button list Exposure result display field

: Displays detailed information on the exposure menu selected in the “Exposure Menu list”. : Displays various operation buttons for the selected exposure menu. : Displays exposure results in overlay mode in the image display field. Items to be displayed can be specified in the User Utility. : Displays the “Patient Information Input box” or menu for correcting patient information. : A llows you to view the study information list. The “Study Information box” is displayed. : Displays and allows operation of an image saved in the SYNAPSE system (if connected) on the AWS. For details, see “FDR-3000AWS Options Reference Guide”. : Allows you to check whether the exposure order setting is on or off. This icon is displayed only when the setting is enabled in the User Utility. : Adds an exposure menu. The “Exposure Menu Addition box” is displayed. : Changes an exposure menu. The “Exposure Menu Change box” is displayed. : Sets the read image as a mis-exposure image. : Adds the same exposure menu as the selected one. : C hecks or changes exposure parameters used for the exposure menus as necessary. The “Exposure Parameter Selection box” is displayed. : Changes film format. Format can be changed either before or after reading an image. : Deletes the selected exposure menu. : Turns page in the operation button list.

/

/

/

/

/

/

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/

: Changes the display order of the exposure menus or images in the exposure menu list. : Changes the number of displayed images. : Changes the manual-delivery destination of images at the time of a study. : Switches on/off the auto-delivery function used during image reading. This switching is available, if “Distribute automatically with each image received” has been selected for “Auto-distribution Setting” in the User Utility. : Switches on/off monitor mode. Monitor mode can be set to either “priority operation mode” or “priority image display mode” in the User Utility. : Sets the auto mammography image positioning to auto, manual, or off.

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: Changes the GA/GS value of an image. : Sets the overlay display of exposure result data to on or off. : Locks the currently displayed study to prevent its images from being deleted. Selecting this icon again releases the lock. : Edits information on the read image. : Performs QC for mammography (optional). To use this function, the setting must be made at the time of installation. : Completes or suspends a study.

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2.1.6 “Image Edit Window” This is a window for editing image information by an image level and also by a study level. For image information editing by an image level, processing such as image information editing and film output will be performed on images read in the “Study window”. For image information editing by a study level, processing such as image information editing

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and image output will be performed on images of a study for which the exposure has already been completed. Patient information display field

Technologist display field

Exposure result display field

QA image controller buttons Palette 1

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Image display field

Palette 2

List display area

Exposure menu detail display field Palette 3

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Patient information : Displays patient information. display field Technologist display field

: Displays the name of the logged-in technologist. Whether a technologist (user) name is displayed or not in the technologist display field depends on the settings at the time of installation.

Image display field : Displays the image to be edited. The exposure result data items can also be displayed in overlay mode. Palettes 1 to 3

: Edits image information. The buttons that are displayed in the pallets are as follows.

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: Exposure menu can be changed. The character string displayed on the button is the name of the selected menu. : Displays the “Image Information Edit box”. : Displays the “Technologist Information Edit box”. : Displays the “Film Mark Setting box”. : Displays the “Image Comment/Study Comment Input box”. : Parameters of GA (contrast) and GS (density) can be changed. : Change each parameter by selecting or . : Displays the “Flip/Rotation Setting box”. : Displays the “Trimming Setting box”. : Displays the “Marker Setting box”. : Displays the “Annotation Setting box”. : Displays the “S/L Value Setting box”. : Displays the “Image Laterality Setting box”. : Displays the “Patient Orientation Setting box”. : Displays the “Detailed Image Processing Parameter Change box”. : Displays the “Mammography Image Positioning box”. : Displays the “View Code Sequence Change box”. : Displays the “View Modifier Code Sequence Change box”. : Displays the “Pixel Padding Value Setting box”. : Displays the “Blackening Processing box”. : Starts up the region of interest (ROI) measurement software. : Starts up the distance between two points measurement software. : Sets the overlay display of exposure result data to ON or OFF. : Displays the “Print Setting box”. : Displays the “Filing Device Setting box”. 897N102565N FDR-3000AWS Operation Manual

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QA image : Operates various utility functions (Magnifying display image / Reprinting controller buttons display image / Setting failed image / Locking study etc.). The buttons that are displayed in the QA image controller are as follows. : The displayed image can be magnified. : The currently displayed image can be reprinted. :T  he currently displayed image can be set as a mis-exposure image. Select the icon again to cancel the setting. : The currently displayed image in a study can be locked to avoid the image from being deleted. : The currently selected image can be locked to avoid the image from being deleted. : The currently displayed image can be converted to JPEG format and saved to a USB flash memory. : The currently displayed image can be converted to DICOM stream format and saved to a USB flash memory. : All the images of the currently displayed study are output to a printer or filing device. : Activates the Free Layout Print Software.

2

: The image processing parameters edited in the “Image Edit window” can be restored to those preset for the exposure menu. : The image can be restored to the conditions it was first displayed in the “Image Edit window”.

List display area

: Displays the “Selected Exposure Menu list” when editing an image by a study level.

Exposure menu : Displays detailed information on the exposure menu selected in the list detail display field display area. Exposure result display field

: Displays exposure results in overlay mode in the image display field. Items to be displayed can be specified in the User Utility. : Authenticates the operational authority of the functions for changing image processing parameters. The display and non-display of the button for changing the image processing parameters are alternately switched. Whether this button is displayed or not depends on the settings at the time of installation. : Saves edited image information.

* or *

: Terminates image information editing and returns to the previous window. However, the display varies depending on how the “Image Edit Window” has been displayed. If this screen has been displayed by selecting in the “Study Window”, is displayed. Otherwise, is displayed.

*T  he displayed button and its operation differ depending on the settings at the time of installation. For details, see “FDR-3000AWS Reference Guide”. NOTE Displaying only (or ) or both and (or ) varies depending on the settings at the time of installation. When and (or ) are displayed, select and then (or ) to reflect the setting. The display property settings for the QA buttons in a palette or QA image controller buttons can be set in the User Utility. For details, see “FDR-3000AWS Reference Guide”.

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2.1.7 “Study List Screen” This section explains various lists configuring the initial window. These lists can be displayed by selecting a tab at the top of the window. Each list is comprised of levels of study, series, and image (from the largest). Series level and image level are displayed by expanding the information in their higher levels. Note, however, that only an image level is displayed for the “Queue list”. The number of studies and information items to be displayed, display/non-display of a series level, and other settings can be customized for each list. For details see “FDR-3000AWS Reference Guide”. Directory by a study level

Scroll bar

Lists up information for each study.

The scroll bar is displayed only when all the information cannot be displayed at a time. In other cases, they will not be displayed.

Directory by a series level

Directory by an image level

Lists up series information of a study selected in the directory by a study level. Directory by a series level can be displayed or hidden.

Lists up image information of a series selected in the directory by a series level. Lists up image information of the study selected in the directory by a study level if the directory by a series level is not displayed.

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: Cancels all filtering parameters. : Searches study information. : Sets the sort order of the list. : Updates the list.

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: Finishes the study. : Executes the next processing (study). : Displays detailed study information. : Sets the delivery destination. *This icon appears in the “QA list”, “Delivered list”, “All list” and “Today list”. : Delivers the selected study. *This icon appears in the “QA list”, “Delivered list”, “All list” and “Today list”. : Deletes study information. In the “Queue List”, image data are deleted. : Switches the display information. : Selects all study information. : Moves images to other study/series. *All images are displayed only in list form.

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Chapter 3 Starting Up and Shutting Down

3 Page

3.1 Starting Up and Shutting Down the AWS··································· 3-2

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3.1 Starting Up and Shutting Down the AWS This section explains how to start up, shut down, and calibrate the AWS. Start up the AWS after starting up the exposure unit.

3.1.1 Starting Up the AWS Turn on the exposure unit, and then the AWS monitor. Check also to make sure that the personal computer is on.

3

NOTE After being started up, the PC updates the application in the background while the message “Please wait” is on the screen. AWS will start when the update is finished.

The application software of the AWS automatically starts and the “Patient Information Input window” is displayed.

NOTE • ‌Do not start up the AWS before turning the exposure unit on. Otherwise, a message indicating a communication error may appear on the AWS. • User authentication may be required to log into the system when starting the operation, depending on the settings at the time of installation. • Depending on the settings of the User Utility, the “Examination Order Issuance window” is displayed.

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n If a message prompting for correcting date and time is displayed If the time displayed on the personal computer is before that of the last time when it was turned on, the following message appears. In this case, contact our official dealer. “The date and time are older than those of the previous startup. Please confirm and correct the date and time.”

Selecting “OK” will display the “Date and Time window”.

3

Set the time and date to the current ones, and then select “OK”. The correct time and data will be displayed on the personal computer. NOTE The exposed images are saved based on the date when starting executing a study. To search the exposed images with a study left suspended, select the information saved before that day. The definitions of study date and exposure date are as follows. Study Date

: Date when a study was started.



: Time when a study was started.

Time

Series Date

: Date when a study was started using a modality.



: Time when a study was started using a modality.

Time

Acquisition Date : Date when an exposure was made.

Time : Time when an exposure was made.

Image Date

: Date when an image was recorded.



: Time when an image was recorded.

Time

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(1) Login The “Login box” is displayed when the AWS starts up and after the previous user has logged off. The user name currently appearing in the “Login box” is the one for the previous user. Input “User Name” and “Password” and then select

.

“Login box”

3

When you log in the system, the “Patient Information Input window” appears with the user name input in the “Login box” displayed in the “Technologist field”. (The technologist name may not be displayed depending on the settings at the time of installation.) NOTE • If you forget your password, contact a user registered as “Administrator”. • If following message is displayed while a user authentication is made in Windows Active and login to the AWS with a user name of “.\EMGUser”, Directory, you can choose which is for emergency accesses.

This name is given the same scope of authorities as a standard user. The default password is “$tandard#User”. Make sure to set different password. For detailed information on changing the password, see “(3) Password change”.

■ If the “Login box” is displayed after a period of time without operation Except during an inspection, if no operations are performed for a period of time after the user has logged in, the user will be automatically logged off. In this case, the “Login box” appears. Login as indicated above to restore the operation. Also, while editing images in the “Image Edit Window”, if no operations are performed for a period of time, the display will be automatically locked and “Password” input dialog will be displayed. Operation is unavailable until the display is unlocked (background processing such as outputting images will still be executed).

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To unlock the display, input the password and press

. The operation can be resumed.

“Password Input box”

(2) Logoff Be sure to log off the system whenever you are terminating/suspending operations, except when shutting down the AWS and turning the personal computer off. to display the menus, and then select

Select

3

.

A confirmation box is displayed. Select

.

Confirmation box

This completes logoff processing and the “Login box” is displayed. Select

to cancel the operation.

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(3) Password change Select

to display the menus, and then select

.

The “Password Change window” below appears. Enter the current password, new password and new password (for confirmation) in respective fields, and then select

. The new password

must be 20 or less characters (alphabets and/or numbers).

3

NOTE • ‌Do not include personal information such as names, birth dates, etc. with which an individual can be identified, in the password. • If the current password entered is expired, a warning message appears after selecting

.

If the current password expires at the time of login, user change and User Utility login, a message prompting password change appears. Select

to display the “Password Change window”, and

change the password. A notice of upcoming password expiration is displayed depending on the settings at the time of installation.

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3.1.2 Performing Calibration (1) Type of calibration In order to maintain the exposure quality, calibration is required for the flat panel detector (FPD). There are the following types of calibration. Type of calibration

Features

Startup calibration (Daily Calib)

The exposure stand automatically selects this type of calibration at the time of startup. “Daily Calib” does not require radiation and is performed daily for corrections.

Calibration at the time of problem (Panel Check and Field Calibration)

This calibration consisted of two types is performed by the AWS according to the user operation. “Panel Check” (without radiation) is performed when line/dot defect occurs. “Field Calibration” (with/ without radiation) is performed when density unevenness or other problem of unknown cause occurs.

3

(2) Performing a calibration ■ Startup calibration Startup calibration is performed automatically when the exposure stand starts up. At this time, a message indicating that “Daily Calib” is in progress is displayed on the AWS. ■ Calibration at the time of problem Selecting

will display menus associated with calibration.

: Aborts calibration. : Aborts field calibration and performs panel check. : Performs panel check. : Performs field calibration. If radiation is necessary, follow the message to be displayed. : Cancels the menu display.

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NOTE • If the calibration is aborted, perform calibration again. • Studies cannot be performed until calibration is completed. Do not perform studies while calibration is in progress. Patient or technologist may be subject to unnecessary X-ray exposure. Images may also be lost.

■ Radiation for calibration If radiation is necessary for calibration, a message to instruct to do so is displayed. Follow the message on the screen and operate the system correctly. Performing operations other than those displayed in the message may result in system malfunction.

3

For radiation operation, see “FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual”. NOTE Do not change the radiation condition when calibration using radiation is in progress. Otherwise, calibration result may not be obtained properly.

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3.1.3 Shutting Down the AWS Select

from the menu shown by selecting

in the “Patient Information

Input window” to shut down both the AWS and the exposure unit. Select

if you

shut down only the AWS due to problems, etc.

3 A confirmation box is displayed. Check a confirming message, and then select

.

NOTE • The AWS cannot operate round the clock. Shut down the system or AWS at least once a day to maintain good system performance. Do not press the power switch on the front of the equipment when turning off the personal computer. • If preparation to update the application is ready, the confirmation dialog shown below appears. You can select a time to update the application. The options to update are as shown below. - Will be updated at the next start-up. - The message will appear again in a day. - The message will appear again in two days. - The message will appear again in three days. - The message will appear again in four days. - The message will appear again in five days. If you put a check in “Update the application automatically without displaying this message from the next time.” the application is set to be automatically updated from the next time. If you want to show the confirmation dialog again after you set the automatic update, you can use the user utility to set it.

After updating the application, perform backing up again in the User Utility. For details, see “10.1 Backup” in the “FDR-3000AWS Reference Guide”.

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Chapter 4 Executing Studies Page

4.1 4.2 4.3 4.4 4.5

Receiving Studies······································································· 4-2 Selecting Exposure Menu··························································· 4-9 Reading Images········································································· 4-13 Editing Images············································································ 4-14 Completing Studies···································································· 4-16

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4.1 Receiving Studies When inputting patient information, both the keyboard and screen keyboard are available. Patient information can also be selected from the database for registered patients. In addition, studies can be received with a magnetic card reader (optional), as well as by receiving patient information (optional) from the devices that the AWS can communicate with through the DICOM MWM services. This chapter describes how to input patient information with the keyboard and screen keyboard as well as to select it from the database for registered patients.

4.1.1 Inputting Patient Information The patient information can be input in the “Patient Information Input window”. All of the patient information items need not be input necessarily. Input in either patient ID or

4

patient name in order to proceed to the next operation. The patient information (either patient ID or patient name is necessarily input.), once received, is automatically registered to the database. The previously registered patient information can be called up from the database and displayed in the “Patient Information Input window” as desired.

(1) Inputting patient information in the “Patient Information Input window” Input data to each item of patient information in the patient information input field. After inputting characters, select

or press the Enter key (or Tab key) on the keyboard.

The caret ( | ) for character input will move to the next input field. The patient information can also be modified or input in the “Exposure Menu Selection window” or the “Study window” later. ■ To correct wrong input Described below is how to correct characters input in the entry fields in the “Patient Information Input window”. When the keyboard is used : For correction of the information using the keyboard of the AWS main unit (personal computer), follow the procedure below. Use the Back Space key or the Delete key to erase the input character before or after the caret ( | ) and enter the correct input. Move the caret ( | ) using the arrow key (f, g). When the screen keyboard is used : For correction of the information using the screen keyboard, follow the procedure below. Select

to delete the character before the caret ( | ), and enter the correct input.

Move the caret ( | ) using the arrow key (

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,

) on the screen keyboard.

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■ Operation of the input items for which selection buttons are displayed When the caret ( | ) showing the point of character input is moved to the input field of “Sex”, “Requesting department”, “Technologist”, “Pregnancy Status”, “Outpatient/inpatient”, and “Blood type (ABO)”, “Blood type (Rh)”, “Implant”, the corresponding setting tab appears at the lower left-hand part of the screen keyboard. For example, when the caret ( | ) is in the input field of “Sex” , the “Sex tab” below appears. . Select one of the options on the tab, and then select The “Sex tab” is closed to complete the input.

4

As for items other than “Technologist” (“Sex”, “Requesting department”, “Pregnancy Status”, “Outpatient/inpatient”, “Blood type (ABO)”, “Blood type (Rh)”, and “Implant”), you can input certain characters. For example, when inputting sex, select the “ABC tab” to input “F” from the screen keyboard or a value for the sex (1 or F for female) at the press of the equivalent key on the keyboard. For details on values to be input, see “2.1.2 “Patient Information Input Window””. ■ If the “Technologist Confirmation box” is displayed when changing the technologist displayed in the “Technologist field” If the user authentication setting is enabled at the time of installation, the name of the logged-in user is displayed in the “Technologist field”. Selecting other technologist (user) on the “Technologist tab” displays the “Technologist Confirmation box”. Input a new user name and . password, and then select The logged-in technologist (user) is changed.

“Technologist Confirmation box”

Select

to cancel operation.

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(2) Ending input of patient information to display the “Exposure Menu Selection window” Input the patient information, and then select

.

The patient information input is then finished and the “Exposure Menu Selection window” is displayed.

When

4

is selected, a received study can be reserved as an unexecuted study. The reserved

study can be executed from the “Local WL list”. NOTE Whether inputs for “Requesting Department Code” and “Requesting department” are linked with each other or not will depend on the settings at the time of installation.

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4.1.2 Patient Information Database Function Approximately 300000 records of patient information can be registered to the database. The patient information registered to the database can be retrieved by keyword (keyword retrieval). Also, in the displayed list of patient information registered to the database, patient information can be retrieved (list retrieval) or deleted from the list.

(1) Input by keyword retrieval Patient information can be retrieved from the database using one of the input items in the “Patient Information Input window” as a keyword. The retrieved patient information is displayed in the “Patient Information Input window”. The following items can be used as a keyword to retrieve the patient information from the database.

4

• Patient ID • Patient’s Name • Date of Birth • Telephone no. Enter the keyword in one of the above item fields. Leave the caret ( | ) in the input field that the keyword is entered. When inputting multiple items, only items with the caret ( | ) can be available as keyword. Select

.

Retrieval of patient information or the input item will be executed and the retrieved information will be displayed in the “Patient Information Input window”. If a keyword is input in the “Patient ID field” retrieval is possible by pressing the Enter key on the keyboard.

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■ To retrieve patient information by inputting part of a keyword Even if the input string in each item does not agree with the registered string completely, the retrieval processing is valid (This function is called fuzzy retrieval). A fuzzy retrieval processing is not valid for date of birth. In case of using patient ID for a fuzzy retrieval, inputting “ * (for characters of any length)” or “ % (for a single character)” is required as a wildcard. The following cases are examples for fuzzy retrieval using patient ID. Example 1: Retrieving all patients whose patients IDs are set to “2” and “3” in the second and third digits and range from “0” to “9” in the first digit Input “?12*” in the “Patient ID field”. Example 2: R  etrieving all patients named “HANAKO” Input “HANAKO” in the “Patient’s Name field”.

4 Sample of a fuzzy search performed by inputting “HANAKO” in the “Patient’s Name field” When the hit patient information result is only one, it will be displayed in the “Patient Information Input window” automatically after the completion of retrieval processing. By fuzzy retrieval, the information of more than one patient may be listed. In such a case, the “Patient Information Selection box” will be displayed after the completion of retrieval processing. . Select the appropriate patient information, and then The patient information will be input in the “Patient Information Input window”.

If all of the retrieved patient information cannot be displayed on one page, use to scroll the window. to cancel the selection of patient information. Select

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(2) Input by list retrieval It is possible to display a list of patient information registered in the database on the “Patient Information Selection box” and then to retrieve patient information in the list. The selected patient information will be displayed in the “Patient Information Input window”. Select

without any input item in the patient information input field. When selecting

, the

caret ( | ) for input characters must be placed in any of “Patient ID”, “Patient’s Name”, “Date of Birth”, and “Telephone no.”.

4

The “Patient Information Selection box” will be displayed. Select the group folder tab on the “Patient Information Selection box”. The desired patient information will be displayed. Select the appropriate patient information, and then

.

The selected patient information will be input in the “Patient Information Input window”.

If all of the retrieved patient information cannot be displayed on one page, use

or

to scroll the window. Select

to cancel the selection of patient information.

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(3) Deletion Unnecessary patient information can be deleted from the database. It is possible to display the list of patient information registered to the database on the “Patient Information Selection box” and to delete the unnecessary patient information. Select

with no data input in the patient information input field of the “Patient Information

Input window” or by inputting keywords for fuzzy retrieval. The “Patient Information Selection box” will be displayed. Select the patient information to be deleted in the “Patient Information Selection box”, and then . The patient information will be deleted accordingly.

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4.2 Selecting Exposure Menu Select an exposure menu. When the patient information input is completed, the “Exposure Menu Selection window” is displayed. Select a display group to display the desired exposure menus, and then select an exposure menu. More than one menu can be selected. The selected exposure menu(s) is displayed in the “Selected Exposure Menu list” on the righthand side of the window. turns one page If there is more than one page of the “Selected Exposure Menu list”, backward or forward. To change order of the selected exposure menus, move a desired menu up or down on the “Selected Exposure Menu list”. Select

/

to scroll the “Selected Exposure Menu list”.

Confirm that the exposure menu selection is correct, and then select Finish the selection of exposure menu to display the “Study window”.

.

4

“Exposure Menu Selection window”

To cancel the settings in the “Patient Information Input window” and the “Exposure Menu Selection window”, select

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. Then, return to the “Patient Information Input window”.

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To reserve a received study as an unexecuted study, select

.

The “Patient Information Input window” is displayed to receive the next study. The reserved study can be executed from the “Local WL list”. For how to perform an already-reserved study from the “Local WL list”, see “FDR-3000AWS Reference Guide”.

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4.2.1 Modifying Exposure Menu Described below are the operations for adding, changing, and deleting an exposure menu.

(1) Adding exposure menus To add exposure menus in the “Exposure Menu Selection window”, use this function with no exposure menus selected in the “Selected Exposure Menu list”. For how to operate processing for selection of exposure menus, see “4.2 Selecting Exposure Menu”.

4

NOTE Make sure that no exposure menus have been selected in the “Selected Exposure Menu list”, and then add exposure menus. An attempt to operate selection of exposure menus, with exposure menus selected in the “Selected Exposure Menu list”, will result in adding those already-selected exposure menus to menus to be newly added in the list.

(2) Changing exposure menus To change an exposure menu in the “Exposure Menu Selection window”, select an exposure menu you want to change from the “Selected Exposure Menu list” and then perform operations necessary to actually change the selected exposure menu. For how to select an exposure menu, see “4.2 Selecting Exposure Menu”.

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(3) Deleting exposure menus To delete a specific exposure menu in the “Exposure Menu Selection window”, select a menu and then

.

4 To delete all the exposure menus, select

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4.3 Reading Images This section explains how to read and display the images already exposed. The re-exposure/additional exposure can be performed if necessary. For details on re-exposure/additional exposure, see “FDR-3000AWS Reference Guide”. Select the exposure menu for the image to be read.

After executing an X-ray exposure by the exposure unit, an exposed image is displayed in the “Study window”. Check the image. Repeat the above procedure (executing an X-ray exposure, and then checking the exposed image) per exposure menu. To switch the exposure menu currently displayed to another one, select an appropriate thumbnail from the exposure menu list at the lower part of the screen. NOTE • Perform the calibration before an X-ray exposure.

4

• Do not operate the AWS while performing the operation for exposure. • Before making an exposure, make sure that exposure menus with an image already read for them are not selected. Add exposure menus if necessary, and then make an exposure with the menus selected. For how to add exposure menus, see “FDR-3000AWS Reference Guide”. • When the “Exposure order setting” is set to “ON” in the User Utility and is displayed, selecting the displayed image disables the exposure order setting. Make sure that the currently selected exposure menu is appropriate before making an exposure.

NOTE If the images read in the “Study window” of the AWS are displayed as below, stop the operation of exposure immediately and contact our official dealer. • The exposed image is displayed entirely in white. • The exposed image is displayed in one tone other than white. NOTE Ultrafine mesh image pattern over the entire exposed region may not be suitable for image processing.

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4.4 Editing Images This section explains how to edit information on the displayed image.

After displaying the target image, select any of the QA function shortcut buttons or

.

The image processing function that includes image rotation is denominated the QA function. Individual QA functions are assigned to the relevant shortcut buttons and displayed in the “Study window”. The display property settings for the QA function shortcut buttons (icons) can be set in the User Utility. For details, see “FDR-3000AWS Reference Guide”.

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QA function shortcut buttons

When

is selected, the “Image Edit window” (by an image level) is displayed. See “FDR-

3000AWS Reference Guide” to edit image information appropriately.

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To save the setting, select

.

To end image information editing and return to the “Study window”, select (or

).

4

NOTE Whether

(or

) or

/

(or

) is displayed depends on the settings

at the time of installation. When

/

(or

) is displayed, select

and then

(or

) to

reflect the settings.

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4.5 Completing Studies This section explains how to complete the current study. Operate appropriately depending on the status of study process. When the study is completed, the images are delivered automatically.

(1) In the case that the image reading has been done for all exposure menus in the study Select

.

The conditions set in the “The method at the time pushed “Study Finish” button (There is no unregistration menu.) field” in the Property Setting of the User Utility is applied.

4

Explained below are the conditions set in the “The method at the time pushed “Study Finish” button (There is no unregistration menu.) field” in the Property Setting of the User Utility and the operations applied when a study ends. Finish exposure and QA : If this condition is set, the exposure and the image editing (QA) are terminated, and the study is stacked in the “Queue list”. If the study concerned is for the exposure menu for which images have not been read, the study will be stacked to or deleted from the “Local WL list”. Whether or not to be stacked to or deleted from the “Local WL list” depends on the User Utility settings. If the study concerned is for the exposure menu for which images have been read, the study will be stacked to the “Queue list”. If terminating exposures with a different condition from the User Utility settings, wait for a moment while holding down

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to display the menu, and select

.

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Suspend Exposure : The exposure is stopped halfway through processing and the current study is suspended. For details, see “FDR-3000AWS Reference Guide”. Exposure/QA Completed : The exposure (image reading) and the image editing (QA) are terminated. The study is stacked in the “Queue list”. If the study concerned is for the exposure menu for which images have not been read, the study will be stacked to or deleted from the “Local WL list”. Whether or not to be stacked to or deleted from the “Local WL list” depends on the User Utility settings. If the study concerned is for the exposure menu for which images have been read, the study will be stacked to the “Queue list”. If a dose control system is connected to the AWS at the time of installation, exposure result information is sent to the system when exposure and image editing are completed.

4

(2) In the case that exposure menus of unread images remain in the study Select . The conditions set in the “The method at the time pushed “Study Finish” button (The unregistration menu exists.) field” in the Property Setting of the User Utility is applied. The exposure can be completed with a different condition from the User Utility settings. See “(1) In the case that the image reading has been done for all exposure menus in the study”.

Explained below are the conditions set in the “The method at the time pushed “Study Finish” button (The unregistration menu exists.) field” in the Property Setting of the User Utility and the operations applied when a study ends. The unregistered menu is deleted, and study is finished : If this condition is set, the study is completed automatically deleting the exposure menus for which the images have not been read. The condition for “Finish exposure and QA” will be applied. The unregistered menu is not deleted, and study is suspended : If this condition is set, the study is suspended without deleting the exposure menus for which the images have not been read. So, the study cannot be completed. When completing the study, use the same procedure as for “(1) In the case that the image reading has been done for all exposure menus in the study” to complete the exposure with different condition from the User Utility settings. 897N102565N FDR-3000AWS Operation Manual

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User confirmation : If this condition is set, the confirmation box below is displayed.

Confirmation box

To complete the study, select

.

The exposure menus will be terminated automatically deleting those menus for which the

4

images have not been read. The condition for “Finish exposure and QA” will be applied. To suspend the study without deleting the exposure menus of images which have not been read, select

.

To cancel the operation and close the confirmation box, select

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Chapter 5 Troubleshooting Page

5.1 Error Messages·········································································· 5-2 5.2 How to Handle an Error······························································ 5-4

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5.1 Error Messages This section explains warning dialog boxes and error messages. If an error which cannot be handled occurs or the same error recurs frequently, contact our official dealer.

(1) If a warning dialog box appears on the screen If a communication error or an unexpected error occurs, a warning dialog box pops up on the screen. In this case, read the displayed message thoroughly, close the dialog box, and then take necessary actions immediately by following the message. Be sure not to continue operating the AWS unless you take appropriate actions. If you perform operations on the screen while a warning dialog box is displayed, another screen may appear causing the dialog box to be hidden behind it. If you press the Enter key on the keyboard in this case, the hidden dialog box can be closed.

(2) If an error occurs in the exposure stand

5

If an error occurs in the connected exposure stand, the “Error Message box” appears on the screen.

In this case, select “OK” in the box. The box closes and the exposure stand is reset. If the same “Error Message box” is not displayed, operation can be continued. If the box appears again, take note of the error code displayed in it, and then contact our official dealer.

(3) If an error occurs in this equipment (AWS main unit) If an error occurs in the AWS, the “Error Message box” appears on the screen. In this case, check the error details, select “OK” in the box, and then take appropriate actions.

(4) If an error occurs in the flat panel detector (FPD) If an error occurs in the FPD, an error message is displayed on its status display. In this case, check the error details, and then restart the AWS main unit without continuing operations.

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(5) If an error occurs in a destination device If an error occurs in a destination device,

is displayed in the upper right of the window. In this

case, operate as follows. Select

.

The “Error Display box” is displayed. Check the connection status, select

, and then take

appropriate actions.

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“Error Display box”

(6) If an error message is displayed in the AWS monitor The error messages displayed in the AWS monitor, their causes, and solutions are as shown below. Error codes 24256, 34149, 44788

24257, 34150

Error messages Patient orientation, image laterality, and view code are not set. >Set patient orientation, image laterality, and view code, and then retry the output.

Patient orientation, image laterality, and view code are not set. Outputting to a server or a viewer may fail. >Open the QA screen and set patient orientation, image laterality, and view code. Delete studies having failed in outputting from the list (waiting for output) and retry the output.

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Causes The information needed for outputting images, for example, patient orientation, image laterality, or view code is not set.

Solutions Try the following method. Display the “Image Edit Window” and set patient orientation, image laterality, and view code. See the“FDR-3000AWS Reference Guide” for detailed information. When you want to configure the targeted exposure menus permanently, use the following method. Use the User utility to set patient orientation, image laterality, and view code for targeted exposure menus. See the“FDR-3000AWS Reference Guide” for detailed information.

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5.2 How to Handle an Error (1) If the AWS hangs up If an improper processing is executed while operating the AWS, the screen may freeze and the AWS may hang up (processing disabled). If this happens, forcibly shut down the AWS and restart it by following the procedure below. NOTE If the screen freezes and a hangup occurs, remove the keyboard and mouse and reconnect them. If this operation does not solve the problem, restart the AWS.

1. Press the Ctrl, Alt and Del keys simultaneously. 2. “Windows Security” is displayed. Select “Start Task Manager” (“Task Manager” in Windows 10).

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3. “Windows Task Manager” is displayed. From the list under the “Processes” tab (“Details” tab in Windows 10), select IIPMAIN.exe, right-click, and then select “End Process” from the menu that is displayed. 4. A message box is displayed. Click “End Process” to terminate the AWS. Depending on equipment condition, the message box may not be displayed. 5. The Windows desktop appears. After closing the “Windows Task Manager” window, select the “Start” button at the bottom left corner of the screen and select “Restart” (“Power - Restart” in Windows 10) from the menu that is displayed.

NOTE • If the AWS hangs up, always follow the procedure above to shut it down. If you turn off the personal computer without the shutdown operation, abnormality may result. • Do not forcibly shut down the AWS main unit in normal situations. Such action should be taken only in an emergency.

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(2) If the AWS terminates abnormally If the AWS terminates abnormally and the Windows desktop appears, restart the AWS by following the procedure in “(1) If the AWS hangs up”.

(3) If deadlock occurs in the AWS If deadlock (state where processes are unable to proceed until necessary resources are released after multiple programs lock them) occurs, restart the AWS by following the procedures in “(1) If the AWS hangs up”.

(4) If the AWS is turned off due to blackout, etc. If the AWS is turned off due to blackout, etc., take the following actions depending on power recovery condition. • If power is recovered soon after blackout Wait until the AWS restarts. After the AWS starts running, shut it down once using the normal procedure. For details on system shutdown, see “3.1.3 Shutting Down the AWS”.

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When restarting the AWS, follow the procedure for starting up the system. If power is disconnected while X-rays are being emitted, the study in progress may not be resumed even after restarting the AWS. In this case, delete that study from the study list after the restart, and then perform re-exposure. Note that the image information of the deleted study will be erased as well. NOTE Deleted image information cannot be restored in any case.

(5) If the displayed dialog is hidden behind other screens and you cannot operate AWS, press the [Alt] + [Tab] key or the [Alt] + [Esc] key multiple times on your key board. The dialog will reappear and you will be able to continue working.

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(6) If a hard disk is damaged (for RAID-type PC) If one of the hard disks is damaged, a window indicating so will appear at the time of startup of the AWS. In such a case, press the F1 key and contact our official dealer. If the function described below is installed, the state of the hard disks can be displayed. If one of them is damaged, the following message appears. Contact our official dealer. The details can also be displayed by clicking the icon.

After the hard disk is restored, make sure that the following message is displayed before using the AWS.

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NOTE • D o not select “Exit” from the menu displayed by right-clicking the icon. This function terminates when the menu is selected. • If the message, etc. overlaps other items on the screen, move the icon to change the display position.

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Chapter 6 Daily Inspection and Maintenance Page

6.1 Performing Daily Inspection and Maintenance···························· 6-2

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6.1 Performing Daily Inspection and Maintenance Perform daily inspection and maintenance to use the AWS under optimal conditions.

(1) Personal computer • Checking for normal startup and shutdown of the AWS as well as the establishment of proper communication with the connected devices • Checking the fan for its operation Check if strange noise or odor is not perceived. • Checking the built-in clock for the time and adjustment The AWS identifies and manages images based on time information. Make sure that the time of the clock is always set correctly. • Cleaning the color LCD monitor • Cleaning the keyboard and mouse

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

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Appendix A Main Specifications Page

A.1 Specifications············································································· A-2 A.2 External Dimensions and Weight················································ A-4

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A.1 Specifications Shown below are the specifications of the AWS. NOTE The power supply and environment conditions may change due to changes in the product specifications. For details, see the operation manuals of the respective products being used.

■ Personal Computer Main Unit

Power Supply Conditions Input voltage : AC90V ~ 269V Frequency : 47Hz ~ 66Hz Environmental Conditions (1) Operating conditions Temperature : 5°C ~ 35°C Humidity : 10%RH ~ 85%RH (No dew condensation) Altitude : Less than 10000 feet (2) Non-operating conditions Temperature : -40°C ~ 60°C Humidity : 10%RH ~ 90%RH (No dew condensation) Altitude : Less than 30000 feet

Keyboard

USB keyboard

Mouse

USB mouse

2M Color LCD monitor (1600 x 1200)

Power Supply Conditions Input voltage : AC100V ~ 120V/AC200V ~ 240V Input current : 1.1A ~ 0.9A/0.6A ~ 0.5A Frequency : 50Hz/60Hz Environmental Conditions (1) Operating conditions Temperature : 0°C ~ 35°C Humidity : 20%RH ~ 80%RH (No dew condensation) Atmospheric pressure : 540hPa ~ 1060hPa (2) Non-operating conditions Temperature : -20°C ~ 60°C Humidity : 10%RH ~ 90%RH (No dew condensation) Atmospheric pressure : 200hPa ~ 1060hPa

3M Color LCD monitor (2048 x 1536)

Power Supply Conditions Input voltage : AC100V ~ 120V/AC200V ~ 240V Input current : 1.3A ~ 1.0A/0.6A ~ 0.5A Frequency : 50Hz/60Hz Environmental Conditions (1) Operating conditions Temperature : 0°C ~ 35°C Humidity : 20%RH ~ 80%RH (No dew condensation) Atmospheric pressure : 540hPa ~ 1060hPa (2) Non-operating conditions Temperature : -20°C ~ 60°C Humidity : 10%RH ~ 90%RH (No dew condensation) Atmospheric pressure : 200hPa ~ 1060hPa

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3M monochrome LCD monitor (2048 x 1536)

Power Supply Conditions Input voltage : AC100V ~ 120V/AC200V ~ 240V Input current : 0.9A ~ 0.75A/0.5A ~ 0.45A Frequency : 50Hz/60Hz Environmental Conditions (1) Operating conditions Temperature : 0°C ~ 35°C Humidity : 20%RH ~ 80%RH (No dew condensation) Atmospheric pressure : 700hPa ~ 1060hPa (2) Non-operating conditions Temperature : -20°C ~ 60°C Humidity : 10%RH ~ 90%RH (No dew condensation) Atmospheric pressure : 200hPa ~ 1060hPa

5M monochrome LCD monitor (2048 × 2560)

Power Supply Conditions Input voltage : AC100V ~ 120V/AC200V ~ 240V Input current : 1.1A ~ 0.9A/0.6A ~ 0.5A Frequency : 50Hz/60Hz Environmental Conditions (1) Operating conditions Temperature : 0°C ~ 35°C Humidity : 20%RH ~ 80%RH (No dew condensation) Atmospheric pressure : 540hPa ~ 1060hPa (2) Non-operating conditions Temperature : -20°C ~ 60°C Humidity : 10%RH ~ 90%RH (No dew condensation) Atmospheric pressure : 200hPa ~ 1060hPa

■ Hub Power Supply Conditions Input voltage : AC100V ~ 240V Input current : 0.1A Frequency : 50Hz/60Hz Environmental Conditions (1) Operating conditions Temperature : 0°C ~ 50°C Humidity : Less than 80%RH (No dew condensation) (2) Non-operating conditions Temperature : -20°C ~ 60°C Humidity : Less than 95%RH (No dew condensation)

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A.2 External Dimensions and Weight Shown below are the dimensions and weights of the AWS.

Width (mm (in.))

Depth (mm (in.))

Height (mm (in.))

Weight (kg (lb))

314 (12.4)

563 (22.2)

568 (22.4)

11.3 (24.9)

2M Color LCD monitor (Note) (1600×1200)

361.5 (14.2)

195.5 (7.7)

517 (20.4) 612 (24.1)

9.3 (20.5)

3M Color LCD monitor (Note) (2048×1536)

361.5 (14.2)

195.5 (7.7)

517 (20.4) 612 (24.1)

10.4 (22.9)

3M monochrome LCD monitor (Note) (2048×1536)

361.5 (14.2)

195.5 (7.7)

517 (20.4) 612 (24.1)

9.8 (21.6)

5M monochrome LCD monitor (Note) (2048×2560)

361.5 (14.2)

195.5 (7.7)

517 (20.4) 612 (24.1)

9.5 (20.9)

160 (6.3)

105 (4.1)

35 (1.4)

0.5 (1.1)

Personal computer (Note)

Hub (Note) NOTE

Dimensions and weight are subject to change due to the specification changes, etc. For details, see the operation manuals of the respective products being used.

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Appendix B Optional Software Page

B.1 Optional Software······································································· B-2

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B.1 Optional Software Overview and precautions regarding each optional software product for the Console are shown below.

DICOM Modality Worklist Management Software (Specifications for the Network WL) The DICOM Modality Worklist Management Software permits query/retrieve of the study information with the Console that is connected online (DICOM specification interface) to the host units (DICOM server, RIS terminal unit, and others). NOTE Study information that does not comply with the specification of the Console cannot be retrieved.

DICOM Modality Worklist Management Software (Specifications for Patient Information) The DICOM Modality Worklist Management Software permits search/obtaining of patient information with the Console that is connected online (by DICOM-conformant interface) to the host units (such as DICOM server, RIS terminals, and others).

Performed Procedure Step (PPS) Description Software The PPS Description Software offers the functions to edit film output count and size as well as the name of an employed contrast medium and the amount of its use and to send the information to the RIS.

Media Storage Software The Media Storage Software enables the user to store images in DICOM format on removable media (DVD-RW, DVD+RW, USB memory, or external USB hard disk drive) and to retrieve/deliver the stored images on the AWS. NOTE • It may take some time until you can remove a DVD after selecting “Handling end”. When removing the DVD, do not press the Eject button until the DVD is automatically ejected after the writing process or until a process completion message is displayed indicating that you can remove the DVD. Whether the writing in the media is completed or not can be checked on the “Queue list”. • When purchasing a USB memory or external USB hard disk drive, note the following points: - Purchase a product that complies with the FCC/VCCI/CE standards or equivalent. - Select a product that supports USB2.0 specification. - Select a product that does not require you to install an exclusive driver or software. - Select a product with a capacity of 2GB or more. -M  ake sure that the product operates normally by performing “Write/Read & Compare” in Windows Explorer. If you have any enquiries, contact our official dealer. • When using a USB memory, be careful not to lose it by mistake. • The USB memory or external USB hard disk drive to be used for the Media Storage Software should not be used for other purposes. • Connect only one USB memory or external USB hard disk drive. If more than two USB memories or external USB hard disk drives are connected simultaneously, they may not operate normally. • It may take some time until you can remove a USB memory or external USB hard disk drive after selecting “Handling end”. Before removing a USB memory or external USB hard disk drive, make sure that the writing in the USB memory or external USB hard disk drive is completed, that a process completion message is displayed, and that the USB memory or external USB hard disk drive access lamp is not flashing. Whether the writing in the media is completed or not can be checked on the “Queue list”.

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• Only DVD-RW and DVD+RW discs can be used. • Unformatted DVDs cannot be used. • Format a new DVD before use. • Information contained in a DVD will be fully deleted when it is formatted. Information once deleted can never be restored after formatting the DVD. Prior to formatting, make sure that there will be no problem even if the information in the disc is deleted. - “ Quick Format” is not available for a new DVD. -D  epending on the media type, the formatting time varies. -B  efore formatting a USB memory or external USB hard disk drive, make sure that it is not write-protected. - Information contained in a USB memory or external USB hard disk drive will be fully deleted when it is formatted. Information once deleted can never be restored after formatting the USB memory or external USB hard disk drive. Prior to formatting, make sure that there will be no problem even if the information in the USB memory or external USB hard disk drive is deleted. -W  hether or not the high-density shift button appears depends on the settings at the time of installation. -W  hen an image is output with the high-density shift button, “+” is highlighted at the end of the image processing conditions printed on film. The highlighted “+” mark indicates that highdensity shift processing is applied to the image. - If all the study information cannot be displayed in the “Network WL list” at a time, a scroll bar is displayed on the right-hand side of the window. You can use this scroll bar to scroll the information in the list. -D  o not press the Eject button of the DVD drive when a DVD is in use or during the media mounting process. Also, do not remove the USB memory or external USB hard disk drive when in use. -W  hen “Pixel Padding Value Auto Calculation Setting” is set to “ON” in the User Utility, the pixel padding value setting becomes enabled when reading back a medium. For information on the exposure menu items that allow the calculation or confirmation of the pixel padding value, see “FDR-3000AWS Reference Guide”. • ‌If the size of the images delivered exceeds the capacity, set during installation, of the selected destination folder, the drive is automatically mounted and the images are stored in a new folder. The name of the new folder is the name of the selected destination folder to which “-XXX” has been added (“XXX” is a number between 002 and 999). • Match the status of optional software related to image processing for both image writing and image reading devices when you read back media. Otherwise, the view of image differs from each other. • Do not read the studies on a medium back on the FDR-3000AWS, if the version of the AWS is earlier than that of when the studies were stored with the Media Storage Software. • Depending on the number of images stored on the medium, the reconstruction process may take several tens of minutes. • For an unformatted blank medium, a message saying “The file cannot be handled because itis unformatted or illegally formatted.” appears. In such an instance, check the medium and format it accordingly. • If an error message is displayed during USB memory or external USB hard disk drive reconstruction, the USB memory or external USB hard disk drive may be write-protected. After confirming that the USB memory or external USB hard disk drive is not write-protected, perform reconstruction again. If the same message appears even after retry, contact our official dealer.

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Portable Data for Imaging (PDI) Software This is a software application used to write AWS image-related information on CD-R, DVD-R and DVD±RW according to IHE portable data for imaging (PDI) integration profiles. NOTE • PDI writing can be operated by using the following hardware: - Internal drives having the function to write on CD-R, DVD-R and/or DVD±RW. • Image-related information can be written in PDI format on the media satisfying the following conditions: - Writable CD-R, DVD-R and DVD±RW - Unformatted CD-R, DVD-R and DVD±RW • Only one PDI can be created at one operation. • If the image data to be written exceed the capacity of a single medium, the PDI processing cannot be performed. In such a case, the AWS displays a message prompting to reduce the amount of data and retry writing. • When the “PDI Wizard” is displayed, the “Delivered List window” cannot be operated. • It is not possible to write rejected images. If the image-related information including rejected images only is selected on the “Delivered List window”, such information will not be displayed in the “Patient List window”. • When selecting the multiple patients’ image-related information, “Multiple patients are being selected.” appears. There will be no problem in writing the information, however, confirm the patient’s name in the “Patient List window”. • Do not press the Eject button of the personal computer drive or operate other programs during writing. These operations may prevent correct writing. • The cancellation of writing is not possible in the “Processing Writing window”. • If an error occurs and writing cannot be continued, a message dialog box is displayed. Select to close the “PDI Wizard” and return to the “Delivered List window”, and then start the writing procedure over. • Do not display the written image-related information on the AWS.

Network Image Search Software The Network Image Search Software enables the user to search and display images from storage devices or workstations connected to the AWS using any item as a key element and then to print out those images on film. NOTE • Images printed using this software can be available for reference only. • ‌Film format and other settings may not be reflected correctly when images are printed using the exposure unit not covered by warranty. • ‌It is not allowed to use the information input from a BCR (barcode reader) or MCR (magneticcard reader), instead of using information input on the keyboard. • When a standard image, converted from a high-density image and filed (stored) in a storage device or the like, is printed after it has been read on the AWS, there are cases where the margins of the image appear white (or black). • ‌If search results include images output via other companies’ terminals, those images cannot be acquired or displayed. This is because such image sizes are not supported. In such cases, the following message is displayed: “The study you wish to acquire does not include information necessary for you to verify images. Processing to acquire the study cannot be continued.”

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• ‌Search results may include images that cannot be acquired or displayed, as such images are unavailable because their predetermined specifications are not supported. An attempt to acquire or display such image will cause the following message to appear: “Study acquisition processing has failed. Images that are unable to be displayed may exist within the study.” • ‌If the search results contain linear images, these images cannot be acquired or displayed. In such a case, the following message is displayed. “Failed in processing to acquire studies. Studies include images that cannot be displayed. Check only images that can be displayed.”

Image Browse Software When the SYNAPSE is connected on the network, the Image Browse Software allows images stored in the SYNAPSE to be displayed or operated on the AWS. To use the Image Browse Software, you are required to have a SYNAPSE Viewer license. NOTE Study information that does not comply with the specification of the Console cannot be retrieved.

Referral Viewing Function Software The Referral Viewing Function Software is designed to perform searches for studies stored on the server and to acquire and display images from those studies on the AWS screen and another monitor (hereafter referred to as the “option monitor”). NOTE • If the AWS has failed to start up, the Referral Viewing Function Software is not activated either. • If the Referral Viewing Function Software terminates abnormally, a message appears on the monitor of the AWS. However, the AWS can be used continuously. To activate the Referral Viewing Function Software again, restart the personal computer. • When the optional Precise Enlargement Function Software is installed along with the Referral Viewing Function Software, the settings at the time of installation determine which software appears on the option monitor when the AWS is started up. • Either “Patient ID” or “Patient’s name” must be entered. • “No. of Data” includes information not only on the number of image data but also on DICOM Structured Reporting (SR), etc. The type and number of data contained vary depending on the system configuration. Example: If a study containing images of 4 exposures is stored on the server temporarily via CAD equipment, “5“ is displayed in the “No. of Data” field at the time of acquisition of this study, since the number of images is 4 and SR is 1. • It is not possible to obtain or display images from DICOM Service Class studies that are incompatible with the Referral Viewing Function Software. If images cannot be acquired or image processing has failed, the “Error Screen” is displayed for all the images in a study. • The density or contrast adjustment on the AWS main unit only allows the adjustment of the GA or GS value. To adjust density or contrast, adjust it visually.

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Retake Analysis Software The Retake Analysis Software is incorporated as the Retake Analysis function in the User Utility and analyzes the cause of mis-exposure by referring to the exposure result log, misexposure log, and mis-exposure images saved in the AWS. NOTE • The Retake Analysis Software is available only for the user who has logged in the AWS as an administrator. • When selecting the destination for the calculation result, do not select the C drive of the AWS, since it is for system use.

Patient ID Auto Convert Software The Patient ID Auto Convert software is designed to enable batch data conversion that gives complete patient information to screening studies performed with temporary patient information.

Precise Enlargement Function Software The Precise Enlargement Function Software is designed to display the same image as that on the AWS screen on another monitor (hereafter referred to as the “option monitor”) for more detailed image display. NOTE • If the AWS has failed to start up, the Precise Enlargement Function Software is not activated either. • If the Precise Enlargement Function Software terminates abnormally, a message appears on the monitor of the AWS. However, the AWS can be used continuously. To activate the Precise Enlargement Function Software again, restart the personal computer. • When the optional Referral Viewing Function Software is installed along with the Precise Enlargement Function Software, the settings at the time of installation determine which software appears on the option monitor when the AWS is started up.

Region of Interest (ROI) Measurement Software The ROI Measurement Software is designed to manage image quality by measuring the mean pixel value and other data values in an ROI that is specified in an exposed image. NOTE • This software should not be used for any purpose other than the management of image quality. • For the FDR-3000AWS, wait until a 50μm image is input, and then start the ROI Measurement Software. Otherwise, an error message is displayed. • The layout of image properties display area and the measurement results display area is different depending on the direction of the monitor. • If you select a size while an ROI is already displayed, the ROI will be deleted. • If you select “Exit” from the pull-down menu, the ROI Measurement Software quits, and the AWS display returns. • If an ROI is extremely small, the displayed coordinates may overlap. If this occurs, the coordinates can be viewed in the ROI information field at the bottom of the screen. • If you left-click the mouse at the edge of the image (at a location where an ROI of the selected size cannot be displayed in its entirety), the ROI is automatically created at a position where it can be displayed with the selected size. Note that the position where you left-click the mouse does not become the starting point in this case.

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• If you move the mouse cursor to a point beyond the display range of the image while holding down the mouse button and then release the button, an ROI is created only within the display range. • Each information of the created ROI is within the following margins of error: -S  tarting and ending point coordinates: 0.05 mm or less - Width (width of the ROI) and Height (height of the ROI): 0.05 mm or less -A  rea (area of the ROI): 0.05 mm2 or less - Mean (mean pixel value): 0.0005 or less -M  edian (median pixel value): 0.05 or less -S  tandard Deviation: 0.0005 or less • To cancel creating an ROI, create it first, right-click the mouse, and then select “Exit” from the displayed menu. • Measurement results and an ROI are not saved. • Compared to the images acquired in software version 3.2 or earlier of the AWS, the measurement results of Mean (mean pixel value), Median (median pixel value), and Standard Deviation are quadrupled in version 4.0 or later.

QA Measurement Software The QA Measurement Software is designed to measure the distance between two points on a captured image for locating the calcified areas or determining a position for additional exposures. NOTE • The unit of distance is mm or inch, depending on the settings at the time of installation. • The measured distance is within the following margins of error: - 0.005 mm or less when displayed in mm - 0.005 inch or less when displayed in inch • ‌If, while pressing down the left button, you move the cursor outside of the image display area and then release the button, the line segment that is set will consist of the part that lies within the image display area. ‌ however, you have magnified the image until it appears larger than the image display area, If, then the line segment extends outside of the image display area. • ‌In the normal exposure, the distance between two points is measured on the image projected on the Flat Panel Detector (FPD). • ‌In the magnification exposure, the image projected on the FPD is corrected using the magnification ratio, and then the distance between two points on the image is measured. • ‌In the magnification exposure, the magnification ratio for the image projected on the FPD is 180%. (The plane 30 mm above the magnification exposure table is specified as the magnification ratio of 100%.) • A line segment cannot be moved outside the image. • ‌The magnification level for each mouse click and the maximum magnification level depend on the settings at the time of installation. • Measurement results and line segments cannot be saved.

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Free Layout Print Software The Free Layout Print Software is designed to lay out images of the same study freely. NOTE • ‌The image quality of printed film using this Software, which is for a reference use only, is inferior to that of printed film using the DICOM Print Software. Do not use the former printed film for diagnosis. • Note that the image quality of printed film varies depending on the size of the laid out images.

Breast Density Measurement Software Breast Density Measurement Software is intended for 2D exposure and Tomosynthesis exposure and calculates breast density information from captured images and then displays and outputs the information. NOTE • ‌When the calculation results for breast density information are used for diagnosis, always check the 2D image or Tomosynthesis image of each exposure direction (CC, MLO, etc.), and then judge the breast category of the subject comprehensively. • ‌Exposures for breast density measurement are as follows. Calculations are not performed for other exposures. Furthermore, calculations are not possible for images captured in the past. 2D exposure menu Tomosynthesis exposure menu

MPM code 03X8 or 03X9* 23X0*

Target/Filter W/Rh W/Al

Grid IN OUT

*”X” is an arbitrary setting character • ‌The breast density information calculated by this software may change for various reasons, including exposure conditions, positioning, and the conditions of the subject. In particular, the calculation results for breast density information may be inappropriate with the following exposures. - When the entire breast does not fit within a single image (split exposures, damaged images, CV exposure, etc.)

- When taking an image of a breast that includes an implant or other artificial object - When taking an image of a breast that includes a large tumor lesion (because it is difficult to distinguish between the mammary gland and tumor) - When taking an image of a breast that is undergone a partial mastectomy (sufficient pressure expansion is difficult, which makes it easy to miss part of the mammary gland) - When the frame of the compression plate is on top of the breast • ‌Because breast density information is calculated for each exposure image, the calculated value may differ even for an image of the subject taken at the same time. When 2D exposure and Tomosynthesis exposure are carried out at the same time, refer to the breast density information calculated from the 2D image which is less affected by scattered radiation. • ‌When the mammary gland of the breast is small, such as with a fatty breast, the “mammary gland region” cannot be identified, and the entire breast may be judged as the “mammary gland region”. In such cases, the calculated breast density information will be the same value regardless of the settings of the region of interest.

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FDR-3000AWS Operation Manual

897N102565N

Dynamic Visualization II Software This image processing software has automatic density correction processing, frequency processing, and dynamic range compression processing to improve image quality. On the AWS screen, Dynamic Visualization II is called “DYN”. NOTE • You cannot switch Dynamic Visualization II to GP (Gradation Processing), RP (Spatial Frequency Processing), DRC (Dynamic Range Control Processing), or MFP (Multi-objective Frequency Processing). • This software can render signals of a region saturated by conventional image processing (standard image processing and multi-frequency processing) by performing dynamic range (DR) compression processing so that the whole breast can be displayed. In a radiation dose area in which the amount of penetrating x-rays is extremely low, such as a breast implant, there may be both signals and noise. • The S and L values calculated by this software and conventional image processing (standard image processing and multi-frequency processing) are different. With this software, the latitude of the image is controlled by comparing fat, which has a small x-ray absorption difference with breast, to the skin line so that the density of the breast and fat is appropriate. As a result, the L value tends to be lower. Because this software controls the density of the breast section so that it is the same level of conventional image processing, if the L value is lower, the latitude of the high-density range narrows, and the center of latitude moves to the low-density range (and the S value becomes larger).

897N102565N FDR-3000AWS Operation Manual

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Maintenance and Inspection

897N102565N FDR-3000AWS Operation Manual

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

Periodical Maintenance Make sure that the periodical maintenance and inspection assigned to our official dealer are performed as specified.

Maintenance and Inspection Items Assigned to Specified Dealer Periodical Maintenance and Inspection Items

Period

Checking of the operation record by referring to the error log

Every year

Checking of the image

Every year

Checking of the image storage function

Every year

Use of the fault diagnosis tool

Every year

Checking of each unit

Every year

The cycles of periodical maintenance and inspection differ depending on the usage and the daily operation time. For details, contact us directly or our official dealer.

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FDR-3000AWS Operation Manual

897N102565N

897N102565N FDR-3000AWS Operation Manual