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System Operator Manual Mobile Digital Medical X-ray Imaging System uDR 380i&380i Pro SW-100R 2, uExceed R001 51002333-04-202304-ENG...
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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.
This manual applies to the following products: Product name Product model Software version Mobile Digital Medical X-ray uDR 380i, uDR 380i SW-100R 2, uExceed R001 Imaging System Audience Users of the Mobile Digital Medical X-ray Imaging System. UIH training and customer service engineers.
About this manual This manual applies to the Mobile Digital Medical X-ray Imaging System developed by Shanghai United Imaging Heathcare Co., Ltd. This manual contains all the information necessary to understand and operate this system. It provides general instructions, safety information, operation instructions, and technical specifications of the system.
1.2.1 Indications for use uDR 380i/uDR 380i Pro is a mobile device intended to acquire X-ray images of human anatomy for medical imaging diagnosis by a qualified/trained doctor or technician. This device is not intended for mammography.
Introduction Personnel qualifications and training requirements Personnel qualifications and training requirements Users or operators of this equipment must have the basic knowledge about medical images and system operation, such as exam procedures, and basic principles and fea- tures of imaging. In order to safely and effectively operate this system, the user must undergo strict training, fully understand the contents of this manual, and abide by local laws and regulations.
Safety information Overview Overview In order to use this equipment safely for a long time, follow the instructions in this operator manual. Equipment operators and technical maintenance personnel must carefully study this operator manual. They must read and understand relevant instructions before using this equipment, especially the instructions regarding safety, regulations, dose, and radia- tion protection.
Safety information Safety marks and symbols 2.2.2 Safety symbols and labels Table 2-1 Safety symbols Symbol Description Symbol Description Refer to instruction Warning, hot sur- manual/booklet (Man- face datory requirement) Warning, dangerous Warning, ionizing voltage radiation Warning, crushing of Warning, laser hands beam 50 years environmen-...
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Safety information Safety marks and symbols Label Description Location Movement warning label You can move the equip- ment when the telescopic arm is in the home posi- tion. You cannot move equipment when the tele- scopic arm is not in the home position.
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Safety information Basic safety regulations The purchaser or customer is responsible for providing audio and video communica- tions between the operator and the patient. Before examining the patient, the operator has the responsibility to ensure that all exposure parameters are correct, so as to prevent the patient from receiving redun- dant X-rays.
Safety information Personal safety Personal safety 2.5.1 Radiological protection The leakage radiation of this equipment meets the requirements of IEC 60601-1-3 rele- vant standards, that is, the leakage radiation does not exceed 1.0 mGy/h. The basic load- ing conditions of leakage radiation are 150 kV and 3.4 mA. Although this equipment complies with relevant safety standards and it has high-level pro- tection against X-rays (except useful beams), the actual design of this equipment neither provides complete protection to the operator, nor compels the operator to take adequate...
Safety information Personal safety 2.5.2 Laser safety This equipment is equipped with a linear laser localizer for positioning and quick locating. To avoid eye injury, do not look directly at the laser beam. 2.5.3 Electrical safety WARNING This equipment must only be connected to the supply mains with protective earth in order to avoid the risk of electric shocks.
Safety information Personal safety CAUTION Resume motorized motion You can release the E-Stop button and resume motorized motion only after the cause of failure or danger has been found and eliminated. Location The E-Stop button (red and like a mushroom) is located in the upper right corner of the console.
Safety information Personal safety 2.5.6 Cleaning protection WARNING Risk of infection Users should clean and disinfect all contaminated surfaces or parts of the system and all surfaces or parts that may (or have) come into contact with patients after the exam is completed.
Safety information System safety This equipment is intended to be used only by medical professionals. The equipment may cause radio interference or disturb the operations of other equipment nearby. Mit- igation measures may be required, such as reorienting and positioning the equipment or shielding the site.
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Safety information System safety Data communication is only possible in limited ways. All unnecessary ports or channels are blocked. MSE will scan data that is imported into the image post-processing software system for viruses. MSE will automatically scan the USB devices inserted into the system. ...
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Safety information Data security NOTICE Uninterruptible power supply (UPS) is recommended to ensure information and data safety in case of sudden power failure. After the mains supply fails, save the data as soon as possible. NOTICE After the mains supply fails, save the data as soon as possible. 2-24 System Operator Manual...
Safety information Environment safety WARNING Battery leakage may result in environmental pollution and equipment damage. When the equipment will not be used for a long time, take out the battery to avoid possible leakage. Toxic substances may leak and pollute the environment when the battery is damaged by physical impact.
Safety information Service life Service life The service life of this product is 10 years. After the service life expires, the product should be handled according to relevant laws and regulations. In case of any problems, contact UIH Customer Service Center. 2-28 System Operator Manual...
System operations Overview Overview The Mobile Digital Medical X-ray Imaging System can provide various digital X-ray imag- ing solutions. This equipment can be applied to the imaging of human bones, skulls, chests, abdomens, limbs, and other body parts, with a wide range of applications. This equipment can operate in an independent mode (without external power supply).
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System operations Main components of the system Component Description Speaker button Used to alert pedestrians while you move the equipment. Transport handle Driving the equipment to move. Charging slot for the flat Holding the flat panel detector. panel detector ...
System operations X-ray tube-collimator assembly X-ray tube-collimator assembly Figure 3-3 X-ray tube-collimator assembly Component Description X-ray tube Generating X-rays. Used to move the X-ray tube assembly vertically, rotate it Collimator handle (on about the vertical axis (RVA), and adjust the telescopic both sides) arm.
System operations X-ray tube-collimator assembly dent with the cross lines of the flat panel detector, and the flat panel faces towards the col- limator. Figure 3-4 Collimator Component Description Knob for controlling the Clockwise: Zooming in horizontally light field size horizon- ...
System operations X-ray tube-collimator assembly NOTICE Restoring the collimator position After you have manually rotated the collimator, you should restore it to the 0° position in time. The purpose is to avoid unnecessary radiation by limiting the radiation field to the range of the bucky.
System operations Flat panel detector Name Description Infrared commu- Used to connect to the system. nication port Ready indicator Displaying the FPD state. Switching the FPD. The FPD becomes available after you press the Ready button button (the Ready indicator is on). When the power is connected, the power indicator lights up Power indicator (depending on the battery level of the FPD).
System operations Flat panel detector POWER READY LINK Detector state Blue Green Blue green Flat panel detector Blinking slowly selection state (sleep) Image data transmis- On/blinking slowly Blinking slowly sion Low battery level (the battery needs to be Blinking slowly Unspecified Unspecified replaced)
System operations Flat panel detector The indicators are marked with the words "FULL" and "CHARGE", meaning "fully charged" and "charging" respectively. The FULL and CHARGE indicators blink at the same time when a battery charger error occurs. 1. Remove the battery from the flat panel detector. 2.
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System operations Flat panel detector Do not use the flat panel detector in an environment with water. Do not splash any liq- uid, especially chemicals on the detector. Prevent blood and other liquids of an injured patient from flowing onto the detector. When the digital flat panel detector is not in use, use the special container to store and protect it.
System operations Console 3.6.2 ON/OFF button 3.6.2.1 Starting the system Press the ON/OFF button in the upper left corner of the console After the system is started, the indicator of the ON/OFF button lights up. 3.6.2.2 Shutting down the system ...
System operations Safety lock Safety lock NOTICE If the telescopic arm cannot move up or down, the wire rope may be broken. Contact UIH Customer Service Center. The telescopic arm is usually fixed by the safety lock except during imaging and exams.
System operations Transport handle The telescopic arm is in the retracted state without stretching. The RHA angle is 0° The tilting angle is 0° The collimator is at 0° position 3.8.1.2 Transport handle NOTICE When you move the trolley, do not suddenly press or release the transport handle. Oth- erwise, you may be pulled by the trolley when the trolley suddenly moves or you may bump into the trolley when the trolley suddenly stops.
System operations Anti-collision bumper Anti-collision bumper Figure 3-12 Anti-collision bumper If the anti-collision bumper encounters an obstacle, the system will generate an alert sound and stop moving forward. If the system is equipped with a uVision remote console, the uVision remote console will show that there is an obstacle ahead and prompt you to detour.
System operations Exposure hand switch 3.11 Exposure hand switch NOTICE Before exposure, make sure that the exposure hand switch is in the holder. When the system and the patient are ready, start exposure. 1. Press the exposure button to the first-stage position to prepare for exposure. 2.
System operations Peripheral connection 3.13 Peripheral connection Figure 3-14 Peripheral connection The system is equipped with USB ports and a network port for peripheral connection. The Ethernet (ETH) port connects the equipment to the hospital network for the trans- fer of images and data.
System operations Storage space 3.15 Storage space Figure 3-15 Storage space of the trolley Name Description It can be used for holding the remote control, exam Console storage tank sheets, stationery, disposable gloves, face masks, etc. You can place the flat panel detector on it so that you can Support for the flat panel easily put it into sterile bags.
Workflow Starting up or shutting down the system Starting up or shutting down the system NOTICE Users should restart the system once every day to maintain the best performance of the software. This equipment can operate in an independent mode (without external power supply). ...
Workflow Starting up or shutting down the system 4.1.6 System sleep 4.1.6.1 Sleep State The system automatically enters the sleep state if no operation is performed on the system within 10 min or when the gantry is locked in the home position. The display screen of the workstation is off.
Workflow Driving system When you move the equipment down a ramp with the angle not greater than 13°, con- trol the speed to prevent the system from moving out of control. When you push the system on a flat ground, the system can pass thresholds or steps that are 2 cm high and can pass speed bumps that are 6 cm high.
Workflow Using the flat panel detector Using the flat panel detector 1. Logon to system software, hold down the leftmost area in any interface and slide it to the right to open the hidden GCS interface. 2. Tap FPD Unlock in the GCS interface. ...
Workflow Creating an exam Creating an exam See the Software Operation Manual for details. 1. In the EXAM > Manual screen, enter the patient name, date of birth, and patient ID, and select the patient's gender in the gender column. 2.
Workflow Performing an exam 4.6.2 Performing X-ray exposure NOTICE Ensure that all irrelevant personnel in the room have left before exposure (especially remote exposure), so as to prevent irrelevant personnel from receiving X-ray radia- tion. If the uVision remote console or remote control is required for remote exposure, ensure that there is only one X-ray equipment in the exposure environment of the video monitoring communication, so as to avoid unnecessary X-ray radiation received by the patients due to false triggering.
Workflow Reviewing images Reviewing images 4.7.1 Reviewing images on the Exam > Examination screen NOTICE It is best to disengage the Ready status of the next available protocol during a pro- longed review. Click Unselect in the study information pane so that "Not Ready" appears in the system status indicator.
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Workflow Printing and transferring images The storage commitment results (Committed, Committing, Commitment error, or no setup) can also be confirmed in the SC column in the same list. Sending patient data anonymously NOTICE To protect patient privacy, you should not export the basic information of patients when you export patient data.
Workflow GCS interface 4.10 GCS interface Logon to system software, hold down the leftmost area in any interface and slide it to the right to open the hidden GCS interface. 4.10.1 Network connection status Wired network connection state ...
Workflow GCS interface 4.10.3.2 Remote exposure pairing Remote control pairing 1. Click Remote Exposure Pairing. 2. Click Pairing in the pop-up window. 3. Press the Collimator Lights button, exposure button, and safety operation switch at the same time in 10 s for more than 3 s. ...
Workflow Pediatric use guide 4.11 Pediatric use guide According to regulations, the following recommendations should be observed for pediatric applications: Reduce the exposure time of X-ray generators. Reduce the dose of imaging operations so that children receive the lowest dose possi- ble.
uVision remote console/remote control uVision remote console (optional) uVision remote console (optional) 5.1.1 Overview You can place the uVision in the uVision holder or you can hold it in your hands and remotely control the system. When placed in the uVision holder: Used for displaying system status while being charged on-line.
uVision remote console/remote control uVision remote console (optional) 5.1.3.3 Putting the uVision into sleep state When the uVision is not being charged, you can put it into sleep state by pressing its power button. When the uVision is being charged, the uVision will not automatically enter the sleep state.
uVision remote console/remote control uVision remote console (optional) Figure 5-2 uVision motion information interface Trolley status When there is an obstacle ahead, the uVision prompts the user to step back and make a detour. Motor temperature When the motor is overheated, the current limiting protection is triggered for 10 min. The uVision shows "Slope <...
uVision remote console/remote control uVision remote console (optional) Inching function is prohibited under the following circumstances: The system is being charged The system is in low power consumption mode The uVision is not in the uVision holder ...
uVision remote console/remote control uVision remote console (optional) Selecting and viewing system status Click the system status to be viewed, and the status interface is opened. Returning to the Patient Administration interface Slide upward in the system status summary interface or click the arrow at the bottom of the interface to exit system status monitoring and return to the Patient Administration interface.
uVision remote console/remote control uVision remote console (optional) 5.1.9.6 Setting exam parameters Setting protocols The default patient protocol is the protocol selected in the database. You can select a completed protocol to view details and you can select a new protocol for exposure. Figure 5-9 Protocol setting interface of the uVision Adjusting exposure parameters The exposure parameters are set in the same way as those in the system software inter-...
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uVision remote console/remote control uVision remote console (optional) Display You can adjust the brightness and set the time for uVision automatic screen-off. Display setting You can adjust the screen brightness or turn on the automatic brightness adjustment func- tion. ...
uVision remote console/remote control Remote control (optional) Remote control (optional) 5.2.1 Introduction to the remote control The optional remote control of this equipment is used to start exposure and switch on or off the collimator lights. Figure 5-11 Remote control Name Description Indicating the status of exposure...
uVision remote console/remote control Remote control (optional) 5.2.3.2 Collimator Lights button 1. Press the Collimator Lights button to turn on the collimator lights. 2. Press the Collimator Lights button again to turn off the collimator lights. 5.2.4 Battery replacement The remote control is powered by batteries. The batteries must be replaced regularly. Power supply mode: Two triple A batteries (AAA).
Cleaning and maintenance Overview Overview To ensure continuous and safe use of the equipment, you must have a regular mainte- nance schedule. It is the responsibility of the equipment owner to provide or arrange such services. There are two types of maintenance. One is performed by users, and the other is per- formed by professional X-ray maintenance personnel or UIH customer service engi- neers.
Cleaning and maintenance Disinfection and cleaning Only use water or mild household detergent to clean plastic surfaces. Using other deter- gent (such as high concentration alcohol) will cause tarnish and cracks. Do not use any corrosive or soluble detergent or polish. Observe the following principles during cleaning: ...
Cleaning and maintenance System maintenance 6.3.2 Regular maintenance WARNING After the equipment is started, do not remove any cover, or remove or handle the components inside the equipment. Serious personal injury and equipment damage may be caused. Do not clean the equipment after it is started. Before you clean the equipment, make sure that the equipment is shut down and disconnected from the main power supply.
Cleaning and maintenance Disposal Disposal Some components in the system contain hazardous materials that need proper disposal. The following table provides the type, quantity, and location of hazardous materials in the system. Table 6-1 List of hazardous materials Component Hazardous material Quantity Lead 2.5 kg...
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Cleaning and maintenance Error list Error Solution Please still equipment until the error disap- Motor aid system temperature is too high. peared, if the error is not resolved.,please con- Please restart the system. [X401032] tact UIH customer service engineer. Motor aid system locked-rotor. Please get Please get around obstacles.
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