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UNITED IMAGING uDR596i Operator's Manual

Digital medical x-ray imaging system
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Shanghai United Imaging Healthcare Co., Ltd.
www.united-imaging.com
,
Address: No. 2258 Chengbei Road
Jiading District, Shanghai, 201807, P.R. China
TEL: +86(21)-67076888
FAX: +86(21)-67076889
Shanghai International Holding Corp. GmbH (Europe)
,
,
Address: Eiffestrasse 80
20537 Hamburg
Germany
TEL: +49-40-2513175
FAX: +49-40-255726
System Operator Manual
Digital Medical X-ray Imaging System
uDR 266i
uExceed R002
51001265-02-202101-ENG

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  • Page 1 Shanghai United Imaging Healthcare Co., Ltd. System Operator Manual www.united-imaging.com Digital Medical X-ray Imaging System Address: No. 2258 Chengbei Road Jiading District, Shanghai, 201807, P.R. China TEL: +86(21)-67076888 FAX: +86(21)-67076889 Shanghai International Holding Corp. GmbH (Europe) uDR 266i Address: Eiffestrasse 80...
  • Page 2 It is the responsibility of users to comply with any applicable copyright law. Without explicit written permission from Shanghai United Imaging Healthcare Co.,Ltd. (hereinafter referred to as "UIH"), no part of this document can be reproduced, transmitted, stored in or introduced into a retrieval system in any form or by any means (electronic, mechanical, photographic or otherwise) for any purpose.

  • Page 4: Applicable Products

    Foreword This manual provides instructions on safety information, functions, site planning, installa- tion, and maintenance of the system. Applicable products This manual applies to the following products: Product name Product model Software version Digital medical X-ray imaging system uDR 266i R002 Audience ...

  • Page 6: Table Of Contents

    4.6 Position of flat panel detector carrier assembly ........4-16 4.7 Collision protection ................4-18 4.8 Use of the wireless digital flat panel detector ........4-19 4.9 Light field adjustment of the collimator ..........4-22 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 7 Table of Contents 4.10 Use of the console system ..............4-23 4.11 Exposure operation ................4-25 5 Optional accessories 5.1 Principle....................5-2 5.2 Mobile radiographic table ..............5-3 5.3 Stitching stand..................5-5 5.4 Additional filter plate ................5-8 6 Technical reference for system operation 6.1 Overview ....................
  • Page 8 Figure 4-5 Infrared induction device ...............4-18 Figure 5-1 Mobile radiographic table ..............5-3 Figure 5-2 Stitching stand.................5-5 Figure 5-3 Additional filter plate position ............5-8 Figure 6-1 Room layout (unit: mm)..............6-3 Figure 6-2 System installation flowchart............6-6 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 9 List of Figures System Operator Manual...
  • Page 10 Emission ..................8-14 Table 8-10 Enclosure Port ................8-14 Table 8-11 Proximity fields from RF wireless communications equipment ..8-14 Table 8-12 Input a.c. power Port ..............8-15 Table 8-13 Signal input/output parts Port............8-15 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 11 List of Tables System Operator Manual...

  • Page 12: Introduction

    1.3.2 Application scope ..............1-6 1.3.3 Contraindication ................ 1-6 Personnel qualifications ................1-7 Terms, acronyms and abbreviations ............1-8 1.5.1 Terms ..................1-8 1.5.2 Acronyms and abbreviations ............. 1-9 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 13: About This Manual

    About this manual This manual applies to the digital medical X-ray imaging system developed by Shanghai United Imaging Healthcare Co., Ltd. ("UIH" for short). Operators must observe safety instructions in this manual during operation and understand application functions of the system.

  • Page 14: Applicable Scope

    China Food and Drug Administration. If there are relevant laws and regulations covering the use of the system, operators have to observe such laws and regulations. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 15: Related Documents

    Introduction About this manual 1.1.5 Related documents This system is delivered with the onlinehelp. System Operator Manual...

  • Page 16: About This System

     The system supports stitch check. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 17: Clinical Use

    Introduction Clinical use Clinical use 1.3.1 Intended use The System is intended for radiography of the human body to acquire X-ray images for medical imaging diagnosis. 1.3.2 Application scope  Suitable for the radiography of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites of subjects at all ages who need radiography.

  • Page 18: Personnel Qualifications

     This system can only be operated by trained personnel with required professional knowledge, such as trained physicians, radiologists, or technicians. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 19: Terms, Acronyms And Abbreviations

    Introduction Terms, acronyms and abbreviations Terms, acronyms and abbreviations 1.5.1 Terms Term Description Refers to the electron-beam current that strikes an X-ray tube target. It is X-ray tube current generally represented with average milliampere (mA). Refers to the potential difference between the anode and cathode of an X- X-ray tube voltage ray tube.

  • Page 20: Acronyms And Abbreviations

    Automatic Exposure Control DICOM Digital Imaging and Communications in Medicine Digital Radiography Power Distribution Unit Rotation around Horizontal Axis Radiology Information System Source to Image Receptor Distance Source to Object Distance © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 21 Introduction Terms, acronyms and abbreviations This page intentionally left blank. 1-10 System Operator Manual...

  • Page 22: Safety

    Electrostatic protection ............2-24 Environmental protection ..............2-25 2.7.1 Handling of hazardous substances and components ....2-25 2.7.2 Product disposal ..............2-25 System messages ................. 2-26 Service life .................... 2-27 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 23: Safety Signs And Symbols

    Safety Safety signs and symbols Safety signs and symbols 2.1.1 Definition of safety level This manual involves four levels of safety warning signs: Before operating this system, users must read through and get familiar with all safety infor- mation involved in this manual, strictly observe safety information marked with the words "Danger", "Warning", "Caution", and "Note", and keep in mind various safety measures to prevent safety accidents.

  • Page 24: Table 2-1 Warning Symbols

    No trampling Component surface This symbol indicates that the maxi- Maximum load capacity: mum load on the component is 15 kg. 15 kg  Surface of detector carrier MAX.LOAD 15KG © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 25: Table 2-3 Instruction Symbols

    Safety Safety signs and symbols Symbol Description Usage and position This symbol indicates that the maxi- Weight limit: 150 kg mum load on the component is 150 kg.  Mobile radiographic table MAX.LOAD 150KG Table 2-3 Instruction symbols Symbol Description Usage and position This symbol indicates that operators Refer to the operation...

  • Page 26: Table 2-6 Label

    No.2258 Chengbei Road,Jiading District, Shanghai, 201807, P.R. China Input Voltage: Input power Rear of movable Input Frequency: Standby Power: label radiographic table Momentary Power: Operation Mode: Continuous operation with intermittent loading © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 27: Basic Safety Specifications

    Safety Basic safety specifications Basic safety specifications Strictly observe safety instructions in the manual when using this system. Always abide by the following installation and operation instructions for medical equip- ment:  If the system encounters any electrical or mechanical fault, stop using it. ...

  • Page 28: System Safety Features

     Based on whether the equipment has signal input/output parts: equipment with signal input/output parts.  Based on whether the equipment is permanently installed: permanently installed equipment. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 29: Precautions For Examination And Diagnosis

    Safety Precautions for examination and diagnosis Precautions for examination and diagnosis 2.4.1 Image orientation  Operators should ensure that the image orientation on the monitor or film is correct.  When "free flat panel" is selected on the acquisition system, operators should confirm the image orientation.

  • Page 30: Patient Constant-Contact Components

     Some system function faults cannot be rectified within a short period of time, resulting in the examination delay or suspension. Therefore, appropriate emergency proce- dures should be established to cope with such cases. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 31: Personal Safety

    Safety Personal safety Personal safety 2.5.1 System motion safety Assemblies of the digital medical X-ray imaging system move at a certain speed. There- fore, exercise caution when operating such assemblies. When system components crush or collide with personnel during system motion, mechan- ical damage or personnel injuries may be incurred.

  • Page 32: Figure 2-1 Potential Collision Areas On Mobile Radiographic Table

     Patients should place their hands and feet on the table top when lying on the mobile radiographic table, to prevent crushing. Figure 2-2 Potential collision areas on X-ray tube-collimator assembly Figure 2-3 Potential collision areas on FPD assembly © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-11...

  • Page 33: Emergency Stop Switch

    Safety Personal safety WARNING Hazard of crushing  Patients should place their hands and feet on the table top when lying on the mobile radiographic table, to prevent crushing.  Ensure that components move at a low speed carefully when they are close to poten- tially dangerous crushing and collision areas, to prevent crushing.

  • Page 34: Figure 2-4 Emergency Stop Switch On The Control Console

    There are two emergency stop switches on the U-arms in the scanning room. Figure 2-4 Emergency stop switch on the control console Figure 2-5 Emergency stop switch on U-arm Figure 2-6 Emergency stop switch on U-arm (FPD carrier side) © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-13...

  • Page 35: Patient Positioning Safety

    Safety Personal safety 2.5.3 Patient positioning safety The maximum allowable patient load of mobile radiographic table is 150 kg. MAX.LOAD 150KG  It is important to evenly distribute patient weight on the top of the mobile radiographic table. Otherwise, there will be risks of material deformation and personnel injury. ...

  • Page 36: Repair And Maintenance Safety

     Ensure that no patient is caught between the top of the mobile radiographic table and the X-ray tube - collimator assembly when the mobile radiographic table is positioned or the X-ray tube - collimator assembly is moved downwards. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-15...

  • Page 37: Electrical Safety

    Safety Personal safety  When the X-ray tube - collimator assembly is rotated around the horizontal axis, ensure that no patient get stuck between the column of the X-ray tube - collimator assembly and the table top.  A patient may be caught between the detector carrier and the ground. Ensure that no patient is stuck between the detector carrier and the ground when the detector carrier is moved downwards.

  • Page 38: Radiation Safety

    Otherwise, patients may be exposed to unexpected or excessive radiation.  Always keep the distance between the X-ray beam and the skin as long as possible, to minimize the dose absorbed through the skin of patients. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-17...

  • Page 39: X-Ray Protection

    Safety Personal safety  Keep the examination time as short as possible to reduce the total radiation dose.  Put the ROI close to the wireless digital flat panel detector, to reduce radiation and optimize the image quality.  Do not place any object on the exposure path between a patient and the wireless dig- ital flat panel detector.

  • Page 40: Figure 2-7 Warning Sign For The Collimator

    All operators of the system should be fully aware of how to use fire extinguishers, and receive the training on how to use fire extinguishers and other fire extinguishing equipment as well as training on local fire prevention regulations. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-19...

  • Page 41: Explosion Safety

    Safety Personal safety Conductive liquid entering the running operator console circuits will result in short circuits and cause the equipment to be on fire. Therefore, do not place any liquid or food on the console or other components. If the system cannot be shut down for a special reason or the power supply cannot be cut off due to other needs, operators must select a non-conductive extinguishing agent to quench fire while the power is on, for example: ...

  • Page 42: System Safety

     The use of hardware/software assemblies that are not approved by UIH or tampered may damage the system.  UIH provides follow-up services only when users use software/hardware approved by UIH and reach written agreements with UIH. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-21...

  • Page 43: Electromagnetic Compatibility

    Safety System safety Signal input/output interface Only the equipment tested and approved by UIH can be connected to the system to ensure the operating safety of the system. Equipment connected to the system through interfaces must pass relevant standard certi- fication, for example: ...

  • Page 44: Transportation Protection

    (including the monitor, mouse, keyboard, and cable) are discon- nected and transported safely. Ensure that packing cases are securely fastened during transportation to avoid internal damage caused by shaking. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-23...

  • Page 45: Electrostatic Protection

    Safety System safety NOTICE To ensure personal safety, wear proper safety equipment such as safety shoes and pro- tective gloves during unpacking or equipment installation. 2.6.4 Electrostatic protection Electrostatic discharge can damage electronic components of the system, resulting in sys- tem malfunctions.

  • Page 46: Environmental Protection

    Handle harmful substances in an appropriate manner. UIH allows you to dispose of the system in a proper way. Reusable components can be recycled by certified waste processing companies to help reduce environmental pollution. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-25...

  • Page 47: System Messages

    Safety System messages System messages System messages are displayed on the operation UI of the image processing system in the operation room. Based on the influence on the system, system messages are classified into three levels: Image processing system Message Description level Icon...

  • Page 48: Service Life

    The expected service life of this product is 10 years. Please contact UIH Customer Service Center for the disposal of this product at the end of its service life. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 2-27...
  • Page 49 Safety Service life This page intentionally left blank. 2-28 System Operator Manual...

  • Page 50: System Components

    Motion control buttons ................3-21 Console system ..................3-22 3.6.1 Image processing system ............3-22 3.6.2 Control console ............... 3-24 3.6.3 Exposure hand switch ............. 3-26 DAP meter .................... 3-27 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 51: System Overview

    System components System overview System overview This section describes the structure of the digital medical X-ray imaging system. 3.1.1 System components in the scanning room Figure 3-1 System components in the scanning room 1. U-arm 4. U-arm column 2. Wireless digital flat panel detector 5.

  • Page 52: Figure 3-2 System Components In The Operation Room

    The control console consists of a control console and an exposure hand switch. It can complete system Control console power-on/off, motion control, and exposure opera- tions. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 53 System components System overview Component name Description The monitor consists of an image processing system Monitor monitor and a diagnostic monitor (optional). The keyboard and mouse are used to assist with the Keyboard and mouse operations on the image processing system. NOTICE Do not issue the same motion instruction to the system from the scanning room and operation room at the same time.

  • Page 54: Definition Of Coordinate Axes And Directions

    The X-ray tube assembly, using the tube focus as the center, rotates TUBE-RHA leftward and rightward around the horizontal axis (Y-axis in the fig- ure). The X-ray tube assembly moves relative to the detector carrier along the U-arm. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 55: X-Ray Tube - Collimator Assembly

    System components X-ray tube - collimator assembly X-ray tube - collimator assembly The X-ray tube - collimator assembly is composed of an X-ray tube assembly, a collimator, and an angle indicator. 3.3.1 X-ray tube assembly This system supports two X-ray tube assembly models: XRR-3331X (tube sleeve: XH-121; tube core: XRR-3331) and E7876X (tube sleeve: XH-121;...

  • Page 56: Figure 3-4 X-Ray Tube Assembly Xrr-3331X

     Inherent filtration of the X-ray tube: 0.9 mm Al @75 kV  Nominal voltage of the X-ray tube: 150 kV  Standard loading conditions: 150 kV,3.4 mA  Rated value of the rotating anode motor © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 57 System components X-ray tube - collimator assembly Parameter Startup Running Power frequency (Hz) Input power (W) 1100 Voltage Current Minimum acceleration Capacitor (µF) 3/90 V (DC) Minimum braking time a. The voltage imposed each time cannot exceed 110% of the specified values above. b.

  • Page 58: Figure 3-5 Filament Emission Feature Curve

    (Representative value) 80KV 100KV 125KV 150KV 60KV 40KV Filament current (A) Figure 3-5 Filament emission feature curve  Maximum rated value table of the XRR-3331X (stator drive frequency: 50 Hz) © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 59: Figure 3-6 Maximum Rated Value Table Of The Xrr-3331X

    System components X-ray tube - collimator assembly Focus nominal value: 1.2 50kV 40kV 60kV 70kV 80kV 90kV 100kV 110kV 125kV 150kV 0.01 0.03 0.2 0.3 0.5 0.02 0.05 Exposure time (s) Focus nominal value: 0.6 40kV 50kV 60kV 70kV 80kV 90kV 100kV 110kV...

  • Page 60: Figure 3-7 Heating And Cooling Feature Curves Of Xrr-3331X

    Figure 3-7 Heating and cooling feature curves of XRR-3331X Cooling COOLING 142W Heating HEATING Time (minute) Time (minute) Figure 3-8 Heating and cooling feature curves of anode of XRR-3331X © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-11...

  • Page 61: Figure 3-9 X-Ray Tube Assembly E7876X

    System components X-ray tube - collimator assembly 3.3.1.2 X-ray tube assembly E7876X Anode 152.4 Cathode Terminal connection 9 8 7 Temperature control relay (Normally closed) Note: Do not connect termi- nals 1, 5, and 6 in series. Focus -1.5mm A 1.5mm C: pubic -1.5mm B 1.5mm L: large focus...

  • Page 62: Figure 3-10 Maximum Rated Value Table Of The E7876X

    Exposure time (s) Figure 3-10 Maximum rated value table of the E7876X  For the emission feature of the cathode filament, see the emission feature curves in the following figure. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-13...

  • Page 63: Figure 3-11 Filament Emission Feature Curve

    System components X-ray tube - collimator assembly Focus nominal value: 1.2 40kV 50kV 60kV 80kV 100kV 125-150kV Filament current (A) Focus nominal value: 0.6 50kV 60kV 80kV 100kV 125-150kV 40kV Filament current (A) Figure 3-11 Filament emission feature curve  Heating and cooling feature curves of the X-ray tube assembly 3-14 System Operator Manual...

  • Page 64: Figure 3-12 Heating And Cooling Feature Curves Of E7876X

    6. Tape measure 3. Additional filter plate slot  Light field adjustment knobs are used to adjust the light field scope of the collimator in horizontal and vertical directions. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-15...

  • Page 65: Angle Indicator

    System components X-ray tube - collimator assembly  The laser positioning light is used to indicate the position of the X-ray field centerline and is turned on with the switch-on of the light field positioning light.  The dimmer is used to switch off the laser positioning light. ...

  • Page 66: Figure 3-14 Angle Indicator

    X-ray tube - collimator assembly rotates 0 around the horizontal axis (RHA). When the X-ray tube - collimator assembly rotates around the horizontal axis (RHA), interpret the direction correctly. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-17...

  • Page 67: Digital Flat Panel Detector Carrier Assembly

    System components Digital flat panel detector carrier assembly Digital flat panel detector carrier assembly The following figure shows the main components of the detector carrier. The aluminum equivalent of the top of the detector carrier assembly is not greater than 1.2 mm Al.

  • Page 68: Figure 3-16 Structure Of The Wireless Digital Flat Panel Detector

    Table 3-1 Indicators of the wireless digital flat panel detector Icon Description Icon Description Wireless network sig- Data transmission © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-19...

  • Page 69: Wireless Digital Flat Panel Detector Tray

    System components Digital flat panel detector carrier assembly Icon Description Icon Description Battery level 3.4.2 Wireless digital flat panel detector tray The handle of the wireless digital flat panel detector tray is located in the upper part on one side of the detector carrier and is marked with "PULL". Pull the handle outward to pull out the wireless digital flat panel detector tray, and then put the wireless digital flat panel detector inside.

  • Page 70: Motion Control Buttons

    After this button is pressed, the U-arm rotates Counterclockwise rota- around the central axis counterclockwise. tion of the U-arm After this button is pressed, the motor-driven rotation is stopped. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-21...

  • Page 71: Console System

    System components Console system Console system The console system is used to control the system power-on/off in the operation room, to set the system positioning and display the positioning status, and to trigger exposure. The console system consists of the following system components: ...
  • Page 72  When adding functions or modifying the current configuration, ensure that all neces- sary preventive measures are taken for the network security of the current level. WARNING © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-23...

  • Page 73: Equipment Connection

    System components Console system Counterfeit software and hardware  Using counterfeit software or hardware may lead to system failures and impose a threat to patients or the equipment.  UIH will take no responsibility for the use of hardware and software not approved by UIH.

  • Page 74: Table 3-3 Control Buttons On The Control Console

    The service switch, located at the rear of the Service switch control console, is used to enable/disable the flat panel calibration function. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-25...

  • Page 75: Exposure Hand Switch

    System components Console system 3.6.3 Exposure hand switch The exposure handle switch is integrated into the control console and is used to control the exposure. Exposure control button 3-26 System Operator Manual...

  • Page 76: Dap Meter

     Check and maintenance DAP meter should be equipped with a metering device to check and maintain the accuracy of dosimetric. The accuracy range of dosimetric is from -35% to +35%. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 3-27...
  • Page 77 System components DAP meter This page intentionally left blank. 3-28 System Operator Manual...
  • Page 78 Use of the wireless digital flat panel detector ........4-19 4.8.1 Installation ................4-19 4.8.2 Disassembly ................4-20 4.8.3 Charging .................. 4-20 4.8.4 Precautions ................4-20 Light field adjustment of the collimator ..........4-22 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 79 System operations 4.10 Use of the console system ..............4-23 4.10.1 Startup/Shutdown of the image processing system ....4-23 4.10.2 Use of the control console ............4-23 4.10.3 Use of the mouse ..............4-23 4.10.4 Use of the keyboard ..............4-24 4.11 Exposure operation ................

  • Page 80: System Operations

    Operator register a new new patient. Manual. patient. For more informa- tion about the Adjust the position position, see of U-arm posi- "System opera- tioner. tions" on page 4- © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 81: One-Key System Power-On

    System operations Normal workflow Step Diagram Reference For more informa- tion, see the Soft- Conduct a check ware Operator before exposure. Manual. For more informa- tion about expo- Perform exposure. sure, see "Use of the mouse" on page 4-23. For more informa- tion, see the Soft- Preview the ware Operator...

  • Page 82: Patient Input

    1. Instruct a patient to sit down, lie down, or stand up according to the radiographic requirements for the selected site. 2. Determine whether external support is needed, for example a nurse, other technicians, parents of young patients, or relevant auxiliary equipment for patients. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 83: Check Before Exposure

    System operations Normal workflow 3. If no external support is needed, instruct the patient to position himself/herself in the direction preset in the exam protocol. 4. Move the wireless digital flat panel detector close to the projection site of the patient as much as possible.

  • Page 84: Advanced Post Processing Of Images

    After the patient examination ends, ask the patient to leave the scanning room to prepare for the next examination. For more specific operations on the image processing system, see the Software Operator Manual. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 85: Stitching Workflow (Optional)

    System operations Stitching workflow (optional) Stitching workflow (optional) This system can be configured with an optional stitching software package. In combination with a stitching stand, this system can complete the acquisition of images to be stitched, image stitching, and image post-processing. Contact UIH Customer Service Center to add the stitching function to your system.

  • Page 86: Exposure

    After completing the stitching, use an image processing tool to edit the image on the Stitching interface of the image processing system. For specific operations, see the Soft- ware Operator Manual delivered with the product. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 87: System Startup And Shutdown

    System operations System startup and shutdown System startup and shutdown There are <ON> and <OFF> keys on the control console. 4.3.1 System status This digital medical X-ray imaging system can be in either of the following states:  Off: Indicates that all system components and the image processing system are shut down.

  • Page 88: Shutdown Cancellation

    After pressing the <OFF> key, you can press the <ON> key within 10 seconds to cancel the shutdown. In this case, the system ignores the shutdown instruction and you do not need to log in again. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-11...

  • Page 89: Positioning Of The U-Arm

    System operations Positioning of the U-arm Positioning of the U-arm You can press motion control buttons to adjust the movement position of the U-arm, to assist with patient positioning. 4.4.1 Vertical movement of the U-arm 1. Press the <Up> button or <Down>...

  • Page 90: Figure 4-2 Rotation Of The U-Arm Around The Horizontal Axis

    2. When the U-arm rotates to the required position, release the motion control button to stop the rotation. +120° -30° Figure 4-2 Rotation of the U-arm around the horizontal axis © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-13...

  • Page 91: Positioning Of The X-Ray Tube-Collimator Assembly

    System operations Positioning of the X-ray tube-collimator assembly Positioning of the X-ray tube-collimator assembly Use motion control buttons to position the X-ray tube - collimator assembly. Only one but- ton can be triggered at a time and the latter motion control button triggered at the same time is deemed invalid.

  • Page 92: Figure 4-4 Sid Adjustment

    WARNING Hazard of collision  Before moving the X-ray tube - collimator assembly, confirm that no person or object exists in the motion path. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-15...

  • Page 93: Position Of Flat Panel Detector Carrier Assembly

    System operations Position of flat panel detector carrier assembly Position of flat panel detector carrier assembly The wireless digital flat panel detector assembly can be rotated through the detector car- rier handle at the rear of the assembly. WARNING Hazard of collision ...
  • Page 94 3. After the wireless digital flat panel detector is rotated to the required position, press and lock the detector carrier handle to fasten the wireless digital flat panel detector assem- bly. +45° -45° © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-17...

  • Page 95: Collision Protection

    System operations Collision protection Collision protection This system is equipped with infrared protection devices and there are two symmetrical infrared induction holes on the inner side of the U-arm. If a patient or an operator is in the infrared induction area and blocks the induction holes during the motor-driven U-arm positioner movement, the movement is stopped to prevent accidental collision injuries.

  • Page 96: Use Of The Wireless Digital Flat Panel Detector

    6. Push the tray installed with the wireless digital flat panel detector into the detector car- rier till it is locked. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-19...

  • Page 97: Disassembly

    System operations Use of the wireless digital flat panel detector 4.8.2 Disassembly 1. Hold the handle of the wireless digital flat panel detector tray tightly. 2. Pull the wireless digital flat panel detector tray outward slowly. 3. Grasp the wireless digital flat panel detector with the left hand tightly, and hold the bot- tom of the wireless digital flat panel detector.
  • Page 98  If the wireless digital flat panel detector is overheated, its performance may deterio- rate. Ensure that air vents are well-ventilated. NOTICE Do not put the wireless digital flat panel detector in a place near the heat source or fire. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-21...

  • Page 99: Light Field Adjustment Of The Collimator

    System operations Light field adjustment of the collimator Light field adjustment of the collimator For the position of the light field adjustment knob of the collimator, see "Collimator" on page 3-15. 1. Press the <Light Field Positioning Light Switch> to turn on the light field positioning light.

  • Page 100: Use Of The Console System

    Select an object, and start an application and function. Right mouse button The "context menu" pops up. Scroll wheel Drag the scroll bar to flip over films and to view the exam list. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-23...

  • Page 101: Use Of The Keyboard

    System operations Use of the console system  The shape of the mouse cursor or pointer displayed on the screen may vary with the current application.  The mouse is right-handed by default. In "Control Panel" of the Windows, you can mod- ify the mouse control mode to left-handed.

  • Page 102: Exposure Operation

    Select at least one measurement field for the ionization chamber based on clinical requirements: L, C, R, LR, LC, RC, or LCR. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 4-25...
  • Page 103 System operations Exposure operation  You can select a required measurement field for the ionization chamber on the moni- tor in the operation room based on clinical requirements.  When confirming the selection of one measurement field for the ionization chamber, ensure that a patient's body part to be examined is correctly within the range of the measurement field, to prevent incorrect exposure.

  • Page 104: Optional Accessories

    Stitching stand ..................5-5 5.3.1 Intended use ................5-5 5.3.2 Placement of the stitching stand ..........5-6 5.3.3 Adjustment of the stitching stand armrests ....... 5-7 Additional filter plate ................5-8 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 105: Principle

    Optional accessories Principle Principle  Your system may not have all the optional accessory functions. If you need to purchase optional accessories, contact UIH Customer Service Center.  For the cleaning of optional accessories, see "Optional accessories" on page 7-12. NOTICE Only UIH original optional accessories or optional accessories approved by UIH can be used.

  • Page 106: Mobile Radiographic Table

    2. Mobile wheel (four) Name Description Supports a patient for examinations in the lying or sit- Table top ting position. Mobile wheel Moves the mobile radiographic table in any direction. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 107 Optional accessories Mobile radiographic table Name Description Controls the motion status of the mobile radiographic table. Locking pedal  Step on locking pedals of the four mobile wheels to lock the mobile radiographic table thoroughly. Then, the mobile radiographic table cannot be moved. ...

  • Page 108: Stitching Stand

    The aluminum equivalent of the stitching stand is not greater than 1.7 mm Al. Patients should keep still during the stitching process to reduce invalid radiography and excessive radiation. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 109: Placement Of The Stitching Stand

    Optional accessories Stitching stand 5.3.2 Placement of the stitching stand 1. Move the stitching stand to the fixing groove.  Raise the locking pedals of the mobile wheels of the stitching stand to release the mobile wheels.  On the locking pedal, indicates the unlocking state while indi- cates the locked state.

  • Page 110: Adjustment Of The Stitching Stand Armrests

    1. Raise the armrests of the stitching stand. 2. Move the armrests vertically along the guide rails on the back plate of the stitching stand. 3. Adjust the armrests to specified positions and release the armrests. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 111: Additional Filter Plate

    Optional accessories Additional filter plate Additional filter plate You can use an additional filter plate to reduce exposure radiation dose, especially when performing X-ray exposure on children. You can select 0.1 mm Cu or 0.2 mm Cu additional filter plates. Figure 5-3 Additional filter plate position 1.

  • Page 112: Technical Reference For System Operation

    System installation process ............6-6 6.4.2 Installation preparations ............6-6 6.4.3 Physical installation ..............6-8 6.4.4 System configuration ..............6-9 6.4.5 System commissioning ............6-10 6.4.6 End of installation ..............6-10 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 113: Overview

    Technical reference for system operation Overview Overview This chapter describes the preparations required for the normal operation of the system and important safety information. The preparations include site requirements, system transportation safety, system installation and tune-up, software configuration, and system performance testing.

  • Page 114: Site Requirements

     If there is a special fixture, for example, iron stand in the installation area, the fixture should meet the strength requirements for the civil structure.  The horizontal error of the installation floor should be smaller than 5 mm. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 115: Network Requirements

    Technical reference for system operation Site requirements 6.2.3 Network requirements  The system supports the TCP/IP network protocol. The images stored in the host com- ply with the DICOM 3.0 standard, and can be transmitted over Ethernet.  Network interfaces provided for the system must be IEC 60603-7-compliant RJ-45 interfaces and support the 100 M to 1000 M self-adaptive function.

  • Page 116: Transportation And Storage

     Relative humidity: 10% to 90% (no condensation)  Atmospheric pressure range: 700 hPa to 1060 hPa  Transportation and storage environment for grids  Temperature range: 0°C to 40°C © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 117: Installation And Tune-Up

    Technical reference for system operation Installation and tune-up Installation and tune-up NOTICE  The equipment installation and maintenance must be performed by trained service engineers authorized by UIH. Service engineers must be aware of possible dangers in the case of improper installation or use and know how to deal with emergencies. ...

  • Page 118: Table 6-1 List Of Installation Tools

     If a packing case is damaged or has other exceptions, take photos and inform UIH promptly. 3. Print the template of System Installation and Tune-up Report to make records. 4. Check the configuration data of the system. 5. Position the system. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 119: Physical Installation

    Technical reference for system operation Installation and tune-up 6.4.3 Physical installation 6.4.3.1 Installing the U-arm 1. Transport the U-arm column to the target position according to site planning require- ments, and erect the U-arm column. 2. Adjust the levelness of the column base and fasten the foundation bolts. 3.

  • Page 120: Installing Other Components

    6.4.4 System configuration 1. Conduct boot checkup prior to commissioning. 2. Power on the system. 3. Configure system information. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 121: System Commissioning

    Technical reference for system operation Installation and tune-up  Configure customer information.  Configure TCP/IP.  Configure DICOM information.  Configure the room height.  Configure a wireless AP and register the flat panel detector. WARNING  Always abide by related safety information during commissioning and testing. Other- wise, serious personal injuries or even death will be caused.
  • Page 122 Upon completion, turn the DIP switch SW3 of the motion control board (D1300) on the rear side at the bottom of the U-arm column to "OFF". 4. Clean the site and make records. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 6-11...
  • Page 123 Technical reference for system operation Installation and tune-up This page intentionally left blank. 6-12 System Operator Manual...

  • Page 124: Maintenance, Repair, And Disposal

    Repair and replacement of spare parts ........7-7 Disinfection and cleaning ..............7-10 7.4.1 Disinfection ................7-10 7.4.2 Cleaning .................. 7-10 7.4.3 Disinfection and cleaning suggestions ........7-11 7.4.4 Optional accessories ............... 7-12 Disposal ....................7-13 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 125: Installation And Repair

    Maintenance, repair, and disposal Installation and repair Installation and repair The system installation, repair, and component addition or reduction must be performed in accordance with engineering standards. UIH assumes no responsibility for the security and reliability of the system in any of the fol- lowing cases: ...

  • Page 126: Periodic Maintenance

    Users must check the X-ray system for visible defects (see the table below). If an operation failure or an exception deviated from normal operation responses occur, users must shut down the system and contact UIH Customer Service Center. The system operation can be © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 127: Result Recording

    Maintenance, repair, and disposal Periodic maintenance restored only after the fault is rectified successfully. Using faulty components may lower the system safety and expose patients or operators to unnecessary high dose radiation. Time interval Test type Method Look up local reg- Stability test ulations Faulty indicator, damaged component,...

  • Page 128: Maintenance Contract

    Periodic inspection is part of the system maintenance performed by UIH Customer Service Center in accordance with the maintenance contract. Contact UIH Customer Service Cen- ter to sign a maintenance contract. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 129: Professional Maintenance

    Maintenance, repair, and disposal Professional maintenance Professional maintenance In addition to routine maintenance conducted by users, the system needs periodic profes- sional maintenance to ensure the normal system operation and the quality of scanned images. For this, UIH has the following advice: You can reach a maintenance and repair agreement with UIH to better retain the value and safety of the equipment.

  • Page 130: Calibration Of The Wireless Digital Flat Panel Detector

    Unqualified personnel are not allowed to carry out the repair. UIH assumes no liability for the loss of life or property damage caused by unauthorized repair. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 131 Maintenance, repair, and disposal Professional maintenance WARNING  There is still a risk of electric discharge after the high voltage generator and filter are powered off. Necessary protective measures must be taken.  Wait for a long time after power cut for the equipment to release electricity on live parts of the equipment.
  • Page 132 The spring of mechanical components needs to be checked during repair and mainte- nance to prevent spring failures. The chains, wire ropes, and synchronous belts of mechanical parts need to be main- tained periodically during repair and maintenance. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 133: Disinfection And Cleaning

    Maintenance, repair, and disposal Disinfection and cleaning Disinfection and cleaning 7.4.1 Disinfection The disinfection methods must comply with related regulations and guidance principles pertaining to disinfection and explosion protection. WARNING Do not use corrosive, soluble or gas disinfectant.  Cut off all power supplies to the system before disinfection. ...

  • Page 134: Disinfection And Cleaning Suggestions

     Be sure to use slightly damp cloth without detergent for cleaning.  Dry the monitor and keyboard with soft cotton cloth. NOTICE Wear proper protective gloves during cleaning and disinfection. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 7-11...

  • Page 135: Optional Accessories

    Maintenance, repair, and disposal Disinfection and cleaning NOTICE Using non-recommended detergent may lead to system damage. NOTICE The LCD screen is very sensitive to mechanical damage. Therefore, avoid scratches and shock. Wipe off water droplets immediately. Long-term contact with water will lead to surface discoloration.

  • Page 136: Disposal

    2.72 kg X-ray tube 4 kg Generator 10 L Collimator 1.3984 kg Host Lithium battery 1 pcs Monitor 1 pcs Vice monitor (optional) 1 pcs Grid Lead 430 g © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 7-13...
  • Page 137 Maintenance, repair, and disposal Disposal This page intentionally left blank. 7-14 System Operator Manual...

  • Page 138: Technical Data

    X-ray field range ..................8-10 Electromagnetic interference requirements .......... 8-11 8.7.1 Electromagnetic compatibility of the system ......8-11 8.7.2 Electromagnetic compatibility of the remote control ....8-12 8.7.3 EMI&EMS compliance ............. 8-14 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 139: Configuration Difference

    Technical data Configuration difference Configuration difference Table 8-1 System configuration difference Component Parameter Configuration name √ GEN-SK (maximum output power: 65 kW) High voltage gen- erator √ GEN-SK (maximum output power: 50 kW) Wireless digital √ √ Mars1717XU-VSI flat panel detector Tube sleeve: XH-121 √...

  • Page 140: Working Conditions

     Power capacity for HV generator with a maximum output power of 50 kW: not lower than 95 kVA  Power capacity for HV generator with a maximum output power of 65 kW: not lower than 120 kVA © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 141: Performance Indexes

    Technical data Performance indexes Performance indexes 8.3.1 Electric power Table 8-2 Maximum output power Maximum output power Loading conditions 50 kW 100 kV, 500 mA 65 kW 103 kV, 630 mA Table 8-3 Nominal power Nominal output power Loading conditions 50 kW 100 kV, 500 mA, 0.1s 63 kW...

  • Page 142: Loading Time

    400 mAs for HV generator with a maximum output power of 65 kW.  The deviation of the current-time product of the X-ray tube is not greater than ±( 10% + 0.2 mAs). © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 143: Major Components

    Technical data Major components Major components 8.4.1 High voltage generator  HV generator with a maximum output power of 50 kW Parameter Value Tube voltage range 40 kV to 150 kV Tube current range 10 mA to 630 mA Loading time range 1 ms to 10,000 ms Current-time product 0.4 mAs to 1000 mAs...

  • Page 144: Table 8-6 X-Ray Tube Assembly E7876X

    Large focus: 1.2 Nominal tube voltage 150 kV Maximum heat capacity of the X-ray tube 900 kJ (1,250 kHU) assembly Target angle 12° Anode target material Rhenium, tungsten and molybdenum alloy © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 145: Wireless Digital Flat Panel Detector

    Technical data Major components 8.4.5 Wireless digital flat panel detector Parameter Value Model Mars1717XU-VSI × Acquisition matrix 3072 3072 × Imaging area 427 mm 427 mm Data transmission Wireless Imaging medium Cesium iodide/Amorphous silicon Limiting resolution 3.6 lp/mm Pixel dimension 139 µm 8.4.6 Grid...

  • Page 146: Mechanical Movement

    Rotation of the X-ray tube assembly around the horizontal axis (TUBE- -120° to + 120° RHA) Rotation of the wireless digital flat panel detector around the horizontal -45° to + 45° axis (FPD-RHA) © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.

  • Page 147: X-Ray Field Range

    Technical data X-ray field range X-ray field range Focus SID range: 1100 mm ~ 1800 mm 8-10 System Operator Manual...

  • Page 148: Electromagnetic Interference Requirements

     An exemption has been used and that the equipment has not been tested for radiated RF immunity over the entire frequency range 80 MHz to 6 000 MHz. © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 8-11...

  • Page 149: Electromagnetic Compatibility Of The Remote Control

    Technical data Electromagnetic interference requirements WARNING Electromagnetic compatibility — improper operation.  This equipment has been tested for radiated RF immunity only at selected frequen- cies, and use nearby of emitters at other frequencies could result in improper opera- tion. ...
  • Page 150 Frame Ground Unshielded Ground cable High-voltage High-Voltage Shielded 1300 anode cable Cable High-voltage cath- High-Voltage Shielded 1300 ode cable Cable Chamber cable Shielded 1300 Control © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 8-13...

  • Page 151: Table 8-10 Enclosure Port

    Technical data Electromagnetic interference requirements Shielded/ Exposed Name Quantity Remark Unshielded length(cm) Mouse cable Unshielded Control Keyboard cable Unshielded Control 8.7.3 EMI&EMS compliance EMI Compliance Table Table 8-9 Emission Phenomenon Compliance Electromagnetic environment CISPR 11 RF emissions Professional healthcare facility environment Group 1, Class A NOTICE The EMISSIONS characteristics of this equipment make it suitable for use in industrial...

  • Page 152: Table 8-12 Input A.c. Power Port

    3 V, 0.15 MHz - 80 MHz bances induced IEC 61000-4-6 6 V in ISM bands between 0.15 MHz and 80 MHz by RF fields 80% AM at 1 kHz © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved. 8-15...
  • Page 153 Technical data Electromagnetic interference requirements This page intentionally left blank. 8-16 System Operator Manual...

  • Page 154: Index

    6-4 image processing system 3-22 network 6-4 intended use 1-6 power cable 6-4 room dimension 6-3 startup 4-10 light field measurement 4-22 stitching workflow (optional) 4-8 liquid prevention 2-6 © 2021 Shanghai United Imaging Healthcare Co., Ltd. All Rights Reserved.
  • Page 155 Index system commissioning 6-10 system components angle indicator 3-16 collimator 3-15 detector carrier 3-18 digital flat panel detector 3-19 exposure handle switch 3-26 operation room 3-3 scanning room 3-2 system Installation 6-6 system messages 2-26 technical data E7876X 3-12 image processing system 3-23 XRR-3331X 3-7 terms 1-8 text conventions 1-2...

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