Shimadzu FLEXAVISION Remote-Controlled R/F System Operation Manual M517-E132 Rev B

Description

Shimadzu FLEXAVISION Remote-Controlled R/F System Operation Manual

This is the complete operation manual for the Shimadzu FLEXAVISION remote-controlled R/F system, a fluoroscopy and radiography diagnostic imaging platform used in chest and GI examinations. Document M517-E132 Rev B covers the SF, HB, and FD package configurations, providing detailed operating procedures for the X-ray diagnostic table, digital radiography unit, control cabinet, remote console, and cassette radiography devices. Every major system function is described with step-by-step instructions, accompanying illustrations, and safety precautions.

File Details

• Manual Type: Operation Manual
• Brand: Shimadzu
• Model: FLEXAVISION Remote-Controlled R/F System
• Document Number: M517-E132
• Revision: Rev B
• Revision Date: December 2007
• Language: English
• Page Count: 158 pages
• File Format: PDF

Chapters Covered

• For Safety Use — Danger, Warning, Caution, and Note classifications; illustrated symbols; disclaimer; general safety instructions for installation, operation, maintenance, and storage
• Precautions for System Use — Environment for equipment; system operation warnings; X-ray exposure precautions; accessories and options; digital radiography unit cautions; maintenance; emergency stop; cellular telephone warnings; EMC compatibility; warning label locations; limited product warranty; product service life; WEEE directive
• 1. Outline — 1.1 System Outline (package contents, component units, applications, features, product nameplate and certificate labels); 1.2 Operating Conditions (environmental conditions, installation conditions, operating range, available cassettes, transportation and storage); 1.3 Safety Requirements
• 2. Operations — 2.1 Operating X-ray Diagnostic Table (tilting tabletop, moving tabletop laterally, moving tabletop up/down, moving imaging unit longitudinally, inclining imaging unit, operating compression cone, specifying X-ray exposure field)
• 3. SF Package — 3.1 System Start/Shutdown; 3.2 Cassette Spot Radiography; 3.3 Cassette Radiography; 3.4 Chest Radiography (1.5 m)
• 4. HB Package — 4.1 System Start/Shutdown; 4.2 Study/Radiography in Digital Radiography Technique (registering patient information, normal registration, emergency registration, auto ID mode, SPOT/SERIAL radiographic study, ending study, editing image, image printing/saving/transferring); 4.3 Cassette Spot Radiography; 4.4 Cassette Radiography; 4.5 Chest Radiography (1.5 m)
• 5. FD Package — 5.1 System Start/Shutdown; 5.2 Study/Radiography in Digital Radiography Technique (registering patient information, normal registration, emergency registration, auto ID mode, SPOT/SERIAL radiographic study, ending study, editing image, image printing/saving/transferring); 5.3 Cassette Tray Radiography; 5.4 Cassette Radiography; 5.5 Chest Radiography (1.5 m)
• 6. Specification — 6.1 SF Package (X-ray diagnostic table, X-ray high-voltage generator, dimension of control cabinet); 6.2 HB Package (X-ray diagnostic table, X-ray high-voltage generator, dimension of control cabinet, digital radiography unit); 6.3 FD Package (X-ray diagnostic table, X-ray high-voltage generator, dimension of control cabinet, digital radiography unit); 6.4 Environmental Conditions of EMC (classification of EMI, performance to be EMC immunity tested, list of cables, guidance and manufacturer declaration); 6.5 Statement of Compliance [For Europe] (regulatory information, company quality system, international standards)
• 7. Troubleshooting — 7.1 Emergency Stop (emergency stop/canceling emergency stop); 7.2 Error Display (remote console, X-ray high-voltage generator-related codes, X-ray diagnostic table-related codes, digital radiography unit, error messages manageable for user, error messages unmanageable for user, error Nos. and remedies)
• 8. Maintenance — 8.1 Maintenance (daily maintenance, cleaning and disinfection, periodic inspection); 8.2 Product Service Life; 8.3 Periodic Replacement Parts (X-ray diagnostic table, digital radiography unit)
• 9. Checklists — 9.1 Start-up Maintenance; 9.2 Post-operation Maintenance; 9.3 Equipment Malfunction Record; 9.4 Safety Explanation Record

This manual provides the complete operational framework for the FLEXAVISION system. It begins with essential safety information and system outlines, then progresses through package-specific operating procedures for each configuration. The specification chapter delivers full technical data including tube voltage ranges, current settings, mAs values, exposure times, tabletop dimensions, maximum allowable loads, travel distances, speeds, and power supply requirements. The troubleshooting section covers error codes for the X-ray high-voltage generator and diagnostic table, along with user-manageable error messages and countermeasures. Maintenance checklists and periodic replacement part schedules complete the document, making it a comprehensive resource for any facility operating this system.

System Coverage and Configurations

The FLEXAVISION system is available in three package configurations, each covered in dedicated chapters:

• SF Package — Cassette spot radiography device system
• HB Package — Combination of cassette spot radiography device and digital radiography unit
• FD Package — Combination of cassette tray radiography device and digital radiography unit

Each package is further distinguished by the type of X-ray diagnostic table: the ZSU-5DS with elevating tabletop or the ZSU-5D without elevating tabletop. The X-ray high-voltage generator is available in four output variants: ZSU-5PF (20 kW), ZSU-5LF (50 kW/32 kW), ZSU-5VF (65 kW), and ZSU-5BF (80 kW). The manual specification chapter provides separate technical data tables for each generator variant.

Key Systems and Components Covered

The Shimadzu FLEXAVISION operation manual addresses every major system component and its operation:

• X-ray Diagnostic Table — Tilting tabletop (-30° Trendelenburg to +90° upright), lateral movement (220 mm motor-driven), vertical movement for 5DS models (690 mm to 950 mm), imaging unit longitudinal travel (900 mm motor-driven), oblique angle (patient head direction 30° to foot direction 30° with optional oblique projection unit), compression cone operation
• X-ray High-Voltage Generator — Radiography settings (tube voltage 40-125 kV or 40-150 kV depending on model, tube current 10-1000 mA, mAs 0.5-800, time 0.001-10 sec), fluoroscopy settings (tube voltage 50-125 kV, tube current 0.3-4.0 mA, continuous fluoroscopy time 10 min)
• Digital Radiography Unit — SDR-100 with 1 million pixel CCD camera, 1000 × 1000 matrix, 12 bits/4096 graduation density resolution, 17-inch LCD monitor, image processing functions including brightness/contrast, black and white inversion, AWC, gamma, H/V inversion, noise reduction, edge reinforcement, zoom, multi display, annotation, distance measurement, DICOM printing and storage compatibility
• Image Processing Unit — SF-6020ZD with 400,000 pixels for SF package configurations
• Remote Console — Tabletop/imaging unit control lever, tabletop tilt-down/tilt-up buttons, tabletop ascending/descending buttons, imaging unit head/foot buttons, oblique projection head-side/foot-side buttons, compression control lever, squeeze compression button, collimator handles, exposure field buttons, APR selection, technique selection
• Cassette Radiography Devices — Cassette spot radiography device (available cassette sizes from 8 x 10 to 14 x 17 in INCH series and 18 × 24 to 35 × 43 in CM series), cassette tray radiography device (14 x 17 INCH series, 35 cm × 43 cm CM series)

Operating Procedures and Workflows

The manual details complete operating workflows for each package configuration. For the SF package, this includes cassette spot radiography (loading the cassette, selecting APR, performing fluoroscopy, determining exposure position, making an exposure, removing the cassette), cassette radiography, and chest radiography at 1.5 m FFD. For HB and FD packages, the digital radiography workflow is covered in depth, including patient information registration (normal, emergency, and auto ID mode), SPOT and SERIAL radiographic studies, ending a study, image editing with radiogram interpretation tools, and image printing, saving to external media, and DICOM server transfer.

Safety is addressed throughout with specific precautions for tabletop operation, compression cone use, patient positioning, and radiation protection. The emergency stop procedure is clearly documented, with instructions for pressing the STOP button and canceling the emergency stop by rotating the button clockwise.

Specifications and Technical Data

The specification chapter provides detailed technical data for all three packages, including:

• X-ray diagnostic table dimensions, maximum allowable load (135 kg, 150 kg for some specifications), lateral movement speed (30 mm/sec at 50 Hz, 36 mm/sec at 60 Hz), tilting speed (6°/sec maximum, 5°/sec for some specifications)
• X-ray high-voltage generator ratings for all four output variants, including short-time and long-time ratings, number of connectable X-ray tubes, and setting ranges
• Power supply facility requirements for each generator type, including system configuration (single-phase or three-phase), frequency (50/60 Hz), rated voltage, capacity, power-supply impedance, grounding resistance, and circuit breaker requirements
• Electric cable length and nominal cross-sectional area tables for different transformer capacities and cable lengths
• Digital radiography unit specifications including CPU, memory, OS, HDD capacity, number of saved images, camera matrix, density resolution, display monitor, image processing capabilities, and DICOM compatibility

Maintenance and Troubleshooting

Daily maintenance procedures are provided for start-up and post-operation checks, including visual inspections, manual inspections, system start-up verification, and remote control operation checks. The manual specifies cleaning and disinfection procedures using alcohol or disinfectants applied to a cloth — never sprayed directly onto the system. Periodic inspection by a Shimadzu Service Representative is recommended every six months.

The troubleshooting section provides error code tables for the X-ray high-voltage generator and X-ray diagnostic table, along with error messages displayed by the digital radiography unit. User-manageable error messages are listed with countermeasures such as restarting the system, replacing storage media, or canceling operations. Error codes displayed as [Cxx] automatically disappear after taking the appropriate countermeasure, while [Exx] codes require pressing a button to clear.

Periodic Replacement Parts

The manual includes a comprehensive schedule of periodic replacement parts with part numbers and replacement cycles. For the X-ray diagnostic table, this covers halogen lamps, batteries, fuses, relays, V-belts, roller chains, gear covers, and various detection switches. For the digital radiography unit, it covers HDD, battery assembly, CPU fan, power unit fan, case fan, and input devices. Replacement cycles range from one year for lamps, batteries, and fuses to seven years for chains.

Safety and Compliance

Safety information is woven throughout the manual, with specific warnings for X-ray exposure, electrical hazards, mechanical pinch points, and patient positioning. The manual classifies safety information into DANGER, WARNING, CAUTION, and NOTE categories, with corresponding illustrated symbols for prohibited actions, compulsory actions, and reference information. Protection class is Class I equipment, protection degree against electric shock is Type B equipment, and protection degree against harmful ingress of water is ordinary equipment.

The FLEXAVISION system complies with Medical Device Directive 93/42/EEC and carries the CE mark (0197), TUV-GM mark, and SEG address label. The manual includes a statement of compliance listing international standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN ISO 10993-1, EN ISO 980, EN ISO 1041, and EN ISO 14971.

Who This Manual Is For

This Shimadzu FLEXAVISION operation manual is intended for radiologic technologists, diagnostic radiology technicians, and medical equipment operators who use the FLEXAVISION system in clinical settings. It assumes the operator has the appropriate training and certification. The manual explicitly states that the medical equipment is restricted to use and management by, or on the order of, a diagnostic radiology technician or a person with a certificate indicating equal proficiency. Repair and inspection of the equipment interior must be performed by a Shimadzu Service Representative.

Why This Manual Matters

Operating a remote-controlled R/F system like the FLEXAVISION requires precise knowledge of tabletop movements, imaging unit positioning, exposure field adjustment, and radiation safety. Incorrect operation can result in patient injury, unnecessary radiation exposure, equipment damage, or misdiagnosis. This manual provides the exact procedures, safety precautions, and technical specifications needed to operate the system correctly and safely. It covers every package configuration, every major component, and every operating scenario from routine fluoroscopy to emergency studies.

For facilities maintaining a FLEXAVISION system, this manual serves as the primary reference for operator training, procedure verification, and safety compliance. The checklists in Chapter 9 support daily and periodic maintenance routines. The troubleshooting chapter helps operators identify and resolve common errors without unnecessary service calls. The specification chapter provides the data needed for installation planning, power supply preparation, and system configuration verification.

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This Shimadzu FLEXAVISION Remote-Controlled R/F System Operation Manual is delivered as an instant PDF download after purchase. There is no shipping, no waiting for a physical book, and no need to track down a printed copy that may be lost or damaged. The PDF can be viewed on any device — computer, tablet, or smartphone — and relevant pages can be printed for quick reference at the console or in the examination room. Whether you are setting up a new system, training a new operator, or need a reliable reference for daily operations, this manual provides the complete documentation you need.