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FDR MS-3500
Operation Manual
14th Edition : March 2017
Original Instructions
When the manual is provided in languages other
than English, it is considered to be a "Translation
of the original instructions".
In this case, it must bear the words "Translation of
the original instructions" in place of "Original
Instructions" above.
897N102525N
( FDR-3500DRLH )
This Operation Manual describes details on basic operations of the FUJIFILM
Digital Mammography System FDR MS-3500 and cautions to be observed when
operating it. Please read the Operation Manual thoroughly before actually
operating the FDR MS-3500 system.
After reading this manual, store it nearby the FDR MS-3500 system so that you
can see it whenever necessary.
Refer to the reference guide for more details of operation methods and functions
(including options).
For Safe Operation
Product Overview
Operations
Troubleshooting
Daily Inspection and
Maintenance
Appendices
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Related Manuals for FujiFilm AMULET Innovality FDR MS-3500
Summary of Contents for FujiFilm AMULET Innovality FDR MS-3500
- Page 1 Original Instructions When the manual is provided in languages other This Operation Manual describes details on basic operations of the FUJIFILM than English, it is considered to be a “Translation Digital Mammography System FDR MS-3500 and cautions to be observed when of the original instructions”.
- Page 2 If you would like to receive such source codes, please contact FUJIFILM dealer or the service representatives at the agency from which you purchased this product. (Please be noted that any inquiries concerning the contents of source codes should be directed to original licensers of open source software.)
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Page 3: How To Read This Manual
Indicates procedures requiring special attention, instructions that must be followed, supplementary explanations, etc. HINT Shows an item helpful for further effective system operation. Shows a more detailed operation method or an item that describes additional information. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 4: Table Of Contents
Contents Introduction ..........................ii FUJIFILM Digital Mammography System Operation Manuals ..........iii How to Read This Manual ....................... iii Chapter 1 For Safe Operation Precautions Before Operating This Equipment ............1 Precautions to be Observed When Using the Electric Medical Equipment ....2 Safety .......................... -
Page 5: Chapter 1 For Safe Operation
• You shall not modify the System and/or its components, and shall not disassemble, decompile, or in any other way reverse engineer the System and/or its components. FUJIFILM shall not be liable to you for any defects caused by such modification, disassembly, decompilation or reverse enginerring, and shall not liable to you for any damages caused by said defetcs. -
Page 6: Precautions To Be Observed When Using The Electric Medical Equipment
Do not use any other cleansers or disinfectants. Also, do not scrub the equipment’s surface vigorously. 7-3. Follow the Operation Manual and operate the equipment correctly. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 7: Safety
14 exposures or more in total or an exposure continued for 40 seconds or more. Japan (Type A) Connection instructions WARNING Make sure that the devices to be connected to the equipment are authorized for connection. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 8 • Reduce the radiation field size to the minimum necessary size for the exposure. If X-rays are unavoidably radiated to areas outside of the subject region, take other protective measures such as readjusting the collimator or wearing a Pb apron. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 9 Do not install any software in addition to the preinstalled software. Do not uninstall the preinstalled software. The system is preinstalled with the appropriate software. If it is deleted or other software is added, various operational errors may result. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 10 Cautions on Network CAUTIONS After connecting this system to the network with other systems, confirm that the other systems are not affected. If they are affected, take countermeasures such as network separation. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 11 • Disinfection may be required for the optional items of the system. See the related Operation Manuals for details. • Clean/disinfect the compression plate using the specified method. Do not sterilize the compression plate. Doing so may cause the compression plate to become deformed or damaged. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 12 AWS. Otherwise, fire or electrical shock may occur due to the electrical load exceeding the allowable limit. • Always use optional items and supplied items recommended by FujiFilm. Using optional items and supplied items other than those recommended by FujiFilm may cause electrical shock or damage to occur.
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Page 13: Electromagnetic Compatibility (Emc)
EN 61000-4-11 Further information for IEC 60601-1-2 (EN 60601-1-2) Model name FUJIFILM Digital Mammography System FDR MS-3500 is referred to as FDR MS-3500 in this section. • Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. - Page 14 IEC 61000-4-8 location in a typical commercial or hospital environment. NOTE: U is the a.c. mains voltage prior to application of the test level. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 15 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. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 16: Precautions In Using Fdr Ms-3500
• During an X-ray exposure, a technologist or doctor should be where the emergency stop button is within their reach. • Install the magnification table horizontally. If slanted, the stainless stay will fall down under its own weight and could cause injury to the patient or technologist. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 17 • When making an exposure with the compression plate removed, make sure to use manual mode. Using full auto or semi auto mode may result in insufficient image quality. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 18 90 seconds or more *1: Successive compression plate operation without making X-ray exposures *2: The operation interval is the time period that should be left between a grid dismounting and the next mounting. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 19 The system identifies and manages images by the date and time they were read. Make sure that the correct date and time are displayed when the AWS has started. Managing data • When disposing of the AWS, completely delete all personal information. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 20: Location Of Each Label
2. Sub-circuit OFF 3. Stop Label 4. Caution Label (Regarding Physical Contact) 5. Type B applied part label Do not touch the biopsy positioner connector. Touching it may cause a system failure. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 21 See the graph “Minimum exposure interval for energy input to X-ray system (tube)” in “A.1 Specifications”. X X X X X X X 3. Remote Exposure Foot Switch Label n Generator 1. High voltage 2. System Label 3. Rating Label warning label FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 22 1. Identification Label 401Y120026 18×24LOW(H) X X X X X X X 2. Model Number Label 1. Identification Label • 18×24 (High) 401Y120005 18×24HIGH(H) X X X X X X X FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 23 • 18×24 (FS Shift P) 401Y200001 18×24FS SP(H) X X X X X X X 1. Identification Label 2. Model Number Label • Rectangle spot 401Y100118 SPOT(H) X X X X X X X FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 24 • Round spot magnification 401Y120011 MAG1.8SPOT_R(H) X X X X X X X 1. Identification Label 2. Model Number Label • 2D biopsy 401Y100114 2D-BIOPSY(H) X X X X X X X FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 25 X X X X X X X 2. Magnification Table Name Plate : Type B applied part X X X X X X X X 3. Type B applied part label FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 26 For non-EU countries Identification Label n Software product for FDR-3000AWS Identification Label • The month and year of actual manufacture are printed on the label. • Store the CD case with care. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 27 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. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 28: Diagnosis System Safety Standard Requirements
For details, see “3.1.5 Shutting Down the Exposure Unit” and “3.1.6 Shutting down the Diagnosis System”. Stopping the System in Emergency For details, see “3.3.1 Exposure Unit Emergency Stop Button”, “3.3.2 Exposure Unit Emergency Stop Operation” and “3.3.3 Exposure Unit Restoration”. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 29: Chapter 2 Product Overview
(low energy) exposure taken under conditions similar to standard mammography exposure and a high tube-voltage (high energy) exposure that applies a Cu filter. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 30: Diagnosis System Configuration
• When installing the AWS in a study room, use the protective shield (optional) to protect the technologist from exposure to X-rays. CAUTIONS Handle and keep all the Operation Manuals for each component of FDR MS-3500 as a whole. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 31 • CEDM Software • Rectangle spot compression plate • Axillary pad R *2 *2 For replacement. n AWS Refer to “FUJIFILM Mammography Workstation FDR-3000AWS Operation Manual”. Separately-sold items n Exposure Unit • Biopsy positioner (FDR-2000BPY) • Wall Holder for Compression Plate •...
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Page 32: Part Names And Functions
Contact a designated contractor for details. plate of the swivel arm. switch Lightly stepping on the switch turns on the light field lamp, indicating the radiation field. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 33 30N. In this case, unless the compression force is set to 0N, the swivel arm operations cannot be performed. n Control cabinet n Generator Principally no user operation is required. Breaker ON Breaker OFF Circuit breaker CAUTIONS Do not turn off the power to the control cabinet. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 34 G Designed to meet the relevant requirements of 21 CFR 1020 and IEC60601-2-45:2011. Monitor arm (optional) Use this to install and secure the AWS monitor. Operation desk Place the AWS on this. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 35 (3) Calibration menu setting section display section button (5) Flat panel detector (6) Exposure stand status (7) Exposure (9) Time display (FPD) status display display message display (8) Exposure status indicator FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 36: Chapter 3 Operations
AWS. However, daily calibration must be performed every day to keep the flat panel sensor in optimal conditions. If daily calibration is cancelled or aborted, artifacts may appear in the image. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 37 • As the AWS is not supposed to operate continuously all day long, turn the personal computer off once a day by performing shutting down operation. Do not press the power switch when turning off the personal computer. • To deactivate AWS, select FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 38: Changing The Compression Plate
Projection of the compression plate Display on the operation panel Projection of the compression plate mounting slot Check the compression plate mounting slot. Make sure that the compression plate is correctly locked. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 39 • If using the optional magnification table, attach it in this step. See “O.1 Using the Magnification Table” for details. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 40: Emergency Stop
See “3.1.2 Starting up the Diagnosis System” for how to start up the system. • Before restoring the system, make sure that the patient is away from the exposure stand. Information during an exposure or being input cannot be restored. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 41: Sleep Mode
Sleep Mode will be released by selecting the unexposed menu from the AWS study screen after the device switches to Sleep Mode. The status bar in the image below will be displayed when releasing Sleep Mode, and exposures can be conducted after the status bar disappears. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 42: Chapter 4 Troubleshooting
Single-touch button swivel arm can be rotated. Operate the buttons until the position of the tube returns to 0°. * Press 1 and then 2. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 43: Chapter 5 Daily Inspection And Maintenance
• If the exposure switch lights up yellow even though it has not been pressed, turn off the exposure stand and contact our official dealer. During the startup of the exposure unit, the exposure switch briefly turns on yellow. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 44 Perform X-ray exposures the specified number of times for each exposure condition to complete the warming up. For the daily inspection and periodic maintenance of the system, refer to “Chapter 5 Daily Inspection and Maintenance”. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 45 • Cleaning the color LCD monitor • Cleaning the keyboard and mouse n Hub • Checking if the power lamp is on • Checking if the link lamp/activity (operational) lamp is on or blinking FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 46: Periodical Inspections Of The Exposure Unit
After a minute, confirm that changes of the value are within the range of ±20N. CAUTIONS If the compression force changed more than ± 20N, turn off the exposure stand and contact our official dealer. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 47 2D biopsy compression plate *1 : Equal to 60,000 times. However, this number is based on FUJIFILM’s evaluation conditions. *2 : Equal to 900 days if exposures are made 200 times per day (four exposures (in two directions for each breast) for 50 patients).
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Page 48: Appendix A Main Specifications
Operating characteristic curves Maximum (60A~63A) Reference ambient temperature (40°C) Maximum (40A~50A) Reference ambient temperature (45°C) Ambient temperature (°C) Minimum Maximum Current (Percentage of rated current) * Recommended product : NF63-CV (50A) (Mitsubishi) FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 49 Large focal spot: 0.3 X-ray tube focal spot size Small focal spot: 0.1 * Per IEC 60336, determined with the slit camera method. Specific filter 0.63mm Be Anode and filter combination W/50μmRh, W/700μmAl, W/(250μmCu+700μmAl) FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 50 4728 (vertical) x 5928 (horizontal) = 28,027,584 pixels Output gradation (1) FDR-3000DRL 16bit (2) FDR-3000AWS 10bit to 14bit (For details, contact our official dealer.) A.1.2 Refer to “FUJIFILM Mammography Workstation FDR-3000AWS Operation Manual” FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 51: Checking Radiation Field Sizes With Each Compression Plate
(Hold the light exposure field ON/ OFF button to switch the radiation 9 cm field sizes between 9.2 × 9 cm and (3.54 in.) 18 × 24 cm.) Chest wall edge Chest wall edge FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 52 (9.3 in.) field sizes between 14 × 23.7 cm and 18 × 24 cm.) Chest wall edge Chest wall edge 2D biopsy compression plate 22.4 cm (8.81 in.) Chest wall edge FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 53 Compression plate for magnification MAG 1.8 Rectangle spot magnification compression plate MAG 1.8 SPOT Round spot compression plate SPOT R Round spot magnification compression plate MAG 1.8 SPOT R 2D biopsy compression plate 2D-BIOPSY FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 54: Automatic Exposure Control (Aec)
W/Rh 76 (2.99) ~ 80 (3.15) W/Rh 81 (3.18) ~ 85 (3.34) W/Rh 86 (3.38) ~ 90 (3.57) W/Rh 91 (3.58) ~ 95 (3.74) W/Rh 96 (3.78) ~ 100 (3.93) W/Rh FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 55 However, when the 2D biopsy or biopsy compression plate is used, i-AEC is turned off regardless of whether the indication is ON or OFF. i-AEC [ON] i-AEC [OFF] See “Workstation FDR-3000AWS Operation Manual” for details. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 56: Agd Measurement
L-mode (mGy) N-mode (mGy) H-mode (mGy) (mm) (mm) 0.32 0.52 0.75 0.42 0.69 0.99 0.55 0.92 1.32 0.75 1.24 1.79 1.00 1.66 2.40 1.36 2.25 3.24 1.79 2.79 4.27 2.39 3.96 5.71 FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 57 Example of surface dose and average entrance dose calculated with the formula above PMMA: 40mm (breast thickness of 45mm) N-mode Surface Dose (mGy) (mGy) JAPAN (Type A) 1.00 US (Type B) 0.92 EU (Type C) FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 58: Storage Environment Label
Storage environment label FPD, Controller Unit, Generator and Accessories Mammographic stand FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 59: Appendix B Test Report
The AMULET Innovality system has a pixel pitch of 50µm, producing a Nyquist frequency of 10 cycles/mm. Measurements were conducted in accordance with IEC 62220-1-2. Figure 18-2: Spatial Resolution of AMULET Innovality FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 60 All DQE calculations were made using the NPS results that were provided in this section under “Noise Analysis” and performed in accordance with IEC 62220-1-2, W/Rh Target/Filter combination, 28KVp, with 2.0mm Al. Figure 18-4: Signal-to-Noise Transfer for AMULET Innovality FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 61 The Addendum on Digital Mammography: The European Protocol for the Quality Control of the physical and technical aspects of mammography screening, version 1.0, November 2003. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 62 26kVp 0.3mGy WRｈ 30mm 27kVp 0.4mGy WRｈ 40mm 28kVp 0.5mGy WRｈ 50mm 30kVp 0.7mGy WRｈ 60mm 31kVp 0.8mGy 70mm WRｈ 33kVp 1.1mGy Table 18-3: AEC Performance – L Mode Exposure Conditions FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 63 6cm with corresponding exposure conditions are provided in Figures 18-8 through 18-10, respectively. The Nuclear Associates NA18-220 Phantom (MAP) was used for these measurements. Three observers, engineers at Fujifilm’s Research and Development Center, all with significant mammography-specific imaging experience, including special training in ACR MAP phantom evaluation, provided the scoring.
- Page 64 W/Rh W/Rh W/Rh Tube Voltage 30 kV 30 kV 30 kV File Name 25340 25343 25346 25341 25344 25347 25342 25345 25348 Table 18-4: ACR MAP Phantom Images - Exposure Conditions. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 65 103.8 125.7 Anode material/x-ray filtration W/Rh W/Rh W/Rh Entrance Surface Exposure level (mGy) 1.53 4.43 6.74 Average Glandular Dose (mGy) 0.73 1.37 1.78 Table 18-5: Patient Radiation Dose – H Mode FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 66 41.1 50.0 Anode material/x-ray filtration W/Rh W/Rh W/Rh Entrance Surface Exposure level (mGy) 0.59 1.75 2.68 Average Glandular Dose (mGy) 0.29 0.57 0.74 Table 18-7: Patient Radiation Dose – L Mode FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
- Page 67 Table 18-8: Compression force measurement (Automatic) Display (N) Measurement value (N) 39.2 117.6 205.8 Table 18-9: Compression force measurement (Manual) Note: The maximum compression force in Automatic mode is 200 N. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 68: Clinical Image Evaluation
These radiologists met the radiologists’ qualifications as required by the guidance document. An overall assessment was made by the two independent reviewers that image sets exposed by the Fujifilm AMULET Innovality FFDM system collectively are of sufficiently acceptable quality for mammographic usage. No image evaluation issues were raised. - Page 69 • Fuji or its authorized representative(s) monitored the study. Study monitors visited sites routinely throughout the study. The monitors confirmed that the study was conducted according to the protocol. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 70: Appendix O Using Exposure Unit Optional Items
Pull the right- and left-hand side hinge locks forward (3) and fold the Unfold the reft-hand side stay first. stays (4) after using the magnification table. Hinge lock Stay Stay Hinge lock FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... - Page 71 The grid is automatically set to “OUT”. CAUTIONS Make sure that the magnification table is securely installed. If it is not correctly locked, the patient may be subject to an unnecessary X-ray dose. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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Page 72: Attaching The Chest Wall Pad
Exposure table The axilla pads are intended to be used symmetrically. Affix them on both the right- and left-hand sides. CAUTIONS Do not use tape other than the supplied double-sided tape. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 73: Connecting The Remote Exposure Switch
Attach the shielding plate, sliding it Guide into the right and left guides. Shielding Plate CAUTIONS Before conducting exposures in a case where shielding is required, make sure that the shielding plate is correctly set. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N... -
Page 74: How To Use The Face Guard T
Attaching the Face Guard T Attach the Face Guard T by sliding it Face guard T O.6.2 Detaching the Face Guard T Detach the Face Guard T by sliding it out. FUJIFILM Digital Mammography System FDR MS-3500 Operation Manual 897N102525N...
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