TrueView 200 Pro-US User Manual PDF

TrueView 200 Pro-US Specimen Radiography System User Manual P000220 V3.0 Copyright Right Reserved By CompAI Healthcare（Suzhou）Co., ltd TrueView 200 Pro-US User Manual P000220 V3.0 0.1 Pro...

TrueView 200 Pro-US Specimen Radiography System User Manual P000220 V3.0 Copyright Right Reserved By CompAI Healthcare（Suzhou）Co., ltd TrueView 200 Pro-US User Manual P000220 V3.0 0.1 Product Introduction This manual is developed by CompAI Healthcare (Suzhou) Co., ltd, for both the product specimen radiography system (TrueView 200 Pro-US) and its accessory, specimen container (QuadraView 100). The product name is TrueView 200 Pro-US Specimen Radiography System. 1  TrueView 200 Pro-US User Manual P000220 V3.0 0.2 Manufacturer Information Registrant: CompAI Healthcare (Suzhou) Co., ltd Registered Address: Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China After-sales Service: CompAI Healthcare (Suzhou) Co., ltd Telephone: (+86) 0512-67236750 Manufacturer: CompAI Healthcare (Suzhou) Co., ltd Manufacture Address: Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China Telephone: (+86) 0512-67236750 2 TrueView 200 Pro-US User Manual P000220 V3.0 0.3 Conformance Standards The following classifications are in accordance with the IEC/ EN/UL 61010-1: According to IEC/EN 61010-1, IEC/EN 61010-2-101 Equipment is Class I. According to EN55011, Equipment is Group 1, Class A ISM Equipment. This product complies with the following standards: IEC/EN/UL 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 1: General Requirements IEC/EN/UL 61010-2-091 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 2-091: Particular Requirements for Cabinet X-ray Systems IEC/EN/UL 61010-2-101 Safety requirements for electrical equipment for Measurement, Control, and Laboratory Use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipmentIEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices IEC 62304 Medical device software - Software life cycle processes. 3  TrueView 200 Pro-US User Manual P000220 V3.0 CSA C22.2#61010-1-12Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 1: General Requirements. CSA C22.2#61010-2-091 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 2-091: Particular Requirements for Cabinet X-ray Systems CSA C22.2#61010-2-101Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 4 TrueView 200 Pro-US User Manual P000220 V3.0 0.4 Attention 1) This manual is designated for TureView 200 Pro-US. This manual contains necessary and sufficient information to operate the system safely. Read and understand all instructions in this manual before attempting to use the system. It is advised to retain this manual with the equipment at all time. Regularly review the operational procedures and safety precautions outlined within. 2) Routine maintenance of this product is essential, and any faulty products should not be used. In the event that components are damaged, lost, deformed, or contaminated, immediate replacement is necessary. 3) In cases where repair or replacement is warranted, please reach out to the service department of CompAI Healthcare. Only individuals with the appropriate qualifications are authorized to undertake repairs on the system. Any modifications to this product should not be made without prior authorization. 4) If the product malfunctions as a result of improper utilization, incorrect maintenance procedures, inadequate repairs, or component replacements performed by unqualified individuals, the owner of the product will be held entirely accountable for any resulting issues. 5) Caution: In the United States, federal law restricts the sale of medical devices to be conducted solely by or under the order of a physician. For locations outside the United States, it is advised to thoroughly review and adhere to any applicable local legal restrictions. 6) Avoid using disinfectants, cleansers, or any other substances that are incompatible with the equipment. 7) Any serious incidents must be promptly reported to both the manufacturer and the relevant regulatory authority in the jurisdiction where the user and/or patient is located. 8) When using or positioning this equipment, ensure that the casters are locked to prevent the equipment from sliding. 9) Placing other objects on the console is strictly prohibited. 10) Please take care to avoid pinching hands when opening and closing the cabinet door. 5  TrueView 200 Pro-US User Manual P000220 V3.0 11) When pushing this equipment, it is recommended that two people move with one person behind the other to prevent the equipment from tipping over or colliding with others. 12) When disposing of this equipment or any accessories, adhere to all necessary precautions. Do not dispose of this equipment or its accessories without consulting our company. For further information, please reach out to the manufacturer's authorized representatives. 6 TrueView 200 Pro-US User Manual P000220 V3.0 Table of Contents 0.1 Product Introduction..................................................................................................... 1 0.2 Manufacturer Information............................................................................................ 2 0.3 Conformance Standards............................................................................................... 3 0.4 Attention....................................................................................................................... 5 Table of Contents............................................................................................................... 7 1. System Overview................................................................................................. 12 1.1 Product Description.............................................................................................. 12 1.2 Intened Use of the Product................................................................................... 13 1.3 Contraindication................................................................................................... 13 1.4 Compatibility........................................................................................................ 13 1.5 Product Operation Principle................................................................................. 14 1.6 Product Function and Features............................................................................. 14 1.7 Product Service Life............................................................................................. 14 1.8 Symbol Description.............................................................................................. 15 1.9 Peripheral............................................................................................................. 16 1.10 Safety Interlock of the System............................................................................. 16 1.11 Specimen Tray...................................................................................................... 17 1.12 Specimen Container............................................................................................. 17 1.12.1 Assembly Steps:.............................................................................................................. 18 1.12.2 Specimen Container Function......................................................................................... 20 7  TrueView 200 Pro-US User Manual P000220 V3.0 1.12.3 Method of Use................................................................................................................. 20 1.12.4 Attention Points.............................................................................................................. 22 1.12.5 Specimen Holder Specifications..................................................................................... 22 2. Safe and Effective Use......................................................................................... 24 2.1 Environment Conditions...................................................................................... 24 2.1.1 Environment Conditions for System............................................................................... 24 2.1.2 Environment Conditions for Specimen Container.......................................................... 24 2.2 Protection against X-ray Radiation...................................................................... 25 2.3 Protection against the Risk of Electric Shock...................................................... 25 2.4 Protection of Equipment....................................................................................... 26 2.5 Information Security............................................................................................ 27 2.6 Precautions for Operation..................................................................................... 28 2.6.1 Check before Use............................................................................................................ 28 2.6.2 Special Instructions for Operation.................................................................................. 29 2.6.3 Shutdown........................................................................................................................ 31 2.6.4 Noise............................................................................................................................... 31 2.7 System Defect and Limitation.............................................................................. 31 2.8 System Maintenance............................................................................................ 31 2.9 Decommissioning and Resuming Use.................................................................. 32 2.10 Environmental Protection..................................................................................... 32 2.10.1 About the Disposal of Waste Electronic Articles........................................................... 32 2.10.2 Insulating Oil.................................................................................................................. 32 3. Installation and Configuration.............................................................................. 33 3.1 Installation Preparation........................................................................................ 33 8 TrueView 200 Pro-US User Manual P000220 V3.0 3.2 Installation Process............................................................................................... 34 3.3 System Configuration........................................................................................... 35 3.3.1 System Self-Check.......................................................................................................... 35 3.3.2 System Information Check............................................................................................. 35 3.3.3 General Setting................................................................................................................ 36 3.3.4 Connectivity Setting........................................................................................................ 38 3.3.5 Barcode Reader Settings and Use................................................................................... 42 4. Control System Operation.................................................................................... 45 4.1 Control System Function Keys and Indicators..................................................... 45 4.1.1 Power Button and Indicator............................................................................................ 45 4.1.2 X-ray Exposure Indicator................................................................................................ 46 4.2 System Startup Procedure.................................................................................... 46 4.2.1 Check before Starting..................................................................................................... 46 4.2.2 Startup Steps................................................................................................................... 47 4.3 System Shutdown Procedure................................................................................ 49 5. Software Operation............................................................................................... 51 5.1 General Layout of Interface................................................................................. 51 5.1.1 Login............................................................................................................................... 52 5.1.2 Touchscreen General Layout.......................................................................................... 55 5.1.3 System Monitor General Layout..................................................................................... 63 5.2 Utilities................................................................................................................. 64 5.2.1 General............................................................................................................................ 64 5.2.2 User Management........................................................................................................... 67 5.2.3 Exposure Settings............................................................................................................ 73 5.2.4 Connectivity.................................................................................................................... 74 9  TrueView 200 Pro-US User Manual P000220 V3.0 5.2.5 Miscellaneous................................................................................................................. 77 5.2.6 About.............................................................................................................................. 86 5.3 Home.................................................................................................................... 88 5.3.1 New Patient..................................................................................................................... 89 5.3.2 Worklist.......................................................................................................................... 90 5.3.3 Q/R.................................................................................................................................. 91 5.3.4 Review............................................................................................................................ 92 5.4 Imaging................................................................................................................. 95 5.4.1. Exposure......................................................................................................................... 95 5.5 Tools..................................................................................................................... 97 5.5.1. Window Level............................................................................................................... 100 5.5.2. Zoom In/Out.................................................................................................................. 101 5.5.3. Magnifier...................................................................................................................... 104 5.5.4. Calcification.................................................................................................................. 104 5.5.5. Ruler.............................................................................................................................. 105 5.5.6. Arrow............................................................................................................................ 107 5.5.7. Annotation..................................................................................................................... 108 5.5.8. Ellipse........................................................................................................................... 110 5.5.9. Layout........................................................................................................................... 111 5.5.10. Image Enhancement...................................................................................................... 111 5.5.11. Next Screen................................................................................................................... 112 5.5.12. Show Info...................................................................................................................... 112 5.5.13. Invert............................................................................................................................. 113 5.5.14. Sharpen......................................................................................................................... 114 5.5.15. Fit to Image................................................................................................................... 115 5.5.16. Fit to Window............................................................................................................... 116 10 TrueView 200 Pro-US User Manual P000220 V3.0 5.5.17. Fit to Specimen............................................................................................................. 117 5.5.18. Rotate 90°..................................................................................................................... 117 5.5.19. Mirror............................................................................................................................ 117 5.5.20. Flip................................................................................................................................ 118 5.5.21. Free Rotate.................................................................................................................... 119 5.5.22. Image Note.................................................................................................................... 120 5.5.23. Functional Icons of the Touchscreen............................................................................ 121 6. System Maintenance........................................................................................... 125 6.1 System Maintenance.......................................................................................... 125 6.1.1 Daily Inspection and Maintenance................................................................................ 125 6.1.2 Periodic Check and Calibration.................................................................................... 126 6.1.3 Event-triggered Calibration.......................................................................................... 126 6.1.4 Barcode Scanner Maintenance and Repair................................................................... 127 6.1.5 Replace the Power Socket Fuse.................................................................................... 127 6.2 Cleaning............................................................................................................. 130 6.2.1 Cleaning the System Cover........................................................................................... 130 6.2.2 Cleaning System Monitor............................................................................................. 131 6.2.3 Cleaning Touchscreen and Touchpad........................................................................... 132 6.2.4 Cleaning Imaging Cabinet............................................................................................ 132 6.2.5 Cleaning Specimen Tray............................................................................................... 133 6.2.6 Inspecting the System................................................................................................... 133 Appendix I Technical Specifications............................................................................. 134 Appendix II Electromagnetic Compatibility.................................................................. 136 11  TrueView 200 Pro-US User Manual P000220 V3.0 1. System Overview 1.1 Product Description The TrueView 200 Pro-US is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView 200 Pro-US includes the following major components: system monitor, touch-screen control display, and an imaging cabinet. This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters for easy transportation. This system is intended to be used in the following environments: Surgical suites Biopsy suites Pathology labs 1 8 2 7 10 3 6 9 4 5 Figure1. system overview 12 TrueView 200 Pro-US User Manual P000220 V3.0 1. System Monitor 2. Touch Screen 3. Exposure Indicator 4. Imaging Cabinet 5. Casters 6. Barcode Scanner Holder 7. Side Handle 8. Back Handle 9. Cable Hook 10. Touchpad 1.2 Intened Use of the Product The TrueView 200Pro system is designed for use in biopsy suites, surgical suites, and pathology departments. Its primary purpose is to deliver digital X-ray images of surgical and core biopsy specimens from diverse anatomical regions, enabling swift verification of the excised tissue's accuracy during the procedure. Performing the verification in proximity to the procedure room enhances workflow, ultimately leading to a reduction in overall operative time. This system is intended for use by professionals such as surgeons, pathologists, nurses, and surgical technologists. 1.3 Contraindication There is no contraindication. 1.4 Compatibility The system’s data interaction occurs through the network and USB port. Patient data can be transmitted to the hospital’s DICOM server via the network, and it can also be transferred to external storage media (USB 13  TrueView 200 Pro-US User Manual P000220 V3.0 disk) through the USB port. Device data can only be transferred to external storage media (USB disk) through the USB port. Network interaction supports both wired and wireless (Wi-Fi protocol 802.11) and adheres to the standard DICOM 3.0 protocol. The USB port is compatible with USB 2.0. 1.5 Product Operation Principle The TrueView 200 Pro-US has one physical imaging methods: X-ray radiography. In X-ray radiography, a fixed focal source distance is utilized (referring to the distance from the X-ray tube's focus to the active array of the flat-panel detector). The computer control software manages the process of placing pathological specimens on the bracket within the imaging area for X-ray radiography. Subsequently, the digital image data obtained is saved, and the image is displayed directly in the specified section of the display screen. 1.6 Product Function and Features The main functions of the system are as follows： 1) X-ray digital image acquisition function, including automatic and manual modes; 2) Auto detect magnification ratio based on specimen position 3) Highlight suspected calcification 4) X-ray exposure parameters default-setting; 5) DICOM protocol supporting; 6) Image analysis tools 7) Barcode scanner support as option 8) Mobility 9) Local printing 1.7 Product Service Life Under appropriate conditions of use, maintenance, and storage, the product has a service life of 10 years from the date of delivery. 14 TrueView 200 Pro-US User Manual P000220 V3.0 1.8 Symbol Description No Symbol Description Location 1 Warning Above the power input 2 Warning: electricity Above the power input 3 Beware of ionizing radiation Above the switch button A conspicuous location of cabinet 4 Biological Risk door 5 Refer to instruction manual Above the switch button Attention static sensitive 6 Above the switch button devices Warning ： Recommended two persons to move the 7 system during the long Above the switch button distance to avoid the System tilt down. 8 RoHS compliant Above the switch button 9 Assembled in China Above the switch button 10 Manufacturer Above the switch button 15  TrueView 200 Pro-US User Manual P000220 V3.0 11 The ETL Listing Mark Above the switch button Table 1.1 Description of graphic symbols a） The warning graphic symbols used in this manual are as follow: Warning: Failure to pay attention to or avoid this condition or situation may result in personal injury or significant damage to the equipment or data. 1) Do not connect any other (non-system component) equipment or components to the system without authorization to integrate them as part of the system. 2) Do not connect any other (non-system component) detachable socket (MPSO) or extension cord to the system. 3) To ensure users achieve the optimal intended use, it is advisable to follow the steps outlined in the system's installation program during installation. 1.9 Peripheral Three recommended peripherals for TrueView 200 Pro-US: Name Manufacturer Type Use instruction Barcode Scanner Honeywell Xenon 1900 Refer to 3.3.5 Wireless card Tenda U18 Refer to 5.2.4.2 Specimen Container CompAI Healthcare QuadraView100 Refer to1.12 Table 1.3 peripheral list 1.10 Safety Interlock of the System The system incorporates the following safety interlocks through hardware and software to ensure safe operation: 16 TrueView 200 Pro-US User Manual P000220 V3.0 a） Safety interlock with cabinet door: When the cabinet door is open, the system is prevented from conducting exposure operations. If the cabinet door is inadvertently opened during exposure, the system promptly halts the exposure process. b） X-ray image operation confirmation prompt: As X-rays are emitted during the imaging procedure, the software includes a prompt box to confirm the X-ray beaming operation. A confirmation prompt box is displayed by the software, requiring acknowledgment before exiting the prompt. 1.11 Specimen Tray The specimen tray is designed for placing specimens during imaging. The system features three slots that correspond to different imaging magnifications (1.0x, 1.5x, 2.0x) from bottom to top. The innermost marker line aligns with a magnification of 2.0x, the middle marker line corresponds to 1.5x, and the outermost marker line corresponds to 1.0x. This design allows for easy selection and positioning of the specimens according to the desired imaging magnification level. It is not recommended to place specimens directly onto the specimen tray. To NOTE: avoid biological risks, the specimen should first be collected using a specimen collection bag before being placed on the tray. Wrapping the tray and placing it in the cabinet may interfere with the NOTE: identification of the imaging magnification. Therefore, it is not advisable to place the tray into the cabinet after wrapping it. 1.12 Specimen Container 17  TrueView 200 Pro-US User Manual P000220 V3.0 The QuadraView 100 is an accessory designed for the TrueView 200 Pro-US, serving the purpose of securely positioning specimens and facilitating multi-angle X-ray radiography. It is worth noting that the QuadraView 100 is intended as a disposable accessory. QuadraView 100 1.12.1 Assembly Steps: Step 1. Open the package of specimen container. Step 2. There is one small raised cylinder and one hole in each side of the bracket. 18 TrueView 200 Pro-US User Manual P000220 V3.0 Step 3. Close it and pinch it Step 4. Three brackets connect together. Step 5. Open the buckle in the left and right side Step 6. The specimen container is ready and the specimen can be put between the film and cover 19  TrueView 200 Pro-US User Manual P000220 V3.0 Step 7. Close the buckle. It’s ready for use. 1.12.2 Specimen Container Function Put specimen into specimen container and then put the specimen container on the specimen tray, it supports: ⚫ To obtain multi-angle image. ⚫ To calculate the distance from the calcification point to the incisal edge ⚫ To locate the position of the tumor specimen to avoid blindly expanding the scope of surgical resection ⚫ To assist the pathology department in locating the specimens 1.12.3 Method of Use After the specimen container is assembled, open the buckle, put the specimen into the specimen bag between the film and the cover, close the buckle, and finally put the specimen container on the tray. Four ways to put the specimen container on the tray are as follows: 1) The number 4 marked on the specimen container is directly above, as shown in the figure below: 20 TrueView 200 Pro-US User Manual P000220 V3.0 2) The number 8 marked on the specimen container is directly above, as shown in the figure below: 3) The number 12 marked on the specimen container is directly above, as shown in the figure below: 21  TrueView 200 Pro-US User Manual P000220 V3.0 4) Open the three brackets of the specimen container and put the specimen container on the specimen tray, as shown in the figure below: 1.12.4 Attention Points 1) When using the specimen container, it is recommended to place the specimen into the specimen bag first and then insert the specimen bag into the container. This precaution helps prevent tissue from inadvertently falling into the cabinet or becoming contaminated due to accidental dropping. 2) After using the specimen holder, there may be microbial residue present. It is important to dispose of the holder as medical waste following use. 3) The imaging area is defined by the central circle marked on the cover of the specimen holder. 4) The maximum weight capacity of the holder is 0.20 kg. 5) The specimen container has a quality guarantee period of 2 years. 1.12.5 Specimen Holder Specifications 1) The net size of folded specimen holder is less than 250mm x 250mm x 100mm (length x width x height) as below: 22 TrueView 200 Pro-US User Manual P000220 V3.0 2) The net size of open specimen holder is less than 250mm x 250mm x 200mm (length x width x height) as below: 23  TrueView 200 Pro-US User Manual P000220 V3.0 2. Safe and Effective Use The design and manufacturing of this system incorporate effective protective measures to ensure the safe and efficient use of the product, thereby preventing any harm under normal operating conditions. Prior to using this system, users are strongly advised to meticulously read and comprehend both the system and its accompanying user manual. Throughout the product's lifecycle, operational procedures and maintenance should strictly adhere to the guidelines outlined in the manual. The company will not be held liable for any harm resulting from user error, unauthorized modifications, or failure to adequately maintain the equipment in accordance with the manual's specifications. 2.1 Environment Conditions 2.1.1 Environment Conditions for System The system should be operated, stored, or transported within the parameters as shown in the table. Either its operational environment must be constantly maintained or the system must be turned off. Operation Storage Transport Temperature +10℃– +40 °C -10℃– +55℃ -10℃– +55℃ 35%- 80% non- Humidity 10% – 90% 10% – 90% condensing Pressure 80 kPa – 106kPa 70 kPa – 106kPa 70 kPa – 106kPa 2.1.2 Environment Conditions for Specimen Container The container should be operated, stored, or transported within the parameters as shown in the table: 24 TrueView 200 Pro-US User Manual P000220 V3.0 Operation Storage Transport Temperature +10℃– +40 °C -10 – +55 -10 – +55 35%- 80% non- Humidity 10% – 90% 10% – 90% condensing Pressure 70 kPa – 106kPa 70 kPa – 106kPa 70 kPa – 106kPa 2.2 Protection against X-ray Radiation This system needs to generate X-ray radiation in the process of achieving the intended use, and leakage of X-ray radiation will be dangerous to personnel. The emitted X-radiation of TrueView 200 Pro-US meets the requirements of IEC60601-2-091 Clause 12.101.1. The radiation emitted from the system did not exceed 5 μSv/h at any point 50 mm outside the external surface. The user does not need special protection under normal use.. It is strictly forbidden to disassemble equipment ， please contact the NOTE: maintenance engineer if necessary. It is imperative to strictly adhere to the radiation protection regulations and the specific requirements outlined in this manual to prevent harm to the operator. It is essential that all authorized individuals who operate and maintain the system understand the risks associated with X-rays and have acquired the necessary training to proficiently handle relevant knowledge. 2.3 Protection against the Risk of Electric Shock Upon powering on the system, the equipment components carry hazardous voltage, and improper use or maintenance may result in electric shock. 25  TrueView 200 Pro-US User Manual P000220 V3.0 It is strictly prohibited to dismantle the protective shells of equipment components while the power is on or to activate the system after removing these protective shells to mitigate the risk of electric shock. It is strictly prohibited to clean the components of the equipment when the system is powered on. When cleaning the interior of the imaging cabinet, it is advisable to use a slightly damp cloth to prevent dripping. When cleaning the equipment surfaces, precautions should be taken to prevent liquids from entering the components to avoid electric shock and preserve the product's fundamental performance. 2.4 Protection of Equipment a） It is strictly forbidden to disassemble the shells of equipment parts such as high-voltage generators, X-ray tubes, X-ray flat panel detectors and computers without authorization to avoid the risk of electric shock; b） It is strictly forbidden to connect other equipment to this system, or install other software into this system, so as not to cause safety hazards and affect the basic performance of the system; c） It is strictly forbidden to hit or collide with the components of the system, and it is strictly forbidden to disassemble the mechanical connection devices of the system to avoid damaging the equipment; d） The environmental conditions for storage and use of the system should meet the requirements specified in this manual, so as to avoid inappropriate environmental conditions affecting the basic performance of the product or leading to early failure of product functions; e） It is strictly forbidden to modify the software and the hardware of this system, so as to avoid safety hazards affecting the basic performance of the product; 26 TrueView 200 Pro-US User Manual P000220 V3.0 f） The X-ray flat panel detector should be properly protected. It is strictly forbidden to press or touch the imaging area of the X-ray flat panel detector with a hard object, so as to avoid damaging the X- ray flat panel imaging area leading to deterioration or loss of the basic performance of the product; g） In any case, it is strictly forbidden to move the X-ray tube and X-ray flat panel detector. After the installation and calibration of the system is completed, the geometric parameter value is fixed, and the software configuration file is entered. Any movement to it will cause the basic performance of the product to be reduced or lost. h） As the system is intended to be used in a hospital environment, there is no special protection for liquid entering the equipment parts. When storing, using, maintaining and cleaning the equipment, users should pay attention to avoid the liquid entering the equipment parts, so as not to cause electric shock danger and affect the basic performance of the product. In any case, if an unexpected event mentioned in a) ~ h) occurs, please contact the manufacturer to perform professional maintenance and verification of the system. The company shall not be liable for the losses and legal liabilities caused by users who violate the above requirements. 2.5 Information Security The integrity and availability of the product’s cybersecurity features are taken into consideration based on the product’s intended use, environment for use, and core functionality. The following main measures (see Cybersecurity Overview for details) are required as product inputs to be controlled by design, including the identification of product inputs, and related testing processes and results, all of which are included in the design control process and currently have met the requirements. Specific design inputs, design verification and definite evidence are detailed in the Document of Risk Control Analysis. ⚫ The system should disable unnecessary software 27  TrueView 200 Pro-US User Manual P000220 V3.0 ⚫ The system should keep the Principle of Least Privilege ⚫ No command-access rights ⚫ Customization of software update method and strategy ⚫ System integrity check ⚫ External storage media control ⚫ Health information control ⚫ Backup and restore strategy ⚫ User Access Control (UAC) ⚫ Audit Control ⚫ Port Access Policy ⚫ Physical Interface Locking Policy ⚫ Network transmission protection 2.6 Precautions for Operation 2.6.1 Check before Use The pre-use inspection includes pre-power-on inspection, power-on process inspection, and exposure inspection, as follows: a） Check before Starting Before turning on the power, the user should carefully check to make sure that the device is in good condition. Do not power on the system if it is found that the device covering is removed, the cable is disconnected (including the ground wire), or the insulator is damaged. b） Check during the Boot Process Turn on the hardware components of the system in the order specified in the 4.2 system startup process, and check during the startup process: 28 TrueView 200 Pro-US User Manual P000220 V3.0 ⚫ After the device is started, check whether the power indicator of the device is on; c） Exposure Check After the system is powered on, use the TrueView 200 Pro-US software to verify: ⚫ Whether the system can normally complete exposure and imaging operations; ⚫ Whether the image is blocked by foreign objects; ⚫ Whether the image quality is clear. NOTE: Before the exposure inspection, make sure that the cabinet door is closed. If any problems are found during the above inspection process, trained professionals should follow the relevant instructions on system repair and maintenance in this manual to eliminate the problems before applying them to the clinic. If the user is not competent to solve the problem, please contact the manufacturer to provide technical support. 2.6.2 Special Instructions for Operation a） Precautions for Clinical Application During clinical use, specimens cannot be placed directly on the specimen tray or specimen holder. Please place the clinically collected specimens in a specimen bag or container first, and then place the specimen bag or container on the specimen tray or specimen holder. b） Prevent X-ray Tube Damage due to Overheating In the case of frequent exposure, the X-ray tube may be damaged due to overheating and high temperature. To prevent this from happening, the manufacturer prompts: 29  TrueView 200 Pro-US User Manual P000220 V3.0 When the system detects that the X-ray tube is overheating, the exposure operation will be prohibited. The system monitor displays the status of the X-ray tube in real time. When the temperature reaches the critical value of the device, the software "Exposure" button will be disabled and the user will not be able to perform the exposure operation. At the same time, the Fault Condition column of the software interface will display the true status, as shown in Figure 2.1. Figure 2.1 Related parameters and status feedback of the generator At this piont, the user needs to wait for the temperature of the X-ray tube to cool down before continuing to work. The cooling time is determined by the environmental conditions. Once the system detects that the temperature of the X-ray tube drops to a normal state, the system will release the alarm and resume the working state. c） Smoke or Fire from the Equipment If it is found that the device emits smoke or fire during use, the user must immediately turn off the device power button and unplug the network power cable. 30 TrueView 200 Pro-US User Manual P000220 V3.0 The sealed device must not be used. Contact the manufacturer for fault diagnosis and repair. It is strictly forbidden to turn on the device again until the fault is not resolved. 2.6.3 Shutdown Operators should turn off the hardware components and system power before leaving work to extend the service life of the system and prevent unpredictable accidents. For the operation sequence of shutting down the system, see 4.3 System Shutdown Process. 2.6.4 Noise The noise-producing parts of this system are speakers. If you hear an abnormal sound from the speakers, you should immediately turn off the power button of the device and contact the manufacturer for troubleshooting. 2.7 System Defect and Limitation As our software is based on the Windows, it is unavoidable to encounter crashes, slow response and other situations when it is unable to operate. It is recommended to restart the device by pressing the power button which can shut down and restart the system. If it fails, the user can unplug the power cord to force the system shutdown, and then restart. 2.8 System Maintenance The safe and effective application of this system depends on the basic performance of the product. Using the product in an abnormal state of the system may cause unexpected consequences. The user should maintain the system according to the requirements of Chapter 6 of this manual. Please contact the manufacturer for replacement of the system's accessories, and consumables. 31  TrueView 200 Pro-US User Manual P000220 V3.0 2.9 Decommissioning and Resuming Use When the system has been shut down for a long time, its environmental conditions should meet the storage conditions specified in this manual to ensure that the basic performance of the system is maintained. When the period of deactivation is over three months, the system should be calibrated and maintained before resuming use. 2.10 Environmental Protection 2.10.1 About the Disposal of Waste Electronic Articles This system contains electronic components such as electronic circuit boards and capacitors. When the service life of equipment parts or systems is over, these components or materials are harmful to the environment. Please do not dispose of these components or materials as ordinary garbage. Disposal should follow the legal requirements of the country / region where it is located. The user can contact the manufacturer to recycle all the scrapped components and parts including electronic waste in this system, and the manufacturer will dispose of them in accordance with the regulations. 2.10.2 Insulating Oil The X-ray tube device contains insulating oil for stable high voltage, and its sealing device is designed and manufactured to ensure that no leakage will occur under normal circumstances. Due to the hazardous nature of insulating oil that pollutes the environment and harms human health, discarded or leaking insulating oil due to accidents should be disposed of in accordance with the regulations of the country / region where it is located. 32 TrueView 200 Pro-US User Manual P000220 V3.0 3. Installation and Configuration 3.1 Installation Preparation 1) Power Condition Preparation Input Voltage: 100V-240V~ Input Power: not less than 500W Frequency: 50/60 Hz 2) Floor Space Preparation The minimum floor space should be prepared is: 800mm (length) * 700mm (width) * 1800mm (height). Minimum load weight: 200kg. Due to the volume of the product itself, it is necessary for the hospital to provide the corresponding site conditions as a prerequisite. 3) Temporary Installation Area Condition The minimum installation area should be prepared is: 3m (length) * 4m (width). TrueView 200 Pro-US is all-in-one and includes shielding that is NOTE: incorporated within the cabinet chamber system design, eliminating the need for separate shielding. 33  TrueView 200 Pro-US User Manual P000220 V3.0 3.2 Installation Process The total installation process should be done by qualified personnel. Process in detail can be found in the service manual. NOTE: The installation of the device and software should be done by the qualified and professional person of the manufacturer. NOTE: The content of this chapter is only as the reference for the user of this system to strengthen the understanding of the structure and performance of the equipment. NOTE: Please read the manual carefully before installing. Unqualified personnel are prohibited from the system installation. Any accident caused by it would be investigated and affixed legal liability. 34 TrueView 200 Pro-US User Manual P000220 V3.0 3.3 System Configuration After the installation finished, connect the power supply and then power on the system. 3.3.1 System Self-Check Upon powering on the system, the operating system will automatically initiate the specialized software designed for initial hardware connection checks. The touch screen and system monitor will concurrently display the status of the hardware link, indicating whether it is functioning normally. 3.3.2 System Information Check a) Login the system (detail refer to section5.1), click the (Utility button) in the upper right corner, then click the “About” button, and the system information will be shown, see Figure 3.3- 1. Figure 3.3- 1 The system information page b) Check system function options, check “Features” to switch to the page, check the option keys and their validity period (Function keys can be added together or separately, but it is recommended to add them one by one for the convenience of functional key management in the future), see Figure 3.3-2. 35  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 3.3- 2 The system function options page 3.3.3 General Setting 3.3.3.1 System Setting Click (Utility button) in the top right corner, then click the “General” button. The system setting page Figure 3.3- 3 is shown as follow. Figure 3.3- 3 The general settings page 36 TrueView 200 Pro-US User Manual P000220 V3.0 ⚫ System Language: Set system language to English or Chinese; ⚫ Keyboard Language: Set keyboard language; ⚫ Time Zone: Set time zone; ⚫ System Date: Set system date； ⚫ Date Format: Set date format, the date format options are “dd/MM/yyyy”, “MM/dd/yyyy” and “yyyy/MM/dd”; ⚫ System Time: Set system time； ⚫ Time Format: Set time format, time format options are “12 hour” and “24 hour”; ⚫ Screen Saver: Set the interval of screen saver, the interval options are "After 10 minutes", "After 30 minutes", "After 1 hour", "After 3 hours", "After 8 hours" or "Never". After setting all items, click “Save” button. Restart the software, then the system will execute according to the current settings. 3.3.3.2 Facility Setting Click the “Facility” button beside the “System” button. The facility setting page Figure 3.3- 4 is shown as follow. Figure 3.3- 4 The general facility settings page 37  TrueView 200 Pro-US User Manual P000220 V3.0 ⚫ Facility Name: Set the facility name; Note: Only the ADM user is authorized to change the facility name; ⚫ Facility Address: Enter the facility address; ⚫ Host Name: Host name is shown accordingly; it is not recommended to change host name; ⚫ Station Name: The default station name is SDR; it is not recommended to change station name; ⚫ Department: Set department to breast surgery, laboratory dept or radiology. After setting all items, click “Save” button. Restart the software, the system will execute according to the current settings. 3.3.4 Connectivity Setting Click the “Utility” button in the top right corner and then choose the “Connectivity” button. The connectivity setting page (Figure 3.3- 5) is shown as follow. Figure 3.3- 5 The connectivity setting page a） Wired Network Please follow these steps to connect the device to the network: 1. Insert the network cable into the network port located at the rear of the device. 38 TrueView 200 Pro-US User Manual P000220 V3.0 2. Click on the “Wired” button to access the network settings. Verify the IP address and connection status, which will be displayed on the touchscreen. The default wired configuration is set to DHCP (refer to Figure 3.3-6). 3. If manual network configuration is required, click on the “Edit” button and select “Manual” to establish the network connection (refer to Figure 3.3-7). Figure 3.3- 6 The wired network connection page for DHCP Figure 3.3- 7 The wired network connection page for Manual 39  TrueView 200 Pro-US User Manual P000220 V3.0 b） Wireless Network Plug the wireless card into the USB port under the monitor or behind the device, click “Wireless” button, then click “Scan” button, and then the screen will display all currently WIFI hot spots you can connect as shown in the Figure 3.3- 8. Figure 3.3- 8 The Wireless function page Select a hot spot name, click “Connect” button, enter correct passphrase, then click “Connect” button again (see Figure 3.3- 9), and wireless network connects successfully. Caution: Do not connect the suspicious hot spot to avoid possible data leakage or other cybersecurity issues. 40 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 3.3- 9 The wireless network connects c） DICOM Click “DICOM” button, you can configure the DICOM worklist connection, MPPS connection, DICOM PACS connection, DICOM print connection, DICOM query and DICOM retrieve, the configuration page Figure 3.3- 10 as follow. Figure 3.3- 10 The DICOM configuration page 41  TrueView 200 Pro-US User Manual P000220 V3.0 Enter IP address, AE Title and Port number of the PACS server, and click the “Connection Test” button to check the test results. If the connection fails, you can use the Ping tool to diagnose whether the IP address is connected or not. The operation procedure of the DICOM PACS connection, DICOM MPPS connection, DICOM print connection, DICOM query and DICOM retrieve can refer to the DICOM worklist connection. d） Ping Tool Enter IP address of PACS server, click “Ping” button as shown in Figure 3.3- 11, and check whether the communication between the system and the PACS computer is normal. Figure 3.3- 11 The Ping Tool function page 3.3.5 Barcode Reader Settings and Use a） Barcode Reader Settings Click the “Utility” button in the top right corner and then click the “MISC” button. When the barcode reader is enabled, you can set the “ReadTo” as “Patient ID (Local)”, “Patient ID (Worklist)” and “Accession Number (Worklist)”, the configuration page is shown in Figure 3.3- 12. 42 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 3.3- 12 The Barcode reader setting page b） Barcode Reader Use Methods Plug barcode reader to the system and set the “ReadTo” as “Patient ID(Local)”, enter “Home-New patient” page, click Patient Id and scan the code with a barcode reader as shown in Figure 3.3- 13. Figure 3.3- 13 The patient ID input via the Barcode reader as a New Patient Set the DICOM worklist connection and make sure that the system is connected to the DICOM server. Plug barcode reader, set the “ReadTo” as “Patient ID(Worklist)” or “Accession Number 43  TrueView 200 Pro-US User Manual P000220 V3.0 (Worklist)”, enter “Home-worklist” page, scan the code with a barcode reader as shown in Figure 3.3- 14. Figure 3.3- 14 The patient ID input via the Barcode reader as Worklist 44 TrueView 200 Pro-US User Manual P000220 V3.0 4. Control System Operation The proper functioning of this system requires the initialization of hardware devices such as high-voltage generators and flat panel detectors. This initialization process involves the seamless coordination between software and hardware components to ensure the completion of the entire procedure. Through the software, the system can effectively control the high-voltage generator, X-ray tube, and X-ray flat panel detector, while also providing important information to the user. This chapter primarily focuses on elucidating the operation rules and precautions pertaining to the control system and its various components. 4.1 Control System Function Keys and Indicators 4.1.1 Power Button and Indicator A physical power button is in the upper right corner of the equipment operation console, with a halo indicator in the middle. As shown below: Figure 4. 1 Physical power button When pressing this button, the button will be concave. After the system is normally powered on and started, the middle green halo indicator will be lit, as shown in the Figure 4. 2: Figure 4. 2 Physical power button with green halo indicator lit 45  TrueView 200 Pro-US User Manual P000220 V3.0 4.1.2 X-ray Exposure Indicator An exposure indicator is set on the front panel of the device, as shown in the following figure: Figure 4. 3 X-ray exposure indicator As the exposure continues, the exposure indicator lights up in a yellow halo, as shown in the following figure: Figure 4. 4 X-ray exposure indicator lit 4.2 System Startup Procedure 4.2.1 Check before Starting Before turning on the system, make a routine check of the system: ⚫ The electrical equipment covering should be properly tightened, placed in a normal position, with the appearance not being damaged; ⚫ The cables should be connected normally, and its appearance should not be damaged; ⚫ The mechanical devices should be properly tightened and its appearance should not be damaged. 46 TrueView 200 Pro-US User Manual P000220 V3.0 When an abnormal situation occurs during the inspection, the maintenance personnel should be notified in time to avoid system failure. 4.2.2 Startup Steps To initiate the system after confirming its readiness, follow these steps: a) Activate the System: Press the power button to switch on the system. Upon startup, the software operating system login interface will be displayed on both the system monitor and touchscreen. Figure 4. 5 Software login interface screens NOTE: In the event that the user logs in quickly after system startup, the imaging page may display "Panel is connecting." After a brief delay, the connection will automatically establish successfully. b) Software for TrueView 200 Pro-US Started Upon system startup, the specialized software for TrueView 200 Pro-US is automatically launched by the operating system. 47  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 4. 6 Login interface c) Status on the Software Interface ——A red bar signifies an error, indicating that the system has detected an error condition. Figure 4. 7 The system is detecting an error ——A yellow bar indicates a warning, signifying that the system is not prepared for exposure. For example, the software cannot perform exposure because cabinet door is open. 48 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 4. 8 X-ray cabinet door has not been closed ——A green bar signifies that the system is ready, indicating that exposure can be utilized for image acquisition. Figure 4. 9 X-ray system ready indicator 4.3 System Shutdown Procedure 49  TrueView 200 Pro-US User Manual P000220 V3.0 To shut down the system, follow these steps: a) Turn off the System Figure 4. 10 Power button To power down the system, follow these steps: 1. Press the power button and then release it. 2. Set the power button to the OFF position. 3. The software for the system will exit, initiating an automatic shutdown of the control computer and other components. Note: It is advisable to wait for at least 5 seconds before restarting the system after it has been powered off. 50 TrueView 200 Pro-US User Manual P000220 V3.0 5. Software Operation After the system starts normally (see 4.2.2), the user login interface will be automatically displayed on the touchscreen. The software operation of the TrueView 200 Pro-US will be performed by using the touchpad, the touchscreen, and the monitor as seen in Figure 5. 1 (Note: For this chapter, screen shots with a green border represent the touchscreen, while those with the blue border are for the system monitor.). 5.1 General Layout of Interface The TrueView 200 Pro-US software features two primary user interfaces. The touchscreen enables users to select icons, buttons, and provides a virtual keyboard interface for entering textual information. Additionally, the touchpad allows for the selection of icons and buttons displayed on the screen. The initial step to access the software involves the user logging in. 51  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 1 TrueView 200 Pro-US login in screens on the system monitor and the touchscreen This document will use the convention that screens with a blue border are displayed on the system monitor, while screens with a green border are on the touchscreen. 5.1.1 Login The system categorizes users into three levels based on their roles. Users are required to select the appropriate user role corresponding to the task they intend to perform and then proceed with logging into the system. The ADM user assumes the administrative role within the system, Specimen users represent clinical users, and Service users are exclusively designated for factory authorized technicians. Each system will have one ADM user and one Service user, while the number of Specimen users can vary as needed. In 52 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5.2, the default users - ADM, Specimen, and an additional Specimen user - are displayed in the user pull-down menu on the login screen. It is important to note that the Service user's functionalities, reserved for factory authorized technicians, are not covered in this manual. Figure 5. 2 TrueView 200 Pro-US login screen with user pulldown menu shown To Login: 1. Use the touchpad or the touchscreen to select the pull-down menu of users, and then select the appropriate user for the planned task. 2. Use the touchpad or the touchscreen and select the Password text input box. A blinking cursor will appear in the text box, and the touchscreen will display a keyboard for the user to enter the password (see Figure 5.3). 3. Use the touchpad or the touchscreen to select the “Login” button and the system will display the home screen on the touchscreen and the image review interface on the system monitor. If the wrong password is entered, a message indicating failure to login in due to error password will appear (see Figure 5. 4). Use the touchpad or the touchscreen to select “OK” button to return to the login interface. Make sure that you have selected the correct user and that the correct password has been entered. Passwords are case sensitive, and if there is any question about the values entered, then select the Display 53  TrueView 200 Pro-US User Manual P000220 V3.0 Password icon at the right side of the text box to show the entered values. If the correct values are entered and the login still fails, then contact the administrative user to reset the password. Figure 5. 3 Password input Use the touchscreen keyboard to enter the user password and then select the “Login” button to complete the login procedure. Figure 5. 4 Failure to login due to wrong password error message 54 TrueView 200 Pro-US User Manual P000220 V3.0 Upon successful login by the initial user, the system will present the default Home menu and system monitor screens. If a previous user had utilized the system and subsequently logged out, the system will restore the screens to the state at the time of the previous user's logout. To conclude a session, a user can log out by selecting the user icon from the system information ribbon displayed on the touchscreen (refer to section 5.1.2.1.2 User Icon) Caution: It is crucial not to disclose passwords to others, particularly the ADM password, to prevent potential data breaches or cybersecurity concerns. 5.1.2 Touchscreen General Layout Following the initial user login of the system, the user will be presented the screens seen in Figure 5. 5. 55  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 5 Default display configuration of the system monitor (upper) and touchscreen (lower) of the software following initial login The touchscreen seen Figure 5. 5 maintains the same general layout for all software operations of the system, except for user login. This layout is characterized by three distinct regions of the touchscreen: The system information ribbon (Figure 5. 6); the common workflow icons (Figure 5.14); and the system workspace (Figure 5. 8). 5.1.2.1 System Information Ribbon The system information ribbon (see Figure 5. 6) displays the system status icons on the left (see Figure 5. 7), the currently open patient’s name and ID in the middle (this area is blank if no patient is selected), and the time/date display and functional icons on the right (see Figure 5. 9). 56 TrueView 200 Pro-US User Manual P000220 V3.0 System Information Ribbon Figure 5. 6 System information ribbon of the touchscreen indicated by the red border 5.1.2.1.1 System Status Overview The user can select any of the system status icons seen in Figure 5. 7 to display the system status overview screen. Figure 5. 8 highlights the system workspace with a red border, and shows an example of a system status overview screen in the system workspace. The user can review the status of the system power, driver component, network, safely ejecting a removable storage device, and review the details of the DICOM spooler queue. Since the system status icons of the system information ribbon act as a toggle between the current system workspace screen and the system status overview screen, the user can return to their previous system workspace screen by selecting any of the status overview icons of the system information ribbon. Figure 5. 7 Example of system status overview icons This display can change depending on the overall configuration of the system, but selecting any one of the icons in this area will bring up the system status overview page on the touchscreen. 57  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 8 Example of a system status overview screen appearing in the system workspace (system workspace indicated with a red border) when any one of the system status icons on the system information ribbon is selected. The center of the system information ribbon will display the open patient’s last name, first name, and patient I.D. Note: This area will be blank if no patient is currently open. The right side of the system information ribbon displays the current date and time and four functional icons (Figure 5. 9). Note: to adjust the date and time and set the format, see section 5.2.1. The four functional icons allow the user to access the login screen, the utilities menu, bring up the touchscreen keyboard, and check system status messages. Figure 5. 9 Individual selectable icons on the upper right of the touchscreen 5.1.2.1.2 User Icon of the System Information Ribbon From left to right on the selectable icons seen in Figure 5. 9, the first icon represents the user. Use the touchscreen or the touchpad to select this icon to logout as the current user. Figure 5. 10 shows the interface 58 TrueView 200 Pro-US User Manual P000220 V3.0 on the touchscreen after selecting the user icon from the system information ribbon. The user is prompted to select either the “Logout” or “Exit” button from the “User Login” dialog box. If the selection of the user icon from the system information ribbon is unintended, the user can select the “Exit” button and return to the previous screen to continue working, without logging out. If the user chooses to logout, then the system is ready for the next user to login (see Figure 5. 10). 7.65 Figure 5. 10 Interface on the touchscreen after selecting the user icon from the system information ribbon 5.1.2.1.3 Utilities Icon of the System Information Ribbon The next selectable icon on the system information ribbon is the gear icon which can open the utilities page in the system workspace. The utilities page provides the user access to the configurable parameters of the system. Some system parameters require administrative authority to configure. A detailed information about of the configuration options for the Utilities menu items can be found in section 5.2 Utilities. 59  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 11 The utilities page displayed in the system workspace when the gear icon of the system information ribbon is selected 5.1.2.1.4 Keyboard Icon of the System Information Ribbon The next selectable icon of the system information ribbon is the touchscreen keyboard icon. By selecting this icon, the user can have access to the touchscreen keyboard. Whenever the user selects a text input box, the touchscreen keyboard will automatically appear, and the icon will change from white to blue. The touchscreen keyboard functionality is limited to entering information into text boxes. Manually selecting the touchscreen keyboard will not offer any additional functions to the user, since the touchscreen keyboard can only be used in conjunction with a text input box. 5.1.2.1.5 Message Bubble Icon of the System Information Ribbon The last selectable icon of the system information ribbon is the message bubble icon that toggles the system workspace between the current page and the system status messages overview. Figure 5. 12 shows an example of the system status messages overview in the system workspace. The user can use the history pulldown menu to configure the number of messages displayed. The user can also choose whether to display 60 TrueView 200 Pro-US User Manual P000220 V3.0 all system messages or only error messages by selecting the corresponding button to the right of the history menu. Figure 5. 12 The System Status Messages page is accessed by selecting the message bubble icon of the system information ribbon. 5.1.2.2 System Workspace The system workspace area of the touchscreen display is a dynamic interface that changes depending on the selected icon or menu item (Figure 5. 13). In contrast, the system information ribbon and the system workflow icons remain basically unchanged while the user is logging in and using the system. The individual icons of the system status overview icons of the system information ribbon will change depending on the exact hardware configuration of the system. 61  TrueView 200 Pro-US User Manual P000220 V3.0 System Workplace Figure 5. 13 The dynamically set system workspace area of the touchscreen The individual screens displayed in the system workspace will be detailed in the following sections of this software operation guide. 5.1.2.3 System Workflow Icons The major steps for any specimen analysis will follow the system workflow icons visible on the right side of the touchscreen (Figure 5. 14). 62 TrueView 200 Pro-US User Manual P000220 V3.0 Workflow Icons Figure 5. 14 Workflow icons of the touchscreen These icons, their respective menu items, and the functionality available to the user are individually described in detail in sections 5.3, 5.4, and 5.5. 5.1.3 System Monitor General Layout The upper screen shown in the general layout (Figure 5. 5) is the system monitor for image analysis. Since there are no images to review upon initial login, the system monitor has only two active icons in the Image Tools area (see Figure 5. 15). The “Layout” icon changes the number of image display windows on the system monitor. The system monitor can display one, two, or four images; however, the touchscreen will only display the single currently selected image. Users can assign up to four images from a patient’s image list to the four active windows. The user can then change the currently selected image by using the “Next Screen” tool to cycle through any of the four images in the four active windows for review, and select the active window by using the toggle active window icon, or by using the touchpad to move the cursor to the desired image window on the system monitor and then to select it. The other image tool functions are only available when an image has been selected. When the DICOM print, PACS store, and image delete functions of the Image list area are enabled, they will display a blue background (see 5.5.23). 63  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 15 System monitor with Image tools highlighted by yellow border and configured for single image display. Only the “Layout” and “Next Screen” icons are enabled. A detailed review of the menu items and functionality available to the user of the software is provided in the following sections. 5.2 Utilities The gear icon of the system information ribbon is the link to the utilities page. This section details the menu items and functionality available to the user when accessing the utilities page. The utilities page will be visible in the system workspace area on the touchscreen. From the home screen, select the gear icon to open the utilities screen. In this section, the six menu items of the utilities page in the system workspace will be reviewed. 5.2.1 General Clicking the “Utilities” button, the general settings page will be displayed by default (Figure 5. 16). 64 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 16 The default view of the utilities page in the system workspace opens with the General settings selection from the utilities menu. The general settings allow the user to set system and facility information. The facility information includes facility name, facility address, host name, station name, department and patient id input helper; system information includes system language, keyboard language, time zone, system date, date format, system time, time format, and the screen saver activation time. Note: only the ADM user can change the Facility Name. The current date and time are displayed on the system information ribbon. To change the values or formats, use the touchscreen or touchpad to select the configurable item that is to be changed and then select from the pulldown menu values (e.g. Figure 5. 17) or the scroll wheel (e.g. Figure 5. 18) to set the desired values. To change any of the other values or formats, just select the current value in the box and enter the new desired value or format from the available values. Values are either entered by using the touchscreen keyboard, the scroll wheel, or from a selection in a pulldown menu. 65  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 17 Pulldown menu of the configurable time format value Figure 5. 18 Scroll wheel interface for the configurable current date The facility settings allow an authorized user to set the facility name, facility address, and department. As the host name is shown accordingly and the default station name is SDR, it is not recommended to change them. Note: only the ADM user can change the Facility Name. 66 TrueView 200 Pro-US User Manual P000220 V3.0 5.2.2 User Management The ADM user can create new clinical users, delete old clinical users, and change the password for all clinical users and for the ADM user. A clinical user only has the authority to change his own current password. 5.2.2.1 Create / Delete User Account as ADM User When logged in as the ADM user, the User Mgr. menu item of the utilities page allows you to create a new clinical user (Figure 5. 19). Figure 5. 19 When logging in as the ADM user, select the User Mgr. menu item and then select the “Create User” button to create a new clinical user. 67  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 20 Using the touchscreen keyboard, the ADM user enters the new clinical user's username and password and then selects the Create User button. After entering the new user’s name and password, select the “Create User” button to create the new user. The system will display a confirmation message (Figure 5. 21) acknowledging the creation of the new user. After hitting “Ok” in the confirmation window, the new user’s name will appear in the user list. Figure 5. 21 System acknowledgment of the creation of the new clinical user 68 TrueView 200 Pro-US User Manual P000220 V3.0 5.2.2.2 Delete Clinical User Account as ADM User The ADM user can delete any new clinical user account, but cannot delete the three default users: ADM, Specimen, or Service. To delete any clinical account other than the Specimen account, select the user from the user list and then select the Delete User button (the user must log in as the ADM user). Once the “Delete User” button is pressed, confirm the action (Figure 5. 22) and then the system will display a message that the action has been successful (Figure 5. 23). Figure 5. 22 Confirm user deletion. 69  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 23 System acknowledgment of user deletion. 5.2.2.3 Change User Password The ADM user can change any clinical user password and the ADM user password from the user management page of the Utilities workspace. A clinical user can only change his own password from the user management page, but the process is the same. As the ADM user, select the clinical users name from the user list and then press the “Change Password” button (Figure 5. 24). 70 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 24 As the ADM user, select a new clinical username from the user list and push the Change password button to initiate the change password workflow. The ADM user is then required to enter the current ADM password as well as the new password for the clinical user and re-enter the new password to ensure it is correct (Figure 5. 25). Click the “Change Password” button and, if the new password and the confirmed password match, then the system will confirm that the password has been changed (Figure 5. 26). If logging in as a clinical user, the user management page will have only one function available, the change password function (Figure 5. 27). The procedure is basically the same as when the ADM changes the password. The clinical user must first enter the current password before changing a new password. Select the “Change password” button, and as long as the new password and the confirmed password have been matched, then the system will confirm the action has been successful. 71  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 25 ADM user change clinical user password workflow Figure 5. 26 System confirmation that the user password has been changed successfully 72 TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 27 Change password as a clinical user 5.2.3 Exposure Settings The exposure menu item of the utilities page in the system workspace allows the user to set the default exposure parameters for the Imaging workflow. Figure 5. 28 shows the options available for the default exposure settings. As for exposure mode, the user may choose automatic exposure control (AEC) or manual exposure control for specimen imaging. The user can also set the default tube voltage between 20kVp to 50kVp, and the default tube current between 5mAs to 20mAs. 73  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 28 Exposure setting interface The exposure menu item of the utilities page in the system workspace allows the user to set the default exposure mode, the default values for the voltage and current for the X-ray tube, whether shows information as default. The user can click the “Quality Control” button, and a patient called Quality Control will be automatically established where the user can capture image to check image quality. 5.2.4 Connectivity The connectivity menu item of the utilities page in the system workspace provides the user the functionality to manage the connectivity of the system. Besides the DICOM connectivity properties only available to the ADM user, the clinical user has access to most of the functionality as the same as the ADM user to check the system connectivity status. NOTE: The subnetwork segment is used by the hospital cannot be the same as that was used by the panel. At present, the panel subnetwork segment is 172.16.8.x. If the segments collide, please contact The CompAI Healthcare operation and maintenance personnel to reset the panel IP address. 74 TrueView 200 Pro-US User Manual P000220 V3.0 5.2.4.1 Wired If the user selects the Wired page, the status of the Ethernet connection is displayed (Figure 5. 29). Figure 5. 29 The Wired page of the connectivity menu item of the utilities page in the system workspace. 5.2.4.2 Wireless The wireless page of the connectivity menu item of the utilities page in the system workspace allows the user to scan available networks, create a new connection, and to check the properties of the currently connected wi-fi network (Figure 5. 30) after the USB wireless card is connected. 75  TrueView 200 Pro-US User Manual P000220 V3.0 Figure 5. 30 The wireless page of the connectivity menu item of the utilities page in the system workspace. 5.2.4.3 DICOM The DICOM page of the connectivity menu item of the utilities page in the system workspace allows the clinical user to test the DICOM worklist, MPPS, PACS Image storage, DICOM print connectivity, DICOM query and DICOM retrieve. If any of the connecting tests fail, contact the ADM user to configure the IP Address, AE title, and Port for each connection. Figure 5. 31 shows the PACS Image st