Page 1 M517-V056D Apr. 2024 Remote-Controlled R/F SYSTEM F4 Package Instruction Manual Read this instruction manual thoroughly before you use the product. Keep this instruction manual for future reference.
Page 2: About The Symbols Appearing In This Operation Manual
• Screen images and illustrations contained in this manual may differ from those in actual use, and are intended for example purposes only. Illustrations may also use partial images. • FLEXAVISION is a registered trademark of Shimadzu Corporation in the United States and Europe (Office for Harmonization in the Internal Market).
Page 3: Operating Precautions
Operating Precautions Read the instruction manual thoroughly before you use the product. Keep this instruction manual for future reference. Operating Precautions for Safety in the Use of Electric Medical Equipment 1. Only an experienced technician should operate the equipment. 2. When installing the equipment, pay attention to the following items: (1) Do Not install system near water faucet or similar equipment.
Page 4 5. After operating the equipment, pay attention to the following items: (1) Return the operation buttons and the dial to their original states before use in the prescribed order. Then, turn off the main power. (2) Do Not pull the power cable forcibly from the outlet. (3) When storing the equipment, pay attention to the following factors: (i) Keep the equipment away from the water.
Page 5: Precautions In Usage
This equipment is restricted to use by, or under supervision of, a diagnostic radiology technician or a person with a certificate indicating equal proficiency. Repair and inspection of the inside of the equipment is dangerous. Be sure to contact your Shimadzu service representative for repair and inspection. Never modify the equipment.
Page 6: Be Sure To Read The Safety Items To Prevent Explosion, Electric Shock, Or Injury
Any such liquid entering into system electronics may cause failure or malfunction. Should liquid drip on the operation panel or enter the covers, immediately turn off the power and contact your Shimadzu service representative. When there is any abnormality in operation, or unusual smell...
Page 7 WAR NI NG Thoroughly confirm the safety of patient in squeeze compression. Squeeze compression can fracture the patient's ribs if not performed correctly. After the squeeze compression, press the [Squeeze Compression] button to turn it off. If the imaging unit or tabletop is moved while the compression cone is operating, the compression cone may collide with the shoulder rests or foot rest and could be damaged.
Page 8 WAR NI NG The operator must instruct the patient to hold handgrips firmly on the tabletop. Otherwise, the patient may fall off the tabletop and be injured. Ensure that the patient does not put his or her hand between the tabletop and imaging unit when moving the imaging unit.
Page 9 C AU TI ON Do NOT place anything on the console. The system may be unintentionally activated if anything hits the operation lever. Do NOT place anything on the control cabinet. The internal devices may be damaged if anything falls into the control cabinet ventilation openings.
Page 10: Cautions On Environmental Conditions
C AU TI ON Carefully operate the X-ray diagnostic table to avoid the contact between wheelchair patients and the diagnostic table. Be extremely careful about the movement of table tilting and Imaging Unit in the vertical position. N OT E Accuracy of displayed values is not guaranteed.
Page 11 • While operating the equipment, the operator and caregiver must not enter the operating range for their safety. Contact your Shimadzu service representative for installation and relocation of the equipment. N OT E • When isolating the equipment from the power supply, open the circuit breaker or knife switch of the switchboard that the equipment is connected to.
Page 12: Cautions On Fluoroscopy/Radiography
 Cautions on Fluoroscopy/Radiography WAR NI NG Restrict all persons other than the patient from accessing the equipment in accordance with local regulations. To avoid unnecessary exposure, acceptable distances (maximum access values) to the equipment by any person other than the patient are defined for each region.
Page 13 WAR NI NG During X-ray irradiation, ensure that the X-rays irradiate the necessary region only. To avoid unnecessary exposure, narrow down the collimator and take protection measures, such as wearing a protective apron. Do NOT place any unnecessary object in the location within the X-ray exposure region.
Page 14: Cautions On The Fpd
 Cautions on the FPD DA NG E R Do NOT touch plugs or connectors with wet hands. You could be seriously injured or killed by an electric shock. WAR NI NG The surface of the FPD might be hot, such as right after fluoroscopy.
Page 15 C AU TI ON Use FPD on an even floor or a table. If force is applied to FPD which is put diagonally, it may cause damage or breakage of a sensor inside FPD. Do NOT apply any force to the top of the FPD tray while it is pulled out.
Page 16 C AU TI ON If radiography is carried out with the FPD in the vertical position, it must be held securely. It could fall, cause injuries, fail or be damaged. Do NOT apply any force to the top of the FPD tray while it is pulled out.
Page 17: Cautions On The Lcd Monitor
 Cautions on the LCD Monitor WAR NI NG Do NOT connect devices other than those specified by Shimadzu to the monitor power supply socket or monitor connection terminal. Such connections may damage the system and cause fire to break out.
Page 18: Accessories And Options
 Accessories and Options WAR NI NG Do NOT place the foot switch (optional) under the diagnostic table. The operator's foot may become caught under the table and injured. Do NOT place anything on the foot switch. Pay extra attention not to step on the foot switch carelessly. Unintended X-rays may be radiated.
Page 19: Cautions On The System And Software
Do NOT install any other software on the computer. Otherwise, the system may not run due to environmental changes of operating system and driver conflicts. Shimadzu is not responsible for the failure and damages caused by neglecting this warning. C AU TI ON Do NOT turn off the power to the computer while shutdown is in progress.
Page 20: Cautions On Measurement Accuracy
The data stored in the system disk such as images may be deleted due to any system malfunction or unintentional accident. Make several backups to avoid the loss of data. Shimadzu is not responsible for the deleted data such as images.
Page 21: Cautions On Network Connections
 Cautions on Network Connections This equipment connects to the network for the following purposes. • Obtains patient information, study information, and previous study images from an external equipment. • Sends study images, study results information, dose information, and maintenance information of equipment to an external equipment.
Page 22 C AU TI ON Shimadzu accepts no responsibility for any of the following items due to infection by malware (i.e. malicious software, including computer viruses and worms, which cause damage to the infected computer): • Loss, alteration, and leakage of data, including images, recorded on this equipment •...
Page 23: Cautions On Cleaning And Disinfection
Repeated disinfection over a long time may lead to discoloring and cracking on the equipment surface, and deterioration of rubber and plastic. If any abnormality is found on the equipment after disinfection, stop using the equipment immediately. Contact your Shimadzu service representative for repair. "Cleaning and Disinfection"...
Page 24: Cautions Relating To Cellular Telephones
Do not use accessories, transducers and cables other than those specified or provided by Shimadzu. The use of accessories, transducers and cables other than those specified or provided by Shimadzu could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Page 25: Cautions When Irradiating Consecutive Pulse X-Rays
 Cautions When Irradiating Consecutive Pulse X-rays WAR NI NG Observe the following precautions when irradiating consecutive pulse X-rays: • Conducting studies involving irradiating consecutive pulse X-rays onto the region where an implantable pacemaker or defibrillator is implanted may cause these devices to malfunction. •...
Page 26: Cautions On Wireless Communication Using Af-B1
• If this system causes damaging RF interference to affect an RFID premises radio station, stop using the system immediately and contact your Shimadzu service representative. • If this system causes damaging RF interference to affect an RFID specified low-power radio station or amateur radio station, contact your Shimadzu service representative.
Page 27: Warning And Caution Labels
Inspect the safety labels periodically (once a year). If any label is peeled or unreadable by stain or scratch, replace it with a new one. For new labels, contact your Shimadzu service representative.  X-ray Diagnostic Table Described 5DS (elevating tabletop) as an example.
Page 28  FPD Radiography Device  X-Ray Diagnostic Table (Options) Extension Table (Option) Oblique Radiography Unit (Option) XXVIII...
Page 29  Remote Console  Control Cabinet  Monitor Cart XXIX...
Page 30  Equipment Operating Range in Examination Room  Collimator (R-300) Refer to COLLIMATOR TYPE R-300 OPERATION MANUAL (M526-E024).
Page 31: Warranty
The system is warranted to be free from defects in material and workmanship for one year from the date of delivery. If found to be defective, the system must be offered to Shimadzu for inspection and examination. Upon examination, Shimadzu, at its sole option, will repair or replace at no charge, the system or any part found to be defective.
Page 32 Shimadzu accepts no responsibility for failure of or damage to the FPD caused by the following factors. Please be forewarned. (1) Failure or damage caused by hitting the FPD against something or dropping it. (2) Failure or damage caused by applying a load outside the specified range.
Page 33: Software License Agreement
• Transferring the software outside Japan without prior permission of the Japanese or U.S. government. Service Life The equipment lifetime is 10 years (based on Shimadzu's criteria) assuming the specified maintenance checks are performed. Software This operation manual corresponds to the following software.
Page 34: Disposal Precautions
WEEE Mark Contact your Shimadzu service representative when the equipment has reached the end of its life. They will advise you regarding the equipment take-back. With your co-operation we are aiming to reduce contamination from waste electronic and electrical equipment and preserve natural resource through re-use and recycling.
Page 35: Abbreviations
Abbreviations Abbreviation Explanation Automatic Exposure Control Anatomical Program Digital Radiography Image Brightness Stabilizer Electromagnetic Compatibility Flat Panel Detector Source Image Distance Radiology Information System Deadman function milliampere milliampere second minute ms (msec) millisecond second kilovolt XXXV...
Page 36: List Of Related Manuals
This manual should be kept available for future reference. If the user or usage location changes, ensure that this operation manual is always kept together with the equipment. Periodically check to be sure that the operation manual and the warning labels are not missing or damaged. If they are, contact your Shimadzu service representative for replacement.
Page 37: Table Of Contents
Software License Agreement ...............XXXIII Service Life ....................XXXIII Software .......................XXXIII Disposal Precautions .................. XXXIV Action for Environment (WEEE) To all users of Shimadzu equipment in the European Union: ................XXXIV System Activation ..................XXXIV Abbreviations ....................XXXV List of Related Manuals ................XXXVI Outline 1.1 System Outline .....................
Page 38  Storage Conditions for FPD .................... 9  Operating Range ......................10  Installation Requirements ....................10  Power Supply ........................ 11  Grounding ........................11  Wireless Communications ..................... 12 1.3 Classification of Equipment ................13 1.4 Product Safety ....................14 1.5 Symbols and Product Nameplates ..............
Page 39  Operating the Compression Cone ................. 49  Specifying the X-ray Irradiation Field ................50  Selecting an X-Ray Filter ....................51 3.5 Extending the X-ray Tube Unit (1.5 m Extension) ..........52 3.6 X-ray Tube 180° Swing Unit (Optional) .............. 53 3.7 X-ray Tube 37/90°...
Page 40  List of Cables ....................... 103  Electromagnetic Immunity Test Level ................. 107 Troubleshooting 6.1 Emergency Stop ....................110  Emergency Stop of X-ray Diagnostic Table Operation ..........110  Emergency Stop of X-ray Generator ................111 6.2 Error Display ....................112 ...
Page 41  Fluoroscopy ......................... 146  Radiography ........................ 148 1.4 Useful Features for Pediatric Imaging .............. 149  Removable Anti-scatter Grid ..................149  Irradiation Field Adjustment from Remote Console ............. 149  X-ray Filter Selection ....................149 1.5 NOTATION FOR WIRELESS REGULATIOIN ..........150 1.5.1 EU/EFTA *including Northern Ireland................
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Page 43 Chapter Outline System Outline ..............2 Environmental Conditions............ 8 Classification of Equipment ..........13 Product Safety ..............14 Symbols and Product Nameplates ........15 Operator Profile ..............20 Statement of Compliance [For Europe] ......21 Statement of Compliance with Standards......22 Manufacturer Information...........
Page 44: System Outline
System Outline  Intended Use FLEXAVISION F4 Package is intended to be used as a diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F (radiographic and fluoroscopic) and pediatric examinations.  Indications for Use • FLEXAVISION F4 Package is used for radiographic and fluoroscopic examinations of...
Page 45: Applications
"digital radiography" in which the images from the FPD are recorded as digital images. The figure below shows the X-ray diagnostic table, control cabinet, and remote control console. Control Cabinet X-ray Diagnostic Table Remote Control Console Fig 1.1 FLEXAVISION F4 Package...
Page 46: Features
 Features  User-friendly Console Various operations are available from a single console, i.e. operating diagnostic table and configuring fluoroscopy/radiography settings. Advanced console design can respond flexibly to an immediate radiography setting change. Changing Fluoroscopy/Radiography Settings Selecting Technique and APR Operating X-ray Diagnostic Table Fig 1.2 Console Features ...
Page 47  Supportable to Various Optional Units  Oblique Projection Unit ° Oblique projection by tilting the X-ray tube at a maximum 30 allows for effective GI, orthopedics and other examinations.   - 30 Fig 1.3 Tilting X-ray Tube  X-ray Tube 37°/90° Swing-out Unit Allows rotating the X-ray tube toward the front side of the diagnostic table to perform chest radiography combined with a lieder stand or bucky stand.
Page 48: Principle
 X-ray Tube 180° Swing Unit Allows rotating the X-ray tube by 90°,180° to perform chest radiography combined with a bucky table, etc. and lieder stand.  Mobile bucky table, etc. Fig 1.5 In case of bucky table Lieder stand ...
Page 49: Standard Components
 Standard Components Name Condition *1,*2 Foot Rest Used to support the patient's body when tilting the tabletop to vertical position. *1,*2 Grid Used according to the radiography region, SID, etc. *1,*2 Hand Grips Used to support the patient's body. *1,*2 Grips Used to support the patient's body.
Page 50: Environmental Conditions
Environmental Conditions  Operation Environmental When the equipment is combined with the FPD, use the equipment under the environmental conditions listed below: The installation of a dedicated air-conditioner is recommended if the building air-conditioner cannot maintain the necessary environmental conditions 24 hours a day. The calorific power of the power supply is not significant enough to affect the use environment of the equipment.
Page 51: Transportation And Storage Environment
 Transportation and Storage Environment The environmental conditions for transportation and storage are described below. Item Condition Atmosphere No explosive or corrosive gases Temperature - 10 °C to 50 °C Relative Humidity 10 % to 90 % (no dew condensation) Atmospheric Pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar) C A UT IO N...
Page 52: Operating Range
 Operating Range The unit operating range is shown in 1.7. X-ray Tube Position for Vertical Radiography (SID 1500) X-ray Tube Position for Vertical Radiography (SID 1100) Operating Range Tape Fig 1.7 Unit Operating Range  Operating Range NOTE • Do NOT place any other equipment inside the operating range tape around this unit to avoid damage by interference from other units.
Page 53: Power Supply
 Power Supply For power supply, See " Specification" P.89 D AN G ER Be sure to use the power supply specified in the operation manual. Using a power supply other than the one specified may cause equipment malfunction or serious accidents such as fire, smoke emission, or explosions.
Page 54: Wireless Communications
Wireless communication is performed based on the IEEE 802.11n (2.4 GHz/5 GHz) LAN standard. During installation, your Shimadzu service representative will change the frequency band from 2.4 GHz/ 5 GHz and select a specific frequency (channel) for use.
Page 55: Classification Of Equipment
Classification of Equipment This equipment is classified as follows, based on safety standards for electrical medical equipment.  Protection Method Against Electric Shock Class I equipment  Classification of Applied Parts Equipment including Type B Applied Parts  Operation Mode Continuous operation with intermittent loading ...
Page 56: Product Safety
C A UT IO N If the equipment is seen to be making abnormal movements, stop operation. Contact your Shimadzu service representative for maintenance and inspection. Be sure to ground the equipment. Carry out grounding according to the installation manual to avoid the danger of electric shock.
Page 57: Symbols And Product Nameplates
Symbols and Product Nameplates  Symbols The symbols used with this system are indicated below. Symbol Location Meaning On name plate Alternating current On name plate Direct current Inside the equipment, where protective Protective earth ground earth conductor in power cord is connected On applied parts Safety classification: Type B...
Page 58: Product Nameplate And Certificate Labels
Symbol Location Meaning On warning and caution labels Refer to operation manual  Product Nameplate and Certificate Labels ZS-5DS (Lifting Type) ZS-5D (Non-lifting Type) ② ② ① ① (1) Nameplate of FLEXAVISION (2) CE Label (3) Bar Code Identification Label (4) TYPE B Applied Part Label...
Page 59   Position where nameplate affixed Nameplate for Nameplate for the main body wireless  Nameplate for the main body  Nameplate for wireless...
Page 60  Multibox(MB-01)  Position where nameplate affixed Nameplate for the main body Nameplate for ratings  Nameplate for ratings  Nameplate for the main body  Collimator (R-300) Refer to COLLIMATOR TYPE R-300 OPERATION MANUAL (M526-E024).
Page 61  Transportation and Storage Environment Labels  Except the FPD  FPD...
Page 62: Operator Profile
Operator Profile Item Details Old enough to be a radiologic technologist or hold an equivalent qualification Gender No restriction Nationality No restriction Education Must be a radiologic technologist or hold an equivalent qualification. Knowledge Must be a radiologic technologist or hold an equivalent qualification. Language Must be able to read and understand Japanese or English.
Page 63: Statement Of Compliance [For Europe]
Medical Systems Division Address: 1, NISHINOKYO-KUWABARACHO, NAKAGYO-KU, KYOTO, 604-8511, JAPAN Authorized SHIMADZU EUROPA GmbH Representative in EU: Address: Albert-Hahn-Strasse 6-10, 47269 Duisburg Germany  Company's Quality System The company's quality management system complies with the requirements of Annex II, excluding Section 4 of the MDD 93/42/EEC, which is certified by TÜV Rheinland LGA Products GmbH (Notified under No.0197)
Page 64: Statement Of Compliance With Standards
Statement of Compliance with Standards • X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY REMOTE-CONTROLLED R/F SYSTEM FLEXAVISION EN 60601-2-54:2009+A1:2015...
Page 65: Manufacturer Information
Manufacturer Information Manufacturer: SHIMADZU CORPORATION Medical Systems Division Address: 1, NISHINOKYO-KUWABARACHO, NAKAGYO-KU, KYOTO, 604-8511, JAPAN...
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Page 67: Contents
Chapter Contents Package Contents ............. 26 Diagnostic Table ..............28 Remote Control Table ............29 Digital Radiography Unit ............ 31...
Page 68: Package Contents
Package Contents The FLEXAVISION comprises an X-ray diagnostic table, DR unit, control cabinet, remote console, FPD and other units. The required components vary with applications. The X-ray diagnostic table is available in two types: one with a tabletop that can be raised and lowered and the other without this capability.
Page 69 WAR N ING Do NOT connect the equipment other than the designated equipment to the system.
Page 70: Diagnostic Table
Diagnostic Table Rear Front...
Page 71: Remote Control Table
Remote Control Table...
Page 72 Anode Rotation Stop Pulse Rate Selection...
Page 73: Digital Radiography Unit
Digital Radiography Unit Digital Radiography System Basic Screen [EXAM > Worklist] Screen Screen Names On Line/Off Line Study List Patient Information pane Study Information pane Search For Study List pane Worklist button Edit Exam button EXAM Start Exam button Emergency button Manual button...
Page 74 [EXAM > Examination] Screen Screen Names Study Information pane Image View pane Image Processing buttons Info button Cancel button System Status Send to Storage button Output Setting button Suspend Exam button View Mode buttons Toolbar for Reviewing Images Patient Information pane...
Page 75 FPD Sensor Unit FPD (AF-B1) Name Function Controls a power supply ON/OFF and infrared Power switch communication. Status indicator lamps Indicate the status of the FPD (see the table below). Detect an infrared data-communication unit and Infrared transmission part make the system recognize a sensor unit. Wireless aperture Transmits image data with wireless communication.
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Page 77: Preparation
Chapter PREPARATION Mounting/Removing the FPD..........36 Mounting/Removing the Grid ..........39 Preparing Wireless AF-B1 ..........41 Operating the X-ray Diagnostic Table ........ 45 Extending the X-ray Tube Unit (1.5 m Extension)....52 X-ray Tube 180° Swing Unit (Optional)......53 X-ray Tube 37/90° Swing-out Unit (Optional) ....55...
Page 78: Mounting/Removing The Fpd
Mounting/Removing the FPD The FPD can be mounted and removed while the power to it is ON. NOTE  Mounting the FPD Draw out the FPD tray Press the [Tabletop Rear] button on the local control panel to move the tabletop all the way back.
Page 79 Stow away the FPD tray. Hold it by the handle and push the FPD tray in firmly as far as it will go. Push the FPD tray in firmly as far as it will NOTE If it is not in as far as it will go, the X-ray diagnostic table may not operate, and fluoroscopy and radiography may not be possible.
Page 80: Removing The Fpd
 Removing the FPD Draw out the FPD tray Press the [Tabletop Rear] button on the local control panel to move the tabletop all the way back. Draw the FPD tray toward you by its handle. FPD Tray Take out the FPD. Rotate the knob.
Page 81: Mounting/Removing The Grid
Mounting/Removing the Grid Using the anti-scatter grid improves image quality by reducing the impact of scattered X-ray. However, the X-ray grid should be removed when the exposure level must be reduced to perform radiography for pregnant women or infants. C A UT IO N Move the tabletop all the way back and lift the hand guard when removing or attaching the grid.
Page 82: Mounting The Grid
 Mounting the Grid Mount the grid Press the [Tabletop Rear] button on the local control panel to move the tabletop all Guide Guide the way back. Check the top/bottom orientation of the grid Bottom and insert the grid into the groove of the rail, Grid and then put it firmly in as far as it will go.
Page 83: Preparing Wireless Af-B1
Preparing Wireless AF-B1  Charging Battery Pack When using AF-B1 with Wireless, check the battery status before starting examination. The remaining battery charge can be confirmed on the monitor of the SDR-150C control software. Recharge the battery pack if needed. Display of remaining battery charge Display...
Page 84: Inserting Battery Pack
 Inserting Battery Pack C A UT IO N Place the AF-B1 on a flat surface before starting work. Otherwise, the battery pack may fall when it is loaded. Remove the battery cover. Press the cover lock (1) to release the lock, then lift the battery cover up and pull it out (2).
Page 85 Attach the bafttery cover. Check the rubber inside the battery cover for foreign objects and also check that there is no abnormality such as cracks or twists in the rubber. • Wipe off any foreign matter on the rubber. NOTE •...
Page 86: Removing Battery Pack
 Removing Battery Pack If you don't use the FPD for a while, remove the battery pack. If the battery pack is left attached to the NOTE FPD for a long period of time, a small amount of current may flow, causing overdischarge and shortening of battery life.
Page 87: Operating The X-Ray Diagnostic Table
Should liquid drip on the operation panel or enter the covers, immediately turn off the power and contact your Shimadzu service representative. To operate the diagnostic tabletop or imaging unit, use the buttons and levers with deadman function* (hereinafter represented as [DM]).
Page 88 WAR N ING Confirm that there is no apparatus within the operating range when moving the X-ray diagnostic table. Ensure that no desk, chair, stretcher, foot switch, monitor suspension, etc. is placed within the operating range. The apparatus may be crushed by or collide with the equipment, causing damage. The following label is attached on the front panel and remote console.
Page 89: Moving The Tabletop Laterally
 Moving the Tabletop Laterally Remote Console [DM] X-ray Diagnostic Table Tilt Tabletop/Imaging Unit Control Lever to Right (1) or Left (2). Local Control Panel [DM] (1) Moves to rear. Press Tabletop Rear (2) Moves to front. Button (1) or Tabletop Front Button (2).
Page 90: Moving The Imaging Unit Longitudinally
 Moving the Imaging Unit Longitudinally Remote Console X-ray Diagnostic Table [DM] Tilt Tabletop/Imaging Unit Control Lever to Backward (1) or Forward (2). Local Control Panel [DM] (1) Moves in the head direction. Press (2) Moves in the foot direction. Imaging Unit Head Button (1) or Imaging Unit...
Page 91: Operating The Compression Cone
The compression force changes depending on usage. It is dangerous if the compression force exceeds the prescribed value. The measurement and adjustment of the compression force is performed by Shimadzu services during periodic inspections. Remote Console [DM]...
Page 92: Specifying The X-Ray Irradiation Field
 Specifying the X-ray Irradiation Field  Adjusting by Collimator Handles (when using the DR technique) Remote Console X-ray Diagnostic Table (1) Widens the shutter Tilt Right Handle (vertical). to Forward (1). (2) Narrows the shutter Tilt Right Handle (vertical). to Backward (2).
Page 93: Selecting An X-Ray Filter
 Selecting an X-Ray Filter  Types of X-Ray Filter Display/Material Applications Cu0 mm No filter Cu0.1 mm The limbs, etc. Cu0.2 mm Trunk, vertebral body, etc. Cu0.3 mm Chest, abdomen, etc.  Selecting an X-Ray Filter The X-ray filter is selected automatically in accordance with the set APR, but it is also possible to select the X-ray filter with the collimator's [Filter Selection] button after the APR has been set.
Page 94: Extending The X-Ray Tube Unit (1.5 M Extension)
Extending the X-ray Tube Unit (1.5 m Extension) The X-ray tube can be extended, for example for video fluorographic/radiographic examination while the patient remains in a wheelchair. Pull out the X-ray tube unit Handle Release Lever Tilt the X-ray diagnostic table up to the vertical position, as far as the point where it stops.
Page 95: X-Ray Tube 180° Swing Unit (Optional)
X-ray Tube 180° Swing Unit (Optional) Before taking an exposure, set the diagnostic table in the vertical position, and manually rotate the X-ray tube ° ° unit in the direction of the optional bucky stand BR-120M. The tube rotation angle is 90 or 180 Before taking an exposure, set the diagnostic table in...
Page 96 CAUTION Base Plate Grip Bar Certainly lock the end of grip bar to the base plate when fixing the X-ray tube. The X-ray tube may rotate unexpectedly and cause the misalignment of X-ray beam The X-ray tube unit can only be rotated NOTE when the diagnostic table is in the vertical position.
Page 97: X-Ray Tube 37/90° Swing-Out Unit (Optional)
X-ray Tube 37/90° Swing-out Unit (Optional) Before taking an exposure, set the diagnostic table in the vertical position, and manually rotate the X-ray tube ° ° unit in the direction of the optional bucky stand BR-120M. The tube rotation angle is 37 or 90 Tilt the diagnostic table up to the vertical position.
Page 98 Be sure to hold the collimator with your hand when returning the X-ray tube unit to its original position. NOTE Collimator may move unintentionally and cause injury.
Page 99 Chapter Radiography Radiography Flowchart............59 Starting Up the System............60 Reading and Registering Patient Information and Examination Items ............. 61 Digital Fluoroscopy/Radiography........65 FPD Portable Radiography..........70 Radiography in Vertical Position Using X-ray Tube of Diagnostic Table ..............74 DSA Option................ 77 Post Processing..............
Page 100: Radiography
Digital X-ray Radiography Diagnostic Unit Table Exposure Button Remote Console Hand Switch...
Page 101: Radiography Flowchart
Radiography Flowchart A flowchart for radiography with FLEXAVISION F4 Package is given below. Digital fluoroscopy/radiography "4.4 Digital Fluoroscopy/Radiography" P.65 FPD portable radiography "4.5 FPD Portable Radiography" P.70 "4.2 Starting Up the System" P.60 Prepare the FPD "Mounting the FPD" P.36 "4.3 Reading and Registering Patient Information and Examination Items"...
Page 102: Starting Up The System
Starting Up the System  Starting Up the System Be sure to carry out start-up maintenance before starting the system. NOTE Press [ON]  The system power is turned on.  Power to the FPD and multibox(MB-01) turns on at the same time.
Page 103: Reading And Registering Patient Information And Examination Items
Reading and Registering Patient Information and Examination Items  Reading from the Worklist Read information that is already registered in the worklist. Display the Worklist screen Click [Worklist]. Select the patient information Select a patient from the examination list. Start the examination Click [Start Exam].
Page 104: Emergency Registration
 Emergency Registration Set provisional information in cases where, for example, there is no time to input the patient information. Set patient information for emergencies Click [Emergency].  The Patient's ID will be set automatically, and the Study screen will open. On completing the examination, register the correct ID and name.
Page 105 Select the radiography protocol among the examination options Select the radiography protocol from the examination options under [Tray List] on the protocol screen. When selecting the radiography protocol using [Search by Body Part] or [Search by Category], refer to the "OPERATION GUIDE"...
Page 106 Start the examination Click [Start Exam]. The patient list will be made, and the Start  Examination screen will be displayed.  The indication at the top right of the screen will Display of Grid change from "Waiting" to "Ready". Type ...
Page 107: Digital Fluoroscopy/Radiography
Digital Fluoroscopy/Radiography Mount the FPD Mount the FPD by referring to "Mounting the FPD" P.36. When performing radiography on pregnant women or infants, the X-ray dose can be reduced by removing the grid. Check the patient information Check the Patient ID and Patient's name. Check the radiography technique Check that the...
Page 108 Select spot radiography or Spot/Serial serial radiography Radiography Selector button Press [Spot/Serial Radiography Selector] to select spot radiography or serial radiography. Lamp lit: Serial radiography selected Lamp unlit: Spot radiography selected Digital radiography has limited irradiation NOTE duration as follows: •...
Page 109 If the patient is a person with an NOTE implantable cardiac pacemaker or implantable defibrillator, it is possible to perform fluoroscopy with continuous X-rays instead of pulsed X-rays by the service setting. Please contact your Shimadzu service representative.
Page 110 After performing fluoroscopy, you can adjust the irradiation field on an image of the last image hold. It can reduce dose, because fluoroscopy is not required during collimator adjustment. To enable the virtual collimation, contact Shimadzu service. • L.I.H. needs to be turned on. NOTE •...
Page 111 Make an exposure Check that the [Fluoroscopy Selection] Exposure Button lamp is lit. Hold down the Exposure button.  [X-ray Indicator] will light up during the irradiation. Release the Exposure button.  The exposure will end. Radiography can also be performed using the hand switch.
Page 112: Fpd Portable Radiography
FPD Portable Radiography FPD portable radiography is performed for examinations that do not involve fluoroscopy. Taking the FPD out of the tray and connecting it to the sensor cable (option) or in Wireless, it allows tabletop radiography and stretcher radiography. The X-ray filter can be used in FPD portable radiography.
Page 113 Check the patient information Check the Patient ID, Patient's name and Sex. Check the radiography technique Check that the [Digital Radiography Technique] lamp has lit. The digital radiography technique does NOTE not support fluoroscopy. Check the APR Check that the [APR] lamp corresponding to the relevant examination region has lit.
Page 114 Check that the radiography is ready  For the FPD (AF-B1), check that the top right display of the screen is [Ready]. Check also that the FPD to be used for examination is correctly selected. "FPD (AF-B1)" P.64 step onward of "Registration in Manual Mode"...
Page 115 Release the hand switch.  The exposure will end. Release the Hand Switch NOTE immediately after confirming X-ray irradiation. When the next protocol automatically selection has been set, keep pressing the Hand Switch will keep the current radiographic conditions such as tube voltage and the tube current for the radiography with the next protocol.
Page 116: Radiography In Vertical Position Using X-Ray Tube Of Diagnostic Table
Radiography in Vertical Position Using X-ray Tube of Diagnostic Table Remove the FPD from diagnostic table and place it on the lieder stand to perform chest radiography. Use wireless or special cable for radiography. Prepare the FPD Remove AF-B1 from diagnostic table. For wireless radiography, turn ON if the power source of AF-B1 OFF.
Page 117 Start the examination Select the general radiography protocol for vertical position and start examination. Check that the technique button B is lit.  For the radiography without using the photo timer Check that the technique button B is lit.  For the radiography with the photo timer An optional general radiography console is required.
Page 118 Make an exposure Press the button on the hand switch to the first position.  [Radiography Ready Up Indicator] will light up. Press the button on the hand switch to the second position.  [X-ray Indicator] will light up during the irradiation.
Page 119: Dsa Option
DSA Option DSA imaging is a method of radiographic imaging to generate a difference image between a live image and a mask image by intermittently irradiating X-rays. Acquire a mask image first and then a live image. DSA requires a two-monitor system. DSA radiography is optional.
Page 120 Set the mask and injection start time. See “9.4.2 Setting of Mask and Injection Start Time” in M517-V053 SDR-150C Control Software Instruction Manual for FLEXAVISION F4 (Operation Guide)” for details. Make an exposure  Sequence radiography is available. See “4.2 Serial Radiography” in M517-V053 SDR- 150C Control Software Instruction Manual FLEXAVISION F4 (Operation Guide).
Page 121: Fluoroscopic Roadmap
 Fluoroscopic RoadMap Fluoroscopic roadmap is a function to observe blood vessels and fluoroscopic images superimposed while operating catheter during fluoroscopy. Select DSA protocol and start the examination Click [RoadMap] on the setting panel displayed on the acquisition monitor Step on a fluoroscopy foot switch ...
Page 122 Release the foot switch after acquiring the mask image  Roadmap mask is created.  Thumbnails are displayed on the fluoroscopic switch setting panel and setting information display panel, and radiography mode switches to RMF mode. Thumbnail Select [Landmarking] Select the ratio of the roadmap mask and the ...
Page 123 Step on a foot switch without injecting the contrast medium to the patient A fluoroscopy image is subtracted from a mask image  and subtraction image is displayed in real-time. Release the fluoroscopy foot switch  LIH image is displayed on the acquisition monitor. ref.
Page 124: Post Processing
Post Processing You can use the buttons on the operation panel to change or process the image displayed on the monitor. Select a patient (examination) image Click [PAST]. The Examination List screen will be displayed.  Click a Patient's name. ...
Page 125 If necessary, make fine settings with [ImageProc]. Item Description Brightness/contrast Displayed on clicking the [ImageProc] button. Adjust the brightness and contrast by dragging the mouse up, down, left, or right on the image. Gamma Displayed on clicking the [ImageProc] button and then selecting [3] on the [Image Processing] tab page.
Page 126: Outputting Images To Printer/Archiver
Outputting Images to Printer/Archiver There are the following four modes of image output. • Auto Print/Send: Prints/Sends automatically when the examination ends. • Manual Output from Radiography Screen: Outputs manually after the images are checked. • Manual Output from Image List: Outputs manually from the Image List.
Page 127: System Shutdown
4.10 System Shutdown There are two ways to shut down the system: 1) exiting the control software and shutting down the PC, and 2) entering the resume mode without shutting down the PC.  Exiting Control Software and Shutting down the PC Click Click on the EXAM or PAST screen.
Page 128 Press [OFF] The system power will turn off. Even if the power to the remote console is turned off, the digital radiography unit's power remains on. You can continue to view and print images. How to isolate from SUPPLY MAINS. •...
Page 129: Entering Resume Mode Without Shutting Down The Pc
 Entering Resume Mode without Shutting down the PC Click Click on the Worklist screen.  The System Menu screen will be displayed. Click  A confirmation dialog box will be displayed.
Page 130 Enter the resume mode Check the [Transfer All Data] checkbox. Click [Restart Options].  The resume mode screen will be displayed. Select a mode  One of the following modes can be selected from the resume mode screen. Item Description [SW-110F Restart] Restarts the control software.
Page 131: Specification
Chapter Specification Specifications of Each Part ..........90 Load Condition When Combined with the X-ray Tube Unit ..................100 Environmental Conditions of EMC (ElectroMagnetic Compatibility) ..............102...
Page 132: Specifications Of Each Part
Specifications of Each Part For details, refer to the instruction manual for the configured equipment. NOTE  X-ray Diagnostic Table Item Description Over-Table tube system Configuration of Diagnostic Table Island type X-ray Irradiation Field Method of adjusting irradiation field Adjusted with automatic collimator. The square inscribed in the circular FPD input screen is the Irradiation field for fluoroscopy maximum size.
Page 133: Collimator
30 kg tabletop *1: Option *2: If a tabletop mat other than the SHIMADZU certified parts is used, the attenuation equivalent may be affected.  Collimator For collimator specifications, refer to “M526-E024 COLLIMATOR TYPE R-300” OPERATION MANUAL.  X-ray Tube Unit For X-ray tube unit specifications, refer to the operation manual for the combined X-ray tube unit.
Page 134: X-Ray High-Voltage Generator
 X-ray High-voltage Generator * (asterisk) of ZUD-L4*D(S), a model number symbol, represents D (5D: not elevating tabletop), or DS (5DS: elevating tabletop). The symbol of L represents output of the X-ray high-voltage generator (50 kW/32 kW). Apart from L, there are V (65 kW) and B (80 kW). The model number can be identified by a label attached onto the control cabinet.
Page 135  Power Supply Facilities Item Detail System Single phase AC (3-phase AC) 3-phase AC 50/60 Hz Frequency Rated Voltage 200/220/240 V (200/220/240 V) 380/400/415/440 V Capacity 30 kVA (50 kVA min.) 50 kVA Power-supply Impedance 0.08  max. (0.087  max.) 0.21 ...
Page 136  ZUD-V40D(S) Item Detail System 50 kHz inverter (65 kW) max. 150 kV 400 mA (three-phase) 125 kV 500 mA (three-phase) Short-time Rating 100 kV 650 mA (three-phase) 80 kV 800 mA (three-phase) Long-time Rating 125 kV 4 mA Number of Connectable X-ray Tubes 2 tubes (Second-tube option and tube selector unit are required.) Radiography Tube voltage...
Page 137 Cable Length and Cross-sectional Area to Match the Transformer Capacity Electric Cable Length and <Nominal Cross-sectional Area> (mm Transformer Capacity Length 100 m 75 kVA (200 V) 100, 100, 75 kVA (400 V) 5.5,  ZUD-B40D(S) Item Detail System 50 kHz inverter (80 kW) max. 150 kV 500 mA (three-phase) 125 kV...
Page 138: Dimension Of Control Cabinet
 Power Supply Facilities Item Detail System Three-phase 50/60 Hz Frequency Rated Voltage 200/220/240 V 380/400/415/440 V 75 kVA or more Capacity Power-supply Impedance 0.054  max. 0.13  max. Grounding Resistance Grounding resistance: Grounding resistance: less than 100  less than 10 ...
Page 139: Digital Radiography Unit
 Digital Radiography Unit Item Detail 3.1 GHz quad core Memory 16 GB min. Windows10 Memory Storage Device Input Mouse, keyboard, barcode reader (option) 512 GB No. of saved images 60,000 frames max. (12x12 inch: Radiographic images) Matrix Max. 2656  2592 Image Input Density resolution 12 bits/4096 graduation...
Page 140 Item Detail DICOM Print DICOM Storage DICOM MWM Receives examination information from the server. DICOM DICOM MPPS Sends examination information to the server. DICOM CD-R, DVD-R, DVD+R, DVD-RAM Media Storage RDSR Sends dose information to the server in report format. ...
Page 141: Fpd
 FPD  Item Details External dimensions Width 460 mm  Height 460 mm  Depth 15.5 mm Mass 3.5 kg Pixel spacing 0.16 mm Pixel binning mode 11, 22 Radiography area 17  17 inches (415  425 mm) 14 ...
Page 142: Load Condition When Combined With The X-Ray Tube Unit
Load Condition When Combined with the X-ray Tube Unit  ZUD-L (Single-phase 200 V) X-ray Tube Unit Item 0.3/0.8P324DK-85 0.6/1.2P324DK-85 0.6/1.2P326D-150 Nominal X-ray tube voltage and 125 kV, 2.4 mA 125 kV, 2.4 mA 125 kV, 3.0 mA max. tube current that can flow 150 kV, 200 mA 150 kV, 200 mA 150 kV, 200 mA...
Page 143  ZUD-V X-ray Tube Unit Item 0.3/0.8P324DK-85 0.6/1.2P324DK-85 0.6/1.2P326D-150 Nominal X-ray tube voltage and 125 kV, 2.4 mA 125 kV, 2.4 mA 125 kV, 3.0 mA max. tube current that can flow 150 kV, 400 mA 150 kV, 400 mA 150 kV, 400 mA at nominal X-ray tube voltage Max.
Page 144: Environmental Conditions Of Emc (Electromagnetic Compatibility)
Environmental Conditions of EMC (ElectroMagnetic Compatibility) The equipment satisfies the EMC (Electromagnetic Compatibility) standard below: IEC 60601-1-2:2014 C A UT IO N Pay attention to the electromagnetic environments at the installation site. The equipment is suitable for installing at a professional healthcare facility environment except below: •...
Page 145: List Of Cables
 List of Cables Cable Length Note Cable Name (Length between Shield (Manufacturer) units) Cable between Control Cabinet and Main Power 12 m Shimadzu Main Power Cable 3 Phase 12 m Shimadzu Grounding Cable 20 m Shimadzu Door Switch Cable 20 m Shimadzu...
Page 146 Cable Length Note Cable Name (Length between Shield (Manufacturer) units) 4.5 m Shimadzu Handheld Switch Cable Cable between Step-up Transformer XAT-2 and Control Cabinet Shimadzu XAT-2 Power Cable Shimadzu XAT-2 Grounding Wire Cable for Trans Box of SDR-150C (Option) 20 m...
Page 147 Cable Length Note Cable Name (Length between Shield (Manufacturer) units) 2.5 m Shimadzu Scan Converter TV-Cable DVI Extendor Cable 1.8 m Shimadzu DVI Monitor Cable 1.5 m Shimadzu DVI Splitter power Cable A 1.5 m Shimadzu DVI Splitter power Cable B...
Page 148 Cable Length Note Cable Name (Length between Shield (Manufacturer) units) 5.0 m Shimadzu Ready Indicator Cable DICOM Print Server 20 m Shimadzu LAN CABLE 2nd FPD 25 m CANON FPD Cable The cables listed above are the parts specified to be compliant with the standards.
Page 149: Electromagnetic Immunity Test Level
 Electromagnetic Immunity Test Level Immunity test EN/IEC 60601 test level Compliance level ,      Electrostatic discharge (ESD) 8 kV contact 8 kV contact  ,     ,    EN 61000-4-2/IEC 61000-4-2 15 kV air 15 kV air ...
Page 150  Test specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communications Equipment Test Frequency [MHz] Modulation Test Level Pulse modulation: 18 Hz 19 V/m FM ±5 kHz deviation: 1 kHz sine 28 V/m Pulse modulation: 217 Hz 9 V/m Pulse modulation: 18 Hz 28 V/m 1462 Pulse modulation: 217 Hz...
Page 151: Troubleshooting
Chapter Troubleshooting Emergency Stop .............. 110 Error Display ..............112...
Page 152: Emergency Stop
C A UT IO N If you notice an abnormal smell or smoke generation during operation, shut off the circuit breaker and contact your Shimadzu service representative. Continued use could result in injury or damage to the equipment. If the system software malfunctions and the equipment can no longer be operated, turn off the power to NOTE the multibox(MB-01) and the image processing computer and then turn the power back on.
Page 153: Emergency Stop Of X-Ray Generator
If you find any abnormality, immediately turn off the power, and then contact your NOTE Shimadzu service representative. • To turn on the power of the system again, wait for more than10 seconds after the power is turned off.
Page 154: Error Display
This section describes the codes indicating current system conditions and warnings, as well as countermeasures against errors. If an error occurs and no code is displayed, contact your Shimadzu service representative. Trouble occurs. Is a code ([Exx], [Hxx], [Lxx], or [Cxx]) displayed? "Remote Console"...
Page 155: Remote Console
Send available radiography setting from DR received from DR. again. Battery for control panel data memory is empty. Battery for control panel data memory needs to Contact your Shimadzu service representative. be replaced soon. Clock has been reset. Inputting EEPROM was failed. Input APR again.
Page 156 24 V power supply/voltage for IGBT is abnormal. - 15 V power supply/voltage is abnormal. + 15 V power supply/voltage is abnormal. Contact your Shimadzu service representative. + 24 V power supply/voltage is abnormal. Connection status to high-voltage transformer is abnormal.
Page 157 Starter is abnormal. Measured tube voltage has exceeded permitted range. If the code appears repeatedly, contact your Shimadzu service representative. The tube current has exceeded the set value. The fluoroscopy tube current has exceeded the set value. Arcing occurred repeatedly.
Page 158 ZSU-5D/5DS Operation Manual "3.5.2 Turning Power Off" Installation of the equipment has not been completed. If the time displayed in the Contact your Shimadzu service Radiography Radiography mA/mAs Setting has elapsed, the timer has trouble. representative. radiography cannot be performed.
Page 159: X-Ray Diagnostic Table-Related Codes
(The code appears for 30 seconds.) startup or switching of the console. If the code is still displayed, contact A button was pressed on the front operation panel your Shimadzu service representative. at start-up. (The code appears for 30 seconds.) Battery level is low.
Page 160 If the system still does not recover, Imaging unit potentiometer value does not change contact your Shimadzu service according to the output. representative. Table-elevating potentiometer value does not change according to the output.
Page 161 Code Content Countermeasure Software revision of X-ray high-voltage generator is Contact your Shimadzu Service not correct. Representative. The collimator of the second X-ray tube is abnormal. The potentiometer is disconnected or the Press the [Stop] button, or turn position is not registered.
Page 162: Digital Radiography Unit
 Digital Radiography Unit A confirmation window is displayed when an error occurs in the digital radiography unit. Error messages and error codes are displayed on the fluoroscopy/radiography monitor. For details on error messages, refer to the "OPERATION GUIDE" section of the control software instruction manual for the SDR-150C digital radiography system.
Page 163 Error Code Error Message Corrective Action F040100064 The firmware version may have been Inform a service engineer of the error code. upgraded after sensor registration. Perform Click [OK] to close the confirmation window sensor registration again. and shut down the control software. F040100065 A suitable jumbo packet is not set or a network card that supports jumbo packets is...
Page 164  Error list Error Code Error Message Corrective Action E020201004 Unexpected error has occurred. Gamma Click [OK] to close the confirmation window, adjustment is not available. Restart the and then shut down the control software. system. If the problem is not resolved after Then restart the PC and perform gamma restarting, contact a service engineer.
Page 165 Error Code Error Message Corrective Action E040100001 An invalid workspace has been specified. Click [OK] to close the confirmation window Check the setting information. If the problem and retry the previous operation. is not resolved, contact a service engineer. If this error occurs again, inform a service engineer of the error code.
Page 166 Error Code Error Message Corrective Action E04050000D A transmission error occurred. Locate the Resend the image from the [PAST > View] or failed study in the [PAST > Past List] and [PAST > Past List] screen and delete the data retransmit the study.
Page 167 Error Code Error Message Corrective Action E040505001 An error occurred in DICOM communication. Click [OK] to close the confirmation window. Try again. If the problem is not resolved, Click [Refresh] to acquire the study orders. E040505002 contact a service engineer. If the problem cannot be resolved, contact the system administrator.
Page 168 Error Code Error Message Corrective Action E04050502C An error occurred in the DICOM printer Click [Retry] to retry the previous operation, output. Try again later. or click [OK] to close the confirmation E04050502F window, and then retry the data transmission from the Process Viewer.
Page 169 Error Code Error Message Corrective Action E040800100 Cannot start the examination as an invalid Click the suspended examination including protocol exists in the study. Delete the invalid the target protocol in [EXAM > Worklist] and protocol and retry the examination. then [Edit Exam] to delete it.
Page 170 Error Code Error Message Corrective Action E050501012 An abnormality was detected in the analog Inform a service engineer of the error code. power supply for the detector. Contact a service engineer. E050501014 A grid error was detected. Contact a service engineer.
Page 171 Error Code Error Message Corrective Action W040505030 The transmission was complete normally. Check the DICOM printer. For details on However, the CXDI system received Printer Status, refer to Annex C.13.9.1 in the WARNING status from the destination DICOM standard Part3: Information Object DICOM printer.
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Page 173: Maintenance
Chapter Maintenance Maintenance ..............132 Periodic Replacement Parts ..........135...
Page 174: Maintenance
Once a year Disinfection Operator or equipment manager When needed Periodic Inspection Shimadzu service representative Every 6 months  Daily Maintenance Daily maintenance involves Start-up and Post-operation Maintenance. Perform daily maintenance for longer product life. Follow the procedures listed on "Checklist for Start-up Maintenance "...
Page 175 Repeated disinfection over a long time may lead to discoloring and cracking on the equipment surface, and deterioration of rubber and plastic. If any abnormality is found on the equipment after disinfection, stop using the equipment immediately. Contact your Shimadzu service representative for repair.
Page 176: Inspection For Warning And Caution Labels
 Inspection for Warning and Caution Labels Periodically (once a year) inspect the labels attached on the equipment. If any label is peeled or unreadable by stain or scratch, contact your Shimadzu service representative for replacement of a new one.
Page 177: Periodic Replacement Parts
Periodic Replacement Parts Replace certain parts periodically to maintain the system performance. These parts are called periodic replacement parts. Periodic replacement parts must be replaced by a Shimadzu service representative.  X-ray Diagnostic Table  Battery Part Name Location Replacement Cycle...
Page 178: Digital Radiography Unit
 Switch Part Name Location Replacement Cycle Table up/down detection ASSY Base Assy 3 years Table tilting detection ASSY Base Assy 3 years F/R unit detection ASSY Main Body 3 years Tube oblique detection ASSY Column Assy 3 years  Digital Radiography Unit ...
Page 179: Checklists
Chapter Checklists Start-up Maintenance............138 Post-operation Maintenance ..........140 Equipment Malfunction Record........141 Safety Explanation Record ..........142...
Page 180: Start-Up Maintenance
(3) Turn the system on. Check the following points. Take the recommended corrective action if you find any abnormalities. Item/Area Corrective Action System makes abnormal sound after power is turned on. Contact your Shimadzu service representative. System emits unusual smell. The collimator's lamp is lit brightly. Contact your Shimadzu service representative.
Page 181 Tabletop automatically stops at approx. 90° when tilted. Tabletop does not make an abnormal sound when adjusted laterally. Imaging unit does not make an abnormal sound when adjusted. Contact your Shimadzu service representative. Compression unit does not make an abnormal sound when adjusted.
Page 182: Post-Operation Maintenance
Post-operation Maintenance  Checklist for Post-operation Maintenance Date: Name: • X-ray Diagnostic Table Checklist Item/Area Corrective Action Tabletop is returned to the vertical or horizontal position. Return the tabletop to its proper position. • Cleaning Checklist Item/Area Corrective Action System is free of contrast medium or spilled chemicals. Wipe the tabletop clean of Wipe off any excess liquid using a cloth moistened with a specified disinfectant any spilled liquid.
Page 183: Equipment Malfunction Record
Equipment Malfunction Record  Equipment Malfunction Checklist Fill following blanks and contact your Shimadzu service representative. Hospital: Name: Phone: FAX: E-mail Address: Unit Name: System Name: Serial Number: Date of Installation: Question Answer Did the malfunction injure anyone? When did the malfunction occur?
Page 184: Safety Explanation Record
Name Name A Shimadzu service representative will explain the safety precautions in this operation manual to the system administrator or operator and use this sheet to record what he/she explained when the system is installed or a new operator is hired.
Page 185: Appendix
Appendix Appendix Information on Radiation..........144 Deterministic Effect............145 Reference Air Kerma (Rate) ..........146 Useful Features for Pediatric Imaging ......148 NOTATION FOR WIRELESS REGULATIOIN ....149...
Page 186: Information On Radiation
Information on Radiation 1.1.1 Radiation Protection To minimize X-ray exposure on patients and medical staff, the operator must observe the local laws and regulations specified in each region, as well as the following precautions. It is also highly recommended to study and know about the recommendations of the International Commission on Radiological Protection (ICRP).
Page 187: Deterministic Effect
Deterministic Effect In the examination using this equipment, there is a possibility that the cumulative skin dose during the examination may reach the level that could bring a deterministic effect on the patient. According to the ICRP60, the threshold at which a deterministic effect appears on skin or crystalline lens is 1 to 3 Gy. The following shows an example of X-ray conditions which could bring skin dose of 1 Gy during the examination using this equipment.
Page 188: Reference Air Kerma (Rate)
Reference Air Kerma (Rate) This section describes representative values of reference air kerma rate of fluoroscopy and reference air kerma of radiography.  Measurement Condition (Compliant with IEC 60601-2-54 clause 203.5.2.4.5.102) SID: 1100 mm Anti-scatter grid: Used Phantom: PMMA 400400200 mm Geometry: Spot Dosimeter...
Page 189: Radiography
 Curves of Tube Voltage-tube Current (mA) (0.6/1.2P326D-150) Mode 50 kV 60 kV 80 kV 90 kV 100 kV 115 kV Pulse 15 Pulse 7.5 High-definition  Reference Air Kerma Rate Mode 15 fps 7.5 fps High-Definition X-ray Tube Unit 0.3/0.8P324DK-85 Tube Voltage (kV) 0.6/1.2P324DK-8...
Page 190: Useful Features For Pediatric Imaging
There are several useful features for Pediatric Imaging on FLEXAVISION. It is suggested to utilize those features when pediatric examination is performed. It is also possible to set a protocol suitable for pediatric. Contact your Shimadzu service representative.  Removable Anti-scatter Grid The X-ray grid of the FLEXAVISION is removable.
Page 191: Notation For Wireless Regulatioin
NOTATION FOR WIRELESS REGULATIOIN 1.5.1 EU/EFTA *including Northern Ireland...
Page 193: United Kingdom *Except Northern Ireland
For information on obtaining the original of the declaration, consult your sales representatives. 1.5.2 United Kingdom *except Northern Ireland For information on obtaining the original of the declaration, consult your sales representatives.
Page 194: United States Of America
1.5.3 United States of America...
Page 195: Brazil
1.5.4 Brazil Modelo: BM72065 Este produto contém a placa (BM72065) código de homologação Anatel 08505-20-07857 Este equipamento não tem direito à proteção contra interferência prejudicial e não pode causar interferência em sistemas devidamente autorizados. Para consultas, visite: www.anatel.gov.br 1.5.5 Republic of Korea 이...
Page 196 The table below shows the revision history of this manual. Revision Date Changes Jun. 2021 First edition released. First edition Dec. 2021 Revised for product release. Jan. 2022 Added "System Activation" and relating error codes. Oct. 2023 • Added “WARNING” to “Precautions in Use”. •...

Shimadzu FLEXAVISION F4 Instruction Manual

1 Outline

2 Contents

3 Preparation

4 Radiography

5 Specification

6 Troubleshooting

7 Maintenance

8 Checklists

Appendix

Quick Links

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