FCC ID: 2ACHK-01070189 Wireless Digital Flat Panel Detector

4. Software Setup 3. Parameter read region: read the parameters, the values of the parameters are displayed in this area by Read. 4. Parameter write region: write parameter. Entered value of the corresponding parameter in this area can be write to detector. 5. Operation region: functional operation buttons area. 6. Status bar region: status bar for detector state and information of reading or writing parameters, etc. Configuration parameters description as below:

Name Description Configurable Product No. Type of detector product Serial No. Serial number of the detector Firmware version number of the Main Version FPGA Read Version N/A MCU Version Firmware version number of the N N N N N User Manual of Mars1417X 49 Mars1717V-VSI Digital Flat Panel Detector User MCU Arm Version Version number of the ARM App Kernel Version Version number of ARM Kernel Trigger Mode Tirgger mode of the detector Set Delay Time(ms) Exposure window for AED mode which use a fixed window Exp Window Time(ms) Max exposure window for command trigger which use a dynamic window Src IP Detector IP Src MAC Detector MAC N N Y Y Y Y Y DHCP, Client, not set as on with WLAN DHCP Enable LAN DHCP enabled at the same Y DHCP, Client, not set as on with LAN DHCP Enable WLAN DHCP enabled at the same Y time. time. Button function description:

Function Button Description Reset Detector Reset Detector Read Read parameters Write Write parameters Write RAM Write parameters into RAM(will lost changes after reset) Upgrade Firmware Upgrade firmware L Upload detector log to the specified directory iRay Technology Co. 4. Software Setup Sensor The mainly function in this page is to probe the temperature and humidity of the detector. Click Read button to get the value of the temperature or humidity. Sensor type Explanation Temperature Read detector temperature Humidity Read detector humidity Battery Read the capacity of the battery Wifi User Manual of Mars1417X 51 Mars1717V-VSI Digital Flat Panel Detector User User can config the wireless connect parameters on this tab. Images You can Query and upload Images from detector to Workstation. iRay Technology Co. 4. Software Setup 4.4.5. Calibrate Page Offset, Gain, Defect calibrate files can be generated and managed in this page. User Manual of Mars1417X 53 Mars1717V-VSI Digital Flat Panel Detector User Click Start Generate Templates to enter generating templates page. SubTab Description Mode&Files Manage template files Create Offset Create Offset template Create Gain Create Gain template Create Defect Create Defect template Mode&Files page Description Import to Workdir Copy template file into current calibration directory. Download to FPD Select one item first. Then click this button to download selected template file(s) into detector. UpLoad to Workdir Select one item in Fpd template file control and select one item in Subset settings control. Click this button to upload selected template from detector into specified calibration directory. iRay Technology Co. 4. Software Setup Upload Lag Upload Lag into SDK current directory Active Select one item in list. Click this button to activate selected template for hardware correction. UpdateHWPreOffset Force detector update Offset template(not needed for ReadStatus Get the current state of template for hardware correction, postoffset flow) enable/disable Generate Gain Template File create gain template file. 1. Enter Create Gain page images. If the relative position between tube and detector changed or KV value changed, it suggest to Click "Start" button to start process, the offset type should be selected, then start to get the User Manual of Mars1417X 55 Mars1717V-VSI Digital Flat Panel Detector User 2. Click PREP button, then exposure after Acquire button enable. After receving the PREP request, the detector needs some time to be ready, the decounting bar will apear when the exposure window is opened. After exposure user can click Acquire button to acquire the X-

Ray image. The gain template generation process needs 5 images total, the UI gives the recommended KV and target value, user can use different ones if needed. After accepting the current image, the Stage will turn to 2/5, 3/5 and so on. iRay Technology Co. 4. Software Setup The current value box will show different colors, the definitons are as below:

Yellow: The current value is higher or lower than the expected one, user decides if acceptable. For example, the expected value is 20000, and user needs 40000 as the gain piont, the yellow warning can be ignored, and the value can be accepted still. Green: The value is good. Red:

The value is un-acceptable. 3. After getting 5 images, user can generate the Gain template by Generate button, and the process can be exited from at anytime by using Cancel button. If Download to FPD after generation is checked, then the download UI will appear after finishing generating. User can refer to the part of Generate Defect Template File"

User Manual of Mars1417X 57 Mars1717V-VSI Digital Flat Panel Detector User 4. When the generating process is finished, the UI will give the message of successful. Generate Defect Template File The process of generate defect map is quite similar with the one of gain map. 1. On the Create Defect page, user can start the generating process by Start button. And the process can be quit by Cancel. iRay Technology Co. 4. Software Setup 2. There are 8 images that need to be acquired, the UI gives the recommend KV and expected image value, user should refer with them. 3. If the option Download to FPD after generation is checked, the download UI will appear after finishing generating the defect map which will takes a little time. The field of Index in FPD means that the detector can store several correction maps and choose one set to active as user wants. The Download files part show the directory of the generated map stored on the workstation. User Manual of Mars1417X 59 Mars1717V-VSI Digital Flat Panel Detector User 4. After choosing the stored index of FPD, the download process can be started by the Download button, user should wait the process until it is finished. 5. The correction map also can be managed at anytime on the page of Mode&Files. Choose the item of Default in the Subset settings part and click Download to FPD to finish downloading the maps into the detector. iRay Technology Co. 4. Software Setup Upload the correction files 1. The correction maps can be uploaded to the workstation too. Choose the gain or defect in the Fpd template filesand the Default directory in the Subset settings, then click the Upload to workdir. 2. When the upload process is finished, the UI will give the message. The correction maps should be enabled before using hardware correction, read status first, then choose the gain or defect, enable the map by clicking Active button. User Manual of Mars1417X 61 Mars1717V-VSI Digital Flat Panel Detector User 4.4.6. Local Page In this page user can open the image files saved in local, the file formate can be dcm, raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. The pixel matrix is defined as below:

Active area : 3500*4300 TFT includes active area and dummy pixels: 3524*4330 Full image inlcudes TFT matrix and empty ROIC channels: 3584*4352 What needs to be notice is only the active area pixels will be displayed when use load file funtion, the value of dummy pixels and empty channels will be filled by 65535. iRay Technology Co. 4. Software Setup This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image area by right mouse button. This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Description window width window level X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point User Manual of Mars1417X 63 Mars1717V-VSI Digital Flat Panel Detector User Width Height Mirror ROI Image width Image height Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. 4.5. List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

NETWORK a) The operating system is not compatibility;

b) Change or update the software failed;

c) The compatibility of the interface;

d) The data transfer protocol error;

e) The inconsistent of interface or format leads to data distortion;

f) The data output failed;

iRay Technology Co. Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 5. Operation Instructions for Image Acquisition 5.1. Steps for acquiring image ........................................................................ 66 5.2. Software Mode ........................................................................................ 66 5.3. AED Mode ............................................................................................... 68 5.4. After use .................................................................................................. 70 5.5. Firmware Upgrade ................................................................................... 70 54 User Manual of Mars1417X 5. Operation Instructions for Image Acquisition Mars1417X provides SDK for users to integrate detector into their DR system. Additionally, it also provides an application for demonstration, i.e. IDetector. User can use IDetector to control detector without DR system. 5.1. Steps for acquiring image Make sure the hardware is connected correctly and then power on. Once powered off, please wait at least 60s before power on again Wait until initialization is complete Connect the software choose the synchronization mode equilibrium Acquire images in the selected mode Generate HWPreOffset, Gain and Defect template after the detector reaches thermal To Acquire X-ray image is the main operation of Mars1417X. Most importantly, detector should build synchronization with X-ray generator. Mars1417X has one synchronization modes to acquire X-ray image, which is Software Mode. Software mode is the basic way to acquire X-ray image. Please see figure below for general feature. Workstation is a host PC device installed with iDetector and SDK. FPD is the Wireless Digital Wireless Digital Flat Panel Detector and HVG is the High Voltage Generator. In this mode, Workstation does not have to control X-ray generator. Users would decide when to shoot 5.2. Software Mode 5.2.1. Block Diagram X-ray. User Manual of Mars1417X 55 5. Operation Instructions for Image Acquisition X-Tube HVG FPD Work Station Select HWPostOffsetHWGainHWDefect. If user need the raw image, please de-select all 5.2.2. Work Flow(PrepAcq) these correction options. Also, the software correction is supported. Cmd_PrepAcq Ack_Prohibit Ack_Enable RAWPreview RAWXRayimage

(IfHWoffsetisdisabled) RAWoffset(Orcorrected) image IDLE Prepare XWIN1

(fixed) XRay imaging XWIN1

(fixed) Offset imaging 1. Send CmdPrepAcq on UI Acquire page. 2. After receiving the Cmd_PrepAcq, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The XWIN is configured by parameter Clear Acq Delay Time on SDK page, the unit is ms. 4. User needs to make sure the X-Ray ends within the XWIN. 5. The detector will send the images after the XWIN closed. User Manual of Mars1417X 67 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 6. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-

Ray image will not be sent and only the corrected image will be transferred. 5.2.3. Work Flow(Prep+Acq) Cmd_Prep Ack_Prohibit Ack_Enable XRay Cmd_SingleAcq RAWPreview RAWXRayimage

(IfHWoffsetisdisabled) RAWoffset(Orcorrected) image IDLE Prepare XWIN2

(dynamic) XRay imaging XWIN2

(dynamic) Offset imaging 1. Send CmdPrep on UI Acquire page. 2. After receiving the Cmd_Prep, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The max XWIN is configured by parameter Exp Window Time on Detector page Parameter tab, the unit is ms. 4. User starts the X-Ray. 5. Send SingleAcq on UI Acquire page after the X-Ray is end. 6. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-

Ray image will not be sent and only the corrected image will be transferred. 5.3. AED Mode 56 Manual of Mars1417X User 5. Operation Instructions for Image Acquisition 5.3.1. Inner Prep Ack XRay Info RAWPreview RAWXRayimage RAWOffset(Orcorrected) IfHWoffsetisdisabled image Lowpower IDLE XWIN1

(fixed) XRay imaging XWIN1

(fixed) Offset imaging

1. The detector is in low power state, user needs to send Cmd Prep to make the detector exit to idle state which indicated by the acknowledge to Cmd Prep. 2. When the detector is in idle state, user can start the X-Ray any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-

Ray image will not be sent and only the corrected image will be transferred. 5.3.2. Freesync Mode User Manual of Mars1417X 69 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 5.3.3. XRay Info RAWPreview RAWXRayimage RAWOffset(Orcorrected) IfHWoffsetisdisabled image IDLE XWIN1

(fixed) XRay imaging XWIN1

(fixed) Offset imaging 1. For Freesync mode, there is no low power state. 2. When the detector is Idle, user can start the exposure flow any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-

Ray image will not be sent and only the corrected image will be transferred. 5.4. After use 1. Disconnect the software 2. Power off 3. Keep it clean 4. Store under specified conditions 5.5. Firmware Upgrade On Detector PageParameter Tabuser can upgrade firmware by entrance button 58 anual of Mars1417X User M 5. Operation Instructions for Image Acquisition Upgrade Firmware. The firmware upgrade package may contain firmware of several units: ARM, FPGA, MCU. Mars1417X_IMAGE_44_ALL_20XX_XX_XX.ifrm Word ALL indicates the file contains the firmware upgrade file for all units. Mars1417X_IMAGE_44_ARM_20XX_XX_XX.ifrm Word ARM indicates the file is only for ARM. Mars1417X_IMAGE_44_FPGA_20XX_XX_XX.ifrm Word FPGA indicates the file is only for FPGA. Mars1417X_IMAGE_44_MCU_20XX_XX_XX.ifrm Word MCU indicates the file is only for MCU. User can choose one of these files as required to start the upgrade. Choose the file that needs to be upgraded, and must check the package info to confirm if it is correct. User Manual of Mars1417X 71 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 60 Manual of Mars1417X User 6. Regulatory Information 6. Regulatory Information 6.1. Medical Equipment Safety Standards ..................................................... 74 6.2. Guidance and Manufactures Declaration for EMC ................................. 75 6.3. Radio Frequency Compliance Information .............................................. 78 6.4. Battery Safety Standards ........................................................................ 81 6.5. Product Label .......................................................................................... 81 User Manual of Mars1417X 61 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 6.1. Medical Equipment Safety Standards Medical equipment classification Protection type against electrical Class I equipment, using medically approved shock adaptor supply Internally powered equipment, using battery power supply Protection degree against electrical B Type shock Protection degree against water IP56 (Detector) penetration Mode of operation IP20 (Charger-Combo) Continuous operation Flammable anesthetics Not suitable for use in situation with flammable anesthetic mixture with air, oxygen or nitrous oxide Not suitable for use in oxygen-rich situation The detector has two power supply modes (power adaptor and battery pack) and a single way for signal transmission (wireless) Wireless detector safety standards cover the detector, charger, battery pack and other Safety standards reference accessories. IEC 60601-1:2005/AMD1:2012 IEC 60601-1-2:2014/EN60601-1-2:2015 IEC 60601-2-54:2015/EN 60601-2-54:2015 IEC 62133-2:2017 ANSI/AAMI ES60601-

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 1-2:

General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances Requirements and tests Medical electrical equipment -- Part 2-54:

Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems Medical electrical equipment - Part 1: General 1:2005/(R)2012+A1:2012+C1:2009/(R)2012+A2:20 10/(R)2012 requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CAN/CSA-C22.2No.60601-1:14 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 62 Manual of Mars1417X User 6. Regulatory Information 6.2. Guidance and Manufactures Declaration for EMC 6.2.1. EMI Compliance Table Emissions Phenomenon Compliance Electromagnetic environment RF emissions CISPR 11 Professional healthcare facility Group 1, Class environment Harmonic IEC 61000-3-2 Professional healthcare facility distortion Class A environment Voltage IEC 61000-3-3 Professional healthcare facility fluctuations and Compliance environment flicker 6.2.2. EMS Compliance Table Enclosure Port Phenomenon Basic EMC Immunity test levels standard Professional healthcare facility Electrostatic IEC 61000-4-2 Radiated RF EM IEC 61000-4-3 Discharge 2kV, 4kV, 8kV, 15kV air environment 8 kV contact 3V/m 80MHz-2.7GHz 80% AM at 1kHz Near fields from IEC 61000-4-3 Refer to table Near fields from RF wireless communications equipment Rated power IEC 61000-4-8 30A/m 50Hz or 60Hz B field RF wireless communications equipment frequency magnetic fields Test frequency

(MHz) 385 Near fields from RF wireless communications equipment Band

(MHz) Immunity test levels Professional healthcare facility environment 380-390 Pulse modulation 18Hz, 27V/m User Manual of Mars1417X 75 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 430-470 704-787 FM, 5kHz deviation, 1kHz sine, 28V/m Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1700-1990 Pulse modulation 217Hz, 28V/m 450 710 745 780 810 870 930 1720 1845 1970 62 Manual of Mars1417X User 2400-2570 5100-5800 Pulse modulation 217Hz, 28V/m Pulse modulation 217Hz, 9V/m 7. Trouble Shooting 2450 5240 5500 5785 Electrical fast transients/burst Surges Line-to-line Surges Line-to-ground Conducted by RF fields Input a.c. power port Phenomenon Basic EMC standard IEC 61000-4-4 Immunity test levels Professional healthcare facility environment 2 kV 100kHz repetition frequency IEC 61000-4-5 0.5 kV, 1 kV IEC 61000-4-5 0.5 kV, 1 kV, 2 kV disturbances induced IEC 61000-4-6 3V, 0.15MHz-80MHz 6V in ISM bands between 0.15MHz and At 0, 45, 90, 135, 180, 225, 270 and 80MHz 80%AM at 1kHz 0% UT; 0.5 cycle 0% UT; 1 cycle 315 and 70% UT; 25/30 cycles Single phase: at 0 0% UT; 250/300 cycles Voltage dips IEC 61000-4-

11 Voltage IEC 61000-4-

interruptions 11 Recommended separation distances between portable or mobile RF communication device and detector:

Portable RF communications equipment, including antennas, can effect medical electrical equipment. The warning should include a use distance such as be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by the manufacturer. Cable provided for EMC Cable Shielded/Unshielded Number Recommended length Cable classification AC power cable DC power cable Ethernet cable 1.8m 3m 3.5m Unshielded Shielded Shielded 1 piece 1 piece 1 piece AC power DC power Signal User Manual of Mars1417X 71 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Electromagnetic Compatibility (EMC) Mars1417X requires special precautions regarding EMC and needs to be installed only by iRay or authorized personnel and put into service according to EMC information provided in the user manual. Mars1417X in use may be susceptible to electromagnetic interference from portable and mobile RF communications such as mobile (cellular) telephones. Electromagnetic interference may result in incorrect operation of the system and create a potentially unsafe situation. Mars1417X conforms to this EN60601-1-2:2015 standard for both immunity and emissions. Nevertheless, special precautions need to be observed:

The use of accessories, transmitters and cables other than those specified by this User Manual, with the exception of accessories and cables sold by iRay of Mars1417X as replacement parts for inner components, may result in increased emission or decreased immunity. 6.3. Radio Frequency Compliance Information Country Item U.S.A. European Union KDB 865664 D01 47 CFR part 15, subpart B 47 CFR part 15subpart C 15.247 47 CFR part 15subpart C 15.407 47 CFR 2.1091 KDB447498 D01 General Exposure Guidance v06 ETSTEN 300 328 V2.2.2 ETST EN 301 893 V2.1.1 ETST EN 300 440 V2.1.1 ETSTEN 301 489-1 V2.2.3 ETSTEN 301 489-3 V2.1.1 ETSTEN 301 489-17 V3.2.4 EN 55032:2015+A11:2020 EN 55035:2017+A11:2020 EN 61000-3-2:2014 EN 61000-3-3:2013 EN 50566:2017 IEC 62479:2010 EN 62209-2:2010+A1:2019 6.3.1. FCC Compliance 70 Mars1417X User Manual of 6. Regulatory Information Contains modules FCC ID2ACHK-01070189 The panel has been tested to comply with limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. User Manual of Mars1417X 79 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Operation is subject to the following two conditions. The panel may not cause harmful interference. The panel must accept any interference received, including interference that may cause undesired operation. The panel generates, uses, and radiates radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If the panel does cause harmful interference to radio or television reception, which can be determined by turning the panel off and on, the user is encouraged to correct the interference by one or more of the following measures. Reorient or relocate the antenna. Increase the separation between the panel and receiver. Connect the panel into an outlet different from the receiver is connected. Consult the distributor or an experienced radio/TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment. UNII I is in door use only Radio Frequency (RF) Energy This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the United States. During SAR testing, this device was set to transmit at its highest certified power level in all tested frequency bands, and placed in positions that simulate RF exposure in usage against the body with no separation. Although the SAR is determined at the highest certified power level, the actual SAR level of the device while operating can be well below 70 Mars1417X User Manual of 6. Regulatory Information the maximum value. This is because the device is designed to operate at multiple power levels so as to use only the power required to reach the network. In general, the closer you are to a wireless Base station antenna, the lower the power output. The exposure standard for wireless devices employing a unit of measurement is known as the Specific Absorption Rate, or SAR. The SAR limit recommended by the ICNIRP used by the general public is 2.0W/kg averaged over ten grams of tissue and, is 1,6W/kg Averaged over one gram of tissue by IEEE Std 1528. The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in compliance with the FCC RF exposure guidelines. While there may be differences between the SAR levels of various product and at various positions, they all meet the government requirements. SAR compliance for body-worn operation is based on a separation distance of 0 mm between the unit and the human body. Carry this device at least 0 mm away from your body to ensure RF exposure level compliant or lower to the reported level. To support body-worn operation, choose the belt clips or holsters, which do not contain metallic components, to maintain a separation of 0 mm between this device and your body. RF exposure compliance with any body-worn accessory, which contains metal, was not tested and certified, and using such body-worn accessory should be avoided. 6.4. Battery Safety Standards Standards Description IEC 62133-2:2017 UN38.3 United Nations Recommendations on the Transport of Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications

- Part 2: Lithium systems dangerous goods Manual of tests and Criteria ST/SG/AC.10/11/Rev.6/Amend.1&Amend.1 6.5. Product Label Mars1417X Detector Label User Manual of Mars1417X 81 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 70 Mars1417X User Manual of 6. Regulatory Information Battery Charger Label User Manual of Mars1417X 83 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Battery Label 70 Mars1417X User Manual of 6. Regulatory Information 7. Trouble Shooting Please refer to service manual. If the problem persists, turn off the panel and contact iRay service department (service@iraygroup.com). We would provide the best service. User Manual of Mars1417X 85 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 8. Service Information 8.1. Service Office Information ....................................................................... 87 8.2. Product Lifetime ....................................................................................... 87 8.3. Regular Inspection and Maintenance ...................................................... 87 8.4. Repair ...................................................................................................... 87 8.5. Replacement Parts Support .................................................................... 88 86 anual of Mars1417X User M 8. Service Information 8.1. Service Office Information 8.2. Product Lifetime maintenance. The estimated product lifetime is up to 5 years under appropriate regular inspection and 8.3. Regular Inspection and Maintenance In order to ensure the safety of patients and operator, to maintain the performance and reliability of the panel, be sure to perform regular inspection at least once a year. If necessary, clean up the panel, make adjustments or replace consumables such as fuses etc. There may be cases where overhaul is recommended depending on conditions. Contact iRay service office or local iRay dealer for regular inspection or maintenance. If problem cannot be solved, contact your sales representative or local iRay dealer for repairs. Please refer to the label and provide the following information:

8.4. Repair Product Name:

Series Number:

Description of Problem: as clearly as possible. User Manual of Mars1417X 73 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 8.5. Replacement Parts Support Main parts (parts required to maintain the function of the product) of this product will be stocked for 5 years after discontinuance of production for repairing. 74 Manual of Mars1417X User APPENDIX APPENDIX A INFORMATION OF MANUFACTURES ....................................................... 76 APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE ..................................... 77 User Manual of Mars1417X 89 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X COMPANY:

iRay Technology Taicang Ltd. ADDRESS:

No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Jiangsu, China ZIP CODE:

215434 TELEPHONE:

+86 0512-53690872 FAX:

+86 0512-53690872 HOMEPAGE: WWW.IRAYGROUP.COM Appendix A Information of Manufactures 76 Manual of Mars1417X User APPENDIX Appendix B COMPANY:

iRay Europe GmbH ADDRESS:

IN DEN DORFWIESEN 14, 71720 OBERSTENFELD Information GERMANY of Europe ZIP CODE:

TELEPHONE:

+49-7062-977 88 00 Representat FAX:

+49-7062-976 0571 ive HOMEPAGE: WWW.IRAYEUROPE.COM User Manual of Mars1417X 91

Wireless Digital Flat Panel Detector Luna1012X User Manual Version A0 Doc ID 166-201-02 Release Date:2021.01.13

(reserve). Before operating, please read this user manual and pay attention to all safety precautions. Please ensure that this user manual is properly maintained so that it can be accessed at any time E Please use it correctly based on full understanding of the content. To Customers Congratulations on your purchase of the Flat Panel Detector (hereinafter referred to as Luna1012X) which is manufactured by iRay Technology Company Ltd. (Hereinafter referred to as iRay). Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay Luna1012X. If you have any questions or suggestions, please feel free to contact us. To Customers Congratulations on your purchase of the Fixed Digital Flat Panel (hereinafter referred to as Luna1012X) which is manufactured by iRay Technology Co.Ltd. (Hereinafter referred to as iRay). At iRay, we strive to not only make the world-class products that deliver the best value possible to our customers but also offer the highest quality of service and customer care. Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay Luna1012X If you have any questions or suggestions, pleasedo not hesitate to contact us. Notes on usage and management of the equipment 1. Read all of the instructions in the user guide before your operation. Give particular attention to all safety precautions. 2. Only a physician or a legally certified operator should use this product. 3. The equipment should be maintained in a safe and operable condition by maintenance 4. Use only the dedicated cables. Do not use any cables other than those supplied with this personnel. product. 5. Request your sales representative or local iRay dealer to install this product User Manual of Luna1012X 1 Wireless Digital Flat Panel Detector Caring for your environment commercial waste. Recycling iRay Equipment This symbol indicates that this product is not to be disposed of with your residential or Please do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste items. Contact your local authorities for information about practices established in your region. If collection systems are not available, call iRay Customer Service for assistance. Disclaimer Technology. any reason. Copyright 1. iRay shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product. 2. iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to this product or failure to strictly comply with iRays operating and maintenance instructions. 3. iRay shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as Original iRay Products by iRay 4. It is the responsibilities of the user/attending physicians for maintaining the privacy of image data and providing medical care services. iRay shall not be responsible for the legality of image processing, reading and storage nor it shall be responsible for loss of image data for 5. Information regarding specification, compositions, and appearance of this product is subject to change without prior notice. 2 User Manual of Luna1012X To Customers No part of this publication may be reproduced in any form or by any means without the written permission of iRay. The information contained herein is designed only for use with iRay Luna1012X. All rights reserved Trademarks The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd. User Manual of Luna1012X 3 Wireless Digital Flat Panel Detector Symbols and Conventions The following symbols and conventions are used throughout the user guide. Identify the conditions under which improper use of the product may cause death or serious personal injury. Identify conditions under which improper use of the product may cause minor personal injury. Identify conditions under which improper use of the product may cause property damage. Indicate a prohibited operation. Indicate an action that must be performed Indicate important operations and restrictions. Indicate operations for reference and complementary information. 4 User Manual of Luna1012X To Customers Labels and markings on the equipment The contents of the label and mark on iRay Luna1012X product are indicated as below:

Symbol Description Caution: please refer to the instructions in the user manual. Indicates that the equipment has passed CE testing and the CE Notified Body number follows it. Serial number of the product. Name and address of the manufacturer. Manufacturing date of this product. Expiring date of this product. Name and address of iRay authorized representative in the European region. Consultation of the user guide for general information. This product is not to be disposed of with your residential or commercial waste. Safety Signs:

Safety Signs Dangerous Voltage. Please refer to the user guide for safety instructions. User Manual of Luna1012X 5 Wireless Digital Flat Panel Detector Handled with care. Operational temperature limits. Storage temperature limits. Fragile Keep away from sunlight Keep dry Storage Humidity limits. Keep the equipment up right. Do not roll the transportation package. Stacking limit number. ON Switch to this position means power on for part of the equipment OFF Switch to this position means power off for part of the equipment 6 User Manual of Luna1012X 1. 2. CONTENTS ................................................................................................................................... 7 Contents Contents GENERAL DESCRIPTION .................................................................................. 9 1.1. Safety Precautions ...................................................................................... 9 1.2. Notes for Use ............................................................................................. 14 GENERAL DESCRIPTION ................................................................................ 16 2.1. Scope ......................................................................................................... 16 2.2. Principle ..................................................................................................... 16 2.3. Characteristics ........................................................................................... 17 2.4. Intended Use ............................................................................................. 17 2.5. ESSENTIAL PERFORMANCE .................................................................. 17 2.6. Application Specification ............................................................................ 17 2.7. The relative position between newborns and detector .............................. 18 2.8. Product Components ................................................................................. 18 2.9. Environment ............................................................................................... 19 2.10. Components Dsecription ......................................................................... 19 2.11. Product Specification ................................................................................. 22 3. BASIC OPERATION .......................................................................................... 28 3.1. Preparation ................................................................................................ 28 3.2. Routine Operation ..................................................................................... 29 3.3. Battery Charger Installation ........................................................................ 31 4. SOFTWARE SETUP .......................................................................................... 32 5. OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION ............................ 57 4.1. System requirement ................................................................................ 32 4.2. Environment setup................................................................................... 32 4.3. Wireless Connection................................................................................ 32 4.4. Software UI .............................................................................................. 37 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

4.5. NETWORK ......................................................................................................... 55 5.1. Steps for acquiring image ........................................................................ 57 5.2. Software Mode ........................................................................................ 57 5.3. AED Mode ............................................................................................... 59 5.4. After use .................................................................................................. 60 5.5. Correction and Calibration Template Generation .................................... 61 5.6. Local Image Check .................................................................................. 65 5.7. Firmware Upgrade ................................................................................... 67 REGULATORY INFORMATION ........................................................................ 69 TROUBLE SHOOTING ...................................................................................... 71 SERVICE INFORMATION ................................................................................. 72 8.1. Service Office Information ....................................................................... 72 6. 7. 8. User Manual of Luna1012X 7 Wireless Digital Flat Panel Detector 8.2. Product Lifetime ....................................................................................... 72 8.3. Regular Inspection and Maintenance ...................................................... 72 8.4. Repair ...................................................................................................... 72 8.5. Replacement Parts Support .................................................................... 73 APPENDIX A INFORMATION OF MANUFACTURES .............................................................. 74 APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE ............................................ 75 8 User Manual of Luna1012X 1. Safety Information 1. General Description 1.1. Safety Precautions equipment/data Follow these safeguards and properly use the equipment to prevent injury and damage to any Installation and environment Do not use or store the equipment near flammable chemicals such as alcohol, thinner, benzene, etc. of use WARNING If chemicals spill or evaporate, it may result in fire or electric shock through contact with electric parts inside the equipment. Also, some disinfectants are flammable. Be sure to take care when using them. Do not connect the equipment with anything other than specified. Doing so may result in fire or electric shock. All the patients with active implantable medical devices should keep away from the equipment. Power supply Do not operate the equipment using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in fire or electric shock. Do not handle the equipment with wet hands. You may experience electric shock that could result in death or serious injury. Do not place heavy object such as medical equipment on cables and cords. Do not pull, bend, bundle, or step on them to prevent their sheath from being damaged, and do not alter them neither. Doing so may damage the cords, which could result in fire or electric shock. Do not supply power to more than one piece of equipment using the same AC outlet. Doing so may result in fire or electric shock. Do not turn ON the system power when condensation has formed on the equipment. Doing so may result in fire or electric shock. User Manual of Luna1012X 9 Wireless Digital Flat Panel Detector Luna1012X Power supply Do not connect a multiple portable socket-outlet or extension cord to the system. Doing so may result in fire or electric shock. To avoid the risk of electric shock, this equipment must only be connected to power supply with protective earth. Not doing so may result in fire or electric shock. Handling Securely plug the power cord into the AC outlet. If contact failure occurs, or if metal objects come into contact with the exposed metal prongs of the plug, fire or electric shock may Be sure to turn OFF the power to each piece of equipment before connecting or disconnecting the cords. Otherwise, you may get an electric shock that could result in death result. or serious injury. Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the core wire may be damaged, resulting in fire or electric shock. WARNING Never disassemble or modify the equipment. No modification of this equipment is allowed. Parts of the Luna1012X that are not serviced or maintained while in use with the patient. Doing so may result in fire or electric shock. Also, since the equipment incorporates parts that may cause electric shock as well as other hazardous parts, touching them may cause death or serious injury. Do not place anything on top of the equipment. The object may fall and cause an injury. Also, if metal objects such as needles or clips fall into the equipment, or if liquid is spilled, it may result in fire or electric shock. Do not hit or drop the equipment. The equipment may be damaged if it receives a strong jolt, which may result in fire or electric shock if the equipment is used without Do not put the equipment and pointed objects together. The equipment may be damaged. If so, the equipment should be being repaired. used in bucky. 10 User Manual of Luna1012X When a problem occurs Maintenance and inspection 1. Safety Information Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment. Should any of the following occurs, immediately unplug the powercable or battery, and contact your sales representative or local iRay dealer:

When there is smoke, an odd smell or abnormal sound. When liquid has been spilled into the equipment or a metal object has entered through an opening. When the equipment has been dropped and damaged. Please turn OFF the power of the equipment and unplug the power cord of adaptor before cleaning. NEVER use alcohol, ether and other flammable cleaning agent for safety. NEVER use methanol, benzene, acid and base because they will erode the equipment. DON'T dip the equipment into the liquid. Please make sure that the equipment's surface & plugs are dry before turning ON. Otherwise, it may result in fire or electric shock. Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug, its periphery and AC outlet with a dry cloth. If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture; this could cause insulation failure that may result in a fire. For safety reasons, be sure to turn OFF the power to each piece of equipment when performing inspections indicated in this manual. Otherwise, electric shocks may occur. CAUTION User Manual of Luna1012X 11 Wireless Digital Flat Panel Detector Luna1012X of use Installation and environment Do not install the equipment in any of the locations listed below. Doing so may result in failure, malfunction, equipment falling, fire or injury. Close to facilities where water is used Where it will be exposed to direct sunlight Close to the air outlet of an air-conditioner or ventilation equipment Close to heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where temperature or humidity is high Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area Take care that cables do not become tangled during use. Also, be careful not to get your feet caught by cable. Otherwise, it may cause a malfunction of the equipment or injury of the user due to tripping over the cable. Always connect the three-core power cord plug to a grounded AC power outlet. To make it easy to disconnect the plug at any time, avoid putting any obstacles near the outlet. Otherwise, it may not be possible to disconnect the plug in an emergency. Be sure to ground the equipment to an indoor grounded connector. Also, be sure to connect all the grounds for the system to a common ground. Do not use any power source other than the one provided with this equipment. Otherwise, fire or electric shock may be caused due to leakage. Do not spill liquid or chemicals onto the equipment. In case the patient is injured, it is not allowed to contact with blood or other body fluids. Doing so may result in fire or electric shock. In such a situation, protect the equipment with a disposable cover as Turn OFF the power and pull out the plug to each piece of equipment for safety when not used. necessary. CAUTION Power supply Handling 12 User Manual of Luna1012X Handling 1. Safety Information Handle the equipment carefully. Do not submerge the equipment in water. The internal image sensor may be damaged if something hits against it or it is dropped. Do not place excessive weight on the equipment. Be sure to use the equipment on a protected foam. Otherwise, the internal image sensor may be damaged. Be sure to securely hold the detector while using it in upright positions. Otherwise, the detector may fall over, resulting in injury to the user or patient, or may flip over, resulting in damage to the inner device. Keep the same load (same pressure) on the detector when acquiring the image. Or the image will be incorrect. CAUTION User Manual of Luna1012X 13 Wireless Digital Flat Panel Detector Luna1012X Do not operate close to fire, do not use in high temperatures Do not invert positive and negative poles Do not contact with metal in case of a short circuit Do not insert sharp objects into the battery Do not hit the battery Do not stand on the battery Do not use the battery for purposes other than those stipulated in the rules Do not dispose of the battery or change its internal structure Do not submerge the battery in water; please keep it dry in storage and do not contact with water while in use Please charge the battery with the charger provided by Manufacturer Do not mix the battery with ones not provided by Manufacturer Do not charge the battery with a broken charger. Charge the battery regularly to avoid over-discharge failure. Do not use the battery when it is severe ballooning. 1.2. Notes for Use product may not function correctly. Before exposure When using the product, take the following precautions. Otherwise, problems may occur and the Be sure to check the connection of all the parts are set properly & check the detector is kept in insulated cover that operator or patient cant touch the detector directly before powered up. Be sure to check the product daily and confirm it work properly. Sudden heating of the room in cold areas will cause condensation on the product. In this case, wait until the condensation evaporates before performing an exposure. If it is used when condensation is formed, problems may occur in the quality of captured images. When an air-

conditioner is used, be sure to raise/lower the temperature gradually to prevent condensation. 14 User Manual of Luna1012X 1. Safety Information The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map. Make sure wave form of the energy going to the X ray tube is square not pulse. Be cautious with circumstance that someone has radio isotope recently injected into them, it may cause panel transmit image without x ray. Once powered off, please wait at least 60s before power on again During exposure Do not move Power Cable or Ethernet Cable during exposure, or it may cause image noise or artifacts, even incorrect images. Do not use the product near the equipment generating a strong magnetic field. Otherwise, it may cause image noise, artifacts or even incorrect images. After Usage After every examination, wipe the patient contact surfaces with disinfectants such as ethanol, to prevent the risk of infection. For details on how to sterilize, consult a specialist. Do not spray the product directly with disinfectants or detergents. Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as alcohol, benzene and acid. Doing so may damage the surface of the product. Its recommended to use a waterproof non-woven cover as the isolated layer between product and the blooding patient. User Manual of Luna1012X 15 Flat Panel Detector Luna1012X 2. General Description DR system and retrofit DR system. 2.1. Scope Luna1012XconfigurationLuna1012X, hereinafter referred as Luna1012X is a wireless X-ray flat panel detector based on amorphous flexible silicon thin-film transistor technologies. It is developed to provide the good quality of radiographic image, which contains an active matrix of 33282560 with 100 um pixel pitch. The scintillator of Luna1012X is CsI(Caesium Iodide) which is direct deposit. Since Luna1012X supports multiple trigger modes, it can satisfy both of the general This manual contains information about iRay Luna1012X product. All operators must read and understand this manual before using equipment. All information in this manual, including the illustrations, is based on equipment prototype. If configuration of your equipment does not have any of these items, information about these items in the manual does not apply to your equipment. 2.2. Principle Detectors contain a layer of scintillator material, which converts the x-rays into light. Directly behind the scintillator layer is an amorphous silicon pixel array contains a photodiode which User Manual of Luna1012X 16 2. General Description generates an electrical signal in proportion to the light produced by the portion of scintillator layer in front of the pixel. The signals from the photodiodes are amplified and encoded by additional electronics positioned behind the sensor array in order to produce an accurate and sensitive digital representation of the x-ray image. 2.3. Characteristics Wireless static flat panel detector AED 802.11ac 16-bit AD 2.4. Intended Use This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem of human. The image is obtained as the result of X-ray passing through the human anatomy and detected by the equipment. IRay will provide equipment and software support for integration of system. Luna1012X is a 10x12 wireless portable flat panel detector designed for human, especially for baby. According to the Luna1012X intended use and the result of risk management, identifying and describing the essential performance as the following:

To get image of dark field, the Luna1012X shall be not influenced to the imaging acquisition. To keep the data transmission function, the Luna1012X shall be not influenced to the data and signal transmission 2.5. ESSENTIAL PERFORMANCE According to the Luna series INTENDED USE and the result of risk management, image acquisition and data transmission are defined as ESSENTIAL PERFORMANCE. Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE. Method for getting dark image in detail refers to section installation and operation. 2.6. Application Specification User Manual of Luna1012X 17 Wireless Digital Flat Panel Detector Luna1012X PATIENT population:

Age: not relevant Weight: not relevant Health: not relevant Nationality: multiple Gender: except for pregnant women Intended OPERATOR:

All of use, maintenance and operation steps should be carried out by the operator who has accepted the professional training offered by the company's customer service staff. 2.7. The relative position between newborns and detector Because of the crosstalk effect of Amorphous silicon flat-panel detector, Pay attention to the relative position of newborns and detector, Otherwise, the image is prone to abnormal light lines. 2.8. Product Components The product is configured with the components below Item Description Quantity Luna1012X Detector Adapter Battery pack Gigabit Ethernet cable AC power cable DC power cable Battery charger CD ROM

1pcs 1pcs 2pcs 1pcs 1pcs 1pcs 1pcs 1pcs 18 User Manual of Luna1012X 2.9. Environment Temperature Temperature Variation Humidity Atmospheric Pressure Atmospheric Pressure Variation Operating 10~35

<1k/min 5%~90% RH 700~1060hPa

-20~60

<1k/min 5%~95% RH 600~1060hPa 2. General Description

<10kp/min

(1kp=1.0197E-5Pa)

<10kp/min

(1kp=1.0197E-5Pa) Storage

(without battery) 2.10. Components Dsecription 2.10.1. Detector 2.10.2. Indicator External Signals Input and Control Panel User Manual of Luna1012X 19 Wireless Digital Flat Panel Detector Luna1012X Control Panel NO. Item Description A B C D E Status indicator Detector status Link indicator Detector link status Power Indicator Detector Power indicator Power button Power button DC Input Interface 24V DC input 20 User Manual of Luna1012X 2.10.3. Battery Pack 2. General Description C B D C A B NO. Item Description A B C D Battery Label Guide Block

Battery Interface 7-pin battery connector Touch Display Show battery level after touching User Manual of Luna1012X 21 Wireless Digital Flat Panel Detector Luna1012X 2.10.4. Battery Charger Item Name Description Battery Interface A 8 Pin Battery connector Battery Interface B 5 Pin Battery connector Battery Interface C 5 Pin Battery connector Indicator The indicator definition is as follow The limit ball plug Hand Pull Position

AC Jack 220V AC input A B C D E F G 2.11. Product Specification 2.11.1. Detector 22 User Manual of Luna1012X 2. General Description Item Model Luna1012X Specification Image Sensor a-Si (Amorphous Silicon) TFT Scintillator CsI Pixel Size 100um User Manual of Luna1012X 23 Wireless Digital Flat Panel Detector Luna1012X Fill Factor 60%

Effective Array 3152*2502 Effective Area (H x V) 315.2 mm*250.6mm Spatial Resolution 5 lp/mm Image Transfer Cycle Time WIFI 5s Power Consumption 19W Max Weight 2kg(with battery) Image Transfer Wireless : IEEE802.11 a/b/g/n/ac Wireless Frequency Range 2.412~2.472GHz, 5.18~5.22GHz; 5.745~5.85GHz Data Transmission Power 13dBm (Typ.) @802.11a 16dBm (Typ.) @802.11b 14dBm (Typ.) @802.11g 13dBm (Typ.) @802.11n HT20 11dBm (Typ.) @802.11n HT40 16dBm@2.4GHz 13dBm@5GHz Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK) 11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM) Wireless Band 2.4GHz35MHz 5.GHz50MHz X-ray Energy 40-150kV Trigger Mode Software/AED SID 0-180cm 24 User Manual of Luna1012X 2.11.2. Battery 2. General Description Item Model Specifications Battery-KX Rated Capacity Min. 4700mAh, Typ. 4900mAh @ Discharge 0.2C Operating Temperature Charge 0-+60, Discharge-10-+60 Nominal Voltage Charge Voltage 11.55V 13.2V Discharged End Voltage 9V Charging Method CC-CV Storage Temperature 3 month -20-+45 1 month-20-+50 6 month -20-+35 Relative Humidity 5%~95%

Dimension (L W H) 210 x 105 x 8 mm Weight 0.285kg User Manual of Luna1012X 25 Wireless Digital Flat Panel Detector Luna1012X 2.11.3. Battery Charger Item Model Specifications Charger-Combo Simultaneous Charging 1 battery pack Full charging time 3 hours Rated power supply 90V~264V(AC) Dimension (L W H) 240 x 284 x 38 mm Weight 0.55 kg The battery charger indicator definition:

A B C All off Item Name Description Power Indicator Charging Indicator Charge Full Indicator

X Indicator Lighting Status Operating Status No power input 26 User Manual of Luna1012X ABC A indicator on A indicator on B and C alternately blink 2 times A and B indicator on A and C indicator on A indicator on B and C alternately blinking 2. General Description AC Power input Multiple batteries inserted Battery insertion self-test Battery Charging Battery capacity full, charging stops Battery charging abnormal Two or more battery charging at the same time is prohibited, if inserted at the same time, the charger will automatically stop working. User Manual of Luna1012X 27 Wireless Digital Flat Panel Detector Luna1012X 3. Basic Operation 3.1. Preparation 3.1.1. Attach Battery Pack The product can be powered by both a battery pack and DC power. Once the battery pack is inserted or DC power is connected, detectors will be turned on immediately. If neither battery nor DC power is connected, panel will power off. Please see below for battery installation. Make sure that connectors on the battery pack are pointed to the opening in the battery compartment. Slide battery package into battery compartment

(Make sure battery capacity overpass is 15%). Slide the battery lock lever. 3.1.2. Adapter Detector supports an external adapter powered, It gets CB certificate No. SG PSB-MD-00005 and NRTL certificate No. U8V 093768 0016.The ports defined as bellow:

28 User Manual of Luna1012X No. P1 P2 P3 P4 3.Basic Operation Definition Voltage Range Rated Current DC Power Negative DC Power Positive DC Power Positive 0~0.5V 23~25V 23~25V 0~0.42A 0~0.42A 0~0.42A DC Power Negative 0~0.5V 0~0.42A In order to meet the safety and function requirements of the detector, standard components are recommended. AC Adapter 3.2. Routine Operation 3.2.1. Starting Up On the control panel, users can press the power button to turn on. When the detector is powered down, the user presses the button for 4 seconds to turn on the detector if the battery is inserted and the capacity is not less than 7%, or DC power is connected. After booting up, users can check the indicator of the detector. Power indicator:

User Manual of Luna1012X 29 Wireless Digital Flat Panel Detector Luna1012X Power Indicator Lighting Status Status Battery Capacity DC Input Description Orange Blinking 7% & 15%

NO Detector is on N/A N/A N/A Detector is off YES Detector is on 15% & 95%

YES Detector is on 95%

YES Detector is off Link Indicator Lighting Status Description OFF Green ON Green Blinking Green&Orange Blinking Link indicator:

OFF Blue ON Green ON OFF Green ON Orange ON Detector is turned off Wired connection broken and wireless connection not ready Wireless connection is enabled Wired connection is enabled (Service Mode) Detector is off Exposure is allowed Error Status indicator Mode Indicator Lighting Status Description 30 User Manual of Luna1012X 3.Basic Operation 3.3. Battery Charger Installation Operation Figure Unload Battery from battery charger. Insert battery into battery charger. Note the interface position as figure. Press the battery to the bottom of battery compartment. User Manual of Luna1012X 31 Wireless Digital Flat Panel Detector Luna1012X 4. Software Setup 4.1. System requirement iDetector is developed and deployed on Windows Operation System, it can be run on Windows XP/Windows 7/Windows 8/Windows 10, OS should install latest service pack. And requires computer memory 4 GB minimum. The firewall should be shut down to avoid commuication issue. 4.2. Environment setup Setup files and download url are included in SDK directory: Tools\env_setup 1. Please install Microsoft .NET Framework 4.5(Windows XP only can install V4.0 ). Download from 2. Visual C++ redistributed package need to be installed: vcredist_x86_2013(or 3. For Windows XP, full path should be used in file bind.txt. The wifi information should be configured for first use with wired connection. The configuration Microsoft web site, please. vcredist_x64_vs2013). can be changed when needed. 4.3. Wireless Connection file *\work_dir\Luna1012X\config.ini 4.3.1. AP Mode The default IP address (IPv4) of the detector is 192.168.8.8, the PC address (IPv4) should be configured as 192.168.8.xxx, which should be the same as the value of parameter Cfg_HostIPin 32 User Manual of Luna1012X On the main window of Home page Select the instance of Luna1012X and use the Connect button the build the connection. After finishing building the connection, click Read Configbutton on the Wifitab of Detector pag to get the current wifi configuration. Click Read Network Config to get default setting. Change SSID and password setting. make sure SSID is different from other already exist;

4.Software Setup User Manual of Luna1012X 33 Wireless Digital Flat Panel Detector Luna1012X Change channels and frequency setting Click Channel and choose a clean frequency and channel Click Write Network Config 34 User Manual of Luna1012X Waiting FPD status be Ready 4.Software Setup 4.3.2. Client Mode Add: add the information of the access point, such as SSID and password. Select: Select the Access Point that needs to be connected to. 4.3.3. Configuration of external wireless card Open local wireless signal list User Manual of Luna1012X 35 Wireless Digital Flat Panel Detector Luna1012X Select SSID which belongs to detectors;

Input password and log into system Open wireless card configuration open IPV4 setting IP setting as follows IP address: 192.168.8.188 IP address:

192.168.8.188 Subnet mask: 255.255.255.0 36 User Manual of Luna1012X Subnet mask:

255.255.255.0 Open SDK and choose product start connection 4.Software Setup 4.4. Software UI SDK supply iDetector as tool softwore:

32-bits iDetector.exe: Tools\iDetector\w32 64-bits iDetector.exe: Tools\iDetector\x64 little difference. versions of iDetector. Double click iDetector.exe to run the software. For different software version, the UI maybe has For this manual, the example is based on SDK_*_xxxx. This UI is almost the same for different Tab Function description Home Connect FPD and view the connect state Acquire Acquire image, select correction mode, save image and process image SDK config.ini setting, log level setting Detector Configurate parameters for detector. Calibrate Generate calibration files and manage the calibration files Local File Open and view local images. User Manual of Luna1012X 37 Wireless Digital Flat Panel Detector Luna1012X 4.4.1. HomePage The main function in this page is to connect detector. Item Function description Name Display the name of detector SN Display the SN of detector Product Type Display the type of detector State Display the connection state (BindUnknown, Ready etc.) Button Function description Connect Click this button to connect the selected detector. Close Click this button to disconnect the selected detector. Add Add work directory Remove Remove work directory Syncbox Open Syncbox configuration window(Optional device) 38 User Manual of Luna1012X 4.Software Setup 4.4.2. Acquire Page This page is used to acquire image under different work mode, and user can select correction options too. When acquire image finished there will be a preview image shown on the screen (if the correction option is selected, otherwise only the raw images will be shown).The propertities of image is displayed on the left of image window.And on the right of image window there is a list to show thumbnail of images. User can select it and double click to see for detail. User can rotate, reverse or mirror image. User can get the value of AVG and SNR by ROI tool. The acquired images can be save as raw, tiff or dicom formats. Both raw and tiff formats support single frame and continuous frames save. Status bar shows detectors serial number, the current task and state of detector, and feedback information of command. Status bar is also can be seen in other pages, and they are all the same. Item Description SN SN number of current connected detectors State Detectors state , eg busy, ready Task the current task of detector Message feedback information of command,eg succeed,failed User Manual of Luna1012X 39 Wireless Digital Flat Panel Detector Luna1012X Functions in this Page. Correction Menu Description Offset HWPostOffset Do hardware PostOffset correction for image if checked Gain HWGain Do hardware Gain correction for image if selected Defect HWDefect Do hardware defect correction for image if checked Acqurie Button Description Prep Clear. Prepare to integrate. SingleAcq Acquire once PrepAcq Acquire Save Clear and acquire Seriers acquire images Save the current image, the format is raw and tiff ActiveSensor Active sensor DeactiveSensor Deactive sensor PowerOff Shutdown detector Stitchingflow Image stitching flow Image Properties& Image Process Description WW WL PosX PosY Value Width Height FPS X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point window width window level Image width Image height Frame rate 40 User Manual of Luna1012X Mirror ROI Frames Display the frame count 4.Software Setup Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters with right click. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. Image List Show thumbnails When the image is displayed on the screen, maybe the user want to see details by dragging or zoom in/out the image, for convenience, these are some shortcuts. 1. Click the left mouse button: movie playback function operation area display. 2. Double-click the left mouse button: the image display in center and with maximum size;

3. Double-click the right mouse button: restore the window level and width for WL:32767/WW:65535;

4. Drag the left mouse button to drag the image display;

5. Lateral-drag the right mouse button to adjust the window width, and vertical-drag the right mouse button to adjust the window level;

F3 Key: Quickly locate the image window width and window level. F4 Key: Adjust window width and window level automatically. 6. 7. User Manual of Luna1012X 41 Wireless Digital Flat Panel Detector Luna1012X 4.4.3. SDK Pgae SDK page is used to set parameters in config.ini and log level. Different log level will show different details. It is recommended to set the log level as Debug 4.4.4. Detector Page Parameters page. area by Read. In this page, there are Parameters, Sensor and Images tab. 1. Enter Detector page, the tab of Paramters is activity by default. There are 5 regions in this 2. Parameter name region: lists the paramters. 3. Parameter read region: read the parameters, the values of the parameters are displayed in this 4. Parameter write region: write parameter. Entered value of the corresponding parameter in this area can be write to detector. 5. Operation region: functional operation buttons area. 42 User Manual of Luna1012X 6. Status bar region: status bar for detector state and information of reading or writing parameters, etc. 4.Software Setup Configuration parameters description as below:

Name Description Configurable Product No. Type of detector product Serial No. Serial number of the detector Main Version Firmware version number of the FPGA N Read Version N/A MCU Version Firmware version number of the MCU N Arm Version Version number of the ARM App Kernel Version Version number of ARM Kernel Trigger Mode Tirgger mode of the detector Set Delay Time(ms) Acquire Delay Time(ms) Exposure window for AED mode which use a fixed window Exposure window for getting image which use a dynamic window N N N N N Y Y Y User Manual of Luna1012X 43 Wireless Digital Flat Panel Detector Luna1012X Exp Window Time(ms) Max exposure window for command trigger which use a dynamic window Src MAC Detector MAC Y Y Button function description:

Function Button Description Reset Detector Reset Detector Read Read parameters Write Write parameters Write RAM Write parameters into RAM(will lost changes after reset) Upgrade Firmware Upgrade firmware L Upload detector log to the specified directory Sensor The mainly function in this page is to probe the temperature and humidity of the detector. Click Read button to get the value of the temperature or humidity. 44 User Manual of Luna1012X 4.Software Setup Sensor type Explanation Temperature Read detector temperature Humidity Read detector humidity Battery Read the capacity of the battery Wifi User can config the wireless connect parameters on this tab. Images You can Query and upload Images from detector to Workstation. User Manual of Luna1012X 45 Wireless Digital Flat Panel Detector Luna1012X 4.4.5. Calibrate Page Offset, Gain, Defect calibrate files can be generated and managed in this page. Click Start Generate Templates to enter generating templates page. 46 User Manual of Luna1012X 4.Software Setup SubTab Description Mode&Files Manage template files Create Offset Create Offset template Create Gain Create Gain template Create Defect Create Defect template Mode&Files page Description Import to Workdir Copy template file into current calibration directory. Download to FPD Select one item first. Then click this button to download selected template file(s) into detector. UpLoad to Workdir Select one item in Fpd template file control and select one item in Subset settings control. Click this button to upload selected template from detector into specified calibration directory. Upload Lag Upload Lag into SDK current directory Active Select one item in list. Click this button to activate selected template for hardware correction. User Manual of Luna1012X 47 Wireless Digital Flat Panel Detector Luna1012X UpdateHWPreOffset Force detector update Offset template ReadStatus Get the current state of template for hardware correction, enable/disable Generate Gain Template File If the relative position between tube and detector changed or KV value changed, it suggest to create gain template file. 1. Enter Create Gain page images. Click "Start" button to start process, the offset type should be selected, then start to get the 2. Click PREP button, then exposure after Acquire button enable. After receving the PREP request, the detector needs some time to be ready, the decounting bar will apear when the exposure window is opened. After exposure user can click Acquire button to acquire the X-

Ray image. 48 User Manual of Luna1012X 4.Software Setup The gain template generation process needs 5 images total, the UI gives the recommended KV and target value, user can use different ones if needed. After accepting the current image, the Stage will turn to 2/5, 3/5 and so on. The current value box will show different colors, the definitons are as below:

Yellow: The current value is higher or lower than the expected one, user decides if acceptable. For example, the expected value is 20000, and user needs 40000 as the gain piont, the yellow warning can be ignored, and the value can be accepted still. Green:

The value is good. Red:

The value is un-acceptable. 3. After getting 5 images, user can generate the Gain template by Generate button, and the process can be exited from at anytime by using Cancel button. If Download to FPD after generation is checked, then the download UI will appear after finishing generating. User can refer to the part of Generate Defect Template File"

User Manual of Luna1012X 49 Wireless Digital Flat Panel Detector Luna1012X 4. When the generating process is finished, the UI will give the message of successful. Generate Defect Template File The process of generate defect map is quite similar with the one of gain map. 1. On the Create Defect page, user can start the generating process by Start button. And the process can be quit by Cancel. 50 User Manual of Luna1012X 4.Software Setup 2. There are 8 images that need to be acquired, the UI gives the recommend KV and expected image value, user should refer with them. 3. If the option Download to FPD after generation is checked, the download UI will appear after finishing generating the defect map which will takes a little time. The field of Index in FPD means that the detector can store several correction maps and choose one set to active as user wants. The Download files part show the directory of the generated map stored on the workstation. 4. After choosing the stored index of FPD, the download process can be started by the Download button, user should wait the process until it is finished. 5. The correction map also can be managed at anytime on the page of Mode&Files. Choose the item of Default in the Subset settings part and click Download to FPD to finish downloading the maps into the detector. User Manual of Luna1012X 51 Wireless Digital Flat Panel Detector Luna1012X Upload the correction files 1. The correction maps can be uploaded to the workstation too. Choose the gain or defect in the Fpd template filesand the Default directory in the Subset settings, then click the Upload to workdir. 2. When the upload process is finished, the UI will give the message. 52 User Manual of Luna1012X The correction maps should be enabled before using hardware correction, read status first, then choose the gain or defect, enable the map by clicking Active button. 4.Software Setup 4.4.6. Local Page In this page user can open the image files saved in local, the file formate can be dcm, raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. The pixel matrix is defined as below:

Active area : 4267*4267 What needs to be notice is only the active area pixels will be displayed when use load file funtion, the value of dummy pixels and empty channels will be filled by 65535. User Manual of Luna1012X 53 Wireless Digital Flat Panel Detector Luna1012X This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image area by right mouse button. This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Width Description window width window level X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point Image width Height Image height 54 User Manual of Luna1012X 4.Software Setup Mirror ROI Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. 4.5. List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

NETWORK a) The operating system is not compatibility;

b) Change or update the software failed;

c) The compatibility of the interface;

d) The data transfer protocol error;

e) The inconsistent of interface or format leads to data distortion;

f) The data output failed;

User Manual of Luna1012X 55 6.Regulatory Information 56 User Manual of Luna1012X 6.Regulatory Information 5. Operation Instructions for Image Acquisition Luna1012X provides SDK for users to integrate detector into their DR system. Additionally, it also provides an application for demonstration, i.e. IDetector. User can use IDetector to control detector without DR system. 5.1. Steps for acquiring image Make sure the hardware is connected correctly and then power on. Once powered off, please wait at least 60s before power on again Generate HWPreOffset, Gain and Defect template after the detector reaches thermal To Acquire X-ray image is the main operation of Luna1012X. Most importantly, detector should build synchronization with X-ray generator. Luna1012X has one synchronization modes to acquire Wait until initialization is complete Connect the software choose the synchronization mode equilibrium Acquire images in the selected mode X-ray image, which is Software Mode. 5.2. Software Mode 5.2.1. Block Diagram Software mode is the basic way to acquire X-ray image. Please see figure below for general feature. Workstation is a host PC device installed with iDetector and SDK. FPD is the Flat Panel Detector and HVG is the High Voltage Generator. In this mode, Workstation does not have to control X-ray generator. Users would decide when to shoot X-ray. User Manual of Luna1012X 57 Flat Panel Detector Luna1012X Select HWPostOffsetHWGainHWDefect. If user need the raw image, please de-select all these 5.2.2. Work Flow(PrepAcq) correction options. Also, the software correction is supported. 1. Send CmdPrepAcq on UI Acquire page. 2. After receiving the Cmd_PrepAcq, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The XWIN is configured by parameter Clear Acq Delay Time on SDK page, the unit is ms. 4. User needs to make sure the X-Ray ends within the XWIN. 5. The detector will send the images after the XWIN closed. 6. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 58 User Manual of Luna1012X HVGX-TubeFPDWork StationIDLEPrepareXWIN1(fixed)X-RayimagingCmd_PrepAcqAck_ProhibitAck_EnableXWIN1(fixed)OffsetimagingRAW PreviewRAW X-Ray image(If HW-offset is disabled)RAW offset(Or corrected)image 5. 6. 6.Regulatory Information 5.2.3. Work Flow(Prep+Acq) 1. Send CmdPrep on UI Acquire page. 2. After receiving the Cmd_Prep, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The max XWIN is configured by parameter Exp Window Time on Detector page Parameter tab, the unit is ms. 4. User starts the X-Ray. Send SingleAcq on UI Acquire page after the X-Ray is end. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.3. AED Mode 5.3.1. Inner 1. The detector is in low power state, user needs to send Cmd Prep to make the detector exit to idle state which indicated by the acknowledge to Cmd Prep. 2. When the detector is in idle state, user can start the X-Ray any time. User Manual of Luna1012X 59 IDLEPrepareXWIN2(dynamic)X-RayimagingCmd_PrepAck_ProhibitAck_EnableXWIN2(dynamic)OffsetimagingRAW PreviewRAW X-Ray image(If HW-offset is disabled)RAW offset(Or corrected) imageCmd_SingleAcqX-RayIDLEXWIN1(fixed)X-RayimagingXWIN1(fixed)OffsetimagingX-RayInfoRAW PreviewRAW X-Ray imageIf HW-offset is disabledRAW Offset(Or corrected)imageLow powerPrepAck Flat Panel Detector Luna1012X 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.3.2. Freesync Mode 1. For Freesync mode, there is no low power state. 2. When the detector is Idle, user can start the exposure flow any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.4. After use 1. Disconnect the software 2. Power off 3. Keep it clean 60 User Manual of Luna1012X IDLEXWIN1(fixed)X-RayimagingXWIN1(fixed)OffsetimagingX-RayInfoRAW PreviewRAW X-Ray imageIf HW-offset is disabledRAW Offset(Or corrected)image 6.Regulatory Information 4. Store under specified conditions 5.5. Correction and Calibration Template Generation The correction and calibration should be performed after installation and it is recommended to perform the new correction and calibration after any major change on the system settings and hardware configuration. On the other hand, it is also recommended to do the correction and calibration in each 6 months. 5.5.1. HW pre-offset Template Generation Enter Acquire interface, select HWPostOffset option Enter Calibrate interface, click UpdateHWPreOffset button. Waiting until status bar displayed:

"Task succeed:

HwGeneratePreOffsetTemplate 5.5.2. Gain Calibration Template Generation If the relative position between tube and detector changed or KV value changed, it suggest to create gain template file. User Manual of Luna1012X 61 Flat Panel Detector Luna1012X Enter Create Gain page Click "Start" button to start process. Click PREP button, acquire image. Please exposure after Acquire button enable. And click Acquire button to acquire image after exposure end. Click Accept button after acquired image. If Current Value textbox is yellow, click PREP button. Re-acquire images after adjust generator parameters. Note: In different trigger mode, the operation maybe have little difference. Please follow the UI tips. Mind:

If the detector is in inner or Freesync mode, then user should finish the exposure before the time bar counting ends. And the click on Acquire is not necessary for inner or Freesync. 62 User Manual of Luna1012X 6.Regulatory Information Create gain template need several images. You can click Generate button to generate Gain template once one image was captured. But it may lead to imperfect template quanlity. Download template file dialog will pop up if "Download to FPD after generation" option was checked. Click Download button to download the template into the detector. Select Mode&Files tab. Click Read Status button to check whether just downloaded gain template is enable. If not, please click Active button to enable. 5.5.3. Defect Correction Template Generation User Manual of Luna1012X 63 Flat Panel Detector Luna1012X Enter Acquire UI. Choose HWPostOffset. Enter Calibrate UI. Select Create Defect tab. Click "Start" button to start process. Click PREP button, acquire image. Please exposure after Acquire button enable. And click Acquire button to acquire image after exposure end. Click Accept button after acquired image. If Current Value textbox is yellow , click PREP button. Re-

acquire images after adjust generator parameters. Note: In different trigger mode, the operation maybe have little difference. Please follow the UI tips. You can click Generate button to generate Gain template after acquired required images. 64 User Manual of Luna1012X 6.Regulatory Information Download template file dialog will pop up if "Download to FPD after generation" option was checked. Click Download button to download the template into the detector. Select Mode&Files tab. Click Read Status button to check whether just downloaded gain template is enable. If not, please click Active button to enable. 5.6. Local Image Check OPEN provides two features for image check and uploading. Local Image Check, Panel Image Upload. Local Image Check defines function to check image saved in Workstation. Panel Image Upload defines function to upload images stored in panel. User Manual of Luna1012X 65 Flat Panel Detector Luna1012X Click Local File button in Local File UI, choose the specified file In this page user can open the image files saved in local, the file formate can be raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. Luna1012X image size: 4267*4267 This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image area by right mouse button. This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Width Height Description window width window level Image width Image height X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point 66 User Manual of Luna1012X 6.Regulatory Information Mirror ROI Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI WW/WL Auto adjust WW/WL based on selected area by right area. button of mouse. 5.7. Firmware Upgrade Panel supports upgrading firmware with IDetector, also allows the use of the Web way to upgrade the firmware, if a user needs to upgrade the firmware, please complete the following steps. On Detector PageParameter Tabuser can upgrade firmware by entrance button Upgrade Firmware. The firmware upgrade package may contain firmware of several units: ARM, FPGA, MCU. Luna1012X_IMAGE_44_ALL_20XX_XX_XX.ifrm User Manual of Luna1012X 67 Flat Panel Detector Luna1012X Word ALL indicates the file contains the firmware upgrade file for all units. Luna1012X_IMAGE_44_ARM_20XX_XX_XX.ifrm Word ARM indicates the file is only for ARM. Luna1012X_IMAGE_44_FPGA_20XX_XX_XX.ifrm Word FPGA indicates the file is only for FPGA. Luna1012X_IMAGE_44_MCU_20XX_XX_XX.ifrm Word MCU indicates the file is only for MCU. User can choose one of these files as required to start the upgrade. Choose the file that needs to be upgraded, and must check the package info to confirm if it is correct. Note:

25%

1. There is a progress bar for indication. Make sure battery is inserted and battery capacity is over 2. Please make sure that iDetector shows Ready. It can also be checked by click Config button, there is firmware version. 68 User Manual of Luna1012X 6.Regulatory Information 6. Regulatory Information FCC Compliance The panel has been tested to comply with limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. The panel generates, uses, and radiates radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If the panel does cause harmful interference to radio or television reception, which can be determined by turning the panel off and on, the user is encouraged to correct the interference by one or more of the following measures. Reorient or relocate the antenna. Increase the separation between the panel and receiver. Connect the panel into an outlet different from the receiver is connected. Consult the distributor or an experienced radio/TV technician for help. Operation is subject to the following two conditions. The panel may not cause harmful interference. The panel must accept any interference received, including interference that may cause undesired operation. This device complies with FCC SAR exposure limits set forth for an uncontrolled environment. The equipment can be used in close proximity to the human body without any restrictions. Note: the grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. such modifications could void the users authority to operate the equipment User Manual of Luna1012X 69 6.Regulatory Information 70 User Manual of Luna1012X 7.Trouble Shooting 7. Trouble Shooting Please refer to service manual. If the problem persists, turn off the panel and contact iRay service department (service@iraygroup.com). We would provide the best service User Manual of Luna1012X 71 Flat Panel Detector Luna1012X 8. Service Information 8.1. Service Office Information 8.2. Product Lifetime maintenance. The estimated product lifetime is up to 5 years under appropriate regular inspection and 8.3. Regular Inspection and Maintenance In order to ensure the safety of patients and operator, to maintain the performance and reliability of the panel, be sure to perform regular inspection at least once a year. If necessary, clean up the panel, make adjustments or replace consumables such as fuses etc. There may be cases where overhaul is recommended depending on conditions. Contact iRay service office or local iRay dealer for regular inspection or maintenance. If problem cannot be solved, contact your sales representative or local iRay dealer for repairs. Please refer to the label and provide the following information:

8.4. Repair Product Name:

Series Number:

Description of Problem: as clearly as possible. 72 User Manual of Luna1012X 8.Service Information 8.5. Replacement Parts Support Main parts (parts required to maintain the function of the product) of this product will be stocked for 5 years after discontinuance of production for repairing. User Manual of Luna1012X 73 Flat Panel Detector Luna1012X Appendix A Information of Manufactures COMPANY:

iRay Technology Taicang Ltd. ADDRESS:

No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Jiangsu, China ZIP CODE:

215434 TELEPHONE:

+86 0512-53690872 FAX:

+86 0512-53690872 HOMEPAGE: WWW.IRAYGROUP.COM 74 User Manual of Luna1012X APPENDIX Appendix B Information of Europe Representative COMPANY:

iRay Europe GmbH ADDRESS:

IN DEN DORFWIESEN 14, 71720 OBERSTENFELD GERMANY ZIP CODE:

TELEPHONE:

+49-7062-977 88 00 FAX:

+49-7062-976 0571 HOMEPAGE: WWW.IRAYEUROPE.COM User Manual of Luna1012X 75

Wireless Digital Flat Panel Detector Luna1013XE User Manual Version A0 Doc ID 123-201-02 Release Date:2020.11.24

(reserve). Before operating, please read this user manual and pay attention to all safety precautions. Please ensure that this user manual is properly maintained so that it can be accessed at any time Please use it correctly based on full understanding of the content. E To Customers Congratulations on your purchase of the Flat Panel Detector (hereinafter referred to as Luna1013XE) which is manufactured by iRay Technology Company Ltd. (Hereinafter referred to as iRay). Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay Luna1013XE. If you have any questions or suggestions, please feel free to contact us. To Customers Congratulations on your purchase of the Fixed Digital Flat Panel (hereinafter referred to as Luna1013XE) which is manufactured by iRay Technology Co.Ltd. (Hereinafter referred to as iRay). At iRay, we strive to not only make the world-class products that deliver the best value possible to our customers but also offer the highest quality of service and customer care. Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay Luna1013XE If you have any questions or suggestions, pleasedo not hesitate to contact us. Notes on usage and management of the equipment 1. Read all of the instructions in the user guide before your operation. Give particular attention to all safety precautions. 2. Only a physician or a legally certified operator should use this product. 3. The equipment should be maintained in a safe and operable condition by maintenance 4. Use only the dedicated cables. Do not use any cables other than those supplied with this personnel. product. 5. Request your sales representative or local iRay dealer to install this product User Manual of Luna1013XE 1 Flat Panel Detector Luna1013XE Caring for your environment commercial waste. Recycling iRay Equipment This symbol indicates that this product is not to be disposed of with your residential or Please do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste items. Contact your local authorities for information about practices established in your region. If collection systems are not available, call iRay Customer Service for assistance. Disclaimer 1. iRay shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product. 2. iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to this product or failure to strictly comply with iRays operating and maintenance instructions. 3. iRay shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as Original iRay Products by iRay 4. It is the responsibilities of the user/attending physicians for maintaining the privacy of image data and providing the care services. iRay shall not be responsible for the legality of image processing, reading and storage nor it shall be responsible for loss of image data for any Technology. reason. 5. Information regarding specification, compositions, and appearance of this product is subject to change without prior notice. 2 User Manual of Luna1013XE To Customers Copyright All rights reserved Luna1013XE. Trademarks No part of this publication may be reproduced in any form or by any means without the written permission of iRay. The information contained herein is designed only for use with iRay The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd. User Manual of Luna1013XE 3 Flat Panel Detector Luna1013XE Symbols and Conventions The following symbols and conventions are used throughout the user guide. Identify the conditions under which improper use of the product may cause death or serious personal injury. Identify conditions under which improper use of the product may cause minor personal injury. Identify conditions under which improper use of the product may cause property damage. Indicate a prohibited operation. Indicate an action that must be performed Indicate important operations and restrictions. Indicate operations for reference and complementary information. 4 User Manual of Luna1013XE To Customers Labels and markings on the equipment The contents of the label and mark on iRay Luna1013XE product are indicated as below:

Symbol Description Caution: please refer to the instructions in the user manual. Indicates that the equipment has passed CE testing and the CE Notified Body number follows it. Serial number of the product. Name and address of the manufacturer. Manufacturing date of this product. Expiring date of this product. Name and address of iRay authorized representative in the European region. Consultation of the user guide for general information. This product is not to be disposed of with your residential or commercial waste. Safety Signs:

Safety Signs Dangerous Voltage. Please refer to the user guide for safety instructions. User Manual of Luna1013XE 5 Flat Panel Detector Luna1013XE Handled with care. Operational temperature limits. Storage temperature limits. Fragile Keep away from sunlight Keep dry Storage Humidity limits. Keep the equipment up right. Do not roll the transportation package. Stacking limit number. ON Switch to this position means power on for part of the equipment OFF Switch to this position means power off for part of the equipment 6 User Manual of Luna1013XE Contents CONTENTS ................................................................................................................................... 7 Contents 1. 2. 6. 7. 8. GENERAL DESCRIPTION .................................................................................. 9 1.1. Safety Precautions ...................................................................................... 9 1.2. Notes for Use ............................................................................................. 14 GENERAL DESCRIPTION ................................................................................ 16 2.1. Scope ......................................................................................................... 16 2.2. Principle ..................................................................................................... 16 2.3. Characteristics ........................................................................................... 17 2.4. Intended Use ............................................................................................. 17 2.5. ESSENTIAL PERFORMANCE .................................................................. 17 2.6. Application Specification ............................................................................ 17 2.7. The relative position between Equine and detector .................................. 18 2.8. Product Components ................................................................................. 18 2.9. Environment ............................................................................................... 18 2.10. Components Dsecription ......................................................................... 19 2.11. Product Specification ................................................................................. 22 3. BASIC OPERATION .......................................................................................... 28 3.1. Preparation ................................................................................................ 28 3.2. Routine Operation ..................................................................................... 29 3.3. Battery Charger Installation ........................................................................ 30 4. SOFTWARE SETUP .......................................................................................... 32 4.1. System requirement ................................................................................ 32 4.2. Environment setup................................................................................... 32 4.3. Wireless Connection................................................................................ 32 4.4. Software UI .............................................................................................. 37 5. OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION ............................ 56 5.1. Steps for acquiring image ........................................................................ 56 5.2. Software Mode ........................................................................................ 56 5.3. AED Mode ............................................................................................... 58 5.4. After use .................................................................................................. 59 5.5. Correction and Calibration Template Generation .................................... 59 5.6. Local Image Check .................................................................................. 64 5.7. Firmware Upgrade ................................................................................... 65 REGULATORY INFORMATION ........................................................................ 68 TROUBLE SHOOTING ...................................................................................... 69 SERVICE INFORMATION ................................................................................. 70 8.1. Service Office Information ....................................................................... 70 8.2. Product Lifetime ....................................................................................... 70 User Manual of Luna1013XE 7 Flat Panel Detector Luna1013XE 8.3. Regular Inspection and Maintenance ...................................................... 70 8.4. Repair ...................................................................................................... 70 8.5. Replacement Parts Support .................................................................... 71 APPENDIX A INFORMATION OF MANUFACTURES .............................................................. 72 APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE ............................................ 73 8 User Manual of Luna1013XE 1. Safety Information 1. General Description 1.1. Safety Precautions equipment/data Follow these safeguards and properly use the equipment to prevent injury and damage to any Installation and environment Do not use or store the equipment near flammable chemicals such as alcohol, thinner, benzene, etc. of use WARNING If chemicals spill or evaporate, it may result in fire or electric shock through contact with electric parts inside the equipment. Also, some disinfectants are flammable. Be sure to take care when using them. Do not connect the equipment with anything other than specified. Doing so may result in fire or electric shock. All the patients with active implantable The devices should keep away from the equipment. Power supply Do not operate the equipment using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in fire or electric shock. Do not handle the equipment with wet hands. You may experience electric shock that could result in death or serious injury. Do not place heavy object such as The equipment on cables and cords. Do not pull, bend, bundle, or step on them to prevent their sheath from being damaged, and do not alter them neither. Doing so may damage the cords, which could result in fire or electric shock. Do not supply power to more than one piece of equipment using the same AC outlet. Doing so may result in fire or electric shock. Do not turn ON the system power when condensation has formed on the equipment. Doing so may result in fire or electric shock. User Manual of Luna1013XE 9 Flat Panel Detector Luna1013XE Power supply Do not connect a multiple portable socket-outlet or extension cord to the system. Doing so may result in fire or electric shock. To avoid the risk of electric shock, this equipment must only be connected to power supply with protective earth. Not doing so may result in fire or electric shock. Handling Securely plug the power cord into the AC outlet. If contact failure occurs, or if metal objects come into contact with the exposed metal prongs of the plug, fire or electric shock may Be sure to turn OFF the power to each piece of equipment before connecting or disconnecting the cords. Otherwise, you may get an electric shock that could result in death result. or serious injury. Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the core wire may be damaged, resulting in fire or electric shock. WARNING Never disassemble or modify the equipment. No modification of this equipment is allowed. Parts of the Luna1013XE that are not serviced or maintained while in use with the patient. Doing so may result in fire or electric shock. Also, since the equipment incorporates parts that may cause electric shock as well as other hazardous parts, touching them may cause death or serious injury. Do not place anything on top of the equipment. The object may fall and cause an injury. Also, if metal objects such as needles or clips fall into the equipment, or if liquid is spilled, it may result in fire or electric shock. Do not hit or drop the equipment. The equipment may be damaged if it receives a strong jolt, which may result in fire or electric shock if the equipment is used without Do not put the equipment and pointed objects together. The equipment may be damaged. If so, the equipment should be being repaired. used in bucky. 10 User Manual of Luna1013XE When a problem occurs Maintenance and inspection 1. Safety Information Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment. Should any of the following occurs, immediately unplug the powercable or battery, and contact your sales representative or local iRay dealer:

When there is smoke, an odd smell or abnormal sound. When liquid has been spilled into the equipment or a metal object has entered through an opening. When the equipment has been dropped and damaged. Please turn OFF the power of the equipment and unplug the power cord of adaptor before cleaning. NEVER use alcohol, ether and other flammable cleaning agent for safety. NEVER use methanol, benzene, acid and base because they will erode the equipment. DON'T dip the equipment into the liquid. Please make sure that the equipment's surface & plugs are dry before turning ON. Otherwise, it may result in fire or electric shock. Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug, its periphery and AC outlet with a dry cloth. If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture; this could cause insulation failure that may result in a fire. For safety reasons, be sure to turn OFF the power to each piece of equipment when performing inspections indicated in this manual. Otherwise, electric shocks may occur. CAUTION User Manual of Luna1013XE 11 Flat Panel Detector Luna1013XE of use Installation and environment Do not install the equipment in any of the locations listed below. Doing so may result in failure, malfunction, equipment falling, fire or injury. Close to facilities where water is used Where it will be exposed to direct sunlight Close to the air outlet of an air-conditioner or ventilation equipment Close to heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where temperature or humidity is high Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area Take care that cables do not become tangled during use. Also, be careful not to get your feet caught by cable. Otherwise, it may cause a malfunction of the equipment or injury of the user due to tripping over the cable. Always connect the three-core power cord plug to a grounded AC power outlet. To make it easy to disconnect the plug at any time, avoid putting any obstacles near the outlet. Otherwise, it may not be possible to disconnect the plug in an emergency. Be sure to ground the equipment to an indoor grounded connector. Also, be sure to connect all the grounds for the system to a common ground. Do not use any power source other than the one provided with this equipment. Otherwise, fire or electric shock may be caused due to leakage. Do not spill liquid or chemicals onto the equipment. In case the patient is injured, it is not allowed to contact with blood or other body fluids. Doing so may result in fire or electric shock. In such a situation, protect the equipment with a disposable cover as Turn OFF the power and pull out the plug to each piece of equipment for safety when not used. necessary. CAUTION Power supply Handling 12 User Manual of Luna1013XE Handling 1. Safety Information Handle the equipment carefully. Do not submerge the equipment in water. The internal image sensor may be damaged if something hits against it or it is dropped. Do not place excessive weight on the equipment. Be sure to use the equipment on a protected foam. Otherwise, the internal image sensor may be damaged. Be sure to securely hold the detector while using it in upright positions. Otherwise, the detector may fall over, resulting in injury to the user or patient, or may flip over, resulting in damage to the inner device. Keep the same load (same pressure) on the detector when acquiring the image. Or the image will be incorrect. CAUTION User Manual of Luna1013XE 13 Flat Panel Detector Luna1013XE Do not operate close to fire, do not use in high temperatures Do not invert positive and negative poles Do not contact with metal in case of a short circuit Do not insert sharp objects into the battery Do not hit the battery Do not stand on the battery Do not use the battery for purposes other than those stipulated in the rules Do not dispose of the battery or change its internal structure Do not submerge the battery in water; please keep it dry in storage and do not contact with water while in use Please charge the battery with the charger provided by Manufacturer Do not mix the battery with ones not provided by Manufacturer Do not charge the battery with a broken charger. Charge the battery regularly to avoid over-discharge failure. Do not use the battery when it is severe ballooning. 1.2. Notes for Use product may not function correctly. Before exposure When using the product, take the following precautions. Otherwise, problems may occur and the Be sure to check the connection of all the parts are set properly & check the detector is kept in insulated cover that operator or patient cant touch the detector directly before powered up. Be sure to check the product daily and confirm it work properly. Sudden heating of the room in cold areas will cause condensation on the product. In this case, wait until the condensation evaporates before performing an exposure. If it is used when condensation is formed, problems may occur in the quality of captured images. When an air-

conditioner is used, be sure to raise/lower the temperature gradually to prevent condensation. 14 User Manual of Luna1013XE 1. Safety Information The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map. Make sure wave form of the energy going to the X ray tube is square not pulse. Be cautious with circumstance that someone has radio isotope recently injected into them, it may cause panel transmit image without x ray. Once powered off, please wait at least 60s before power on again During exposure Do not move Power Cable or Ethernet Cable during exposure, or it may cause image noise or artifacts, even incorrect images. Do not use the product near the equipment generating a strong magnetic field. Otherwise, it may cause image noise, artifacts or even incorrect images. After Usage After every examination, wipe the patient contact surfaces with disinfectants such as ethanol, to prevent the risk of infection. For details on how to sterilize, consult a specialist. Do not spray the product directly with disinfectants or detergents. Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as alcohol, benzene and acid. Doing so may damage the surface of the product. Its recommended to use a waterproof non-woven cover as the isolated layer between product and the blooding patient. User Manual of Luna1013XE 15 Flat Panel Detector Luna1013XE 2. General Description Luna1013XEconfigurationLuna1013XE, hereinafter referred as Luna1013XE is a cassette-

size wireless X-ray flat panel detector based on amorphous flexible silicon thin-film transistor technologies. It is developed to provide the good quality of radiographic image, which contains an active matrix of 33182528 with 100 um pixel pitch. The scintillator of Luna1013XE is CsI(Caesium Iodide) which is direct deposit. Since Luna1013XE supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system. 2.1. Scope equipment. This manual contains information about iRay Luna1013XE product. All operators must read and understand this manual before using equipment. All information in this manual, including the illustrations, is based on equipment prototype. If configuration of your equipment does not have any of these items, information about these items in the manual does not apply to your 2.2. Principle Detectors contain a layer of scintillator material, which converts the x-rays into light. Directly behind the scintillator layer is an amorphous silicon pixel array contains a photodiode which generates an electrical signal in proportion to the light produced by the portion of scintillator layer in front of the pixel. The signals from the photodiodes are amplified and encoded by additional User Manual of Luna1013XE 16 electronics positioned behind the sensor array in order to produce an accurate and sensitive digital 2. General Description representation of the x-ray image. 2.3. Characteristics Wireless static flat panel detector AED 802.11ac 16-bit AD 2.4. Intended Use This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem of Equine .The image is obtained as the result of X-ray passing through the Equine and detected by the equipment. IRay will provide equipment and software support for integration of system. This panel is not intended for human. Luna1013XE is a 10x13 wireless portable flat panel detector designed for Equine and EOD application According to the Luna1013XE intended use and the result of risk management, identifying and describing the essential performance as the following:

To get image of dark field, the Luna1013XE shall be not influenced to the imaging acquisition. To keep the data transmission function, the Luna1013XE shall be not influenced to the data and signal transmission 2.5. ESSENTIAL PERFORMANCE According to the Luna series INTENDED USE and the result of risk management, image acquisition and data transmission are defined as ESSENTIAL PERFORMANCE. Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE. Method for getting dark image in detail refers to section installation and operation. 2.6. Application Specification User Manual of Luna1013XE 17 Flat Panel Detector Luna1013XE Equine and EOD application Intended OPERATOR:

All of use, maintenance and operation steps should be carried out by the operator who has accepted the professional training offered by the company's customer service staff. 2.7. The relative position between Equine and detector Because of the crosstalk effect of Amorphous silicon flat-panel detector, Pay attention to the relative position of Equine and detector, Otherwise, the image is prone to abnormal light lines. 2.8. Product Components The product is configured with the components below Item Description Quantity Luna1013XE Detector Adapter AC power cable Battery pack Gigabit Ethernet cable External cable Battery charger CD ROM 2.9. Environment

1pcs 1pcs 2pcs 2pcs 1pcs 1pcs 1pcs 1pcs Temperature Temperature Variation Humidity Atmospheric Pressure Atmospheric Pressure Variation Operating 10~35

<1k/min 5%~90% RH 700~1060hPa Storage

(without battery)

-20~60

<1k/min 5%~95% RH 600~1060hPa

<10kp/min

(1kp=1.0197E-5Pa)

<10kp/min

(1kp=1.0197E-5Pa) 18 User Manual of Luna1013XE 2. General Description 2.10. Components Dsecription 2.10.1. Detector 2.10.2. Indicator External Signals Input and Control Panel User Manual of Luna1013XE 19 Flat Panel Detector Luna1013XE Control Panel NO. Item Description A B C D E Status indicator Detector status Link indicator Detector link status Power Indicator Detector Power indicator Power button Power button DC Input Interface 24V DC input 20 User Manual of Luna1013XE 2.10.3. Battery Pack 2. General Description C B D C A B NO. Item Description A B C D Battery Label Guide Block

Battery Interface 7-pin battery connector Touch Display Show battery level after touching User Manual of Luna1013XE 21 Flat Panel Detector Luna1013XE 2.10.4. Battery Charger Item Name Description Battery Interface A 8 Pin Battery connector Battery Interface B 5 Pin Battery connector Battery Interface C 5 Pin Battery connector Indicator The indicator definition is as follow The limit ball plug Hand Pull Position

AC Jack 220V AC input A B C D E F G 2.11. Product Specification 2.11.1. Detector 22 User Manual of Luna1013XE 2. General Description Specification Item Model Luna1013XE Image Sensor a-Si (Amorphous Silicon) TFT Scintillator CsI Pixel Size Fill Factor 100um 60%

Effective Array 3318*2526 Effective Area (H x V) 331.8 mm*252.6 mm Spatial Resolution 5 lp/mm Image Transfer Cycle Time WIFI 3.5s Power Consumption 19W Max Weight 2kg(with battery) Image Transfer Wireless : IEEE802.11 a/b/g/n/ac Wireless Frequency Range 2.412~2.472GHz, 5.18~5.22GHz; 5.745~5.85GHz Data Transmission Power 13dBm (Typ.) @802.11a 16dBm (Typ.) @802.11b 14dBm (Typ.) @802.11g User Manual of Luna1013XE 23 Flat Panel Detector Luna1013XE 13dBm (Typ.) @802.11n HT20 11dBm (Typ.) @802.11n HT40 16dBm@2.4GHz 13dBm@5GHz Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK) 11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM) Wireless Band 2.4GHz35MHz 5.GHz50MHz X-ray Energy 40-150kV Panel protection IPX5 Trigger Mode Software/AED SID 0-180cm 24 User Manual of Luna1013XE 2.11.2. Battery 2. General Description Item Model Specifications Battery-KX Rated Capacity Min. 4700mAh, Typ. 4900mAh @ Discharge 0.2C Nominal Voltage Charge Voltage 11.55V 13.2V Discharged End Voltage 9V Charging Method CC-CV Operating Temperature Charge 0-+60, Discharge-10-+60 Storage Temperature 3 month -20-+45 1 month-20-+50 6 month -20-+35 Relative Humidity 5%~95%

Dimension (L W H) 210 x 105 x 8 mm Weight 0.285kg 2.11.3. Battery Charger User Manual of Luna1013XE 25 Flat Panel Detector Luna1013XE Item Model Specifications Charger-Combo Simultaneous Charging 1 battery pack Full charging time 3 hours Rated power supply 90V~264V(AC) Dimension (L W H) 240 x 284 x 38 mm Weight 0.55 kg The battery charger indicator definition:

A B C All off Item Name Description Power Indicator Charging Indicator Charge Full Indicator

X Indicator Lighting Status Operating Status No power input 26 User Manual of Luna1013XE ABC 2. General Description AC Power input Multiple batteries inserted Battery insertion self-test Battery Charging Battery capacity full, charging stops Battery charging abnormal A indicator on A indicator on B and C alternately blink 2 times A and B indicator on A and C indicator on A indicator on B and C alternately blinking Two or more battery charging at the same time is prohibited, if inserted at the same time, the charger will automatically stop working. User Manual of Luna1013XE 27 Flat Panel Detector Luna1013XE 3. Basic Operation 3.1. Preparation 3.1.1. Attach Battery Pack The product can be powered by both a battery pack and DC power. Once the battery pack is inserted or DC power is connected, detectors will be turned on immediately. If neither battery nor DC power is connected, panel will power off. Please see below for battery installation. Make sure that connectors on the battery pack are pointed to the opening in the battery compartment. Slide battery package into battery compartment

(Make sure battery capacity overpass is 15%). Slide the battery lock lever. 3.1.2. Adapter Detector supports an external adapter powered, It gets CB certificate No. SG PSB-MD-00005 and NRTL certificate No. U8V 093768 0016.The ports defined as bellow:

28 User Manual of Luna1013XE No. P1 P2 P3 P4 3.Basic Operation Definition Voltage Range Rated Current DC Power Negative DC Power Positive DC Power Positive 0~0.5V 23~25V 23~25V 0~0.42A 0~0.42A 0~0.42A DC Power Negative 0~0.5V 0~0.42A In order to meet the safety and function requirements of the detector, standard components are recommended. AC Adapter 3.2. Routine Operation 3.2.1. Starting Up On the control panel, users can press the power button to turn on. When the detector is powered down, the user presses the button for 4 seconds to turn on the detector if the battery is inserted and the capacity is not less than 7%, or DC power is connected. After booting up, users can check the indicator of the detector. Power indicator:

User Manual of Luna1013XE 29 Flat Panel Detector Luna1013XE Power Indicator Lighting Status Status Battery Capacity DC Input Description Orange Blinking 7% & 15%

NO Detector is on N/A N/A N/A Detector is off YES Detector is on 15% & 95%

YES Detector is on 95%

YES Detector is off Link Indicator Lighting Status Description OFF Green ON Green Blinking Green&Orange Blinking Link indicator:

OFF Blue ON Green ON OFF Green ON Orange ON Detector is turned off Wired connection broken and wireless connection not ready Wireless connection is enabled Wired connection is enabled (Service Mode) Detector is off Exposure is allowed Error Status indicator Mode Indicator Lighting Status Description 3.3. Battery Charger Installation Operation Figure 30 User Manual of Luna1013XE Unload Battery from battery charger. 3.Basic Operation Insert battery into battery charger. Note the interface position as figure. Press the battery to the bottom of battery compartment. User Manual of Luna1013XE 31 Flat Panel Detector Luna1013XE 4. Software Setup 4.1. System requirement iDetector is developed and deployed on Windows Operation System, it can be run on Windows XP/Windows 7/Windows 8/Windows 10, OS should install latest service pack. And requires computer memory 4 GB minimum. The firewall should be shut down to avoid commuication issue. 4.2. Environment setup Setup files and download url are included in SDK directory: Tools\env_setup 1. Please install Microsoft .NET Framework 4.5(Windows XP only can install V4.0 ). Download from 2. Visual C++ redistributed package need to be installed: vcredist_x86_2013(or 3. For Windows XP, full path should be used in file bind.txt. Microsoft web site, please. vcredist_x64_vs2013). can be changed when needed. 4.3. Wireless Connection The wifi information should be configured for first use with wired connection. The configuration The default IP address (IPv4) of the detector is 192.168.8.8, the PC address (IPv4) should be configured as 192.168.8.xxx, which should be the same as the value of parameter Cfg_HostIPin file *\work_dir\Luna1013XE\config.ini 4.3.1. AP Mode 32 User Manual of Luna1013XE On the main window of Home page Select the instance of Luna1013XE and use the Connect button the build the connection. After finishing building the connection, click Read Configbutton on the Wifitab of Detector pag to get the current wifi configuration. Click Read Network Config to get default setting. Change SSID and password setting. make sure SSID is different from other already exist;

4.Software Setup User Manual of Luna1013XE 33 Flat Panel Detector Luna1013XE Change channels and frequency setting Click Channel and choose a clean frequency and channel Click Write Network Config 34 User Manual of Luna1013XE Waiting FPD status be Ready 4.Software Setup 4.3.2. Client Mode Add: add the information of the access point, such as SSID and password. Select: Select the Access Point that needs to be connected to. 4.3.3. Configuration of external wireless card Open local wireless signal list User Manual of Luna1013XE 35 Flat Panel Detector Luna1013XE Select SSID which belongs to detectors;

Input password and log into system Open wireless card configuration open IPV4 setting IP setting as follows IP address: 192.168.8.188 IP address:

192.168.8.188 Subnet mask: 255.255.255.0 36 User Manual of Luna1013XE Subnet mask:

255.255.255.0 Open SDK and choose product start connection 4.Software Setup 4.4. Software UI SDK supply iDetector as tool softwore:

32-bits iDetector.exe: Tools\iDetector\w32 64-bits iDetector.exe: Tools\iDetector\x64 little difference. versions of iDetector. Double click iDetector.exe to run the software. For different software version, the UI maybe has For this manual, the example is based on SDK_*_xxxx. This UI is almost the same for different Tab Function description Home Connect FPD and view the connect state Acquire Acquire image, select correction mode, save image and process image SDK config.ini setting, log level setting Detector Configurate parameters for detector. Calibrate Generate calibration files and manage the calibration files Local File Open and view local images. User Manual of Luna1013XE 37 Flat Panel Detector Luna1013XE 4.4.1. HomePage The main function in this page is to connect detector. Item Function description Name Display the name of detector SN Display the SN of detector Product Type Display the type of detector State Display the connection state (BindUnknown, Ready etc.) Button Function description Connect Click this button to connect the selected detector. Close Click this button to disconnect the selected detector. Add Add work directory Remove Remove work directory Syncbox Open Syncbox configuration window(Optional device) 38 User Manual of Luna1013XE 4.Software Setup 4.4.2. Acquire Page This page is used to acquire image under different work mode, and user can select correction options too. When acquire image finished there will be a preview image shown on the screen (if the correction option is selected, otherwise only the raw images will be shown).The propertities of image is displayed on the left of image window.And on the right of image window there is a list to show thumbnail of images. User can select it and double click to see for detail. User can rotate, reverse or mirror image. User can get the value of AVG and SNR by ROI tool. The acquired images can be save as raw, tiff or dicom formats. Both raw and tiff formats support single frame and continuous frames save. Status bar shows detectors serial number, the current task and state of detector, and feedback information of command. Status bar is also can be seen in other pages, and they are all the same. Item Description SN SN number of current connected detectors State Detectors state , eg busy, ready Task the current task of detector User Manual of Luna1013XE 39 Flat Panel Detector Luna1013XE Functions in this Page. Message feedback information of command,eg succeed,failed Correction Menu Description Offset HWPostOffset Do hardware PostOffset correction for image if checked Gain HWGain Do hardware Gain correction for image if selected Defect HWDefect Do hardware defect correction for image if checked Acqurie Button Description Prep Clear. Prepare to integrate. SingleAcq Acquire once PrepAcq Acquire Save Clear and acquire Seriers acquire images Save the current image, the format is raw and tiff ActiveSensor Active sensor DeactiveSensor Deactive sensor PowerOff Shutdown detector Stitchingflow Image stitching flow Image Properties& Image Process Description WW WL PosX PosY Value Width Height window width window level Image width Image height X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point 40 User Manual of Luna1013XE FPS Frames Mirror ROI 4.Software Setup Frame rate Display the frame count Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters with right click. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. Image List Show thumbnails When the image is displayed on the screen, maybe the user want to see details by dragging or zoom in/out the image, for convenience, these are some shortcuts. 1. Click the left mouse button: movie playback function operation area display. 2. Double-click the left mouse button: the image display in center and with maximum size;

3. Double-click the right mouse button: restore the window level and width for WL:32767/WW:65535;

4. Drag the left mouse button to drag the image display;

5. Lateral-drag the right mouse button to adjust the window width, and vertical-drag the right mouse button to adjust the window level;

F3 Key: Quickly locate the image window width and window level. F4 Key: Adjust window width and window level automatically. 6. 7. User Manual of Luna1013XE 41 Flat Panel Detector Luna1013XE 4.4.3. SDK Pgae SDK page is used to set parameters in config.ini and log level. Different log level will show different details. It is recommended to set the log level as Debug 4.4.4. Detector Page Parameters page. area by Read. In this page, there are Parameters, Sensor and Images tab. 1. Enter Detector page, the tab of Paramters is activity by default. There are 5 regions in this 2. Parameter name region: lists the paramters. 3. Parameter read region: read the parameters, the values of the parameters are displayed in this 4. Parameter write region: write parameter. Entered value of the corresponding parameter in this area can be write to detector. 5. Operation region: functional operation buttons area. 6. Status bar region: status bar for detector state and information of reading or writing parameters, etc. 42 User Manual of Luna1013XE 4.Software Setup Configuration parameters description as below:

Name Description Configurable Product No. Type of detector product Serial No. Serial number of the detector Main Version Firmware version number of the FPGA N Read Version N/A MCU Version Firmware version number of the MCU N Arm Version Version number of the ARM App Kernel Version Version number of ARM Kernel Trigger Mode Tirgger mode of the detector Set Delay Time(ms) Acquire Delay Time(ms) Exp Window Time(ms) Exposure window for AED mode which use a fixed window Exposure window for getting image which use a dynamic window Max exposure window for command trigger which use a dynamic window Src MAC Detector MAC N N N N N Y Y Y Y Y User Manual of Luna1013XE 43 Flat Panel Detector Luna1013XE Button function description:

Function Button Description Reset Detector Reset Detector Read Read parameters Write Write parameters Write RAM Write parameters into RAM(will lost changes after reset) Upgrade Firmware Upgrade firmware L Upload detector log to the specified directory Sensor The mainly function in this page is to probe the temperature and humidity of the detector. Click Read button to get the value of the temperature or humidity. Sensor type Explanation Temperature Read detector temperature Humidity Read detector humidity 44 User Manual of Luna1013XE Battery Read the capacity of the battery Wifi 4.Software Setup User can config the wireless connect parameters on this tab. Images You can Query and upload Images from detector to Workstation. User Manual of Luna1013XE 45 Flat Panel Detector Luna1013XE 4.4.5. Calibrate Page Offset, Gain, Defect calibrate files can be generated and managed in this page. Click Start Generate Templates to enter generating templates page. 46 User Manual of Luna1013XE 4.Software Setup SubTab Description Mode&Files Manage template files Create Offset Create Offset template Create Gain Create Gain template Create Defect Create Defect template Mode&Files page Description Import to Workdir Copy template file into current calibration directory. Download to FPD Select one item first. Then click this button to download selected template file(s) into detector. UpLoad to Workdir Select one item in Fpd template file control and select one item in Subset settings control. Click this button to upload selected template from detector into specified calibration directory. Upload Lag Upload Lag into SDK current directory Active Select one item in list. Click this button to activate selected template for hardware correction. User Manual of Luna1013XE 47 Flat Panel Detector Luna1013XE UpdateHWPreOffset Force detector update Offset template ReadStatus Get the current state of template for hardware correction, enable/disable Generate Gain Template File If the relative position between tube and detector changed or KV value changed, it suggest to create gain template file. 1. Enter Create Gain page images. Click "Start" button to start process, the offset type should be selected, then start to get the 2. Click PREP button, then exposure after Acquire button enable. After receving the PREP request, the detector needs some time to be ready, the decounting bar will apear when the exposure window is opened. After exposure user can click Acquire button to acquire the X-

Ray image. 48 User Manual of Luna1013XE 4.Software Setup The gain template generation process needs 5 images total, the UI gives the recommended KV and target value, user can use different ones if needed. After accepting the current image, the Stage will turn to 2/5, 3/5 and so on. The current value box will show different colors, the definitons are as below:

Yellow: The current value is higher or lower than the expected one, user decides if acceptable. For example, the expected value is 20000, and user needs 40000 as the gain piont, the yellow warning can be ignored, and the value can be accepted still. Green:

The value is good. Red:

The value is un-acceptable. 3. After getting 5 images, user can generate the Gain template by Generate button, and the process can be exited from at anytime by using Cancel button. If Download to FPD after generation is checked, then the download UI will appear after finishing generating. User can refer to the part of Generate Defect Template File"

User Manual of Luna1013XE 49 Flat Panel Detector Luna1013XE 4. When the generating process is finished, the UI will give the message of successful. Generate Defect Template File The process of generate defect map is quite similar with the one of gain map. 1. On the Create Defect page, user can start the generating process by Start button. And the process can be quit by Cancel. 50 User Manual of Luna1013XE 4.Software Setup 2. There are 8 images that need to be acquired, the UI gives the recommend KV and expected image value, user should refer with them. 3. If the option Download to FPD after generation is checked, the download UI will appear after finishing generating the defect map which will takes a little time. The field of Index in FPD means that the detector can store several correction maps and choose one set to active as user wants. The Download files part show the directory of the generated map stored on the workstation. 4. After choosing the stored index of FPD, the download process can be started by the Download button, user should wait the process until it is finished. 5. The correction map also can be managed at anytime on the page of Mode&Files. Choose the item of Default in the Subset settings part and click Download to FPD to finish downloading the maps into the detector. User Manual of Luna1013XE 51 Flat Panel Detector Luna1013XE Upload the correction files 1. The correction maps can be uploaded to the workstation too. Choose the gain or defect in the Fpd template filesand the Default directory in the Subset settings, then click the Upload to workdir. 2. When the upload process is finished, the UI will give the message. 52 User Manual of Luna1013XE The correction maps should be enabled before using hardware correction, read status first, then choose the gain or defect, enable the map by clicking Active button. 4.Software Setup 4.4.6. Local Page In this page user can open the image files saved in local, the file formate can be dcm, raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. The pixel matrix is defined as below:

Active area : 3318*2526 What needs to be notice is only the active area pixels will be displayed when use load file funtion, the value of dummy pixels and empty channels will be filled by 65535. User Manual of Luna1013XE 53 Flat Panel Detector Luna1013XE This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image area by right mouse button. This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Width Description window width window level X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point Image width Height Image height 54 User Manual of Luna1013XE 4.Software Setup Mirror ROI Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. User Manual of Luna1013XE 55 Flat Panel Detector Luna1013XE 5. Operation Instructions for Image Acquisition Luna1013XE provides SDK for users to integrate detector into their DR system. Additionally, it also provides an application for demonstration, i.e. IDetector. User can use IDetector to control detector without DR system. 5.1. Steps for acquiring image Make sure the hardware is connected correctly and then power on. Once powered off, please wait at least 60s before power on again Wait until initialization is complete Connect the software choose the synchronization mode equilibrium Acquire images in the selected mode Generate HWPreOffset, Gain and Defect template after the detector reaches thermal To Acquire X-ray image is the main operation of Luna1013XE. Most importantly, detector should build synchronization with X-ray generator. Luna1013XE has one synchronization modes to acquire X-ray image, which is Software Mode. 5.2. Software Mode 5.2.1. Block Diagram Software mode is the basic way to acquire X-ray image. Please see figure below for general feature. Workstation is a host PC device installed with iDetector and SDK. FPD is the Flat Panel Detector and HVG is the High Voltage Generator. In this mode, Workstation does not have to control X-ray generator. Users would decide when to shoot X-ray. 56 User Manual of Luna1013XE HVGX-TubeFPDWork Station 5.Operation Instructions For Image Acquisition 5.2.2. Work Flow(PrepAcq) correction options. Also, the software correction is supported. Select HWPostOffsetHWGainHWDefect. If user need the raw image, please de-select all these 1. Send CmdPrepAcq on UI Acquire page. 2. After receiving the Cmd_PrepAcq, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The XWIN is configured by parameter Clear Acq Delay Time on SDK page, the unit is ms. 4. User needs to make sure the X-Ray ends within the XWIN. 5. The detector will send the images after the XWIN closed. 6. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.2.3. Work Flow(Prep+Acq) 1. Send CmdPrep on UI Acquire page. User Manual of Luna1013XE 57 IDLEPrepareXWIN1(fixed)X-RayimagingCmd_PrepAcqAck_ProhibitAck_EnableXWIN1(fixed)OffsetimagingRAW PreviewRAW X-Ray image(If HW-offset is disabled)RAW offset(Or corrected)imageIDLEPrepareXWIN2(dynamic)X-RayimagingCmd_PrepAck_ProhibitAck_EnableXWIN2(dynamic)OffsetimagingRAW PreviewRAW X-Ray image(If HW-offset is disabled)RAW offset(Or corrected) imageCmd_SingleAcqX-Ray Flat Panel Detector Luna1013XE 2. After receiving the Cmd_Prep, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The max XWIN is configured by parameter Exp Window Time on Detector page Parameter tab, the unit is ms. 4. User starts the X-Ray. Send SingleAcq on UI Acquire page after the X-Ray is end. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.3. AED Mode 5.3.1. Inner 1. The detector is in low power state, user needs to send Cmd Prep to make the detector exit to idle state which indicated by the acknowledge to Cmd Prep. 2. When the detector is in idle state, user can start the X-Ray any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 58 User Manual of Luna1013XE 5. 6. IDLEXWIN1(fixed)X-RayimagingXWIN1(fixed)OffsetimagingX-RayInfoRAW PreviewRAW X-Ray imageIf HW-offset is disabledRAW Offset(Or corrected)imageLow powerPrepAck 5.3.2. Freesync Mode 5.Operation Instructions For Image Acquisition 1. For Freesync mode, there is no low power state. 2. When the detector is Idle, user can start the exposure flow any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.4. After use 1. Disconnect the software 2. Power off 3. Keep it clean 4. Store under specified conditions calibration in each 6 months. 5.5. Correction and Calibration Template Generation The correction and calibration should be performed after installation and it is recommended to perform the new correction and calibration after any major change on the system settings and hardware configuration. On the other hand, it is also recommended to do the correction and User Manual of Luna1013XE 59 IDLEXWIN1(fixed)X-RayimagingXWIN1(fixed)OffsetimagingX-RayInfoRAW PreviewRAW X-Ray imageIf HW-offset is disabledRAW Offset(Or corrected)image Flat Panel Detector Luna1013XE 5.5.1. HW pre-offset Template Generation Enter Acquire interface, select HWPostOffset option Enter Calibrate interface, click UpdateHWPreOffset button. Waiting until status bar displayed:

"Task succeed:

HwGeneratePreOffsetTemplate 5.5.2. Gain Calibration Template Generation If the relative position between tube and detector changed or KV value changed, it suggest to create gain template file. Enter Create Gain page Click "Start" button to start process. 60 User Manual of Luna1013XE Click PREP button, acquire image. Please exposure after Acquire button enable. And click Acquire button to acquire image after exposure end. Click Accept button after acquired image. If Current Value textbox is yellow, click PREP button. Re-acquire images after adjust generator parameters. Note: In different trigger mode, the operation maybe have little difference. Please follow the UI tips. Mind:

If the detector is in inner or Freesync mode, then user should finish the exposure before the time bar counting ends. And the click on Acquire is not necessary for inner or Freesync. Create gain template need several images. You can click Generate button to generate Gain template once one image was captured. But it may lead to imperfect template quanlity. Download template file dialog will pop up if "Download to FPD after generation" option was checked. Click Download button to download the template into the detector. 5.Operation Instructions For Image Acquisition User Manual of Luna1013XE 61 Flat Panel Detector Luna1013XE Select Mode&Files tab. Click Read Status button to check whether just downloaded gain template is enable. If not, please click Active button to enable. 5.5.3. Defect Correction Template Generation Enter Acquire UI. Choose HWPostOffset. Enter Calibrate UI. Select Create Defect tab. Click "Start" button to start process. Click PREP button, acquire image. Please exposure after Acquire button enable. And click Acquire button to acquire image after exposure end. Click 62 User Manual of Luna1013XE Accept button after acquired image. If Current Value textbox is yellow , click PREP button. Re-

acquire images after adjust generator parameters. Note: In different trigger mode, the operation maybe have little difference. Please follow the UI tips. You can click Generate button to generate Gain template after acquired required images. Download template file dialog will pop up if "Download to FPD after generation" option was checked. Click Download button to download the template into the detector. 5.Operation Instructions For Image Acquisition User Manual of Luna1013XE 63 5.6. Local Image Check OPEN provides two features for image check and uploading. Local Image Check, Panel Image Upload. Local Image Check defines function to check image saved in Workstation. Panel Image Upload defines function to upload images stored in panel. Flat Panel Detector Luna1013XE Select Mode&Files tab. Click Read Status button to check whether just downloaded gain template is enable. If not, please click Active button to enable. Click Local File button in Local File UI, choose the specified file In this page user can open the image files saved in local, the file formate can be raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. Luna1013XE image size: 4267*4267 64 User Manual of Luna1013XE 5.Operation Instructions For Image Acquisition area by right mouse button. This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Width Height Mirror ROI Description window width window level Image width Image height X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI WW/WL Auto adjust WW/WL based on selected area by right area. button of mouse. 5.7. Firmware Upgrade Panel supports upgrading firmware with IDetector, also allows the use of the Web way to upgrade the firmware, if a user needs to upgrade the firmware, please complete the following steps. On Detector PageParameter Tabuser can upgrade firmware by entrance button Upgrade Firmware. User Manual of Luna1013XE 65 Flat Panel Detector Luna1013XE The firmware upgrade package may contain firmware of several units: ARM, FPGA, MCU. Luna1013XE_IMAGE_44_ALL_20XX_XX_XX.ifrm Word ALL indicates the file contains the firmware upgrade file for all units. Luna1013XE_IMAGE_44_ARM_20XX_XX_XX.ifrm Word ARM indicates the file is only for ARM. Luna1013XE_IMAGE_44_FPGA_20XX_XX_XX.ifrm Word FPGA indicates the file is only for FPGA. Luna1013XE_IMAGE_44_MCU_20XX_XX_XX.ifrm Word MCU indicates the file is only for MCU. User can choose one of these files as required to start the upgrade. Choose the file that needs to be upgraded, and must check the package info to confirm if it is correct. 66 User Manual of Luna1013XE 5.Operation Instructions For Image Acquisition 1. There is a progress bar for indication. Make sure battery is inserted and battery capacity is over 2. Please make sure that iDetector shows Ready. It can also be checked by click Config button, there is firmware version. Note:

25%

User Manual of Luna1013XE 67 6.Regulatory Information 6. Regulatory Information 6.1.1. FCC Compliance The panel has been tested to comply with limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. The panel generates, uses, and radiates radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If the panel does cause harmful interference to radio or television reception, which can be determined by turning the panel off and on, the user is encouraged to correct the interference by one or more of the following measures. Reorient or relocate the antenna. Increase the separation between the panel and receiver. Connect the panel into an outlet different from the receiver is connected. Consult the distributor or an experienced radio/TV technician for help. Operation is subject to the following two conditions. The panel may not cause harmful interference. The panel must accept any interference received, including interference that may cause This device complies with FCC SAR exposure limits set forth for an uncontrolled environment. The equipment can be used in close proximity to the human body without undesired operation. any restrictions. Note: the grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. such modifications could void the users authority to operate the equipment 68 E User Manual of Luna1013X 7.Trouble Shooting 7. Trouble Shooting Please refer to service manual. If the problem persists, turn off the panel and contact iRay service department (service@iraygroup.com). We would provide the best service User Manual of Luna1013XE 69 lat Panel Detector Luna1013XE 8. Service Information 8.1. Service Office Information 8.2. Product Lifetime maintenance. The estimated product lifetime is up to 5 years under appropriate regular inspection and 8.3. Regular Inspection and Maintenance In order to ensure the safety of patients and operator, to maintain the performance and reliability of the panel, be sure to perform regular inspection at least once a year. If necessary, clean up the panel, make adjustments or replace consumables such as fuses etc. There may be cases where overhaul is recommended depending on conditions. Contact iRay service office or local iRay dealer for regular inspection or maintenance. If problem cannot be solved, contact your sales representative or local iRay dealer for repairs. Please refer to the label and provide the following information:

8.4. Repair Product Name:

Series Number:

Description of Problem: as clearly as possible. 70 User Manual of Luna1013XE 8.Service Information 8.5. Replacement Parts Support Main parts (parts required to maintain the function of the product) of this product will be stocked for 5 years after discontinuance of production for repairing. User Manual of Luna1013XE 71 lat Panel Detector Luna1013XE Appendix A Information of Manufactures COMPANY:

iRay Technology Taicang Ltd. ADDRESS:

No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Jiangsu, China ZIP CODE:

215434 TELEPHONE:

+86 0512-53690872 FAX:

+86 0512-53690872 HOMEPAGE: WWW.IRAYGROUP.COM 72 User Manual of Luna1013XE APPENDIX Appendix B Information of Europe Representative COMPANY:

iRay Europe GmbH ADDRESS:

IN DEN DORFWIESEN 14, 71720 OBERSTENFELD GERMANY ZIP CODE:

TELEPHONE:

+49-7062-977 88 00 FAX:

+49-7062-976 0571 HOMEPAGE: WWW.IRAYEUROPE.COM User Manual of Luna1013XE 73

Wireless Digital Flat Panel Detector NDT1013LA User Manual Version A0 Doc ID 167-201-02 Release Date:2021.01.13 Before operating, please read this user manual and pay attention to all safety precautions. Please ensure that this user manual is properly maintained so that it can be accessed at any time Please use it correctly based on full understanding of the content. E

(reserve). To Customers Congratulations on your purchase of the Flat Panel Detector (hereinafter referred to as NDT1013LA) which is manufactured by iRay Technology Company Ltd. (Hereinafter referred to as iRay). Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay NDT1013LA. If you have any questions or suggestions, please feel free to contact us. To Customers Congratulations on your purchase of the Fixed Digital Flat Panel (hereinafter referred to as NDT1013LA) which is manufactured by iRay Technology Co.Ltd. (Hereinafter referred to as iRay). At iRay, we strive to not only make the world-class products that deliver the best value possible to our customers but also offer the highest quality of service and customer care. Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay NDT1013LA If you have any questions or suggestions, pleasedo not hesitate to contact us. Notes on usage and management of the equipment 1. Read all of the instructions in the user guide before your operation. Give particular attention to all safety precautions. 2. Only a physician or a legally certified operator should use this product. 3. The equipment should be maintained in a safe and operable condition by maintenance 4. Use only the dedicated cables. Do not use any cables other than those supplied with this personnel. product. 5. Request your sales representative or local iRay dealer to install this product User Manual of NDT1013LA 1 Wireless Digital Flat Panel Detector Caring for your environment commercial waste. Recycling iRay Equipment This symbol indicates that this product is not to be disposed of with your residential or Please do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste items. Contact your local authorities for information about practices established in your region. If collection systems are not available, call iRay Customer Service for assistance. Disclaimer 1. iRay shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product. 2. iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to this product or failure to strictly comply with iRays operating and maintenance instructions. 3. iRay shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as Original iRay Products by iRay 4. It is the responsibilities of the user/attending physicians for maintaining the privacy of image data and providing medical care services. iRay shall not be responsible for the legality of image processing, reading and storage nor it shall be responsible for loss of image data for Technology. any reason. 5. Information regarding specification, compositions, and appearance of this product is subject to change without prior notice. 2 User Manual of NDT1013LA To Customers Copyright All rights reserved NDT1013LA. Trademarks No part of this publication may be reproduced in any form or by any means without the written permission of iRay. The information contained herein is designed only for use with iRay The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd. User Manual of NDT1013LA 3 Wireless Digital Flat Panel Detector Symbols and Conventions The following symbols and conventions are used throughout the user guide. Identify the conditions under which improper use of the product may cause death or serious personal injury. Identify conditions under which improper use of the product may cause minor personal injury. Identify conditions under which improper use of the product may cause property damage. Indicate a prohibited operation. Indicate an action that must be performed Indicate important operations and restrictions. Indicate operations for reference and complementary information. 4 User Manual of NDT1013LA To Customers Labels and markings on the equipment The contents of the label and mark on iRay NDT1013LA product are indicated as below:

Symbol Description Caution: please refer to the instructions in the user manual. Indicates that the equipment has passed CE testing and the CE Notified Body number follows it. Serial number of the product. Name and address of the manufacturer. Manufacturing date of this product. Expiring date of this product. Name and address of iRay authorized representative in the European region. Consultation of the user guide for general information. This product is not to be disposed of with your residential or commercial waste. Safety Signs:

Safety Signs Dangerous Voltage. Please refer to the user guide for safety instructions. User Manual of NDT1013LA 5 Wireless Digital Flat Panel Detector Handled with care. Operational temperature limits. Storage temperature limits. Fragile Keep away from sunlight Keep dry Storage Humidity limits. Keep the equipment up right. Do not roll the transportation package. Stacking limit number. ON Switch to this position means power on for part of the equipment OFF Switch to this position means power off for part of the equipment 6 User Manual of NDT1013LA 1. Safety Information Contents CONTENTS ................................................................................................................................... 7 1. GENERAL DESCRIPTION .................................................................................. 9 1.1. Safety Precautions ...................................................................................... 9 1.2. Notes for Use ............................................................................................. 14 2. GENERAL DESCRIPTION ................................................................................ 16 2.1. Scope ......................................................................................................... 16 2.2. Principle ..................................................................................................... 16 2.3. Characteristics ........................................................................................... 17 2.4. Intended Use ............................................................................................. 17 2.5. ESSENTIAL PERFORMANCE .................................................................. 17 2.6. Application Specification ............................................................................ 17 2.7. The relative position between newborns and detector .............................. 18 2.8. Product Components ................................................................................. 18 2.9. Environment ............................................................................................... 18 2.10. Components Dsecription ......................................................................... 19 2.11 Product Specification .................................................................................. 22 3. BASIC OPERATION .......................................................................................... 28 3.1. Preparation ................................................................................................ 28 3.2. Routine Operation ..................................................................................... 29 3.3. Battery Charger Installation ........................................................................ 30 4. SOFTWARE SETUP .......................................................................................... 32 4.1. System requirement ................................................................................ 32 4.2. Environment setup................................................................................... 32 4.3. Wireless Connection................................................................................ 32 4.4. Software UI .............................................................................................. 37 4.5. List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

NETWORK ......................................................................................................... 55 5. OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION ............................ 56 User Manual of NDT1013LA 7 Wireless Digital Flat Panel Detector NDT1013LA 5.1. Steps for acquiring image ........................................................................ 56 5.2. Software Mode ........................................................................................ 56 5.3. AED Mode ............................................................................................... 58 5.4. After use .................................................................................................. 59 5.5. Correction and Calibration Template Generation .................................... 59 5.6. Local Image Check .................................................................................. 64 5.7. Firmware Upgrade ................................................................................... 66 REGULATORY INFORMATION ........................................................................ 68 FCC Compliance ................................................................................................ 68 TROUBLE SHOOTING ...................................................................................... 69 SERVICE INFORMATION ................................................................................. 70 8.1. Service Office Information ....................................................................... 70 8.2. Product Lifetime ....................................................................................... 70 8.3. Regular Inspection and Maintenance ...................................................... 70 8.4. Repair ...................................................................................................... 70 8.5. Replacement Parts Support .................................................................... 71 APPENDIX A INFORMATION OF MANUFACTURES .............................................................. 72 APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE ............................................ 73 6. 7. 8. 8 User Manual of NDT1013LA 1. Safety Information 1. General Description 1.1. Safety Precautions equipment/data Follow these safeguards and properly use the equipment to prevent injury and damage to any Installation and environment Do not use or store the equipment near flammable chemicals such as alcohol, thinner, benzene, etc. of use WARNING If chemicals spill or evaporate, it may result in fire or electric shock through contact with electric parts inside the equipment. Also, some disinfectants are flammable. Be sure to take care when using them. Do not connect the equipment with anything other than specified. Doing so may result in fire or electric shock. All the patients with active implantable medical devices should keep away from the equipment. Power supply Do not operate the equipment using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in fire or electric shock. Do not handle the equipment with wet hands. You may experience electric shock that could result in death or serious injury. Do not place heavy object such as medical equipment on cables and cords. Do not pull, bend, bundle, or step on them to prevent their sheath from being damaged, and do not alter them neither. Doing so may damage the cords, which could result in fire or electric shock. Do not supply power to more than one piece of equipment using the same AC outlet. Doing so may result in fire or electric shock. Do not turn ON the system power when condensation has formed on the equipment. Doing so may result in fire or electric shock. User Manual of NDT1013LA 9 Wireless Digital Flat Panel Detector NDT1013LA Power supply Do not connect a multiple portable socket-outlet or extension cord to the system. Doing so may result in fire or electric shock. To avoid the risk of electric shock, this equipment must only be connected to power supply with protective earth. Not doing so may result in fire or electric shock. Handling Securely plug the power cord into the AC outlet. If contact failure occurs, or if metal objects come into contact with the exposed metal prongs of the plug, fire or electric shock may Be sure to turn OFF the power to each piece of equipment before connecting or disconnecting the cords. Otherwise, you may get an electric shock that could result in death result. or serious injury. Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the core wire may be damaged, resulting in fire or electric shock. WARNING Never disassemble or modify the equipment. No modification of this equipment is allowed. Parts of the NDT1013LA that are not serviced or maintained while in use with the patient. Doing so may result in fire or electric shock. Also, since the equipment incorporates parts that may cause electric shock as well as other hazardous parts, touching them may cause death or serious injury. Do not place anything on top of the equipment. The object may fall and cause an injury. Also, if metal objects such as needles or clips fall into the equipment, or if liquid is spilled, it may result in fire or electric shock. Do not hit or drop the equipment. The equipment may be damaged if it receives a strong jolt, which may result in fire or electric shock if the equipment is used without Do not put the equipment and pointed objects together. The equipment may be damaged. If so, the equipment should be being repaired. used in bucky. 10 User Manual of NDT1013LA When a problem occurs Maintenance and inspection 1. Safety Information Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment. Should any of the following occurs, immediately unplug the powercable or battery, and contact your sales representative or local iRay dealer:

When there is smoke, an odd smell or abnormal sound. When liquid has been spilled into the equipment or a metal object has entered through an opening. When the equipment has been dropped and damaged. Please turn OFF the power of the equipment and unplug the power cord of adaptor before cleaning. NEVER use alcohol, ether and other flammable cleaning agent for safety. NEVER use methanol, benzene, acid and base because they will erode the equipment. DON'T dip the equipment into the liquid. Please make sure that the equipment's surface & plugs are dry before turning ON. Otherwise, it may result in fire or electric shock. Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug, its periphery and AC outlet with a dry cloth. If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture; this could cause insulation failure that may result in a fire. For safety reasons, be sure to turn OFF the power to each piece of equipment when performing inspections indicated in this manual. Otherwise, electric shocks may occur. CAUTION User Manual of NDT1013LA 11 Wireless Digital Flat Panel Detector NDT1013LA of use Installation and environment Do not install the equipment in any of the locations listed below. Doing so may result in failure, malfunction, equipment falling, fire or injury. Close to facilities where water is used Where it will be exposed to direct sunlight Close to the air outlet of an air-conditioner or ventilation equipment Close to heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where temperature or humidity is high Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area Take care that cables do not become tangled during use. Also, be careful not to get your feet caught by cable. Otherwise, it may cause a malfunction of the equipment or injury of the user due to tripping over the cable. Always connect the three-core power cord plug to a grounded AC power outlet. To make it easy to disconnect the plug at any time, avoid putting any obstacles near the outlet. Otherwise, it may not be possible to disconnect the plug in an emergency. Be sure to ground the equipment to an indoor grounded connector. Also, be sure to connect all the grounds for the system to a common ground. Do not use any power source other than the one provided with this equipment. Otherwise, fire or electric shock may be caused due to leakage. Do not spill liquid or chemicals onto the equipment. In case the patient is injured, it is not allowed to contact with blood or other body fluids. Doing so may result in fire or electric shock. In such a situation, protect the equipment with a disposable cover as Turn OFF the power and pull out the plug to each piece of equipment for safety when not used. necessary. CAUTION Power supply Handling 12 User Manual of NDT1013LA Handling 1. Safety Information Handle the equipment carefully. Do not submerge the equipment in water. The internal image sensor may be damaged if something hits against it or it is dropped. Do not place excessive weight on the equipment. Be sure to use the equipment on a protected foam. Otherwise, the internal image sensor may be damaged. Be sure to securely hold the detector while using it in upright positions. Otherwise, the detector may fall over, resulting in injury to the user or patient, or may flip over, resulting in damage to the inner device. Keep the same load (same pressure) on the detector when acquiring the image. Or the image will be incorrect. CAUTION User Manual of NDT1013LA 13 Wireless Digital Flat Panel Detector NDT1013LA Do not operate close to fire, do not use in high temperatures Do not invert positive and negative poles Do not contact with metal in case of a short circuit Do not insert sharp objects into the battery Do not hit the battery Do not stand on the battery Do not use the battery for purposes other than those stipulated in the rules Do not dispose of the battery or change its internal structure Do not submerge the battery in water; please keep it dry in storage and do not contact with water while in use Please charge the battery with the charger provided by Manufacturer Do not mix the battery with ones not provided by Manufacturer Do not charge the battery with a broken charger. Charge the battery regularly to avoid over-discharge failure. Do not use the battery when it is severe ballooning. 1.2. Notes for Use product may not function correctly. Before exposure When using the product, take the following precautions. Otherwise, problems may occur and the Be sure to check the connection of all the parts are set properly & check the detector is kept in insulated cover that operator or patient cant touch the detector directly before powered up. Be sure to check the product daily and confirm it work properly. Sudden heating of the room in cold areas will cause condensation on the product. In this case, wait until the condensation evaporates before performing an exposure. If it is used when condensation is formed, problems may occur in the quality of captured images. When an air-

conditioner is used, be sure to raise/lower the temperature gradually to prevent condensation. 14 User Manual of NDT1013LA 1. Safety Information The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map. Make sure wave form of the energy going to the X ray tube is square not pulse. Be cautious with circumstance that someone has radio isotope recently injected into them, it may cause panel transmit image without x ray. Once powered off, please wait at least 60s before power on again During exposure Do not move Power Cable or Ethernet Cable during exposure, or it may cause image noise or artifacts, even incorrect images. Do not use the product near the equipment generating a strong magnetic field. Otherwise, it may cause image noise, artifacts or even incorrect images. After Usage After every examination, wipe the patient contact surfaces with disinfectants such as ethanol, to prevent the risk of infection. For details on how to sterilize, consult a specialist. Do not spray the product directly with disinfectants or detergents. Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as alcohol, benzene and acid. Doing so may damage the surface of the product. Its recommended to use a waterproof non-woven cover as the isolated layer between product and the blooding patient. User Manual of NDT1013LA 15 Flat Panel Detector NDT1013LA 2. General Description NDT1013LAconfigurationNDT1013LA, hereinafter referred as NDT1013LA is a wireless X-

ray flat panel detector based on amorphous flexible silicon thin-film transistor technologies. It is developed to provide the good quality of radiographic image, which contains an active matrix of 33282560 with 100 um pixel pitch. The scintillator of NDT1013LA is CsI(Caesium Iodide) which is direct deposit. Since NDT1013LA supports multiple trigger modes, which designed for field inspection application, including Industry Non-Destructive Testing and Security Inspection.. 2.1. Scope equipment. This manual contains information about iRay NDT1013LA product. All operators must read and understand this manual before using equipment. All information in this manual, including the illustrations, is based on equipment prototype. If configuration of your equipment does not have any of these items, information about these items in the manual does not apply to your 2.2. Principle Detectors contain a layer of scintillator material, which converts the x-rays into light. Directly behind the scintillator layer is an amorphous silicon pixel array contains a photodiode which generates an electrical signal in proportion to the light produced by the portion of scintillator layer in front of the pixel. The signals from the photodiodes are amplified and encoded by additional electronics positioned behind the sensor array in order to produce an accurate and sensitive digital representation of the x-ray image. User Manual of NDT1013LA 16 2. General Description 2.3. Characteristics Wireless static flat panel detector AED 802.11ac 16-bit AD 2.4. Intended Use IRay will provide equipment and software support for integration of system. NDT1013LA is a 10x12 wireless portable flat panel detector designed for field inspection application, including Industry Non-Destructive Testing and Security inspection. According to the NDT1013LA intended use and the result of risk management, identifying and describing the essential performance as the following:

To get image of dark field, the NDT1013LA shall be not influenced to the imaging acquisition. To keep the data transmission function, the NDT1013LA shall be not influenced to the data and signal transmission 2.5. ESSENTIAL PERFORMANCE According to the Luna series INTENDED USE and the result of risk management, image acquisition and data transmission are defined as ESSENTIAL PERFORMANCE. Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE. Method for getting dark image in detail refers to section installation and operation. 2.6. Application Specification Intended OPERATOR:

All of use, maintenance and operation steps should be carried out by the operator who has accepted the professional training offered by the company's customer service staff. User Manual of NDT1013LA 17 Wireless Digital Flat Panel Detector NDT1013LA 2.7. The relative position between newborns and detector Because of the crosstalk effect of Amorphous silicon flat-panel detector, Pay attention to the relative position of newborns and detector, Otherwise, the image is prone to abnormal light lines. 2.8. Product Components The product is configured with the components below Item Description Quantity NDT1013LA Detector Adapter Battery pack Gigabit Ethernet cable AC power cable DC power cable Battery charger CD ROM 2.9. Environment

1pcs 1pcs 2pcs 1pcs 1pcs 1pcs 1pcs 1pcs Temperature Temperature Variation Humidity Atmospheric Pressure Atmospheric Pressure Variation Operating 10~35

<1k/min 5%~90% RH 700~1060hPa Storage

(without battery)

-20~60

<1k/min 5%~95% RH 600~1060hPa

<10kp/min

(1kp=1.0197E-5Pa)

<10kp/min

(1kp=1.0197E-5Pa) 18 User Manual of NDT1013LA 2.10. Components Dsecription 2.10.1. Detector 2. General Description 2.10.2. Indicator External Signals Input and Control Panel Control Panel NO. Item Description A B C D Status indicator Detector status Link indicator Detector link status Power Indicator Detector Power indicator Power button Power button User Manual of NDT1013LA 19 Wireless Digital Flat Panel Detector NDT1013LA E DC Input Interface 24V DC input 20 User Manual of NDT1013LA 2.10.3. Battery Pack 2. General Description C B D C A B NO. Item Description A B C D Battery Label Guide Block

Battery Interface 7-pin battery connector Touch Display Show battery level after touching User Manual of NDT1013LA 21 Wireless Digital Flat Panel Detector NDT1013LA 2.10.4. Battery Charger Item Name Description Battery Interface A 8 Pin Battery connector Battery Interface B 5 Pin Battery connector Battery Interface C 5 Pin Battery connector Indicator The indicator definition is as follow The limit ball plug Hand Pull Position

AC Jack 220V AC input A B C D E F G 2.11 Product Specification 2.11. Detector 22 User Manual of NDT1013LA 2. General Description Item Model NDT1013LA Specification Image Sensor a-Si (Amorphous Silicon) TFT Scintillator CsI Pixel Size 100um User Manual of NDT1013LA 23 Wireless Digital Flat Panel Detector NDT1013LA Fill Factor 60%

Effective Array 3152*2502 Effective Area (H x V) 315.2 mm*250.6mm Spatial Resolution 5 lp/mm Image Transfer Cycle Time WIFI 5s Power Consumption 19W Max Weight 2kg(with battery) Image Transfer Wireless : IEEE802.11 a/b/g/n/ac Wireless Frequency Range 2.412~2.472GHz, 5.18~5.22GHz; 5.745~5.85GHz Data Transmission Power 13dBm (Typ.) @802.11a 16dBm (Typ.) @802.11b 14dBm (Typ.) @802.11g 13dBm (Typ.) @802.11n HT20 11dBm (Typ.) @802.11n HT40 16dBm@2.4GHz 13dBm@5GHz Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK) 11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM) Wireless Band 2.4GHz35MHz 5.GHz50MHz X-ray Energy 40-150kV Trigger Mode Software/AED SID 0-180cm 24 User Manual of NDT1013LA 2.11.2. Battery 2. General Description Item Model Specifications Battery-KX Rated Capacity Min. 4700mAh, Typ. 4900mAh @ Discharge 0.2C Operating Temperature Charge 0-+60, Discharge-10-+60 Nominal Voltage Charge Voltage 11.55V 13.2V Discharged End Voltage 9V Charging Method CC-CV Storage Temperature 3 month -20-+45 1 month-20-+50 6 month -20-+35 Relative Humidity 5%~95%

Dimension (L W H) 210 x 105 x 8 mm Weight 0.285kg User Manual of NDT1013LA 25 Wireless Digital Flat Panel Detector NDT1013LA 2.11.3. Battery Charger Item Model Specifications Charger-Combo Simultaneous Charging 1 battery pack Full charging time 3 hours Rated power supply 90V~264V(AC) Dimension (L W H) 240 x 284 x 38 mm Weight 0.55 kg The battery charger indicator definition:

A B C All off Item Name Description Power Indicator Charging Indicator Charge Full Indicator

X Indicator Lighting Status Operating Status No power input 26 User Manual of NDT1013LA ABC A indicator on A indicator on B and C alternately blink 2 times A and B indicator on A and C indicator on A indicator on B and C alternately blinking 2. General Description AC Power input Multiple batteries inserted Battery insertion self-test Battery Charging Battery capacity full, charging stops Battery charging abnormal Two or more battery charging at the same time is prohibited, if inserted at the same time, the charger will automatically stop working. User Manual of NDT1013LA 27 Wireless Digital Flat Panel Detector NDT1013LA 3. Basic Operation 3.1. Preparation 3.1.1. Attach Battery Pack The product can be powered by both a battery pack and DC power. Once the battery pack is inserted or DC power is connected, detectors will be turned on immediately. If neither battery nor DC power is connected, panel will power off. Please see below for battery installation. Make sure that connectors on the battery pack are pointed to the opening in the battery compartment. Slide battery package into battery compartment

(Make sure battery capacity overpass is 15%). Slide the battery lock lever. 3.1.2. Adapter Detector supports an external adapter powered, It gets CB certificate No. SG PSB-MD-00005 and NRTL certificate No. U8V 093768 0016.The ports defined as bellow:

28 User Manual of NDT1013LA No. P1 P2 P3 P4 3.Basic Operation Definition Voltage Range Rated Current DC Power Negative DC Power Positive DC Power Positive 0~0.5V 23~25V 23~25V 0~0.42A 0~0.42A 0~0.42A DC Power Negative 0~0.5V 0~0.42A In order to meet the safety and function requirements of the detector, standard components are recommended. AC Adapter 3.2. Routine Operation 3.2.1. Starting Up On the control panel, users can press the power button to turn on. When the detector is powered down, the user presses the button for 4 seconds to turn on the detector if the battery is inserted and the capacity is not less than 7%, or DC power is connected. After booting up, users can check the indicator of the detector. Power indicator:

User Manual of NDT1013LA 29 Wireless Digital Flat Panel Detector NDT1013LA Power Indicator Lighting Status Status Battery Capacity DC Input Description Orange Blinking 7% & 15%

NO Detector is on N/A N/A N/A Detector is off YES Detector is on 15% & 95%

YES Detector is on 95%

YES Detector is off Link Indicator Lighting Status Description OFF Green ON Green Blinking Green&Orange Blinking Link indicator:

OFF Blue ON Green ON OFF Green ON Orange ON Detector is turned off Wired connection broken and wireless connection not ready Wireless connection is enabled Wired connection is enabled (Service Mode) Detector is off Exposure is allowed Error Status indicator Mode Indicator Lighting Status Description 3.3. Battery Charger Installation Operation Figure 30 User Manual of NDT1013LA Unload Battery from battery charger. 3.Basic Operation Insert battery into battery charger. Note the interface position as figure. Press the battery to the bottom of battery compartment. User Manual of NDT1013LA 31 Wireless Digital Flat Panel Detector NDT1013LA 4. Software Setup 4.1. System requirement iDetector is developed and deployed on Windows Operation System, it can be run on Windows XP/Windows 7/Windows 8/Windows 10, OS should install latest service pack. And requires computer memory 4 GB minimum. The firewall should be shut down to avoid commuication issue. 4.2. Environment setup Setup files and download url are included in SDK directory: Tools\env_setup 1. Please install Microsoft .NET Framework 4.5(Windows XP only can install V4.0 ). Download from 2. Visual C++ redistributed package need to be installed: vcredist_x86_2013(or 3. For Windows XP, full path should be used in file bind.txt. The wifi information should be configured for first use with wired connection. The configuration The default IP address (IPv4) of the detector is 192.168.8.8, the PC address (IPv4) should be configured as 192.168.8.xxx, which should be the same as the value of parameter Cfg_HostIPin Microsoft web site, please. vcredist_x64_vs2013). can be changed when needed. 4.3. Wireless Connection file *\work_dir\NDT1013LA\config.ini 4.3.1. AP Mode On the main window of Home page Select the instance of NDT1013LA and use the Connect button the build the connection. 32 User Manual of NDT1013LA After finishing building the connection, click Read Configbutton on the Wifitab of Detector pag to get the current wifi configuration. Click Read Network Config to get default setting. Change SSID and password setting. make sure SSID is different from other already exist;

Change channels and frequency setting 4.Software Setup User Manual of NDT1013LA 33 Wireless Digital Flat Panel Detector NDT1013LA Click Channel and choose a clean frequency and channel Click Write Network Config Waiting FPD status be Ready 4.3.2. Client Mode Add: add the information of the access point, such as SSID and password. 34 User Manual of NDT1013LA 4.Software Setup Select: Select the Access Point that needs to be connected to. list 4.3.3. Configuration of external wireless card Open local wireless signal Select SSID which belongs to detectors;

Input password and log into system User Manual of NDT1013LA 35 Wireless Digital Flat Panel Detector NDT1013LA Open wireless card configuration open IPV4 setting IP setting as follows IP address: 192.168.8.188 Subnet mask: 255.255.255.0 IP address:

192.168.8.188 Subnet mask:

255.255.255.0 36 User Manual of NDT1013LA Open SDK and choose product start connection 4.Software Setup 4.4. Software UI SDK supply iDetector as tool softwore:

32-bits iDetector.exe: Tools\iDetector\w32 64-bits iDetector.exe: Tools\iDetector\x64 little difference. versions of iDetector. Double click iDetector.exe to run the software. For different software version, the UI maybe has For this manual, the example is based on SDK_*_xxxx. This UI is almost the same for different Tab Function description Home Connect FPD and view the connect state Acquire Acquire image, select correction mode, save image and process image SDK config.ini setting, log level setting Detector Configurate parameters for detector. Calibrate Generate calibration files and manage the calibration files Local File Open and view local images. 4.4.1. HomePage User Manual of NDT1013LA 37 Wireless Digital Flat Panel Detector NDT1013LA The main function in this page is to connect detector. Item Function description Name Display the name of detector SN Display the SN of detector Product Type Display the type of detector State Display the connection state (BindUnknown, Ready etc.) Button Function description Connect Click this button to connect the selected detector. Close Click this button to disconnect the selected detector. Add Add work directory Remove Remove work directory Syncbox Open Syncbox configuration window(Optional device) 4.4.2. Acquire Page 38 User Manual of NDT1013LA 4.Software Setup This page is used to acquire image under different work mode, and user can select correction options too. When acquire image finished there will be a preview image shown on the screen (if the correction option is selected, otherwise only the raw images will be shown).The propertities of image is displayed on the left of image window.And on the right of image window there is a list to show thumbnail of images. User can select it and double click to see for detail. User can rotate, reverse or mirror image. User can get the value of AVG and SNR by ROI tool. The acquired images can be save as raw, tiff or dicom formats. Both raw and tiff formats support single frame and continuous frames save. Status bar shows detectors serial number, the current task and state of detector, and feedback information of command. Status bar is also can be seen in other pages, and they are all the same. Item Description SN SN number of current connected detectors State Detectors state , eg busy, ready Task the current task of detector Message feedback information of command,eg succeed,failed Functions in this Page. User Manual of NDT1013LA 39 Wireless Digital Flat Panel Detector NDT1013LA Correction Menu Description Offset HWPostOffset Do hardware PostOffset correction for image if checked Gain HWGain Do hardware Gain correction for image if selected Defect HWDefect Do hardware defect correction for image if checked Acqurie Button Description Prep Clear. Prepare to integrate. SingleAcq Acquire once Clear and acquire Seriers acquire images Save the current image, the format is raw and tiff ActiveSensor Active sensor DeactiveSensor Deactive sensor PowerOff Shutdown detector Stitchingflow Image stitching flow Image Properties& Image Process Description window width window level X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point Image width Image height Frame rate Display the frame count Rotate the image clockwise, 90 degrees every time. PrepAcq Acquire Save WW WL PosX PosY Value Width Height FPS Frames 40 User Manual of NDT1013LA Mirror ROI 4.Software Setup Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters with right click. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. Image List Show thumbnails When the image is displayed on the screen, maybe the user want to see details by dragging or zoom in/out the image, for convenience, these are some shortcuts. 1. Click the left mouse button: movie playback function operation area display. 2. Double-click the left mouse button: the image display in center and with maximum size;

3. Double-click the right mouse button: restore the window level and width for WL:32767/WW:65535;

4. Drag the left mouse button to drag the image display;

5. Lateral-drag the right mouse button to adjust the window width, and vertical-drag the right mouse button to adjust the window level;

F3 Key: Quickly locate the image window width and window level. F4 Key: Adjust window width and window level automatically. 6. 7. User Manual of NDT1013LA 41 Wireless Digital Flat Panel Detector NDT1013LA 4.4.3. SDK Pgae SDK page is used to set parameters in config.ini and log level. Different log level will show different details. It is recommended to set the log level as Debug 4.4.4. Detector Page Parameters page. area by Read. In this page, there are Parameters, Sensor and Images tab. 1. Enter Detector page, the tab of Paramters is activity by default. There are 5 regions in this 2. Parameter name region: lists the paramters. 3. Parameter read region: read the parameters, the values of the parameters are displayed in this 4. Parameter write region: write parameter. Entered value of the corresponding parameter in this area can be write to detector. 5. Operation region: functional operation buttons area. 42 User Manual of NDT1013LA 6. Status bar region: status bar for detector state and information of reading or writing parameters, etc. 4.Software Setup Configuration parameters description as below:

Name Description Configurable Product No. Type of detector product Serial No. Serial number of the detector Main Version Firmware version number of the FPGA N Read Version N/A MCU Version Firmware version number of the MCU N Arm Version Version number of the ARM App Kernel Version Version number of ARM Kernel Trigger Mode Tirgger mode of the detector Set Delay Time(ms) Acquire Delay Time(ms) Exposure window for AED mode which use a fixed window Exposure window for getting image which use a dynamic window N N N N N Y Y Y User Manual of NDT1013LA 43 Wireless Digital Flat Panel Detector NDT1013LA Exp Window Time(ms) Max exposure window for command trigger which use a dynamic window Src MAC Detector MAC Y Y Button function description:

Function Button Description Reset Detector Reset Detector Read Read parameters Write Write parameters Write RAM Write parameters into RAM(will lost changes after reset) Upgrade Firmware Upgrade firmware L Upload detector log to the specified directory Sensor The mainly function in this page is to probe the temperature and humidity of the detector. Click Read button to get the value of the temperature or humidity. 44 User Manual of NDT1013LA 4.Software Setup Sensor type Explanation Temperature Read detector temperature Humidity Read detector humidity Battery Read the capacity of the battery Wifi User can config the wireless connect parameters on this tab. Images You can Query and upload Images from detector to Workstation. User Manual of NDT1013LA 45 Wireless Digital Flat Panel Detector NDT1013LA 4.4.5. Calibrate Page Offset, Gain, Defect calibrate files can be generated and managed in this page. Click Start Generate Templates to enter generating templates page. 46 User Manual of NDT1013LA 4.Software Setup SubTab Description Mode&Files Manage template files Create Offset Create Offset template Create Gain Create Gain template Create Defect Create Defect template Mode&Files page Description Import to Workdir Copy template file into current calibration directory. Download to FPD Select one item first. Then click this button to download selected template file(s) into detector. UpLoad to Workdir Select one item in Fpd template file control and select one item in Subset settings control. Click this button to upload selected template from detector into specified calibration directory. Upload Lag Upload Lag into SDK current directory Active Select one item in list. Click this button to activate selected template for hardware correction. User Manual of NDT1013LA 47 Wireless Digital Flat Panel Detector NDT1013LA UpdateHWPreOffset Force detector update Offset template ReadStatus Get the current state of template for hardware correction, enable/disable Generate Gain Template File If the relative position between tube and detector changed or KV value changed, it suggest to create gain template file. 1. Enter Create Gain page images. Click "Start" button to start process, the offset type should be selected, then start to get the 2. Click PREP button, then exposure after Acquire button enable. After receving the PREP request, the detector needs some time to be ready, the decounting bar will apear when the exposure window is opened. After exposure user can click Acquire button to acquire the X-

Ray image. 48 User Manual of NDT1013LA 4.Software Setup The gain template generation process needs 5 images total, the UI gives the recommended KV and target value, user can use different ones if needed. After accepting the current image, the Stage will turn to 2/5, 3/5 and so on. The current value box will show different colors, the definitons are as below:

Yellow: The current value is higher or lower than the expected one, user decides if acceptable. For example, the expected value is 20000, and user needs 40000 as the gain piont, the yellow warning can be ignored, and the value can be accepted still. Green:

The value is good. Red:

The value is un-acceptable. 3. After getting 5 images, user can generate the Gain template by Generate button, and the process can be exited from at anytime by using Cancel button. If Download to FPD after generation is checked, then the download UI will appear after finishing generating. User can refer to the part of Generate Defect Template File"

User Manual of NDT1013LA 49 Wireless Digital Flat Panel Detector NDT1013LA 4. When the generating process is finished, the UI will give the message of successful. Generate Defect Template File The process of generate defect map is quite similar with the one of gain map. 1. On the Create Defect page, user can start the generating process by Start button. And the process can be quit by Cancel. 50 User Manual of NDT1013LA 4.Software Setup 2. There are 8 images that need to be acquired, the UI gives the recommend KV and expected image value, user should refer with them. 3. If the option Download to FPD after generation is checked, the download UI will appear after finishing generating the defect map which will takes a little time. The field of Index in FPD means that the detector can store several correction maps and choose one set to active as user wants. The Download files part show the directory of the generated map stored on the workstation. 4. After choosing the stored index of FPD, the download process can be started by the Download button, user should wait the process until it is finished. 5. The correction map also can be managed at anytime on the page of Mode&Files. Choose the item of Default in the Subset settings part and click Download to FPD to finish downloading the maps into the detector. User Manual of NDT1013LA 51 Wireless Digital Flat Panel Detector NDT1013LA Upload the correction files 1. The correction maps can be uploaded to the workstation too. Choose the gain or defect in the Fpd template filesand the Default directory in the Subset settings, then click the Upload to workdir. 2. When the upload process is finished, the UI will give the message. 52 User Manual of NDT1013LA The correction maps should be enabled before using hardware correction, read status first, then choose the gain or defect, enable the map by clicking Active button. 4.Software Setup 4.4.6. Local Page In this page user can open the image files saved in local, the file formate can be dcm, raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. The pixel matrix is defined as below:

Active area : 4267*4267 What needs to be notice is only the active area pixels will be displayed when use load file funtion, the value of dummy pixels and empty channels will be filled by 65535. User Manual of NDT1013LA 53 Wireless Digital Flat Panel Detector NDT1013LA This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image area by right mouse button. This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Width Description window width window level X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point Image width Height Image height 54 User Manual of NDT1013LA 4.Software Setup Mirror ROI Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. 4.5. List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

NETWORK a) The operating system is not compatibility;

b) Change or update the software failed;

c) The compatibility of the interface;

d) The data transfer protocol error;

f) The data output failed;

e) The inconsistent of interface or format leads to data distortion;

User Manual of NDT1013LA 55 Wireless Digital Flat Panel Detector NDT1013LA 5. Operation Instructions for Image Acquisition NDT1013LA provides SDK for users to integrate detector into their DR system. Additionally, it also provides an application for demonstration, i.e. IDetector. User can use IDetector to control detector without DR system. 5.1. Steps for acquiring image Make sure the hardware is connected correctly and then power on. Once powered off, please wait at least 60s before power on again Generate HWPreOffset, Gain and Defect template after the detector reaches thermal To Acquire X-ray image is the main operation of NDT1013LA. Most importantly, detector should build synchronization with X-ray generator. NDT1013LA has one synchronization modes to acquire Wait until initialization is complete Connect the software choose the synchronization mode equilibrium Acquire images in the selected mode X-ray image, which is Software Mode. 5.2. Software Mode 5.2.1. Block Diagram Software mode is the basic way to acquire X-ray image. Please see figure below for general feature. Workstation is a host PC device installed with iDetector and SDK. FPD is the Flat Panel Detector and HVG is the High Voltage Generator. In this mode, Workstation does not have to control X-ray generator. Users would decide when to shoot X-ray. 56 User Manual of NDT1013LA 5.Operation Instructions For Image Acquisition Select HWPostOffsetHWGainHWDefect. If user need the raw image, please de-select all these 5.2.2. Work Flow(PrepAcq) correction options. Also, the software correction is supported. 1. Send CmdPrepAcq on UI Acquire page. 2. After receiving the Cmd_PrepAcq, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The XWIN is configured by parameter Clear Acq Delay Time on SDK page, the unit is ms. 4. User needs to make sure the X-Ray ends within the XWIN. 5. The detector will send the images after the XWIN closed. 6. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.2.3. Work Flow(Prep+Acq) User Manual of NDT1013LA 57 HVGX-TubeFPDWork StationIDLEPrepareXWIN1(fixed)X-RayimagingCmd_PrepAcqAck_ProhibitAck_EnableXWIN1(fixed)OffsetimagingRAW PreviewRAW X-Ray image(If HW-offset is disabled)RAW offset(Or corrected)image Wireless Digital Flat Panel Detector NDT1013LA 1. Send CmdPrep on UI Acquire page. 2. After receiving the Cmd_Prep, it will start the prepare process, and send back the acknowlage of Prohibit and Enable, the XWIN will be started. 3. The max XWIN is configured by parameter Exp Window Time on Detector page Parameter tab, the unit is ms. 4. User starts the X-Ray. Send SingleAcq on UI Acquire page after the X-Ray is end. 5. 6. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.3. AED Mode 5.3.1. Inner 1. The detector is in low power state, user needs to send Cmd Prep to make the detector exit to idle state which indicated by the acknowledge to Cmd Prep. 2. When the detector is in idle state, user can start the X-Ray any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 58 User Manual of NDT1013LA IDLEPrepareXWIN2(dynamic)X-RayimagingCmd_PrepAck_ProhibitAck_EnableXWIN2(dynamic)OffsetimagingRAW PreviewRAW X-Ray image(If HW-offset is disabled)RAW offset(Or corrected) imageCmd_SingleAcqX-RayIDLEXWIN1(fixed)X-RayimagingXWIN1(fixed)OffsetimagingX-RayInfoRAW PreviewRAW X-Ray imageIf HW-offset is disabledRAW Offset(Or corrected)imageLow powerPrepAck 5.Operation Instructions For Image Acquisition 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.3.2. Freesync Mode 1. For Freesync mode, there is no low power state. 2. When the detector is Idle, user can start the exposure flow any time. 3. When the X-Ray starts, the detector will sense the X-Ray automaticlly, the XWIN is configured by parameter Set Delay Time on Detector page Parameter tab, the unit is ms, user needs to make sure that the XWIN is larger than the X-Ray time. 4. After the XWIN is end, then the detector will start the acquisition flow. 5. The preview image will be always sent, which is 4x4 averaging, the raw X-Ray image will be sent if the HW correction is disabled with the raw offset image follows, otherwise, the X-Ray image will not be sent and only the corrected image will be transferred. 5.4. After use 1. Disconnect the software 2. Power off 3. Keep it clean 4. Store under specified conditions 5.5. Correction and Calibration Template Generation User Manual of NDT1013LA 59 IDLEXWIN1(fixed)X-RayimagingXWIN1(fixed)OffsetimagingX-RayInfoRAW PreviewRAW X-Ray imageIf HW-offset is disabledRAW Offset(Or corrected)image Wireless Digital Flat Panel Detector NDT1013LA The correction and calibration should be performed after installation and it is recommended to perform the new correction and calibration after any major change on the system settings and hardware configuration. On the other hand, it is also recommended to do the correction and calibration in each 6 months. 5.5.1. HW pre-offset Template Generation Enter Acquire interface, select HWPostOffset option Enter Calibrate interface, click UpdateHWPreOffset button. Waiting until status bar displayed:

"Task succeed:

HwGeneratePreOffsetTemplate 5.5.2. Gain Calibration Template Generation If the relative position between tube and detector changed or KV value changed, it suggest to create gain template file. 60 User Manual of NDT1013LA Enter Create Gain page Click "Start" button to start process. Click PREP button, acquire image. Please exposure after Acquire button enable. And click Acquire button to acquire image after exposure end. Click Accept button after acquired image. If Current Value textbox is yellow, click PREP button. Re-acquire images after adjust generator parameters. Note: In different trigger mode, the operation maybe have little difference. Please follow the UI tips. Mind:

If the detector is in inner or Freesync mode, then user should finish the exposure before the time bar counting ends. And the click on Acquire is not necessary for inner or Freesync. Create gain template need several images. You can click Generate button to generate Gain template once one image was captured. But it may lead to imperfect template quanlity. 5.Operation Instructions For Image Acquisition User Manual of NDT1013LA 61 Wireless Digital Flat Panel Detector NDT1013LA Download template file dialog will pop up if "Download to FPD after generation" option was checked. Click Download button to download the template into the detector. Select Mode&Files tab. Click Read Status button to check whether just downloaded gain template is enable. If not, please click Active button to enable. 5.5.3. Defect Correction Template Generation Enter Acquire UI. Choose HWPostOffset. Enter Calibrate UI. Select Create Defect tab. 62 User Manual of NDT1013LA Click "Start" button to start process. Click PREP button, acquire image. Please exposure after Acquire button enable. And click Acquire button to acquire image after exposure end. Click Accept button after acquired image. If Current Value textbox is yellow , click PREP button. Re-

acquire images after adjust generator parameters. Note: In different trigger mode, the operation maybe have little difference. Please follow the UI tips. You can click Generate button to generate Gain template after acquired required images. 5.Operation Instructions For Image Acquisition User Manual of NDT1013LA 63 Wireless Digital Flat Panel Detector NDT1013LA Download template file dialog will pop up if "Download to FPD after generation" option was checked. Click Download button to download the template into the detector. Select Mode&Files tab. Click Read Status button to check whether just downloaded gain template is enable. If not, please click Active button to enable. 5.6. Local Image Check OPEN provides two features for image check and uploading. Local Image Check, Panel Image Upload. Local Image Check defines function to check image saved in Workstation. Panel Image Upload defines function to upload images stored in panel. Click Local File button in Local File UI, choose the specified file In this page user can open the image files saved in local, the file formate can be raw, tiff, dft. When the software is disconnected to detector, the file still can be opened. 64 User Manual of NDT1013LA 5.Operation Instructions For Image Acquisition Click Load File, there will be an open file wizard. Select file and click open or double click the file. The tiff file will be opened directly. For the raw file or dft file there will be a dialog to select image size. Select correct size to open image files. If the file is not correct user will get an error message. NDT1013LA image size: 4267*4267 This page provides ROI tool, which can see the AVG, SNR, and other properties of the choosen image area by right mouse button. This page provides WW/WL tool as Acquire page . Click this button to auto adjust WW/WL based on selected area by right button of mouse. Image Properties&

Image Process WW WL PosX PosY Value Width Height Mirror ROI Description window width window level Image width Image height X coordinates of the current cursor at the point Y coordinates of the current cursor at the point Value of the current cursor at the point Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters. Press "ctrl" key, can create several ROI WW/WL Auto adjust WW/WL based on selected area by right area. button of mouse. User Manual of NDT1013LA 65 Wireless Digital Flat Panel Detector NDT1013LA 5.7. Firmware Upgrade Panel supports upgrading firmware with IDetector, also allows the use of the Web way to upgrade the firmware, if a user needs to upgrade the firmware, please complete the following steps. On Detector PageParameter Tabuser can upgrade firmware by entrance button Upgrade Firmware. The firmware upgrade package may contain firmware of several units: ARM, FPGA, MCU. NDT1013LA_IMAGE_44_ALL_20XX_XX_XX.ifrm Word ALL indicates the file contains the firmware upgrade file for all units. NDT1013LA_IMAGE_44_ARM_20XX_XX_XX.ifrm Word ARM indicates the file is only for ARM. NDT1013LA_IMAGE_44_FPGA_20XX_XX_XX.ifrm Word FPGA indicates the file is only for FPGA. NDT1013LA_IMAGE_44_MCU_20XX_XX_XX.ifrm Word MCU indicates the file is only for MCU. User can choose one of these files as required to start the upgrade. 66 User Manual of NDT1013LA correct. Note:

25%

5.Operation Instructions For Image Acquisition Choose the file that needs to be upgraded, and must check the package info to confirm if it is 1. There is a progress bar for indication. Make sure battery is inserted and battery capacity is over 2. Please make sure that iDetector shows Ready. It can also be checked by click Config button, there is firmware version. User Manual of NDT1013LA 67 6.Regulatory Information 6. Regulatory Information FCC Compliance The panel has been tested to comply with limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. The panel generates, uses, and radiates radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If the panel does cause harmful interference to radio or television reception, which can be determined by turning the panel off and on, the user is encouraged to correct the interference by one or more of the following measures. Reorient or relocate the antenna. Increase the separation between the panel and receiver. Connect the panel into an outlet different from the receiver is connected. Consult the distributor or an experienced radio/TV technician for help. Operation is subject to the following two conditions. The panel may not cause harmful interference. The panel must accept any interference received, including interference that may cause undesired operation. This device complies with FCC SAR exposure limits set forth for an uncontrolled environment. The equipment can be used in close proximity to the human body without any restrictions. Note: the grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. such modifications could void the users authority to operate the equipment. 68 User Manual of NDT1013LA 7.Trouble Shooting 7. Trouble Shooting Please refer to service manual. If the problem persists, turn off the panel and contact iRay service department (service@iraygroup.com). We would provide the best service User Manual of NDT1013LA 69 Flat Panel Detector NDT1013LA 8. Service Information 8.1. Service Office Information 8.2. Product Lifetime maintenance. The estimated product lifetime is up to 5 years under appropriate regular inspection and 8.3. Regular Inspection and Maintenance In order to ensure the safety of patients and operator, to maintain the performance and reliability of the panel, be sure to perform regular inspection at least once a year. If necessary, clean up the panel, make adjustments or replace consumables such as fuses etc. There may be cases where overhaul is recommended depending on conditions. Contact iRay service office or local iRay dealer for regular inspection or maintenance. If problem cannot be solved, contact your sales representative or local iRay dealer for repairs. Please refer to the label and provide the following information:

8.4. Repair Product Name:

Series Number:

Description of Problem: as clearly as possible. 70 User Manual of NDT1013LA 8.Service Information 8.5. Replacement Parts Support Main parts (parts required to maintain the function of the product) of this product will be stocked for 5 years after discontinuance of production for repairing. User Manual of NDT1013LA 71 Flat Panel Detector NDT1013LA Appendix A Information of Manufactures COMPANY:

iRay Technology Taicang Ltd. ADDRESS:

No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Jiangsu, China ZIP CODE:

215434 TELEPHONE:

+86 0512-53690872 FAX:

+86 0512-53690872 HOMEPAGE: WWW.IRAYGROUP.COM 72 User Manual of NDT1013LA APPENDIX Appendix B Information of Europe Representative COMPANY:

iRay Europe GmbH ADDRESS:

IN DEN DORFWIESEN 14, 71720 OBERSTENFELD GERMANY ZIP CODE:

TELEPHONE:

+49-7062-977 88 00 FAX:

+49-7062-976 0571 HOMEPAGE: WWW.IRAYEUROPE.COM User Manual of NDT1013LA 73

User Manual Canis014D07 Portable X-ray System IMAGING THE FUTURE E E Document version: A0 Document ID:

Release date:

921-201-02 5/13/2022 To Customers To Customers Thanks you for purchasing the CANIS014D07 Portable X-Ray System (hereinafter referred to as CANIS014D07) from iRay Technology Taicang Ltd. (hereinafter referred to as iRay) as your X-ray solution. This manual contains all the general information about the CANIS014D07, which is intended to provide users with instructions on installation, operation and maintenance. All information in this manual, including illustrations, is based on the equipment prototype. If your equipment does not match with these contents, they will not apply to your equipment. Information regarding the specifications, compositions, and appearance of this product is subject to change without prior notice. Store this manual safely so that you can access it in the future. Do not operate this equipment until you have fully read this manual. Copyright iRay Technology Co., Ltd. All rights reserved. Technology Co., Ltd. Trademarks No part of this publication may be reproduced in any form or by any means without the written permission of iRay The name iRay and iRay logo are registered trademarks of iRay Technology Co., Ltd. Environmental Protection This symbol indicates that this product cannot be disposed as domestic or commercial waste. Improper handling of this type of waste may result in a negative impact on health and environment. i Canis014D07 User Manual Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste items. Please contact your local authorities for information about practices established in your region. If collection systems are not available, call iRay Customer Service for assistance. To Customers Disclaimer In no event shall iRay be reliable for any abnormality, equipment damage and personal injury caused due to your failure to follow the warnings and operating instructions in this manual. In no event shall iRay be reliable for any damage, loss, or injury incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product. In no event shall iRay be reliable for any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to this product or failure to strictly comply with iRays operating and maintenance instructions. In no event shall iRay be reliable for any damage or loss arising from the use of any options or consumable products other than those dedicated as original iRay products. During X-ray imaging, collecting, processing, reading and storing of image data, the user should comply with the law of the countries where the product is used. The user and operator are responsible for maintaining the privacy of image data acquired from this product. The clinician is responsible for providing medical service and erroneous treatment due to misdiagnosis. Warning Symbols The warning symbols that appear in this user manual are classfied as follows for better comprehension of their meanings. Make sure that you fully understand them and obey the instructions they contain.

WARNING CAUTION PROHIBITED NOTE REFERENCE This indicates a potentially hazardous situation which, if ignored, may result in severe personal injury, death, or substantial property damage. This indicates a potentially hazardous situation which, if ignored, may result in minor personal injury or property damage. This symbol is used to indicate a prohibited operation. This emphasizes or supplements important information about the main text. This symbol is used to indicate "Consult other sections of this manual for information". Canis014D07 User Manual ii To Customers Abbreviations FCC SSD SN UI WL WW Abbreviations Explanation Federal Communications Commission Source-to-Skin Distance Serial Number User Interface Window Level Window Width iii Canis014D07 User Manual Contents Contents TO CUSTOMERS .......................................................................................................................................................I CONTENTS ............................................................................................................................................................ IV 1 SAFETY PRECAUTIONS ...................................................................................................................................6 Radiation Safety ......................................................................................................................................................6 Equipment and Power Source .................................................................................................................................6 Battery .....................................................................................................................................................................7 Operation ................................................................................................................................................................ 7 Failure Handling ..................................................................................................................................................... 8 Environment ........................................................................................................................................................... 8 2 REGULATORY INFORMATION ........................................................................................................................8 Labels and Symbols ................................................................................................................................................9 Safety Standards for Medical Equipment ............................................................................................................. 11 2.2.1 Medical Equipment Classification ...........................................................................................................11 2.2.2 Product Safety Standards ......................................................................................................................... 11 2.3 FCC .......................................................................................................................................................................12 3 PRODUCT INTRODUCTION .......................................................................................................................... 14 Overview ...............................................................................................................................................................14 Intended Use ......................................................................................................................................................... 14 Key Features ......................................................................................................................................................... 14 Contraindication ................................................................................................................................................... 14 Product Components .............................................................................................................................................15 Product Description .............................................................................................................................................. 15 Component Installation .........................................................................................................................................16 3.7.1 Battery Replacement ................................................................................................................................16 3.7.2 Battery Removal ...................................................................................................................................... 16 Application Scenarios ...........................................................................................................................................16 Recommended Exposure Time .............................................................................................................................17 4 TECHNICAL SPECIFICATIONS ........................................................................................................................18 Portable X-Ray System .........................................................................................................................................18 Adapter ................................................................................................................................................................. 20 Battery ...................................................................................................................................................................20 5 USER INTERFACE ......................................................................................................................................... 22 Login Page ............................................................................................................................................................ 22 Home page ............................................................................................................................................................ 23 Patient Information Page ...................................................................................................................................... 24 Image Acquisition Page ........................................................................................................................................24 Canis014D07 User Manual iv 1.1 1.2 1.3 1.4 1.5 1.6 2.1 2.2 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 4.1 4.2 4.3 5.1 5.2 5.3 5.4 Contents Image View Page ..................................................................................................................................................26 Setting Page .......................................................................................................................................................... 27 6 SERVICE INFORMATION .............................................................................................................................. 31 Service Life ...........................................................................................................................................................31 Periodic Inspection and Maintenance ...................................................................................................................31 Disinfection and Cleaning .................................................................................................................................... 32 Troubleshooting ....................................................................................................................................................32 Company Information ...........................................................................................................................................32 Manufacturing Site ............................................................................................................................................... 33 5.5 5.6 6.1 6.2 6.3 6.4 6.5 6.6 v Canis014D07 User Manual Safety Precautions 1 Safety Precautions To avoid personal injury or product damage, be sure to read the user manual and all accompanying documents carefully and pay attention to all safety precautions before using the equipment. Operation and Maintenance must be in accordance with the instructions contained in this manual. 1.1 Radiation Safety This equipment may be dangerous to the patient and operator unless safe exposure factors and operating instructions are observed. The owner and/or operator of this equipment to comply with all applicable rules and regulations concerning radiation safety and protection in their area. Excessive exposure to X-ray radiation is harmful. Verify the exclusion zone is clear of all personnel. Failure to comply may result in personnel injury. All users should comply with the Radiation Protection Policies established by the government. All users and patients should wear protective garment, such as a lead apron which is covered until collar, for radiation protection. Do not enable this equipment until patient and operator are positioned and ready for the exposure, reducing the likelihood of interruption and preventing inadvertent exposure of anyone to x-rays. 1.2 Equipment and Power Source To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth when charging. Use only the supplied adapter provided by iRay. The equipment may be damaged if you use another power adapter. Do not hit or drop the equipment. The equipment may be damaged if it receives a strong jolt, which may result in fire or electric shock if the equipment is used without being repaired. Be sure to disconnect the power cable by holding the plug or connector, not by pulling CAUTION the cable itself. If you pull the cable too hard, the core wire may be damaged, resulting in fire or electric shock.

WARNING

CAUTION WARNING

Canis014D07 User Manual 6 Safety Precautions 1.3 Battery the battery. Observe and follow all safety information in this manual and on the warning labels on

WARNING Ignoring this warning could result in personal injury or product damage. Do not charge the battery in the environment with patient. Do not use batteries not provided by iRay, do not charge damaged battery, or charge battery with damaged adapter. If the enclosure is broken or emits unusual odors, smoke, overheats, or leaks anything. Avoid contact with any material leaking from the battery pack. If any liquid comes into contact with your skin or eyes, wash the affected area with clean running water and seek immediate medical attention. If the equipment is not used for an extended time period, charge the battery once every 3 months. After full charge, at least 1 exposure has to be made to keep the battery in best function. The battery is a consumable part. After several months, the battery capacity may slowly For reliable function and safety, battery pack should be replaced when its capacity is noticeably decreased. CAUTION decrease. 1.4 Operation Operation should be performed only by qualified and trained dentists, radiologists, dental hygienists, or maintenance service technicians who are experienced in installing and servicing dental X-ray systems.

WARNING patient. Do not try to disassemble or modify the equipment, and its accessories. No modification of this product is allowed. Do not open the equipment enclosure. Have the patient take a fixed posture and do not leave the device within the reach of a Ignoring this warning may cause electrical shock and/or unknown hazards, which may result in severe personal injury, death, or substantial product damage. Pregnant women should not be exposed to X-rays unless it is strictly necessary. Try not to move the equipment or incur vibration during X-ray exposure. The image will not be clear if the equipment moves or there is a vibration during X-ray exposure. CAUTION Do not handle the equipment with wet hands. Otherwise, it may result in electric shock that could result in death or serious injury.

7 Canis014D07 User Manual 1.5 Failure Handling Safety Precautions Turn off the equipment and contact your sales representative or local iRay distributor if any of the following occurs:

When there is smoke, an odd smell or abnormal sound CAUTION When liquid has been spilled into the equipment When the equipment has been dropped and is damaged 1.6 Environment The equipment should be stored and operated in a specified dental clinic environment and maintained by professional maintenance personnel under safe and operable conditions.

WARNING Static electricity may affect this device at any time. Please use this device within the permissible range of humidity defined by the specifications. Please refrain from wearing a garment that may generate such static electricity. Do not store the equipment or its parts in places listed below:

Water sources Heat sources that produce heat In an area prone to vibration Chemicals or gases are generated CAUTION Where flammable materials are placed Oxygen-rich environment Other than the specified storage environment The equipment can be used at an altitude of less than 3,000 meters.

Canis014D07 User Manual 8 Regulatory Information 2 Regulatory Information 2.1 Labels and Symbols The detector and other components have labels and symbols on them. Their contents and locations are indicated below. The labels in this document are only examples, please refer to the actual labels. Product Label other information. A sample label is shown in the figure below. The label information includes model, SN, manufacturer information and Portable X-ray System Model Canis014D07 Power Input Adapter Port Input 24V DC Battery Port Input 18V DC iRay Imaging Technology (Haining) Limited No. 2, Caohejing RD., Haining, Jiaxing, Zhejiang, China 314499 20XX-XX-XX Contains FCC ID: 2ACHK-01070189

(01)0697056909XXXX

(11)XXXXXXXX

(21)XXXXXXXXXXXXXXXXXXX 9 Canis014D07 User Manual Labels on the Battery Regulatory Information Symbol Explanation Location This symbol is used to identify the manufacture series number which is made of 19 digits as shown below:

A1A2A3A4 B1B2 C1C2 L M1M2D1D2Y1Y2 X1X2X3X4 Product label Production Series No. Production Date Production Site Production Version No. Derivative Type Production Type This symbol indicates the name and address of manufacturer. The date of Product label manufacture is combined in this symbol.

Caution: please refer to the instructions in the user manual. Product label symbol This information. represents reference to the user manual for general Product label This symbol indicates that the product must be sent to the appropriate facility for recycling when the end user intends to discard the product. Product label Battery label This symbol represents a safety symbol that indicates "reference to user manual". Product label Canis014D07 User Manual 10 Regulatory Information This symbol is used to indicate that the product is a medical device. Product label This symbol is used to represent nonionizing electromagnetic radiation. Product label This symbol information. This symbol certificate. indicates a carrier that contains unique device identifier is used to indicate Federal Communications Commission Product label Product label 2.2 Safety Standards for Medical Equipment 2.2.1 Medical Equipment Classification Item Classification Type of protection against electrical shock Class I ME equipment, using the medical approved adaptor;

Internally powered ME equipment, using the internal battery Degree of protection against electrical shock Without applied part Degree of protection against ingress of water IPx0 Mode of operation Continous operation Flammable anesthetics CAN NOT be suitability for use in an OXYGEN RICH ENVIRONMENT 2.2.2 Product Safety Standards Standard IEC 60601-1:2005 + A1:2012

/EN 60601-1:2006 + A1:2013 ANSI/AAMI ES60601-1:2005

+ A1:2012 + Amendment 2:2010 CSA CAN/CSA-C22.2 NO. 60601-1:14-2014 IEC 60601-1-2:2014 /EN60601-

1-2:2015 Description Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Medical Electrical Equipment Part 1: General requirements for safety and essential performance Medical Electrical Equipment Part 1: General requirements for safety and essential performance Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard:

Electromagnetic disturbances Requirements and tests IEC 60601-1-3:2008 + A1:2013

/EN 60601-1-3:2008 + A1:2013 Collateral standard: General requirements for radiation protection in diagnostic equipment. IEC 60601-1-6:2010 +

A1:2013/EN 60601-1-6:2010 +

A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral standard: Usability 11 Canis014D07 User Manual Regulatory Information Standard IEC 60601-2-65:2013 +

A1:2017/EN 60601-2-65:2013

+ A1:2017 IEC62366-1:2015/EN62366-

1:2015 IEC62133-2:2017/ EN62133-

2:2017 UL62133-2:2020 CSA C22.2 NO. 62133-2-20 EN ISO 15223-1:2016 Description Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment Medical devices - Part 1:Application of usability engineering to medical devices Secondary cells and batteries containing alkaline or other non-acid electrolytes-safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications-part 2:lithium systems Secondary cells and batteries containing alkaline or other non-acid electrolytes-safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications-part 2:lithium systems Secondary cells and batteries containing alkaline or other non-acid electrolytes-safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications-part 2:lithium systems Medical devicesSymbols to be used with medical device labels, labeling and information to be suppliedPart 1: General requirements 2.3 FCC Contains FCC ID: 2ACHK-01070189 1 2 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/ TV technician for help. Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment. Canis014D07 User Manual 12 Regulatory Information Radio Frequency (RF) Energy This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the United States. The exposure standard for wireless devices employing a unit of measurement is known as the Specific Absorption Rate, or SAR. The SAR limit recommended by the general public is 1.6W/kg Averaged over one gram of tissue by IEEE Std 1528. The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in compliance with the FCC RF exposure guidelines. While there may be differences between the SAR levels of various product and at various positions, they all meet the government requirements.SAR compliance for body-worn operation is based on a separation distance of 0 mm between the unit and the human body. Carry this device at least 0 mm away from your body to ensure RF exposure level compliant or lower to the reported level. 13 Canis014D07 User Manual Product Introduction 3 Product Introduction 3.1 Overview 3.2 Intended Use The Canis014D07 is a portable dental X-ray system for dental diagnosis in adult and pediatric patients and is available only to trained and qualified dentist or dental technician. Essential Performance According to the IEC 60601-2-65, the clause 201.4.3.101, there are 2 potential essential performance:

a. b. Accuracy of loading factors;

Reproducibility of the radiation output 3.3 Key Features Portable portable smart X-ray source Intraoral X-Ray imaging 7 touch LCD display with high resolution (1024600) Rechargeable battery allows mobility, easy to operate and move 2 USB interfaces equipped High capacity battery, up to 400 exposures on one full charge Low radiation dose, safe and reliable High specifications (70kV DC, 0.4mm focal spot) ensures high-quality images Applicable to multiple application scenarios All-in-one system, friendly user interface 3.4 Contraindication Patients (children and pregnant women particularly) must wear lead aprons during their X-ray imaging. Canis014D07 User Manual 14 3.5 Product Components Product Introduction Please check the following items carefully to ensure they are complete and confirmed by iRay engineers. If any items are lost or damaged, please contact your iRay dealer. No. Item 1 2 3 4 5 6 Canis Smart P Adapter Power cord Battery Wrist strap Collimator Cone (200mm) 3.6 Product Description Qty. 1 pc. 1 pc. 1 pc. 1 pc. 1 pc. 1 pc. Remarks Default Default Default Default Default Default DI-IN USB port Power button (ON/OFF) Product label 15 Canis014D07 User Manual Product Introduction Adjusting button Battery cover Cradle head Beam limiting device Exposure indicator Control screen Back scatter shield Wrist buckle Exposure button 3.7.1 Battery Replacement 3.7.2 Battery Removal To be added To be added 3.7 Component Installation 3.8 Application Scenarios Smart P+iRay Sensor Free from a computer, Smart P is an independent dental DR system and could finish the whole workflow: Patient registration, image acquisition, image diagnostics. Smart P+PC+iRay Sensor Smart P is an independent dental DR system, and need a PC for Mini PACS installation. Canis014D07 User Manual 16 Smart P+Third Party Sensor Product Introduction Smart P is just an X-Ray machine, which could adjust the exposure parameters easily, touch or button control. 3.9 Recommended Exposure Time Exposure Time of Digital Dental Film (s) Tooth Position Maxillary incisor Maxillary monocuspid Maxillary bicuspids and first molar Maxillary second and third molars Mandibular incisor Mandibular canine Mandibular bicuspids and first molar Mandibular second and third molars 0.08~0.10 0.12~0.16 0.12~0.16 0.16~0.20 0.06~0.08 0.10~0.16 0.10~0.25 0.10~0.25 The exposure time set in each mode is recommended by the manufacturer, and each time can be adjusted. NOTE 17 Canis014D07 User Manual Technical Specifications 4 Technical Specifications 4.1 Portable X-Ray System Drawing Specifications Item Model Application Output kV Output mA X-ray tube anode angle X-ray tube focal spot X-ray exposure time range HVG frequency Specification Canis014D07 Intraoral X-Ray imaging 70KV10%

2mA20%

12 0.4mm 0.1~2sec 30kHz Canis014D07 User Manual 18 Technical Specifications Item Specification Power Input(adapter) 100-240V AC, 50/60Hz Focal length Exit filed size 200mm 60mm (Circle) Battery: 2400mAh

- 400 exposures (full charge,70KV,2mA, 0.5sec, cycle time 15sec)

-Standby mode(full charge): 1 week (Power off)

-3 hours empty to full charging

-2 months shipping mode: full charge

-battery could be replaced by end-user Hand switch / Button control / Remote control IEEE802.11/USB connection Automatic calculation and display Device power source Exposure control Sync with sensor Shooting angle Data Transmission Power X-ray image transmission USB & IEEE802.11 a/b/g/n/ac Wireless Frequency Range 2412-2462MHz, 5180-5240MHz, 5745-5825MHz 13dBm (Typ.) @802.11a 13.5dBm (Typ.) @802.11b 15dBm (Typ.) @802.11g 15dBm (Typ.) @802.11n HT20 14dBm (Typ.) @802.11n HT40 13dBm (Typ.) @802.11ac Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK) 11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM) Wireless Band 2.4GHz35MHz 5.GHz50MHz Internal radiation shielding 0.1Gy/h @1 meter Total filter 1.5mm Al Display and control 7inch display (Resolution:1024600) with touch panel Full image time

(image processing included) 10s Weight Dimensions Fixed model OS 2.2kg (without shield) 195mm136mm65mm Mountable/portable Android Exposure record Cumulative exposure time and times record Environment Requirements operated in a reliable environment. Please confirm that the environment meets the basic requirements of Canis014D07 to ensure that it can be stored or Item Operation Storage & Transport 19 Canis014D07 User Manual Technical Specifications Item Temperature range Operation 10~40 Storage & Transport

-10~45 Humidity range 30%RH~75%RH 30%RH~75%RH Atmospheric pressure range (mbar) 700mbar~1060mbar 700mbar~1060mbar 4.2 Adapter Drawing 125.01.0 POWER LED 33.51.0 0

. 1 0

. 0 5 Specification LXCP61-024300 100~240V AC input 24V single output mode, 72W Specifications Item Model Input Output 4.3 Battery Drawing

*53.6

+0.15

-0.1 Canis014D07 User Manual 20 Technical Specifications Specifications Item Model Specification BATTERY-KS Rated capacity Typ.2500mAh; Min.2400mAh Nominal voltage Limited charging voltage 18V 21V Discharge cut-off voltage 12.5V Charge method CC-CV Operating temperature Charge: 0T20 0.2C (500mA); 20T45 1.2C (3000mA) Discharge: 20T45 7.2C (18000mA); 45T60 4.0C (10000mA) Storage temperature Less than 3 months: -20+40 Less than 1 month: -20+50 Less than 1 year: -20+20 Relative humidity 6520%RH Dimensions (LWH) 78.55440mm3 21 Canis014D07 User Manual User Interface 5 User Interface The interface mainly includes login page, work list page, patient information page, image acquisition page, image browsing page and setting page. The main functions of each page are described as follows:

Tab Description Login page Enter the user name and password to log in to the home page Home page Query patient information, jump to the patient information page, image acquisition page, image browsing page and setting page Patient information page Modify and manage patient information, including name, gender, tooth position, etc. Image acquisition page Set exposure parameters according to tooth position and age, and display the status related to exposure services Image view page View images and perform related operations on images Setting page Account settings, function settings, network settings, sensor settings, etc. 5.1 Login Page On the login page, enter the account and password information correctly, you can jump to the home page. If one of the account passwords is incorrect, a prompt message will pop up and stay in this interface. The login interface is shown on the right. A touch user interface enables you to enter the user name and password information by a finger touch. The default user name is admin and the password is 123456. Username and password can be changed in the setting page. The length of the user name must be no more than 60 characters, and the length of the password must be within 6~10 characters. NOTE Canis014D07 User Manual 22 5.2 Home page User Interface 2 1 6 3 1 4 5 The home page is mainly divided into 6 areas, and the main functions of each area are as follows:

No. Function Button Description 1 Information management Delete all medical information Add information of a new patient, including name, gender, birth date, and dental location Edit patient information, including name, gender, and birth date Jump to the new information page, select the tooth position and add to the current patient's medical record Delete the selected medical record of the selected patient Enter the keyword/pinyin and click to search to match the information in the database Used to display the patient information of selected patient, including all medical records, patient ID, name, gender, birth date, attending doctor, etc. Click this button to jump to the image acquisition interface Click this button to jump to the image browse interface Current logged-in username Navigation button includes Back to login, Setting, About and Correct. 2 3 4 5 6 Patient-based search Selected information patient

Image acquisition button Image browse button Status bar 23 Canis014D07 User Manual 5.3 Patient Information Page User Interface Button Description Information modification Modify patient information, touch the name, birth date, gender, and click [Save] to save the modified information Addition of tooth position Touch the corresponding tooth position and click [Save] to add the tooth position to be examined Jump to the image acquisition page to examine the selected patient Back to Home page 5.4 Image Acquisition Page The detailed functions of the buttons on this interface are described in the following table:

No. Item Description Status bar Current logged-in username Canis014D07 User Manual 24 No. Item Description Navigation button Connected detector ID User Interface The pitch angle refers to a certain angle between the head and the horizontal line during the shooting process Red symbol means that exposure is prohibited or an error is reported, yellow means that it is being exposed, and green means that it can be exposed In the process of shooting, if there is any tooth position that has not been checked, you can suspend the examination next time Adjust the window width and window level of the acquired pictures to confirm whether they are qualified Delete and re-shoot the tooth position that do not meet the requirements You can save the default parameters according to your needs, and the default parameters set by each user are independent of each other Button There are default exposure times for patients of different genders and ages, and the exposure times are also adjustable Selection of tooth position Select and shoot multiple tooth positions registered by the patient During the shooting process, jump to the patient information page to add the tooth position to be shot Jump to the image view page and view the teeth images that have been shot A prompt box will pop up, "Closing the detector, please wait a moment", and then return to the home page 25 Canis014D07 User Manual 5.5 Image View Page User Interface In this page, you can perform some related operations on the image, including post-processing and image translation and rotation operations. The detailed functions of the buttons on the interface are described in the following table:

Item Description Reset the operated image and undo the previous operation Click this button, and the image rotates 90 clockwise every time You can mark where the image needs to be marked Click to adjust the window width and window level of the selected image The acquired images can be exported to the PC via a data cable Save the image to the local, supporting .jpg, .raw, .dicom three formats Patient information Display patient ID number, name, gender, date of birth, image, etc. Enhance edge Reduce noise Enhance the edge of the image, the range is 0~100, the default value is 75 Perform noise reduction processing on the image, the range is 0~30, the default value is 5 Enhance contrast Enhance the contrast of the image, the range is 0~5, the default value is 3 Adjust light/dark Adjust the overall brightness and darkness of the image, the range is 1~50, the default value is 10 High threshold Adjust the high threshold of the image, the range is 0~5, the default value is 1 Canis014D07 User Manual 26 User Interface Item Description Low threshold Adjust the low threshold of the image, the range is 0~5, the default value is 1 OK Exit Click OK, and the processed image will be obtained if the set parameters do not exceed the range Click the button to return to the image browsing interface, and the image is the processed image 5.6 Setting Page This page is mainly used to set account, function, network, sensor, and application connection mode. General Users Functions Button Description Jump to the Android system for settings, such as brightness, wifi, etc. This page is still under development Set the country code, account number, password, detector IP of the connected sensor Select the applied connection mode, such as demo mode, independent mode, intelligent filming mode, etc. Administrators Functions Button Sub Button Figure Description 27 Canis014D07 User Manual Button Sub Button Figure Description User Interface Change the password of the administrator click

[OK] to change the password account, Reset the users' password: click

[Reset Password] to change the account's password to 123456 Add, modify and delete users:

click an account you want to operate and then click the corresponding add, modify and delete buttons to proceed to the next step after six months, The first boot prompts the user to start the exposurefor the first time;

it prompts the user that exposure is required every six months;

Exposure process: 60KV 2MA 2s repeated 10 times with 15s 70KV 2MA 2s interval;

repeated 10 times with 15s interval Canis014D07 User Manual 28 Exposure Time Setting User Interface You can enter the independent exposure mode by clicking the [application] button of the setting page and selecting the independent mode. The exposure time can be controlled by clicking the ExposureTime increase or decrease on the screen, and the exposure time can also be adjusted through the physical buttons of the equipment head. exposure is performed by long pressing the 1S exposure button, and the exposure conditions are battery voltage, power level, tube temperature, and time interval. Only when certain conditions are met, a buzzer will be heard during exposure, and the end of the buzzer indicates the end of the exposure. If the exposure button is released during the buzzer sound, the exposure will end at any time. Press and hold the exposure button on the equipment for 1 second to expose exposure. When certain conditions are met for battery voltage, power, tube temperature, time interval, and detector status, exposure can be performed. During exposure, you will hear a buzzer sound, and the end of the buzzer indicates the end of the exposure. If you release the exposure button during the buzzer sound, the exposure will end at any time. You can change the exposure judgment adjustment by modifying the configuration file, such as the range of exposure temperature, the range of battery power, the range of battery voltage, the interval of exposure time, the voltage and current during exposure;

The path to the configuration file is in Explorer /iray/default.config. Open the file with an editor, edit and save it. The configured parameters are kv, ua, minTemp, maxTemp, minBattery, maxBattery, minVoltage, maxVoltage, isMarket. Among them, when isMartket is set to false, the time interval of two exposures is 30 times, and when it is set to true, the time interval of two exposures is 7 times. The relevant configuration file page is shown in the figure below 29 Canis014D07 User Manual User Interface Canis014D07 User Manual 30 Service Information 6 Service Information 6.1 Service Life The estimated product lifetime is up to 7 years under appropriate regular inspection and maintenance. The product life is decided by that of the equipment. For other replaceable parts, their service life will not affect the life cycle of the whole product. NOTE Main parts (parts required to maintain the function of the product) of this product will be stocked for 5 years after discontinuance of production for repairing. 6.2 Periodic Inspection and Maintenance To ensure image quality and the safety for the patient and operator, it is highly recommended that periodic inspection and maintenance be carried out by the qualified maintenance personnel. Item Operation Frequency Pre-startup check Before operation, check if the equipment is clean and ready for use Daily Post-shutdown check After each use, check if the equipment has been turned off Daily Sceen Check if the screen can be displayed normally when starting. Daily Exposure button Check if the exposure indicator light turns on when the exposure button is pressed. Buzzer Check if the buzzer sound works OK Charging LED indicator Check if the battery charging LED indicator comes on when charging the battery. Daily Daily Daily Labels Battery Check if all visible labels are intact and legible. Monthly Check the battery life and check whether the battery is swollen Yearly Enssential performance The enssential performance of the equipment should be tested by the local third-party organization. Yearly 31 Canis014D07 User Manual

WARNING For the maintenance and overhaul involving the disassembly of the equipment enclosure, contact qualified service engineers. Please contact iRays Customer Service Department or your product distributors. Service Information 6.3 Disinfection and Cleaning In order to ensure proper hygiene and cleaning of the equipment, the following steps must be followed:

Wipe the surface of the equipment with a cloth/wipe moistened disinfectant to disinfect the patient's contact surface, 96% ethanol is recommended;

Wipe off the disinfectant with a cloth/wipe dampened with water and dry the surface with a dry cloth/wipe;

Store the equipment in specified environment when the surface turns dry.

WARNING The equipment must be powered off before disinfection and cleaning the equipment. Disposable cloth or wipe should be used instead of reusable one. 6.4 Troubleshooting If any fault occurs but cannot be solved, turn off the equipment and contact iRays Customer Service Department

(service@iraygroup.com) for professional technical support and provide the following information as per the product label:

1 2 Product SN Name and model of product 3 Description of product failure as detailed as possible 6.5 Manufacturer Information Company:

Residence:

Tel:

CS dept.:

CS tel:

CS fax:

iRay Imaging Technology (Haining) Limited No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China

+86-21-50720560 Customer service of iRay Imaging Technology (Haining) Limited

+86-21-50720560

+86-4008266163-60610 CS dept. address:

No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China Canis014D07 User Manual 32 Service Information CS email:

Website:

service@iraygroup.com www.iraygroup.com 6.6 Factory Site Factory:

Address:

iRay Imaging Technology (Haining) Limited 3rd floor, Building 1, No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China Tel:

+86-512-53690872 33 Canis014D07 User Manual Maunfacturer:

iRay Imaging Technology (Haining) Limited Address:

No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China Tel:

Fax:

+86-512-53690872

+86-512-53690872 Website:

www.iraygroup.com

Wireless Digital Wireless Digital Flat Panel Detector Mars1417X User Manual Version A1 Doc ID 042-201-02 Release Date:2020.09.01

Before operating, please read this user manual and pay attention to all safety precautions. time (reserve). Please ensure that this user manual is properly maintained so that it can be accessed at any E Please use it correctly based on full understanding of the content. To Customers Congratulations on your purchase of the Wireless Digital Wireless Digital Flat Panel Detector

(hereinafter referred to as Mars1417X) which is manufactured by iRay Technology Company Ltd. (Hereinafter referred to as iRay). Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay Mars1417X. If you have any questions or suggestions, please feel free to contact us. personnel. product. Notes on usage and management of the equipment 1. Read all of the instructions in the user guide before your operation. Give particular attention to all safety precautions. 2. Only a physician or a legally certified operator should use this product. 3. The equipment should be maintained in a safe and operable condition by maintenance 4. Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1. For details, consult our sales representative or local iRay dealer. 5. Use only the dedicated cables. Do not use any cables other than those supplied with this 6. Request your sales representative or local iRay dealer to install this product User 1 Manual of Mars1417X Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Caring for your environment This symbol indicates that this product is not to be disposed of with your residential or commercial waste. Recycling iRay Equipment Please do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste items. Contact your local authorities for information about practices established in your region. If collection systems are not available, call iRay Customer Service for assistance. Disclaimer 1. iRay shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product. 2. iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to this product or failure to strictly comply with iRays operating and maintenance instructions. 3. iRay shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as Original iRay Products by iRay Technology. 4. It is the responsibilities of the user/attending physicians for maintaining the privacy of image data and providing medical care services. iRay shall not be responsible for the 2 Manual of Mars1417X User To Customers legality of image processing, reading and storage nor it shall be responsible for loss of 5. Information regarding specification, compositions, and appearance of this product is image data for any reason. subject to change without prior notice. Copyright All rights reserved Mars1417X. Trademarks No part of this publication may be reproduced in any form or by any means without the written permission of iRay. The information contained herein is designed only for use with iRay The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd. User Manual of Mars1417X 3 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Symbols and Conventions The following symbols and conventions are used throughout the user guide. Identify the conditions under which improper use of the product may cause death or serious personal injury. Identify conditions under which improper use of the product may cause minor personal injury. Identify conditions under which improper use of the product may cause property damage. Indicate a prohibited operation. Indicate an action that must be performed Indicate important operations and restrictions. Indicate operations for reference and complementary information.

4 Manual of Mars1417X User To Customers Labels and markings on the equipment The contents of the label and mark on iRay Mars1417X product are indicated as below:

Symbol

Description Caution: please refer to the instructions in the user manual. Indicates that the equipment has passed CE testing and the CE

Notified Body number follows it. Serial number of the product.

Name and address of the manufacturer. Manufacturing date of this product. Expiring date of this product.

This symbol is used to indicate non-ionized electromagnetic

radiation. European region. Name and address of iRay authorized representative in the Consultation of the user guide for general information. This product is not to be disposed of with your residential or commercial waste.

Safety Signs:

Please refer to the user guide for safety instructions. User Manual of Mars1417X 5 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X B Type. Load limit. (Central area) Handled with care. Operational temperature limits. Storage temperature limits.

Fragile Keep away from sunlight

Keep dry Humidity limits. Keep the equipment up right. Do not roll the transportation package. Stacking limit number. IP56 for working surface only Detector symbol : device is for prescription use only

6 Manual of Mars1417X User To Customers User Manual of Mars1417X 7 Contents Contents CONTENTS............................................................................................................................ 8 SAFETY INFORMATION ..................................................................................... 9 1.1. Safety Precautions .................................................................................. 10 1.2. Notes for Using ........................................................................................ 20 GENERAL DESCRIPTION ................................................................................ 22 2.1. Product Description ................................................................................... 23 2.2. Principle ..................................................................................................... 23 2.3. Scope ......................................................................................................... 24 2.4. Characteristics ........................................................................................... 24 2.5. Intended Use ............................................................................................. 24 2.6. Environment ............................................................................................... 29 2.7. Product Components ................................................................................. 29 2.8. Specification ................................................................................................ 31 3. BASIC OPERATION .......................................................................................... 33 3.1. Preparation ................................................................................................ 34 3.2. Routine Operation ..................................................................................... 35 3.3. Battery Charger Installation ........................................................................ 37 4. SOFTWARE SETUP .......................................................................................... 38 4.1. System requirement ................................................................................ 39 4.2. Environment setup................................................................................... 39 4.3. Wired Connection (for setting&maintenance) ......................................... 39 4.4. Software UI .............................................................................................. 43 4.5. NETWORK ......................................................................................................... 64 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

5. OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION ............................ 65 5.1. Steps for acquiring image ........................................................................ 66 5.2. Software Mode ........................................................................................ 66 5.3. AED Mode ............................................................................................... 68 5.4. After use .................................................................................................. 70 5.5. Firmware Upgrade ................................................................................... 70 6. REGULATORY INFORMATION ........................................................................ 73 6.1. Medical Equipment Safety Standards ..................................................... 74 6.2. Guidance and Manufactures Declaration for EMC ................................. 75 6.3. Radio Frequency Compliance Information .............................................. 78 6.4. Battery Safety Standards ........................................................................ 81 6.5. Product Label .......................................................................................... 81 TROUBLE SHOOTING ...................................................................................... 85 SERVICE INFORMATION ................................................................................. 86 8.1. Service Office Information ....................................................................... 87 8.2. Product Lifetime ....................................................................................... 87 8.3. Regular Inspection and Maintenance ...................................................... 87 8.4. Repair ...................................................................................................... 87 8.5. Replacement Parts Support .................................................................... 88 APPENDIX A INFORMATION OF MANUFACTURES ....................................................... 90 APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE ..................................... 91 1. 2. 7. 8. User 7 Manual of Mars1417X 1. Safety Information 1. Safety Information 1.1. Safety Precautions .................................................................................. 10 1.2. Notes for Using ........................................................................................ 20 User Manual of Mars1417X 9 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 1.1. Safety Precautions equipment/data Follow these safeguards and properly use the equipment to prevent injury and damage to any WARNING Installation and Do not use or store the equipment near flammable environment of use chemicals such as alcohol, thinner, benzene, etc. If chemicals are spilled or evaporate, it may result in fire or electric shock through contact with electric parts inside the equipment. Also, some disinfectants are flammable. Be sure to take care when using them. Do not connect the equipment with anything other than specified. Doing so may result in fire or electric shock. All the patients with active implantable medical devices should be kept away from the equipment. 10 Manual of Mars1417X User 1. Safety Information Power supply Do not operate the equipment using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in fire or electric shock. Do not handle the equipment with wet hands. You may experience electric shock that could result in death or serious injury. Do not place heavy object such as medical equipment on cables and cords. Do not pull, bend, bundle, or step on them to prevent their sheath from being damaged, and do not alter them neither. Doing so may damage the cords, which could result in fire or electric shock. Do not supply power to more than one piece of equipment using the same AC outlet. Doing so may result in fire or electric shock. Do not turn ON the system power when condensation has formed on the equipment. Doing so may result in fire or electric shock. User Manual of Mars1417X 11 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Power supply Do not connect a multiple portable socket-outlet or extension cord to the system. Doing so may result in fire or electric shock. To avoid the risk of electric shock, this equipment must only be connected to power supply with protective earth. Not doing so may result in fire or electric shock. Securely plug the power cord into the AC outlet. If contact failure occurs, or if metal objects come into contact with the exposed metal prongs of the plug, fire or electric shock may result. Be sure to turn OFF the power to each piece of equipment before connecting or disconnecting the Otherwise, you may get an electric shock that could result in death or serious injury. Be sure to hold the plug or connector to disconnect cords. the cord. If you pull the cord, the core wire may be damaged, resulting in fire or electric shock. WARNING 12 Manual of Mars1417X User 1. Safety Information Handling Never disassemble or modify the equipment. No modification of this equipment is allowed. Parts of the Mars1417X that are not serviced or maintained while in use with the patient. Doing so may result in fire or electric shock. Also, since the equipment incorporates parts that may cause electric shock as well as other hazardous parts, touching them may cause death or serious injury. Do not place anything on top of the equipment. The object may fall and cause an injury. Also, if metal objects such as needles or clips fall into the equipment, or if liquid is spilled, it may result in fire or electric shock. Do not hit or drop the equipment. The equipment may be damaged if it receives a strong jolt, which may result in fire or electric shock if the equipment is used without being repaired. Do not put the equipment and pointed objects together. The equipment may be damaged. If so, the equipment should be used in bucky. Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment. User Manual of Mars1417X 13 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X When a problem Should any of the following occurs, immediately occurs unplug the power cord of Control Box, and contact your sales representative or local iRay dealer:

When there is smoke, an odd smell or abnormal sound. When liquid has been spilled into the equipment or a metal object has entered through an opening. When the equipment has been dropped and damaged. Maintenance and Please turn OFF the power of the equipment and unplug the power cord of adaptor before cleaning. NEVER use alcohol, ether and other flammable inspection cleaning agent for safety. NEVER use methanol, benzene, acid and base because they will erode the equipment. DON'T dip the equipment into the liquid. Please make sure that the equipment's surface &

plugs are dry before turning ON. Otherwise, it may result in fire or electric shock. Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug, its periphery and AC outlet with a dry cloth. in a fire. If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture; this could cause insulation failure that may result 14 Manual of Mars1417X User 1. Safety Information For safety reasons, be sure to turn OFF the power to each piece of equipment when performing inspections indicated in this manual. Otherwise, electric shocks may occur. CAUTION User Manual of Mars1417X 15 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Installation and Do not install the equipment in any of the locations environment of use listed below. Doing so may result in failure, malfunction, equipment falling, fire or injury. Close to facilities where water is used Where it will be exposed to direct sunlight Close to the air outlet of an air-conditioner or ventilation equipment Close to heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where temperature or humidity is high Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area Take care that cables do not become tangled during use. Also, be careful not to get your feet caught by Otherwise, it may cause a malfunction of the equipment or injury of the user due to tripping over the cable. cable. 16 Manual of Mars1417X User 1. Safety Information Always connect the three-core power cord plug to a grounded AC power outlet. Power supply To make it easy to disconnect the plug at any time, avoid putting any obstacles near the outlet. Otherwise, it may not be possible to disconnect the plug in an emergency. Be sure to ground the equipment to an indoor grounded connector. Also, be sure to connect all the grounds for the system to a common ground. Do not use any power source other than the one provided with this equipment. Otherwise, fire or electric shock may be caused due to leakage. In case the patient is injured, it is not allowed to contact with blood or other body fluids. Doing so may result in fire or electric shock. In such a situation, protect the equipment with a disposable cover as necessary. Turn OFF the power and pull out the plug to each piece of equipment for safety when not used. CAUTION Handling Do not spill liquid or chemicals onto the equipment. User Manual of Mars1417X 17 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Handling Handle the equipment carefully. Do not submerge the equipment in water. The internal image sensor may be damaged if something hits against it or it is dropped. Do not place excessive weight on the equipment. Be sure to use the equipment on a protected foam. Otherwise, the internal image sensor may be damaged. Be sure to securely hold the detector while using it in upright positions. Otherwise, the detector may fall over, resulting in injury to the user or patient, or may flip over, resulting in damage to the inner device. Keep the same load (same pressure) on the detector when acquiring the image. Or the image will be incorrect. Do not place excessive weight on the panel. Otherwise, the internal image sensor may be damaged and image may be incorrect. Patients stand on the product temporarily, and the intended weight can be 135kg. Based on the internal TFT character, cannot load the dynamic forces due to loading from persons

<Load Limit>

Uniform load300 kg over the whole area of the surface. 18 Manual of Mars1417X User 1. Safety Information Local load150 kg on an area 4 cm diameter. CAUTION Do not close to fire, do not use in high temperature Do not invert positive and negative pole Do not contact with metal in case of short circuit User Manual of Mars1417X 19 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X When using the product, take the following precautions. Otherwise, problems may occur and 1.2. Notes for Using the product may not function correctly. Before exposure Be sure to check the connection of all the parts are set properly & check the detector is kept in insulated cover that operator or patient cant touch the detector directly before powered up. Be sure to check the product daily and confirm it work properly. Sudden heating of the room in cold areas will cause condensation on the product. In this case, wait until the condensation evaporates before performing an exposure. If it is used when condensation is formed, problems may occur in the quality of captured images. When an air-conditioner is used, be sure to raise/lower the temperature gradually to The product should be warmed up for 15 minutes before exposure or updating the gain prevent condensation. map and defect map. Make sure wave form of the energy going to the X ray tube is square not pulse. Be cautious with circumstance that someone has radio isotope recently injected into them, it may cause panel transmit image without x ray. Once powered off, please wait at least 60s before power on again During exposure Do not move Power Cable or Ethernet Cable during exposure, or it may cause image noise or artifacts, even incorrect images. Do not use the product near the equipment generating a strong magnetic field. Otherwise, it may cause image noise, artifacts or even incorrect images. 20 Manual of Mars1417X User 1. Safety Information After Usage After every examination, wipe the patient contact surfaces with disinfectants such as ethanol, to prevent the risk of infection. For details on how to sterilize, consult a specialist. Do not spray the product directly with disinfectants or detergents. Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as alcohol, benzene and acid. Doing so may damage the surface of the product. Its recommended to use a waterproof non-woven cover as the isolated layer between product and the blooding patient. User Manual of Mars1417X 21 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 2. General Description 2.1. Product Description ................................................................................... 23 2.2. Principle ..................................................................................................... 23 2.3. Scope ......................................................................................................... 24 2.4. Characteristics ........................................................................................... 24 2.5. Intended Use .............................................................................................. 24 2.6. Environment ............................................................................................... 29 2.7. Product Components ................................................................................. 29 2.8. Specification ................................................................................................. 31 22 Manual of Mars1417X User 1. Safety Information 2.1. Product Description Mars1417X is a cassette-size wireless X-ray Wireless Digital Wireless Digital Flat Panel Detector based on amorphous silicon thin-film transistor technology. It is designed to provide the high quality radiography image which contains an active matrix of 35004300 with 100um pixel pitch, the TFT module has a pixel matrix of 3584*4352. There are 12 dummy columns for both right and left, 15 dummy rows for both top and bottom. Also, there are 30 unconnected columns for both right and left, and 11 unconnected rows for both top and bottom. The scintillator of Mars1417X is CsI(Caesium Iodide) which is direct deposit. Since Mars1417X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system. 12Columns 30Columns 2.2. Principle 15Rows 11Rows Detectors contain a layer of scintillator material, which converts the x-rays into light. Directly behind the scintillator layer is an amorphous silicon pixel array contains a photodiode which generates an electrical signal in proportion to the light produced by the portion of scintillator layer in front of the pixel. The signals from the photodiodes are amplified and encoded by additional electronics User Manual of Mars1417X 23 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X positioned behind the sensor array in order to produce an accurate and sensitive digital representation of the x-ray image. 2.3. Scope This manual contains information about iRay Mars1417X product. All operators must read and understand this manual before using equipment. All information in this manual, including the illustrations, is based on equipment prototype. If configuration of your equipment does not have any of these items, information about these items in the manual does not apply to your equipment. Wireless static Wireless Digital Wireless Digital Flat Panel Detector 2.4. Characteristics 14 inch 17 inch Removable handle AED 802.11ac 16-bit AD 2.5. Intended Use 24 Manual of Mars1417X User Mars1417X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for 1. Safety Information mammography or dental applications. Suitable patient It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system. PATIENT population:

Adult and pediatric patients Weight: not relevant Health: not relevant Nationality: multiple Patient state: patient is not user Gender: except for pregnant women Pediatric Use: Guidance & Considerations Special care should be exercised when imaging patients outside the typical adult size range, especially smaller pediatric patients whose size does not overlap the adult size range (e.g.less than 50 kg (110 lb) in weight and 150 cm (59 in) in height, measurements which approximately correspond to that of an average 12 year old. The following ranges of pediatric subpopulations are to be used as a guide for manufacturers in developing medical devices:

Pediatric Subgroup Approximate Age Range Newborn (Neonate) From birth to 1 month of age Infant Greater than 1 month to 2 years of age User Manual of Mars1417X 25 Wireless Digital Wireless Digital Flat Panel Detector Mars1417X Child Adolescent Greater than 2 to 12 years of age Greater than 12 through 21 years of age Exposure to ionizing radiation is of particular concern in pediatric patients because:

1) for certain organs and tumor types, younger patients are more radiosensitive than adults (the cancer risk per unit dose of ionizing radiation is higher for younger patients);

2) use of equipment and exposure settings designed for adults of average size can result in excessive and unnecessary radiation exposure of smaller patients;

3) younger patients have a longer expected lifetime putting them at higher risk of cancer from the effects of radiation exposure. To help reduce the risk of excessive radiation exposure, you should follow the ALARA

(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only the amount necessary to obtain images that are adequate clinically. Additional guidance and recommendation are provided by the Alliance for Radiation Safety in Pediatric Imaging (Image Gently Alliance) https://www.imagegently.org/

Table 1 : Techniques for Typical Body Parts BodyParts PatientSize kVp mAs SID Grid Abdomen AP/PA VeryLowBirthWeight (Less than1.5Kg) LowBirthWeight(Between1.5 and2.5Kg) Newborn(Ageislessthan1 monthandWeightabovethan 2.5Kg) 55 1 1m No 55 1.6 1m No 70 1.6 1m No 26 Manual of Mars1417X User 1. Safety Information Abdomen AP/PA BodyParts PatientSize mAs SID Grid Infant (Age is between 1 month and 2 1m No kVp 73 Child (Age is between 2 years and 12 75 7.1 1m Yes Preadolescent (Age is between 12 75 14 1m Yes years and 13 years) Adolescent (Age is between 13 years 75 20 1m Yes Very Low Birth Weight Low Birth Weight 2 years) years) and 21 years) Adult Small Adult Medium Adult Large Newborn Infant Child Preadolescent Adolescent Adult Small Adult Medium Adult Large Newborn Infant Child Preadolescent Adolescent AdultSmall VeryLowBirthWeight LowBirthWeight Chest PA/AP Extremities AP/PA Yes Yes Yes No No No No No Yes Yes Yes Yes Yes no no no no no no no no 75 80 85 50 55 65 70 70 90 90 110 110 120 50 55 57 57 58 62 62 18 22 32 1 1 1 1.6 1.6 2 2 1.8 2.8 4 1 1 1 1.2 1.2 1.6 2 1m 1m 1m 1m 1m 1m 1m 1m 1m 1m 1.8m 1.8m 1.8m 1m 1m 1m 1m 1m 1m 1m Regardingadult detailstechniquesof Extremities,pleaserefer tothetableTechniques forAdultExtrimities Table 2: Techniques for Adult Extrimities AdultExtemitiesList AnkleAP kVp 58 mAs 4 SID 1m Grid no iRay Technology Co. Mars1717V-VSI Digital Flat Panel Detector User AdultExtemitiesList kVp mAs AnkleLateral FemurAP FemurLateral HandAP HandLateral HumerusAP HumerusLateral KneeAP KneeLateral WristPA WristLateral 58 70 70 53 53 75 70 65 65 55 55 4 16 10 1.8 1.8 7.1 3.2 10 10 1.8 1.8 ESSENTIAL PERFORMANCE SID 1m 1m 1m 1m 1m 1m 1m 1m 1m 1m 1m Grid no yes yes no no yes yes yes yes no no According to the Mars1417X INTENDED USE and the result of risk management, image acquisition and data transmission are defined as ESSENTIAL PERFORMANCE. Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE. Method for getting dark image in detail refers to section installation and operation Intended OPERATOR:

All of use, maintenance and operation steps should be carried out by the operator who has accepted the professional training offered by the company's customer service staff. Lifetime:

Life-time: 5 years without frequency limit iRay Technology Co. 2.General Description 2.6. Environment Temperature Humidity Atmospheric Pressure Operating 10~35 5~90% RH 700~1060mbar Storage

-20~55 5~95% RH 600~1060mbar 2.7. Product Components Item Picture Description Mars1417X Detector 1pcs Medical Adapter AC Power Cable 1pcs 1pcs User 19 Manual of Mars1417X Mars1717V-VSI Digital Flat Panel Detector User Gigabit Ethernet Cable 1pcs 2.7.1. Detector iRay Technology Co. 2. General Description 2.7.2. Indicator 2.8. Specification 2.8.1. Basic iRay Technology Co. Item Specification Model Mars1417X Image Sensor a-Si (Amorphous Silicon) TFT Scintillator CsI Pixel Size 100um Mars1717V-VSI Digital Flat Panel Detector User Fill Factor 60%

Effective Array 3500x4300 Effective Area (H x V) 35mm43mm Spatial Resolution 4.3 lp/mm Image Transfer WIFI Full Image Time

<5s (with 1s XWin, from end of XWin) Cycle Time 6s Power Consumption 35W @ Full-Running 7.5W @ Idle Dimension (L W H) 460mmx384mmx15mm @typ. Weight 2.8kg(with battery) X-ray Energy 40-150kV Panel protection IP56 Trigger Mode Software/AED SID 90-180cm iRay Technology Co. 2. General Description 3. Basic Operation 3.1. Preparation ................................................................................................ 34 3.2. Routine Operation ..................................................................................... 35 3.3. Battery Charger Installation ........................................................................ 37 iRay Technology Co. 3.Basic Operation 3.1. Preparation 3.1.1. Attach Battery Pack The product can be powered by both a battery pack and DC power. Once the battery pack is inserted or DC power is connected, detectors will be turned on immediately. If neither battery nor DC power is connected, panel will power off. Please see below for battery installation. Make sure that connectors on the battery pack are pointed to the opening in the battery compartment. Slide battery package into battery compartment (Make sure battery capacity overpass is 15%). Slide the battery lock lever. 3.1.2. Adapter User 27 Detector supports an external adapter powered, It gets CB certificate No. SG PSB-MD-

00005 and NRTL certificate No. U8V 093768 0016.The ports defined as bellow:

Manual of Mars1417X Definition Voltage Range DC Power Negative DC Power Positive DC Power Positive 0~0.5V 23~25V 23~25V No

. P1 P2 P3 P4 DC Power Negative 0~0.5V 0~0.42A 3.Basic Operation Rated Current 0~0.42A 0~0.42A 0~0.42A In order to meet the safety and function requirements of the detector, standard components are recommended. AC Adapter 3.2. Routine Operation 3.2.1. Starting Up On the control panel, users can press the power button to turn on. When the detector is powered down, the user presses the button for 4 seconds to turn on the detector if the battery is inserted and the capacity is not less than 15%, or DC power is connected. User Manual of Mars1417X 35 Mars1717V-VSI Digital Flat Panel Detector User After booting up, users can check the indicator of the detector. Power indicator:

Lighting Status Battery Capacity Status DC Input N/A YES NO YES Description Detector is Detector is Detector is Detector is off on on on YES off Detector is N/A N/A 7% &

15%

15% &

95%

95%

Lighting Status Description Detector is turned off OFF Wired connection broken and wireless connection not ready Wireless connection is enabled Wired connection is enabled (Service Mode) Data transmission Detector is off Detector is off Exposure is allowed iRay Technology Co. Mode Indicator Lighting Status Description Mode Indicator Lighting Status Description Power Indicator OFF Green ON Orange Blinking Green Blinking Green&Oran ge Blinking Link indicator:

Link Indicator Blue ON Green ON Mode indicator:

ON OFF Status indicator OFF Green ON 3.Basic Operation Orange ON Error 3.3. Battery Charger Installation Operation Figure Unload Battery from battery charger. Insert battery into battery Note the interface position charger. as figure. Press the battery to the bottom of battery compartment. User Manual of Mars1417X 37 4. Software Setup 4. Software Setup 4.1. System requirement ................................................................................ 39 4.2. Environment setup................................................................................... 39 4.3. Wired Connection (for setting&maintenance) ......................................... 39 4.4. Software UI .............................................................................................. 43 4.5. NETWORK ......................................................................................................... 64 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-

54 User Manual of Mars1417X 4. Software Setup 4.1. System requirement iDetector is developed and deployed on Windows Operation System, it can be run on Windows XP/Windows 7/Windows 8/Windows 10, OS should install latest service pack. And requires computer memory 4 GB minimum. The firewall should be shut down to avoid commuication issue. 4.2. Environment setup Setup files and download url are included in SDK directory: Tools\env_setup 1. Please install Microsoft .NET Framework 4.5(Windows XP only can install V4.0 ). Download from Microsoft web site, please. 2. Visual C++ redistributed package need to be installed: vcredist_x86_2013(or 3. For Windows XP, full path should be used in file bind.txt. vcredist_x64_vs2013). can be changed when needed. 4.3. Wired Connection (for setting&maintenance) The wifi information should be configured for first use with wired connection. The configuration User Manual of Mars1417X 39 Mars1717V-VSI Digital Flat Panel Detector User Figure 3-3-1 Connect the power cable and data cable to the detector as figure 3-3-1, please mind that there are two type-c interfaces on the detector, the one closes to the edge of the battery component is for data and command, the other one is for service. Figure 3-3-2 iRay Technology Co. 4. Software Setup The default IP address (IPv4) of the detector is 192.168.8.8, the PC address (IPv4) should be configured as 192.168.8.xxx, which should be the same as the value of parameter Cfg_HostIP in file *\work_dir\Mars1417X\config.ini Wireless Configuration On the main window of Home page select the instance ofMars1417X and use the Connect Figure 3-3-3 button the build the connection. After finishing building the connection, click Read Configbutton on the Wifitab of Detector Figure 3-3-4 pag to get the current wifi configuration. User can set the mode of the wifi for detector, AP or Client. User Manual of Mars1417X 41 Mars1717V-VSI Digital Flat Panel Detector User succeed. Clientmode. Figure 3-3-5 For Client mode, user can add the information of the access point with button Add, and set the default access point that the detector should connects to with button Select. Figure 3-3-6 After click Write Configbutton, the new setting of the wifi will be valid after the status shows The detector will connect to the access point when the data cable is removed. What needs to be noticed is, the wifi frequency set on the APinterface will also be valid for iRay Technology Co. 4. Software Setup 4.4. Software UI SDK supply iDetector as tool softwore:

32-bits iDetector.exe: Tools\iDetector\w32 64-bits iDetector.exe: Tools\iDetector\x64 little difference. versions of iDetector. Double click iDetector.exe to run the software. For different software version, the UI maybe has For this manual, the example is based on SDK_*_xxxx. This UI is almost the same for different Tab Function description Home Connect FPD and view the connect state Acquire Acquire image, select correction mode, save image and process image SDK config.ini setting, log level setting Detector Configurate parameters for detector. Calibrate Generate calibration files and manage the calibration files Local File Open and view local images. 4.4.1. HomePage The main function in this page is to connect detector. User Manual of Mars1417X 43 Mars1717V-VSI Digital Flat Panel Detector User Item Function description Name Display the name of detector SN Display the SN of detector Product Display the type of detector Type State Display the connection state (BindUnknown, Ready etc.) Button Function description Connect Click this button to connect the selected detector. Close Click this button to disconnect the selected detector. Add Add work directory Remove Remove work directory Syncbox Open Syncbox configuration window(Optional device) iRay Technology Co. 4. Software Setup 4.4.2. Acquire Page This page is used to acquire image under different work mode, and user can select correction options too. When acquire image finished there will be a preview image shown on the screen (if the correction option is selected, otherwise only the raw images will be shown).The propertities of image is displayed on the left of image window.And on the right of image window there is a list to show thumbnail of images. User can select it and double click to see for detail. User can rotate, reverse or mirror image. User can get the value of AVG and SNR by ROI tool. The acquired images can be save as raw, tiff or dicom formats. Both raw and tiff formats support single frame and continuous frames save. Status bar shows detectors serial number, the current task and state of detector, and feedback information of command. Status bar is also can be seen in other pages, and they are all the same. User Manual of Mars1417X 45 Mars1717V-VSI Digital Flat Panel Detector User Item Description SN SN number of current connected detectors State Detectors state , eg busy, ready Task the current task of detector Message feedback information of command,eg succeed,failed Functions in this Page. Correction Menu Description Offset HWPostOffset checked Do hardware PostOffset correction for image if Gain HWGain Do hardware Gain correction for image if selected Defect HWDefect Do hardware defect correction for image if checked Acqurie Button Description Prep Clear. Prepare to integrate. SingleAcq Acquire once Clear and acquire Acquire once for samples) Make the detector enter sleep mode (not supported Save Save the current image, the format is raw and tiff PowerOff Turn off the detector via command Image Properties& Image Process Description PrepAcq Acquire Sleep WW WL PosX window width window level X coordinates of the current cursor at the point iRay Technology Co. Frames Display the frame count PosY Value Width Height FPS Mirror ROI 4. Software Setup Y coordinates of the current cursor at the point Value of the current cursor at the point Image width Image height Frame rate Rotate the image clockwise, 90 degrees every time. Rotate the image anticlockwise, 90 degrees every time. Open or close mirror ROI toolto view the image of the AVG, SV, SNR and other parameters with right click. Press "ctrl" key, can create several ROI area. WW/WL Auto adjust WW/WL based on selected area by right button of mouse. Image List Show thumbnails When the image is displayed on the screen, maybe the user want to see details by dragging or zoom in/out the image, for convenience, these are some shortcuts. 1. Click the left mouse button: movie playback function operation area display. 2. Double-click the left mouse button: the image display in center and with maximum size;

3. Double-click the right mouse button: restore the window level and width for WL:32767/WW:65535;

4. Drag the left mouse button to drag the image display;

5. Lateral-drag the right mouse button to adjust the window width, and vertical-drag the right mouse button to adjust the window level;

User Manual of Mars1417X 47 Mars1717V-VSI Digital Flat Panel Detector User 6. F3 Key: Quickly locate the image window width and window level. 7. F4 Key: Adjust window width and window level automatically. 4.4.3. SDK Pgae SDK page is used to set parameters in config.ini and log level. Different log level will show different details. It is recommended to set the log level as Debug 4.4.4. Detector Page Parameters page. In this page, there are Parameters, Sensor and Images tab. 1. Enter Detector page, the tab of Paramters is activity by default. There are 5 regions in this 2. Parameter name region: lists the paramters. iRay Technology Co.

User Manual for the CARESTREAM Focus 43C Detector Publication No. AJ4311 2020-02-10 All rights reserved. No part of this manual may be reproduced or copied in any form by any meansgraphic, electronic, or mechanical, including photocopying, typing, or information retrieval systemswithout written permission. Notices and Conventions The information herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including consequential or special damages, even if loss or damage is caused by Carestream Healths negligence or fault. Note:

Notes provide additional information, such as expanded explanations, hints, or reminders. Important:

Important highlights critical policy information that affects how you use this manual and this product. CAUTION:

Caution points out a potentially hazardous situation which, if not avoided, might cause minor or moderate injury. Authorized Representative (European Union) Carestream Health France 1, rue Galile 93192 NOISY-LE-GRAND CEDEX FRANCE Importer for European Union Carestream Health Netherlands B.V. Bramenberg 12 3755 BZ Eemnes The Netherlands AJ4311 | 2020-02-10

-iii Notices and Conventions CAUTION:

Federal law restricts this device to sale by or on the order of a physician. CAUTION:

If you witness or become aware of a potential safety issue with this equipment, take the appropriate safety measures and report this to your Carestream Service representative immediately.

-iv AJ4311 | 2020-02-10 Disclaimer Notices and Conventions Carestream shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by the purchaser or third parties as a result of fire, earthquake, any accident, misuse, or abuse of the product. Carestream shall not be liable for any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to the product or failure to strictly comply with Carestreams operating and maintenance instructions. Carestream shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as original products by Carestream. It is the responsibilities of the user or physician to maintain the privacy of image data and provide medical care services. Carestream shall not be responsible for the legality of image processing, reading, and storage nor shall it be responsible for loss of image data for any reason. Information regarding the specifications, compositions, and appearance of this product is subject to change without prior notice. Copyright All rights reserved. No part of this publication may be reproduced in any form or by any means without the written permission of Carestream. The information contained herein is designed only for use with the CARESTREAM Focus 43C Detector. AJ4311 | 2020-02-10

-v Notices and Conventions

-vi AJ4311 | 2020-02-10 Contents Notices and Conventions Disclaimer.......................................................................................................................................... -v 1 Safety and Regulatory Information Symbols............................................................................................................................................1-1 Cautions...........................................................................................................................................1-4 Medical Equipment Classification................................................................................................1-14 Standards.......................................................................................................................................1-15 Emissions and Immunity Compliance to the IEC60601-1-2 Standard........................................ 1-17 Radio Frequency Compliance.......................................................................................................1-21 Correction and Calibration Template Generation................................................................ 1-23 Battery Safety Standards.............................................................................................................. 1-24 Intended Use and Essential Performance....................................................................................1-25 2 Overview Components and Specifications.....................................................................................................2-2 Product Components................................................................................................................ 2-2 Product Specifications...............................................................................................................2-6 IT Network...............................................................................................................................2-11 Service Information...................................................................................................................... 2-13 Disposal......................................................................................................................................... 2-14 3 Installation Panel Installation............................................................................................................................ 3-1 Install the Detector Battery...................................................................................................... 3-1 Power on the Detector............................................................................................................. 3-2 Install the Detector Battery Charger............................................................................................. 3-8 Detector Battery Lock and Activation........................................................................................... 3-9 4 Operation Notes for Using............................................................................................................................... 4-1 Detector Position............................................................................................................................ 4-3 Appendix (For Service Personnel Only) Software and Settings.....................................................................................................................A-I Operating Modes...........................................................................................................................A-V Software Mode........................................................................................................................ A-V Inner2 Mode............................................................................................................................A-VI Freesync Mode........................................................................................................................ A-VI Software Installation.................................................................................................................. A-VIII AJ4311 | 2020-02-10 i Contents Set the Connection Mode............................................................................................................ A-IX Wireless Client Mode.............................................................................................................. A-IX Wireless AP Mode.................................................................................................................... A-X Shortcuts.......................................................................................................................................A-XII Establish a Connection with the Detector.................................................................................A-XIII Configure the Detector..............................................................................................................A-XIV Correction and Calibration Template Generation.....................................................................A-XV Pre-offset Template Generation........................................................................................... A-XV Gain Calibration Template Generation................................................................................ A-XV Defect Correction Template Generation..............................................................................A-XV Image Check and Upload..........................................................................................................A-XVII Local Image Check............................................................................................................... A-XVII Panel Image Upload............................................................................................................ A-XVII Defect Template Check and Modification.............................................................................. A-XVIII Defect Template Check...................................................................................................... A-XVIII Defect Template Modification...........................................................................................A-XVIII Correction and Calibration Management.................................................................................A-XIX Correction and Calibration Template Synchronization......................................................A-XIX Correction and Calibration Management...........................................................................A-XIX Update the Firmware.................................................................................................................. A-XX Publication History ii AJ4311 | 2020-02-10 1 Safety and Regulatory Information Symbols Symbols and Conventions WARNING:

This is used to identify conditions under which improper use of the product may cause death or serious personal injury. This is used to indicate a prohibited operation. This is used to indicate an action that must be performed. Labels and Markings on the Equipment This indicates that the product has passed CE certification and is followed by the CE number. AJ4311 | 2020-02-10 1-1 Safety and Regulatory Information This is used to identify the manufacturers series number, which is after, below, or adjacent to the symbol. The series number usually consists of 19 digits as shown in the following example:

1A2A3A4 B1B2 C1C2 L M1M2 D1D2 Y1Y2 X1X2X3X4 L - Production site 1A2A3A4 - Product code B1B2 - Derived classes C1C2 - Version M1M2 - Month D1D2 - Day Y1Y2 - Year X1X2X3X4 - Numerical order This indicates the name and address of the manufacturer. This indicates the name and address of a Carestream authorized representative in the European region. This indicates consulting the user guide for general information. Safety sign: Dangerous Voltage Handle with care. This indicates operational temperature limits. 1-2 AJ4311 | 2020-02-10 Safety and Regulatory Information This indicates storage temperature limits. This indicates the product radiates a wireless signal. Package symbol: Fragile Package symbol: Keep away from sunlight. Package symbol: Keep dry. This indicates the humidity limits. Keep the product upright. Do not roll the transportation packaging. This indicates the stacking limit number. FDP is allowed to withstand 100 kg on its surface. Rx only IP Device is for prescription use only. IPX1 for working surface only. AJ4311 | 2020-02-10 1-3 Safety and Regulatory Information Cautions Environment for Installation and Use WARNING:

Do not use or store the product near flammable chemicals such as alcohol, thinner, benzene, etc. Chemicals that are spilled or evaporated may result in fire or electric shock through contact with electric parts inside the product. Also, some disinfectants are flammable. Be sure to take care when using them. Environment for Installation and Use WARNING:

Do not connect the equipment with anything other than the specified connectors to avoid fire or electric shock. WARNING:

Keep all patients with active implantable medical devices away from the product. CAUTION:

Do not install the product in any of the locations listed below to avoid failure, malfunction, falling, fire, or injury. Installation and Environment of Use Close to facilities where water is used Where there is exposure to direct sunlight Close to the air outlet of an air conditioner or ventilation equipment Close to a heat source such as a heater Where the power supply is unstable Where temperature or humidity is high Where there is freezing or condensation On an incline or in an unstable area In a dusty environment In a saline or sulfurous environment In areas prone to vibration 1-4 AJ4311 | 2020-02-10 Safety and Regulatory Information Installation and Environment of Use CAUTION:

Do not allow cables to become tangled to avoid a malfunction of the product. Do not get your feet caught by a cable to avoid tripping and injury. CAUTION:

Non-medical equipment such as battery chargers and access point and infrared register tools cannot be used in the vicinity of a patient. Power Supply AJ4311 | 2020-02-10 1-5 Safety and Regulatory Information WARNING:

Do not operate the product with a power supply other than the one indicated on the rating label to avoid fire or electric shock. WARNING:

Do not handle the product with wet hands to avoid electric shock that could result in death or serious injury. Power Supply WARNING:

Do not place heavy object on cables and cords. Co not pull, bend, bundle, or step on them to prevent damage to the sheath. Do not alter them. Avoid damage to the cords, which could result in fire or electric shock. WARNING:

Do not supply power from the same AC outlet to more than one product to avoid fire or electric shock. WARNING:

Do not turn on system power when condensation has formed on the equipment to avoid fire or electric shock. WARNING:

Do not connect multiple portable socket outlets or extension cords to the system to avoid fire or electric shock. Power Supply WARNING:

Connect this product only to a power supply with protective earth to avoid fire or electric shock. WARNING:

Do not use the adapter cord when connecting the panel to a patient. 1-6 AJ4311 | 2020-02-10 Safety and Regulatory Information Power Supply WARNING:

Securely insert the power cord into the AC outlet to avoid a contact failure. If a contact failure occurs or if metal objects come in contact with the exposed metal prongs of the plug, fire or electric shock may result. WARNING:

Be sure to turn off the power before connecting or disconnecting the cords to avoid an electric shock that could result in death or serious injury. WARNING:

Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the core wire may be damaged, resulting in fire or electric shock. Power Supply CAUTION:

Always connect a three-core power cord plug to a grounded AC power outlet. Keep the outlet free of obstacles for easy access to disconnect the plug at any time and in an emergency. Be sure to ground the product to an indoor grounded connector. Be sure to connect all the grounds of the system to common ground. CAUTION:

Do not use any power source other than the one provided with the product to prevent leakage that could result in fire or electric shock. AJ4311 | 2020-02-10 1-7 Safety and Regulatory Information Handling Handling WARNING:

No modification is allowed. Never disassemble or modify the product to avoid fire or electric shock. The product incorporates parts that may be hazardous or cause electric shock Touching them may cause death or serious injury. WARNING:

Do not place an object on top of the product. The object may fall and cause an injury. Metal objects such as needles or clips that fall into the product or spilled liquid may result in fire or electric shock. WARNING:

Do not strike, drop, or cause a strong jolt to the product to prevent damage and avoid fire or electric shock. WARNING:

Do not place the product and pointed objects together to prevent damage. Handling If so, it should be used in Bucky. WARNING:

Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction. 1-8 AJ4311 | 2020-02-10 Safety and Regulatory Information CAUTION:

Do not spill liquid or chemicals onto the equipment. Do not allow an injured patients blood or body fluids contact with the equipment. Doing so may result in fire or electric shock. Handling In such a situation, protect the equipment with a disposable cover as necessary. CAUTION:

For safety Turn OFF the power and remove the plug for all equipment when not used. CAUTION:

Handle the product carefully. Do not submerge the product in water. CAUTION:

The internal image sensor may be damaged if struck or dropped. If the product is dropped, the drop sensor inside would record and the product would not be under warranty. Handling AJ4311 | 2020-02-10 1-9 Safety and Regulatory Information CAUTION:

Do not place excessive weight on the panel to avoid damage to the internal image sensor and an incorrect image. Patients stand on the product temporarily, and the intended weight can be 135 kg. Based on the internal TFT character, cannot load the dynamic forces due to loading from persons Load Limit Handling Uniform load:150 kg over the whole area of the surface Local load:100 kg on an area 4 cm diameter 1-10 AJ4311 | 2020-02-10 Safety and Regulatory Information CAUTION:

Be sure to use the product on a flat surface to prevent the product from bending and doing damage to the internal image sensor. Be sure to securely hold the product while using it in an upright positions to prevent the product from tipping or flipping over, resulting in injury to the user or patient damage to the inner device. Handling Keep the same pressure on the product when acquiring an image to avoid an incorrect image. AJ4311 | 2020-02-10 1-11 Safety and Regulatory Information Handling CAUTION:

Do not use the product close to fire or in high temperature. Do not invert the positive and negative poles. Do not allow the product to make contact with metal to avoid a short circuit. Do not insert sharp objects into the battery. Do not strike the battery. Do not stand on the battery. Do not use the battery outside of the guidelines. Do not dispose of the battery or change the inner structure. Do not submerge the battery in water. When in use, do not allow the battery to have contact with water. Store the battery in a dry place. Use a charger to charge the battery following the GB 9706.1 Standards provided. Do not replace the battery provided with one from another company. Do not use a damaged charger to charge the battery. Only qualified personnel may replace the battery inside the main unit. Do not touch the output connector for the adapter. Do not remove the battery when the detector is powered on only with the battery. Replace the DC power cable if either of the following occurs:

An arc occurs at the detector interface when connecting the cable The power indicator is not illuminated after connecting the cable 1-12 AJ4311 | 2020-02-10 Maintenance and Inspection Safety and Regulatory Information WARNING:

Turn off the power of the product and disconnect the power cord of the adapter before cleaning. Never use alcohol, ether, and other flammable cleaning agent for safety. Never use methanol, benzene, and acid to avoid corrosion on the equipment. Do not place the product in liquid. Maintenance and Inspection WARNING:

Make sure that the surface and connectors are dry before turning on the product to avoid fire or electric shock. WARNING:

Clean the power cord connector periodically. Disconnect the connector from the AC outlet. Use a dry cloth to remove dust or dirt from the connector, its periphery, and the AC outlet. If the cord is kept plugged in for a long time in a dusty, humid, or sooty place, dust around the plug will attract moisture; this could cause insulation failure that may result in a fire. WARNING:

For safety reasons, be sure to turn off the power when performing the inspections indicated in this manual to avoid electrical shock. When a Problem Occurs When a Problem Occurs WARNING:

If any one of the following occurs, immediately disconnect the power cord of the adapter or battery, and contact your sales representative or local dealer:

When there is smoke, an odd odor, or abnormal sound When liquid has spilled into the equipment or a metal object has entered through an opening When the product has been dropped and damaged AJ4311 | 2020-02-10 1-13 Safety and Regulatory Information Medical Equipment Classification Type of protection against electrical shock External electrical power source equipment Class I Equipment (medical approved adapter) Internal electrical power source equipment (battery) Degree of protection against electrical shock Type-B applied part Degree of protection against ingress of water IPX1 Mode of operation Flammable anesthetics Continuous operation Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Not suitable for use in an oxygen-rich environment 1-14 AJ4311 | 2020-02-10 Standards ISO 13485:2016 IEC 60601-1:2005/AMD1:2012 IEC 60601-1-2:2014/EN60601-1-2:2015 IEC 60601-2-54:2018/EN 60601-2-54:2019 IEC 62133-2:2017 IEC 62220-1-1:2015/EN 62220-1-1:2015 IEC 62304:2006/AMD1:2015 Safety and Regulatory Information Medical devices Quality management systems Requirements for regulatory purposes Medical electrical equipment Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard:

Electromagnetic disturbances v Requirements and tests Medical electrical equipment Part 2-54:

Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy Secondary cells and batteries containing alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-1:

Determination of the detective quantum efficiency

- Detectors used in radiographic imaging Medical device software Software life-cycle processes IEC 62366-1:2015/IEC 62366:2007/EN62366:2008 Medical devices Part 1: Application of usability IEC 60601-1-6:2010+A1:2013 EN ISO14971:2012 engineering to medical devices Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Medical device Application of risk management to medical devices ANSI/AAMI ES60601-1:2005/

(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/

(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) AJ4311 | 2020-02-10 1-15 Safety and Regulatory Information CAN/CSA-C22.2 No.60601-1:14 ISO 15223-1:2016/ EN ISO 15223-1:2016 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Medical devices Symbols to be used with medical device labels, labeling and information to be supplied-Part 1: General requirements 1-16 AJ4311 | 2020-02-10 Safety and Regulatory Information Emissions and Immunity Compliance to the IEC60601-1-2 Standard Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment RF emissions Harmonic distortion Voltage fluctuations and flicker CISPR 11 Group 1, Class B IEC 61000-3-2 Class A IEC 61000-3-3 Compliance The Focus 43C Detector uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Focus 43C Detector is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic Immunity Emissions Test EMC Standard Test Levels Professional healthcare facility environment Electrostatic discharge IEC 61000-4-2 8 kV contact Radiated RF EM field IEC 61000-4-3 2 kV, 4 kV, 8 kV, 15 kV air 3 V/m 80 MHz2.7 GHz 80 % AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 Refer to Proximity Fields From RF Wireless Communications Equipment Rated power frequency magnetic fields IEC 61000-4-8 30 A/m 50 Hz or 60 Hz AJ4311 | 2020-02-10 1-17 Safety and Regulatory Information Proximity Fields From RF Wireless Communications Equipment Test Frequency

(MHz) 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 Band (MHz) 380390 430470 Test Levels Professional healthcare facility environment Pulse modulation 18 Hz, 27 V/m FM, 5kHz deviation, 1 kHz sine, 28 V/m 704787 Pulse modulation 217 Hz, 9 V/m 800-960 Pulse modulation 18 Hz, 28 V/m 17001990 Pulse modulation 217 Hz, 28 V/m 24002570 Pulse modulation 217 Hz, 28 V/m 51005800 Pulse modulation 217 Hz, 9 V/m Input AC Power Port Emissions Test EMC Standard Test Levels Professional healthcare facility environment Electrical fast transients/burst IEC 61000-4-4 2 kV 100 kHz repetition frequency 1-18 AJ4311 | 2020-02-10 Emissions Test EMC Standard Professional healthcare facility environment Safety and Regulatory Information Test Levels Surges Line-to-line Surges Line-to-ground Conducted disturbances induced by RF fields Voltage dips IEC 61000-4-5 0.5 kV, 1kV IEC 61000-4-5 0.5 kV, 1kV, 2 kV IEC 61000-4-6 3 V, 0.15 MHz80MHz 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz 0 % UT; 0.5 cycle IEC 61000-4-11 At 0 , 45 , 90 , 135 , 180 , 225 , 270 and 315 Voltage dips IEC 61000-4-11 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0 Voltage interruptions IEC 61000-4-11 0 % UT; 250/300 cycles Signal Input/Output Parts Port Emissions Test EMC Standard Test Levels Professional healthcare facility environment Electrostatic Discharge IEC 61000-4-2 8 kV contact 2kV, 4kV, 8kV, 15kV air Electrical fast transients/burst IEC 61000-4-4 1 kV 100 kHz repetition frequency AJ4311 | 2020-02-10 1-19 Safety and Regulatory Information Emissions Test EMC Standard Test Levels Professional healthcare facility environment Conducted disturbances induced by RF fields IEC 61000-4-6 3 V, 0.15 MHz80 MHz 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz Reference Cables Provided Against EMC Cable Recommended Cable Length AC Power Cable DC Power Cable LAN Cable

(configuration mode) 3 m 3.5 m 3 m Shielded or Unshielded Unshielded Unshielded Shielded Number Cable Classification 1 pcs 1 pcs 1 pcs AC Power DC Power Signal Important Information Regarding Electromagnetic Compatibility (EMC) Focus 43C requires special precautions regarding EMC and needs to be installed only by Carestream or authorized personnel and put into service according to EMC information provided in the user manual. Focus 43C in use may be susceptible to electromagnetic interference from portable and mobile RF communications such as mobile (cellular) telephones. Electromagnetic interference may result in incorrect operation of the system and create a potentially unsafe situation. The minimum distance between the panel and other equipment should be larger than 12 inch. Focus 43C conforms to this EN60601-1-2:2015 standard for both immunity and emissions. Nevertheless, special precautions need to be observed. The use of accessories, transmitters, and cables other than those specified by this user manual, with the exception of accessories and cables sold by Carestream as Focus 43C replacement parts for inner components, may result in increased emission or decreased immunity. 1-20 AJ4311 | 2020-02-10 Safety and Regulatory Information Radio Frequency Compliance Country Item U.S.A FCC Code CFR47 Part15B (2018) ANSI C63.4(2014) FCC CFR47 Part 15C (2018)Radio Frequency Devices ANSI C63.10(2013) KDB 558074 D01 15.247 Meas Guidance v05r02 FCC CFR47 Part 15E (2018) Unlicensed National information infrastructure devices ANSI C63.10(2013) KDB 789033 D02 General UNII Test Procedures New Rules v02r01 KDB 662911 D01 Multiple Transmitter Output v02r01 248227 D01 802.11 Wi-Fi SAR v02r02 447498 D01 General RF Exposure Guidance v06 648474 D04 Handset SAR v01r03 865664 D01 SAR measurement 100MHz to 6GHz v01r04 865664 D02 RF Exposure Reporting v01r02 941225 D06 Hotspot Mode v02r01 616217 D04 SAR for laptop and tablets v01r02 AJ4311 | 2020-02-10 1-21 Safety and Regulatory Information Country Item European Union ETSI EN 300 328 V2.1.1 ETSI EN 301 893 V2.1.1 ETSI EN 300 440 V2.1.1 ETSI EN 301 489-3 V2.1.1 Draft ETSI EN 301 489-1 V2.2.1 Draft ETSI EN 301 489-17 V3.2.0 EN 55032: 2015 EN 55035: 2017 EN 61000-3-2: 2014 EN 61000-3-3: 2013 EN 50566: 2017 EN 62209-2: 2010 EN 62479: 2010 FCC Compliance The panel has been tested to comply with limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Operation is subject to the following two conditions. The panel may not cause harmful interference. The panel must accept any interference received, including interference that may cause undesired operation. The panel generates, uses, and radiates radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If the panel does cause harmful interference to radio or television reception, which can be determined by turning the panel off and on, the user is encouraged to correct the interference by one or more of the following measure. Increase the separation between the panel and receiver. Reorient or relocate the antenna. Connect the panel into an outlet different from the receiver is connected. Consult the distributor or an experienced radio/TV technician for help. 1-22 AJ4311 | 2020-02-10 Correction and Calibration Template Generation Correction and calibration should be performed after installation and every six months. The new correction and calibration should be performed after any major change on the system settings and hardware configuration. Safety and Regulatory Information AJ4311 | 2020-02-10 1-23 Safety and Regulatory Information Battery Safety Standards Standards Description CAN/CSA E62133:13 1st Ed. Rev. UL 62133, 1st Ed. Rev. Secondary cells and batteries containing alkaline or other non-

acid electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications First Edition Secondary cells and batteries containing alkaline or other non-

acid electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications First Edition UL 2054 Household and commercial batteries IEC 62133-2:2017 UN38.3 Secondary cells and batteries containing alkaline or other non-

acid electrolytes Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems United Nations Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria ST/SG/

AC.10/11/Rev.5/Amend.1 and Amend.2 1-24 AJ4311 | 2020-02-10 Safety and Regulatory Information Intended Use and Essential Performance Intended Use These devices are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. Essential Performance For Focus 43C, the intended use and the result of risk management, getting imaging and function of data transmission is defined as essential performance. Getting qualified dark image proves that essential performance does not influence the intended use. For the method of getting dark image, see the Installation and Operation sections. Application Specification Patient Population Adult and pediatric patients Weight: not relevant Health: not relevant Nationality: multiple Gender: except for pregnant women Patient state: patient is not user Pediatric Use: Guidance & Considerations Special care should be exercised when imaging patients outside the typical adult size range, especially smaller pediatric patients whose size does not overlap the adult size range (e.g.less than 50 kg (110 lb) in weight and 150 cm (59 in) in height, measurements which approximately correspond to that of an average 12 year old. The following ranges of pediatric subpopulations are to be used as a guide for manufacturers in developing medical devices:

Pediatric Subgroup Approximate Age Range Newborn (Neonate) From birth to 1 month of age Infant Child Adolescent Greater than 1 month to 2 years of age Greater than 2 to 12 years of age Greater than 12 through 21 years of age AJ4311 | 2020-02-10 1-25 Safety and Regulatory Information Exposure to ionizing radiation is of particular concern in pediatric patients because:

1. For certain organs and tumor types, younger patients are more radio sensitive than adults (the cancer risk per unit dose of ionizing radiation is higher for younger patients);

2. Use of equipment and exposure settings designed for adults of average size can result in excessive and unnecessary radiation exposure of smaller patients;

3. Younger patients have a longer expected lifetime putting them at higher risk of cancer from the effects of radiation exposure. To help reduce the risk of excessive radiation exposure, you should follow the ALARA

(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only the amount necessary to obtain images that are adequate clinically. Additional guidance and recommendation are provided by the Alliance for Radiation Safety in Pediatric Imaging (Image Gently Alliance) https://www.imagegently.org/

Table 1: Techniques for Typical Body Parts Body Parts Patient Size Very Low Birth Weight (Less than 1.5 Kg) Low Birth Weight (Between 1.5 and 2.5 Kg) Newborn (Age is less than 1 month and Weight above than 2.5 Kg) Infant (Age is between 1 month and 2 years) Abdomen AP/PA Child (Age is between 2 years and 12 years) Preadolescent (Age is between 12 years and 13 years) Adolescent (Age is between 12 years and 21 years) Adult Small Adult Medium Adult Large kVp 55 mAs 1 55 70 73 75 75 75 75 80 85 1.6 1.6 2 7.1 14 20 18 22 32 SID 1m 1m 1m 1m 1m 1m 1m 1m 1m 1m Grid no no no no yes yes yes yes yes yes 1-26 AJ4311 | 2020-02-10 Body Parts Patient Size kVp mAs Safety and Regulatory Information Very Low Birth Weight Low Birth Weight Newborn Infant Child Preadolescent Adolescent Adult Small Adult Medium Adult Large Very Low Birth Weight Low Birth Weight Newborn Infant Child Preadolescent Adolescent Adult Chest PA/AP Extremities AP/PA 50 55 65 70 70 90 90 110 110 120 50 55 57 57 58 62 62 1 1 1 1.6 1.6 2 2 1.8 2.8 4 1 1 1 1.2 1.2 1.6 2 SID 1m 1m 1m 1m 1m 1m 1m 1.8m 1.8m 1.8m 1m 1m 1m 1m 1m 1m 1m Regarding adult details techniques of Extremities, please refer to the table of Techniques for Adult Extremities Grid no no no no no yes yes yes yes yes no no no no no no no no 1-27 Table 2: Techniques for Adult Extremities Adult Extremities List Ankle - AP Ankle - Lateral AJ4311 | 2020-02-10 kVp 58 58 mAs 4 4 SID 1 1 Grid no no Safety and Regulatory Information Adult Extremities List kVp mAs SID Grid Femur - AP Femur - Lateral Hand - PA Hand - oblique Humerus - AP Humerus - Lateral Knee - AP Knee - Lateral Wrist - PA Wrist - Lateral 70 70 53 53 75 70 65 65 55 55 16 10 1.8 1.8 7.1 3.2 10 10 1.8 1.8 1 1 1 1 1 1 1 1 1 1 yes yes no no yes yes yes yes no no Intended Operator All procedures should be carried out by an operator who has completed the professional training offered by the companys customer service staff. Life Time Lifetime: 7 years without frequency limit 1-28 AJ4311 | 2020-02-10 2 Overview The Focus 43C Detector is a cassette-size, wireless x-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It is developed to provide the highest quality of radiographic images with an active matrix of 30723072 with 139 um pixel pitch. The detector supports wireless communication between the panel and the workstation and is powered by an internal battery. Scope This manual contains information about the Focus 43C. Information in the manual, including the illustrations, is based on a prototype. If your system configuration does not have features described in this manual, the information does not apply to your detector. Features Sync-shot exposure trigger Wireless static flat panel detector used for general radiography Cassette-size CsI scintillation screen Battery recycling Easy-to-change cable and easy-to-update firmware AJ4311 | 2020-02-10 2-1 Overview Components and Specifications Product Components Component Description Detector Item Description Notes For optional power input For service DC jack Ethernet port B A C D E Detector indicator Detector indicator of control panel Power button Mode button Power button of control panel Mode switch 2-2 AJ4311 | 2020-02-10 Item Description F G Power indicator Handle Battery Overview Notes The other Power indicator Optional Item Description Notes A B C D Battery label Battery interface Pilot pin Indicator Battery Charger 8 pin battery connector Installation direction indicator AJ4311 | 2020-02-10 2-3 Overview Item Description Notes A B C D E F G Battery Interface A Battery Interface B Battery Interface C Indicator The limit ball plug Hand Pull Position AC Jack Battery Charger Indicator 8 pin battery connector Not used Not used The indicator definition is as follow

220V (ac) input Name Item A B C Power Indicator Charging Indicator Charge Full Indicator 2-4 AJ4311 | 2020-02-10 X Indicator All off A indicator on A indicator on B and C alternately blink 2 times Overview Operating Status No power input AC power input Multiple batteries inserted Battery insertion self test A and B indicator on Battery charging A and C indicator on A indicator on B and C alternately blinking Battery capacity full, charging stops Battery is not charging properly Two or more batteries charging cannot be charged at the same time. Charging will automatically stop if more than one battery is inserted. AJ4311 | 2020-02-10 2-5 Overview Product Specifications Detector Item Specifications Model Image Sensor Pixel Size Active Array Active Area (H x V) Gray Scales Spatial Resolution Cycle Time Power Consumption Dimension (L W H) Focus 43C a-Si (amorphous silicon) TFT 139 m 3072 x 3072 427.0 x 427.0 mm (16.8 x 16.8 in.) 16 bit 3.6 Lp/mm Min. 8.5 sec. Max. 20 W 460.0 x 460.0 x 15.0 mm (18.1 x 18.1 x 0.6 in.) Weight (with one battery) 4.68 kg (10.32 lb) Image Transfer Wireless: IEEE802.11a/b/g/n/ac 2-6 AJ4311 | 2020-02-10 Item Specifications Overview Data Transmission Rate (Wireless) 802.11b: Max. 11 Mbps 802.11a/g: Max. 54 Mbps 802.11n: Max. 300 Mbps (MIMO 2 x 2) 802.11ac: Max. 867 Mbps(MIMO 2 x 2) Battery Item Specifications Model Rated capacity Nominal voltage Charge voltage Discharged end voltage Charging method Battery-KV Typ. 4180 mAh @ Discharge 0.2C 10.8 V 12.6 0.05 V 9 V CC-CV AJ4311 | 2020-02-10 2-7 Overview Item Specifications Operating temperature Storage temperature Charge 060 C (32140 F) Discharge 060 C (32140 F) 3 month -20 - +45 (-4113 F) 6 month -20- +35 (-495 F) Relative humidity 5 %~95 %

Dimension (L W H) 210.0 x 115 x 7.5 mm (8.3 x 4.5 x 0.30in.) Weight 0.28 kg (0.62 lb) Battery Charger Item Specifications Model Simultaneous Charging Full Charging Time Rated Power Supply Dimension (L W H) Charger-Combo 1 Battery Pack 3 hr 90~264 V (ac) 240.0 x 184.0 x 38.0 mm

(9.4 x 7.2 x 1.52 in.) Weight 0.55 kg (1.2 lb) 2-8 AJ4311 | 2020-02-10 Overview Power Supply Item Specifications DC Power (Optional) Battery Package CAUTION:

24V (dc), 0.8A 10.8V (dc), 1.78A The charging cable can only be used in areas not are accessible to the patient, such as in the Bucky. The product must be used with the approved adapter and CB certificate number SG PSB-MD-00191. Wireless Communication Item Specifications Wireless Standard Frequency Range Data Transmission Rate Modulation IEEE 802.11 a/b/g/n/ac 2.412~2.472 GHz: ch1~ch13 5.18~5.24 GHz: ch36~ch48 5.745~5.85 GHz: ch149~ch165 802.11b: Max. 11 Mbps 802.11a/g: Max. 54 Mbps 802.11n: Max. 300 Mbps (MIMO 2x2) 802.11ac: Max. 867 Mbps(MIMO 2x2) 802.11b:

CCK, DQPSK, DBPSK 802.11a/g/n:

64 QAM, 16 QAM, QPSK, BPSK 802.11ac:

256 QAM, 64 QAM, 16 QAM, QPSK, BPSK Transmission Power Max.17 dBm AJ4311 | 2020-02-10 2-9 Overview Item Specifications Security Antenna Mechanical Outlines WPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64 bit & 128 bit 2 dual band inner antenna Use Environment Temperature Temperature Change Humidity Atmospheric Pressure Pressure Change Operating Storage 535 C

(4195 F)

-2055 C

(-4131 F)

< 1k/min 10 %90 %

RH 7001060 hPa

<10 kp/min

(1 kp=1.0197E-5Pa)

< 1k/min 5 %95 % RH 7001060 hPa

<10 kp/min

(1 kp=1.0197E-5Pa) 2-10 AJ4311 | 2020-02-10 Temperature Temperature Change Humidity Atmospheric Pressure Pressure Change Focus 43 detectors shall operate at a specified altitude of not more than 3000.0 m (9842.5 ft). The environment specific is only for the detector. Overview IT Network Purpose for IT-network Transmission of image data and command/status communication between the detector and the workstation. Required Features Wireless communication follows IEEE 802.11a/b/g/n/ac protocol. It works on 2.4 GHz and 5 GHz. It supports at least 2 routers. Hazardous Situations from Failure of the IT Network Incompatibility of the operating system is not compatible Inability to update or change software Incompatibility of the interface Inconsistency of interface or format leads to data distortion Data transfer protocol error Data output failure Required Configuration The wireless card and the detector must work on the same IP segment such as 192.168.8.XXX. They must support IEEE 802.11a/b/g/n/ac. Technical Specifications Item Specifications Wireless Standard IEEE 802.11a/b/g/n/ac Frequency Range 2.412-2.472 GHz: ch1-ch13 5.18-5.24 GHz: ch36-ch48 5.745-5.85 GHz: ch149-ch165 AJ4311 | 2020-02-10 2-11 Overview Item Specifications Data Transmission Rate 802.11b: Max. 11 Mbps 802.11a/g: Max. 54 Mbps 802.11n: Max. 300 Mbps (MIMO 2x2) 802.11ac: Max. 867 Mbps (MIMO 2x2) Modulation 802.11b: CCK, DQPSK, DBPSK 802.11a/g/n: 64 QAM, 16 QAM, QPSK, BPSK 802.11ac: 256 QAM, 64 QAM, 16 QAM, QPSK, BPSK Security WPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64 bit, and 128 bit Intended Information Flow The detector sends the acquired image data to the workstation. The workstation sends the user's commands to the detector. Please refer to the operation manual of the console for detail. Hazardous Situations Resulting From Failure of the IT-network Failure of completing essential performance Failure of finishing configuration of product Incompatibility of operating system Failure of change or update to software Compatibility of interface Data transfer protocol error Data output failed Inconsistency of interface or format leads to data distortion Warning Connection of the main unit to an IT network that includes other equipment could result in previously unidentified risks. The manufacturer of the x-ray machine should identify, analyze, evaluate, and control these risks; subsequent changes to the IT-network could introduce new risks and require additional analysis. Changes to the IT-Network Changes in the IT-network configuration Connection of additional items to the IT-network Disconnecting of items from the IT-network Update of equipment connected to the IT-network 2-12 AJ4311 | 2020-02-10 Service Information Product Lifespan Overview The estimated product lifetime is up to 7 years under appropriate regular inspection and maintenance (battery 5 years). Regular Inspection and Maintenance In order to ensure the safety of patients and operator, and to maintain the performance and reliability of the panel, be sure to perform regular inspections at least once a year. If necessary, clean the panel, make adjustments, or replace consumables such as fuses etc. There may be cases where an overhaul is recommended depending on conditions. Contact Carestream service or your local dealer for regular inspection or maintenance. Repair If the problem cannot be solved, contact Carestream service or your local dealer for repairs. Please refer to the label and provide the following information:

Product Name:

Series Number:

Description of Problem: (as clearly as possible) Replacement Parts Support Main parts (those required to maintain the function of the product) needed to repair the product will be stocked for 5 years after discontinuance of production. AJ4311 | 2020-02-10 2-13 Overview Disposal CAUTION:

Do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste. Contact your local authorities for information about dropping off waste products for recycling. If collection systems are not available, call Carestream Customer Service for assistance. In the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to appropriate facilities for recovery and recycling. See http://recycle.carestreamhealth.com for additional information on the collection and recovery programs available for this product. 2-14 AJ4311 | 2020-02-10 3 Installation Panel Installation Install the Detector Battery The detector can be powered by the battery package or DC power. The detector will be activated as soon as power is supplied and will power off as soon as power is removed. AJ4311 | 2020-02-10 3-1 Installation 1. Make sure that the connectors for the battery and battery compartment are aligned. 2. Slide the battery into the battery compartment. Note:

Make sure the battery level is >10 % of full capacity. 3. Slide the two battery lock levers toward the center of the detector.. Power on the Detector On the control panel, the power button is used to power the detector on and off. 3-2 AJ4311 | 2020-02-10 To power on the detector, press and hold the power button for 4 seconds. The detector must either have a battery installed with >10 % charge or have the DC power connected. To power off the detector, press and hold the power button for 4 seconds. To reset the detector, press and hold the power button for 8 seconds. Installation Power Indicator After booting up, the user can check the status LED indicator. Power Indicator Lighting Status OFF Orange ON Green ON Operating Status Operating Battery Capacity DC Input Power OFF

Power ON 20%

No Power ON Battery capacity 20 %, no DC input DC input (Optional) Orange Blinking Power OFF

<20 %

Yes Green and Orange Blinking Power OFF 20 % and <95 %

Yes AJ4311 | 2020-02-10 3-3 Installation Power Indicator Lighting Status Operating Status Operating Battery Capacity DC Input Green Fast Blinking Power OFF 95 % and <100 %

Yes OFF Power OFF

=100 %

Yes Link Indicator Power Indicator Lighting Status Description Off Green On Blue On Blue Blinking Green and Blue Blinking Shut down Wired connection broken and wireless connection not ready Wired connection is built Client mode, wireless connection is built AP mode, wireless AP is ready (Not used) Client mode, no connection is built Initialization Status Indicator Power Indicator Lighting Status Description Off 3-4 Shut down Exposure prohibit AJ4311 | 2020-02-10 Power Indicator Lighting Status Description Green On Exposure enable Installation Green Blinking Image transmission Orange On Error Orange Blinking Safety mode Mode Indicator Power Indicator Lighting Status Description Off Green On Blue On Shut down Wired connection is built AP mode, wireless AP is ready (Not used) Client mode, wireless client is ready Blue and Green Blinking Initialization AJ4311 | 2020-02-10 3-5 Installation Button Function Action FPD Status Power Mode Note Power ON Short hold No action Hold for 4 seconds Forced restart Long hold No action Exit the battery from ship mode Power OFF Press 3 times No action Enter safety mode Short hold Long hold Forced restart Power ON Long hold No action Enter/exit sleep mode Double click No action Power OFF Short hold No action Restore default configuration Triple check Short hold Long hold Hold for more than 7 seconds. Release the power button when the power indicator is ON. Release after two short presses (interval < 1second). Power button: hold for 4 seconds Mode button: hold for 7 seconds Hold for more than 7 seconds, when the Power indicator is OFF and then ON, release Power button. Release after two short presses (interval <1second) Hold for 4 seconds, Release the Power button when the power indicator is OFF. 1. Hold the Mode button hold for 7 seconds. 2. Press the Power button 3 times. 3. Short hold the Power button for 4 seconds. 3-6 AJ4311 | 2020-02-10 Action FPD Status Power Mode Note Installation Wireless ConnectionMode Switch Power ON No action Long hold and then short click 1. Hold the Mode button hold for 7 seconds. 2. Release the Mode button after Mode indicator starts blinking, and then press again in 5 seconds. The mode starts switching. 3. Press the Mode button to switch modes. The Mode indicator blinks at the corresponding color. 4. Wait at intended mode, the Mode indicator will switch color after several seconds. Blue = client Green = AP (Not used) AJ4311 | 2020-02-10 3-7 Installation Install the Detector Battery Charger 1. Remove the battery from the battery charger. 2. Insert battery into battery charger in the orientation shown below. 3. Press the battery down into the battery compartment. 3-8 AJ4311 | 2020-02-10 Installation Detector Battery Lock and Activation To ensure the safety of the battery during transportation or storage, the battery can be set to ship mode where it is locked and will not provide any voltage output. Enter Ship Mode Method Steps Factory configuration Web write in 1. Connect the adapter to the detector and power it on. 2. Connect the other end of the adapter to the PC. 3. Insert the battery into the detector. 4. Open a web browser and enter the following address: http://10.0.1.150/

cgi-bin/shipmode.cgi?action=on The battery is placed in ship mode. Exit Ship Mode Web exit Adapter + FPD Method Steps 1. Connect the adapter to the detector and power it on. 2. Connect the other end of the adapter to the PC. 3. Insert the battery into the detector. 4. Open a web browser and enter the following address: http://10.0.1.150/

cgi-bin/shipmode.cgi?action=off The detector exits ship mode. 1. Connect the adapter to the detector and power it on. Insert the battery into the detector. 2. 3. Press the power button for approximately 4. 4 seconds to shut down the detector. In the shutdown state, press the power button 3 times to exit ship mode. AJ4311 | 2020-02-10 3-9 Installation Charger Method Steps 1. Power on the charger. 2. Insert the battery into the charger for 3 to 5 seconds to exit ship mode. 3-10 AJ4311 | 2020-02-10 4 Operation Notes for Using Do the following to ensure that the detector functions correctly. Before Exposure Inspect the detector daily and confirm it is working properly. Check that there is no condensation on the any of the surfaces of the detector. Condensation can be caused by the sudden heating of the room in cold areas. If this occurs, wait until the condensation evaporates before performing an exposure or problems may occur with the quality of captured images. When changing the temperature in an air-conditioner environment, be sure to raise or lower the temperature gradually. The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map. Make sure exposure rate is over 900 nGy/s @70 KV. Make sure the wave form of the energy going to the x-ray tube is square and not pulse. Check if the patient has recently been injected with a radio isotope; this may cause the detector to transmit an image without performing an x-ray. During Exposure Important:

To prevent image noise, artifacts, or incorrect images, do not use the product near equipment generating a strong magnetic field.:

After Usage Remove the battery from the detector if the detector will not be used for more than 5 days. If the battery is stored for an extended time, it should be charged (30 % to 50 %) every 3 months or charged (50 % to 70 %) every 6 months. Cleaning, Disinfection, and Sterilization of Patient Contact Surfaces To prevent the risk of infection, wipe the patient contact surfaces after every examination with a nonflammable disinfectant, such as benzalkonium chloride or benzalkonium bromide. For details on how to sterilize, consult a specialist. AJ4311 | 2020-02-10 4-1 Operation CAUTION:

Do not spray disinfectants or detergents directly onto the detector. To prevent damage to the surface of the detector, wipe with a cloth slightly dampened with a neutral detergent. Do not use solvents such as benzene and acid. It is recommended to use a waterproof non-woven cover as the isolated layer between the detector and a patient who is bleeding. Applied Part The front and back of the detector is an application part. 4-2 AJ4311 | 2020-02-10 Detector Position To prevent abnormal light lines, place the detector behind the patient in the orientation shown below. Operation AJ4311 | 2020-02-10 4-3 Operation 4-4 AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Software and Settings Main Interface Button Function Home page, shows the list of the detectors Acquire images, free for use after connecting the detector Configure UI for SDK, free for use after connecting the detector Configure UI for detector, free for use after connecting the detector Calibrate UI, for generation and management of the calibration template Image management, free for use at any time Connect the detector Disconnect the detector Manage the syncbox Message Box Status Box Tab Description Serial number of the detector Status of the detector, busy or ready The task that is currently being executed Home Acquire SDK Detector Calibrate Local File Connect Close Syncbox SN Status Task Message Information AJ4311 | 2020-02-10 I Appendix (For Service Personnel Only) Tab Description Remaining power of the battery, shown as a percentage Progress Bar If the progress bar Is green while taking an x-ray, the image quality is acceptable Is not green while taking an x-ray, the image quality will be degraded General Settings Parameter Description Can be Modified Product No. Type number of the detector Sub Product No. Sub-type of the detector Serial No. Serial number of the panel Main Version Version of the firmware of Main FPGA Main MB CPU Version Version of the MB CPU of Main FPGA MCU Version Version of the firmware of MCU Arm Version Version of the App of ARM Kernel Version Version of the Kernel of ARM Inner Subflow Sub work-flow Prep CapMode Self CapEnable Reserved Reserved Self Cap Span Time Should not be modified; keep the original value Trigger Mode Trigger mode Sequence Interval Time Should not be modified; keep the original value Set Delay Time Exposure window for Freesync mode Exp Window Time Exposure Window for Software/Inner mode, the value should not be larger than 10s Acquire Delay Time Reserved No No No No No No No No Yes No Yes Yes Yes Yes Yes Yes Yes II AJ4311 | 2020-02-10 Parameter Description Can be Modified Appendix (For Service Personnel Only) Integrate Time Should not be modified; keep the original value Src Port Src IP Src MAC Dest Port Dest IP Self Clear Enable Port number for detector IP address for detector MAC address for detector Port number for PC IP address for detector Related to Prep CapMode, the value should be configured as On if Prep CapMode is configured as PrepCapMode_ClearAcq. Otherwise, the value should be Off If the Trigger Mode is Software/Inner, the value should be On Self Clear Span Time Should not be modified; keep the original value Hvg Prep On Hvg XRay Enable Hvg XRay On Reserved Reserved Reserved Tube Ready Time Reserved Image Pkg Gap Time Reserved Out Mode Cap Trigger Reserved SDK Settings Yes No No Yes No No Yes Yes Yes Yes Yes Yes Yes Yes Parameter Description Can be Modified Host IP Host Port IP Address of local workstation Port of local workstation Ftp Download Host IP FTP download server IP; keep the same as Host IP Ftp Download Host Port FTP download server Port; keep the same as Host Port Yes Yes Yes Yes AJ4311 | 2020-02-10 III Appendix (For Service Personnel Only) Parameter Description Can be Modified Ftp Upload Host IP FTP upload server IP; keep the same as Host IP Ftp Upload Host Port FTP upload server Port; keep the same as Host Port Yes Yes Network Settings Button Description Add Del Up Down Select Read Config Write Config Add the information of SSID and the AP Key Delete the information of SSID and the AP Key Move up the AP information Move down the AP information Select the AP Read the parameters of the AP information when the detector is set as AP Write the parameters of the AP information when the detector is set as AP Read Wifi Status Read the WIFI status of the current detector Scan from FPD Scan the AP IV AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Operating Modes Software Mode Block Diagram Software mode is the basic way to acquire an x-ray image. The workstation is a host device installed with iDetector and SDK. Installation describes how to establish connections between the panel and workstation. In software mode, the workstation does not control the x-ray generator. Users decide when to take x-rays. Work Flow 1. Workstation receives prep request and sends clear command to the panel. 2. Panel receives clear from the workstation and starts clearing leakage from the panel. Meanwhile, the panel sends an Exposure Prohibited message to the workstation. 3. Panel finishes clear and sends an Exposure Enable message to the workstation. 4. Workstation shows Exposure Enable on the iDetectors message bar to tell the user to take the x-ray now. 5. User triggers the x-ray generator to initialize and do an anode rotation to prepare for taking x-rays. 6. X-ray generator finishes preparation for taking x-rays and reminds the user to take the x-ray. 7. X-ray generator starts releasing the x-ray. 8. X-ray generator finishes taking the x-ray. 9. Workstation receives acquire request and sends Data Acquisition command to the panel. 10. Panel receives Data Acquisition from the workstation and starts data acquisition operation. 11. Panel completes image acquisition and begins to send data to the workstation. 12. Workstation receives all image data from the panel after calibration if hardware calibration is on. Time Setting To set a clear scenario for programming, see the diagram below. AJ4311 | 2020-02-10 V Appendix (For Service Personnel Only) Inner2 Mode Block Diagram The workstation is a host PC device installed with iDetector and SDK. Installation describes how to establish connections between the panel and workstation. In inner2 mode, the workstation does not control the x-ray generator. Users decide when to take x-rays. Work Flow 1. Workstation receives prep request. 2. X-ray generator is ready to take x-rays and starts releasing the x-ray. 3. Panel starts uploading a Pre-dark image and a Light image to the workstation for preview. If hardware offset is selected, panel first performs an offset and then uploads the preview image. 4. Panel starts uploading Post-dark image to the workstation. If hardware offset is selected, panel first performs correction and calibration and then uploads the processed image to the workstation. 5. Workstation enters exposure prohibit state. Time Setting To set a clear scenario for program, see the diagram below. Freesync Mode Block Diagram The workstation is a host PC device installed with iDetector and SDK. Installation describes how to establish connections between the panel and workstation. In FreeSync VI AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) mode, the user does not interact with the workstation. After taking x-rays, images immediately appear on the screen. Work Flow 1. X-ray generator is ready to take x-rays and starts releasing the x-ray. 2. Workstation receives Exposure Prohibited from the panel. 3. Panel starts uploading a Pre-dark image and a Light image to the workstation for preview. If hardware offset is selected, panel first performs an offset and then uploads the preview image. 4. Panel starts uploading Post-dark image to the workstation. If hardware offset is selected, panel first performs correction and calibration and then uploads the processed image to the workstation. 5. Workstation receives Exposure Enable from the panel. Time Setting AJ4311 | 2020-02-10 VII Appendix (For Service Personnel Only) Software Installation Do the following if the iDetector application is not working:

1. 2. Install MICROSOFT .NET Framework 4.5. Install vcredist_x86_2013 (or vcredist_x64_vs2013). Important:

The iDetector application should not be used for a hospital terminal. VIII AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Set the Connection Mode The detector supports the following two connection modes and should be configured per site requirements. Wireless Client Mode 1. Connect one end of the Gigabit Ethernet cable to the workstation. 2. Connect another end to the LAN port of external wireless AP. 3. From the workstation, open the Control Panel and then the Network and Sharing Center. In the Connections: field, click on Local Network. 4. 5. Open the IPV4 settings. 6. For the IP and network mask setting, select Obtain an IP address automatically. 7. Open the browser and type 10.0.1.1 and log into external wireless AP. 8. Do the wireless setup. 9. Configure 2.4 GHz wireless network. SSID: NETGEAR_BIG_24 Security: WPA2-PSK Password: 12345678 Channel: Check the current Wi-Fi environment, and choose a relatively clean channel. 10. Configure 5G Hz wireless network. SSID: NETGEAR_BIG_50 Security: WPA2-PSK Password: 12345678 Channel: Check the current Wi-Fi environment, and choose a relatively clean channel. 11. Configure LAN IP address. IP address: 10.0.1.1 Subnet Mask: 255.255.255.0 12. Do an external wireless AP reboot: Apply the above settings and reboot your wireless router. 13. Recover the local network IPV4 setting. IP settingIP address: 10.0.1.251 Network mask settingSubnet mask: 255.255.255.0 14. Connect the panel to the workstation with the Ethernet cable. AJ4311 | 2020-02-10 IX Appendix (For Service Personnel Only) 15. Select:

Detector Wifi Read Config Client 16. Select Add and enter the SSID and Password. Select Apply. 17. Choose SSID and select the one with a check mark. Select Write Config to save the parameters. 18. Turn on the wireless router. a. Make sure there is a wired connection between the outer, work station, and IP 10.0.1.251. b. Select Read Wifi Status to check wireless transmission status, numerical value occurred means the link is up and available. The detector will connect to the wireless AP the next time it is powered on. Wireless AP Mode A wired cable can also be used to configure detector in wireless client mode. The wired connection should only be used by the service operator.To start configuration with wired cable, it is necessary to complete this procedure. 1. Connect the panel to the workstation with the Ethernet cable. 2. Select the Detector tab and then Wifi. 3. 4. Select Read Config to display the default settings. 5. Change the settings for SSID and password. In the Mode field, select AP. Important:

6. 7. Make sure that the SSID is different from others already used. In the Frequency field, click on the arrow and select a value from the drop-down list.. In the Country field, click on the arrow and select a country from the drop-down list. In the Channel field, click on the arrow and select a clean frequency and channel. 8. 9. Select Write Config to save the settings. Note:

Do not remove the wired cable until the FPD status is Ready. X AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) The detector will connect to the wireless AP the next time it is powered on. 10. Configure the external wireless card. a. Open the local wireless signal list. b. Select the SSID that belongs to the detectors. Enter the password and select OK. c. Open the wireless card configuration. d. Open the IPV4 setting and set the following values:. IP settingIP address: 10.0.1.251 Network mask settingSubnet mask: 255.255.255.0 e. Open SDK and select the detector. f. Select Connect. AJ4311 | 2020-02-10 XI Appendix (For Service Personnel Only) Shortcuts Shortcut Result Double-click the window using the left mouse button. The image is centered and displayed at the maximum size. Double-click the window using the right mouse button. The window level and width are adjusted to WL: 32767/WW: 65535. Drag the left mouse button to move the displayed image. Drag the right mouse button horizontally to adjust the window width, and drag the right mouse button vertically to adjust the window level. F3 key Quickly adjust the image window width and window level. XII AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Establish a Connection with the Detector 1. Open SDK, select the detector, and select Connect. 2. Confirm that the values for IP address and Port are the same as the values in config.ini. Note:

The value for Cfg_HostPort should be the default of 28000. Note:

When the connection is changed to a different network card, the user must reconnect the detector using a different IP address. The rule of Multi-Share control is based on the IP address. The second terminal with a different IP address is not allowed to operate a detector after the first one is connected. If there is no command transmission between the detector and workstation after 5 minutes, the detector releases access authority. AJ4311 | 2020-02-10 XIII Appendix (For Service Personnel Only) Configure the Detector 1. From the iDetector menu, select the Acquire tab. 2. Acquire the module related setting, such as loading correction and calibration template, acquiring images. 3. See the SDK module-related settings, such as IP address. 4. See the Detector module related settings, such as trigger module, wireless signal. 5. Calibrate the module related setting, such as making correction and calibration template. The template in the panel could be uploaded to a workstation, and the template in a workstation could also be downloaded to panel. 6. See the Local File module related setting, such as import a Raw or DCM image. XIV AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Correction and Calibration Template Generation Correction and calibration should be performed after installation and every six months. The new correction and calibration should be performed after any major change on the system settings and hardware configuration. Pre-offset Template Generation If panel is configured to do Pre-offset correction, Pre-offset Template is necessary. 1. Select Calibrate. 2. Select Start Generate Templates. 3. Select Create Offset. 4. Select Start create offset template file. The screen will display Offset Map Generating. 5. When complete, the screen will display Offset MAP Generated!

Gain Calibration Template Generation Before doing this procedure, make sure SID1.2m, no copper is required. Actual screens may be different from those shown in this procedure. Note:

Use software post offset correction. 1. On the gain template generating page, five images need to be created. 2. Select Start. 3. Select PREP and start the exposure. 4. When completed, select Acquire to get the light image. 5. If the value meets the expected value, select Accept, and then acquire the other four images. If the value does not meet the expected value, do not click Accept. Adjust the exposure dose, and then click PREP to acquire the light image again. 6. When all five images are created, select Generate to generate the gain template. Defect Correction Template Generation Before doing this procedure, make sure SID1.2m, no copper is required. Actual screens may be different from those shown in this procedure. Note:

Use software post offset mode. AJ4311 | 2020-02-10 XV Appendix (For Service Personnel Only) 1. On the Defect Calibration page, start the exposure. Eight images need to be captured. 2. Select Start. 3. Select PREP and start the exposure. 4. When completed, select Acquire to get the light image. 5. If the value meets the expected value, select Accept, and then acquire the other seven images. If the value does not meet the expected value, do not select Acquire. Adjust the exposure dose, then select PREP to acquire the light image again. 6. When all eight images are created, select Generate to generate the gain template. Note:

Make sure your x-ray dose is correct. If your dose is out of the range, iDetector will remind you to adjust the dose. Then you can select start creating and try again. If users operate with two panels, SDK has a probability of automatically quitting. XVI AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Image Check and Upload OPEN provides two features for image check and uploading: Local Image Check and Panel Image Upload. Local Image Check is used to check images saved in the workstation. Panel Image Upload is used to upload images stored in the panel. Local Image Check 1. From the Local File tab, select Load File. Choose the specified file. 2. Choose the images stored in the workstation. The screen will display the images. Panel Image Upload Prerequisites:

Make sure the firewall is closed. 1. Select the Images tab from the Detector interface. 2. Select Query Images. The images stored on the detector will be listed. 3. Select Upload Images and choose the specified image. Select OK. When the state changes to Success, the image has been uploaded. The upload process can be canceled by selecting Stop Upload. The uploaded images are saved in the path of the detector serial number. AJ4311 | 2020-02-10 XVII Appendix (For Service Personnel Only) Defect Template Check and Modification The iDetector software provides the ability to check the defect template. If the template has updates, the user can add and delete pixels or defective lines by modifying the opened defect template. Defect Template Check 1. From the Local File page, select Load File. 2. Select the specified defect template, and select Open. The defect template will be displayed. Defect Template Modification 1. Open the specified defect template. The defect management dialog box will be displayed. 2. Locate the pixel that needs to be managed, type the coordinates of the pixel, and select Add. The information will be added to the template. Note:

If Delete is selected, the information will be removed from the template. 3. Select Save. 4. It is similar to manage the defect pixel. If the user needs to add the defect line, type the coordinates of the line, and select Add. If the information needs to be deleted, select Delete. XVIII AJ4311 | 2020-02-10 Appendix (For Service Personnel Only) Correction and Calibration Management Correction and Calibration Template Synchronization The detector supports correction and calibration template storage. Templates in the detector can be uploaded to a workstation, and templates in a workstation can be downloaded to a detector. 1. After generating the offset, gain, and defect templates, select the templates and select Download to FPD. 2. Select Download. 3. Select Read Status. 4. If the Activity column shows disable, select the row and select Active to enable it. Correction and Calibration Management The detector supports the following ways to do correction and calibration:

In software correction and calibration, the workstation completes all correction and calibration. In hardware correction and calibration, the panel completes all correction and calibration. 1. User can set the calibration method on the Detector page. Note:

The hardware-based calibration is on. 2. Select:

HWPostOffset HWGain HWDefect Note:

The hardware-based calibration is on. 3. Select:

SWPostOffset SWGain SWDefect Note:

The software-based calibration is on. AJ4311 | 2020-02-10 XIX Appendix (For Service Personnel Only) Update the Firmware The Internet can be used to upgrade the detector firmware. This procedure applies to MCU, FPGA, and ARM. 1. Connect the panel to a PC. 2. Open a browser, type detector IP in the search bar, and then press Enter. 3. Enter the following and select login. User name: admin Password: admin 4. Click on the three squares located on the left side of the screen. 5. Select Upgrade and then Browse. 6. Select one the firmware files from the list and select Open. 1717V3TISA07_IMAGE_MCU_xxxx_xx_13.ifm 1717V3TISA07_FPGA_xxxx_xx_13.ifm 1717V3TISA07_IMAGE_ARM_xxxx_xx_13.ifm Important:

Selecting 1717V3TISA07_IMAGE_ALL_xxxx_xx_13.ifm will allow all three versions of firmware to be updated at the same time. 7. When the selected file name is displayed on the interface, select Upgrade. 8. Select Close when the Notice box is displayed. The progress bar will be displayed. If the upgrade is successful, the following interface screen will be displayed. 9. Note:

If the screen is not displayed, the upgrade has failed. XX AJ4311 | 2020-02-10 Publication History Version A Date Changes 2020-02-10 Initial release AJ4311 | 2020-02-10 I Carestream Health, Inc. 150 Verona Street Rochester, NY, USA 14608 Carestream Health, Inc., 2020 Made in China for Carestream Health, Inc. CARESTREAM is a trademark of Carestream Health. Pub. No. AJ4311 Rev A. FCC Regulations:

Contains modules FCC ID2ACHK-01070189 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/ TV technician for help. Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment. W52/UNII I is in door use only Radio Frequency (RF) Energy This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the United States. During SAR testing, this device was set to transmit at its highest certified power level in all tested frequency bands, and placed in positions that simulate RF exposure in usage against the body with no separation. Although the SAR is determined at the highest certified power level, the actual SAR level of the device while operating can be well below 1

..................................................................................................................................................KONICA MINOLTA, INC. the maximum value. This is because the device is designed to operate at multiple power levels so as to use only the power required to reach the network. In general, the closer you are to a wireless Base station antenna, the lower the power output. The exposure standard for wireless devices employing a unit of measurement is known as the Specific Absorption Rate, or SAR. The SAR limit recommended by the ICNIRP used by the general public is 2.0W/kg averaged over ten grams of tissue and, is 1,6W/kg Averaged over one gram of tissue by IEEE Std 1528. The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in compliance with the FCC RF exposure guidelines. For this device, the highest FCC reported SAR value for usage is 0.042W/kg. While there may be differences between the SAR levels of various product and at various positions, they all meet the government requirements. SAR compliance for body-worn operation is based on a separation distance of 0 mm between the unit and the human body. Carry this device at least 0 mm away from your body to ensure RF exposure level compliant or lower to the reported level. To support body-worn operation, choose the belt clips or holsters, which do not contain metallic components, to maintain a separation of 0 mm between this device and your body. RF exposure compliance with any body-worn accessory, which contains metal, was not tested and certified, and using such body-worn accessory should be avoided. IC Notice This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

(1) this device may not cause interference, and

(2) this device must accept any interference, including interference that may cause undesired operation of the device. This Class B digital apparatus complies with Canadian ICES-003. IC:25116-01070189 IC Radiation Exposure Statement This EUT is in compliance with SAR for general population/uncontrolled exposure limits in IC RSS-102 and had been tested in accordance with the measurement methods and procedures specified in IEEE 1528 and IEC 62209. This equipment should be installed and operated with minimum distance of 0 cm between the radiator and your body. This device and its antenna(s) must not be co-located or operating in conjunction with any other antenna or transmitter. Cet appareil est conforme aux Normes RSS d'Industy Canada. Son utilisation est soumise deux conditions:

(1) Ce dispositif ne peut pas provoquer d'interfrences, et

(2) Ce dispositif doit accepter toutes les interfrences reues, y compris les interfrences susceptibles de provoquer un fonctionnement non souhait. Cet appareil de classe B est conforme la norme canadienne ICES-003. IC:25116-01070189 Dclaration d'exposition IC Cet EUT est conforme aux valeurs SAR la norme SAR pour le grand public ainsi qu'aux limites d'exposition non rglemente IC RSS-102 et a t test selon les mthodes et procdures spcifies par les Normes IEEE 1528 et IEC 62209. Cet appareil devrait tre install et utilis en respectant une distance minimale de 0 cm avec votre corps. Cet appareil et son (ses) antenne (s) ne doivent pas tre situs proximit l'un de l'autre et ne doivent pas fonctionner en mme temps qu'une autre antenne ou qu'un autre metteur. UNII I is in door use only Les dispositifs RL- EL sont restreints une utilisation lintrieur seulement dans la ba nde de 5 150 5 250 MHz. Cet appareil est conu et fabriqu de faon ne pas dpasser les limites d'mission pour l'exposition l'nergie de radiofrquence (RF) fixes par la Federal Communications Commission des tats-Unis et Industrie Canada. Au cours des essais SAR, cet appareil est configur pour transmettre des donnes son niveau de puissance le plus lev toutes les bandes de frquences testes et places dans l'ensemble des positions simulant l'exposition aux radiofrquences contre la tte et prs du corps, avec une sparation de 0 mm. Bien que le DAS soit dtermin par le niveau de puissance le plus lev, le niveau SAR rel de l'appareil en fonctionnement peut tre bien infrieur la valeur maximale indique. Cela est d au fait que l'appareil est conu pour fonctionner plusieurs niveaux d'alimentation, pour s'adapter aux capacits des diffrents rseaux lectriques. De manire gnral, plus vous vous trouverez ps d'une station sans fil, plus la frquence de transmission sera basse. La norme d'exposition pour les dispositifs sans fil employant une unit de mesure est connue sous le nom de taux d'absorption spcifique (SAR). La limite SAR fixe par la FCC est de 1,6 W / kg et de 1,6 W / kg par Industry Canada. Cet appareil est conforme la norme SAR pour le grand public ainsi qu'aux limites d'exposition non rglementes ANSI / IEEE C95.1-1992 et Canada RSS 102, et a t test conformment aux mthodes et procdures spcifies par les Normes IEEE1528 et Canada RSS 102. Ce dispositif a t test et respecte les directives FCC et IC sur l'exposition aux radiofrquences lorsqu'il est test en contact direct avec le corps. Pour cet appareil, la valeur SAR la plus leve pour une utilisation prs du corps est de 0.042 W/kg. Bien qu'il puisse exister des diffrences entre les niveaux de SAR selon les dispositifs et les emplacements o ils sont utiliss, tous rpondent aux exigences Gouvernementales. La valeur SAR dclare conforme est une distance de 0 mm entre l'unit et le corps humain. Eloignez cet appareil une distance d'au moins 0 mm de votre corps pour vous assurer que le niveau d'exposition aux RF est conforme ou infrieur au niveau indiqu. Vous pouvez galement opter pour un tui ne contenant aucun composant mtallique, pour maintenir une sparation de 0 mm entre cet appareil et votre corps. Pour tout appareil contenant du mtal, la conformit de l'exposition aux radiofrquences n'a pas encore t teste / certifie de manire prcise.

User Manual for the TRIMAX 43C Detector Publication No. AJ4312 2020-02-10 All rights reserved. No part of this manual may be reproduced or copied in any form by any meansgraphic, electronic, or mechanical, including photocopying, typing, or information retrieval systemswithout written permission. Notices and Conventions The information herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including consequential or special damages, even if loss or damage is caused by Carestream Healths negligence or fault. Note:

Notes provide additional information, such as expanded explanations, hints, or reminders. Important:

Important highlights critical policy information that affects how you use this manual and this product. CAUTION:

Caution points out a potentially hazardous situation which, if not avoided, might cause minor or moderate injury. Authorized Representative (European Union) Carestream Health France 1, rue Galile 93192 NOISY-LE-GRAND CEDEX FRANCE Importer for European Union Carestream Health Netherlands B.V. Bramenberg 12 3755 BZ Eemnes The Netherlands AJ4312 | 2020-02-10

-iii Notices and Conventions CAUTION:

Federal law restricts this device to sale by or on the order of a physician. CAUTION:

If you witness or become aware of a potential safety issue with this equipment, take the appropriate safety measures and report this to your Carestream Service representative immediately.

-iv AJ4312 | 2020-02-10 Disclaimer Notices and Conventions Carestream shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by the purchaser or third parties as a result of fire, earthquake, any accident, misuse, or abuse of the product. Carestream shall not be liable for any damage, loss, or injury arising from unauthorized modifications, repairs, or alterations to the product or failure to strictly comply with Carestreams operating and maintenance instructions. Carestream shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as original products by Carestream. It is the responsibilities of the user or physician to maintain the privacy of image data and provide medical care services. Carestream shall not be responsible for the legality of image processing, reading, and storage nor shall it be responsible for loss of image data for any reason. Information regarding the specifications, compositions, and appearance of this product is subject to change without prior notice. Copyright All rights reserved. No part of this publication may be reproduced in any form or by any means without the written permission of Carestream. The information contained herein is designed only for use with TRIMAX 43C Detector. AJ4312 | 2020-02-10

-v Notices and Conventions

-vi AJ4312 | 2020-02-10 Contents Notices and Conventions Disclaimer.......................................................................................................................................... -v 1 Safety and Regulatory Information Symbols............................................................................................................................................1-1 Cautions...........................................................................................................................................1-4 Medical Equipment Classification................................................................................................1-14 Standards.......................................................................................................................................1-15 Emissions and Immunity Compliance to the IEC60601-1-2 Standard........................................ 1-17 Radio Frequency Compliance.......................................................................................................1-21 Correction and Calibration Template Generation................................................................ 1-23 Battery Safety Standards.............................................................................................................. 1-24 Intended Use and Essential Performance....................................................................................1-25 2 Overview Components and Specifications.....................................................................................................2-2 Product Components................................................................................................................ 2-2 Product Specifications...............................................................................................................2-6 IT Network...............................................................................................................................2-11 Service Information...................................................................................................................... 2-13 Disposal......................................................................................................................................... 2-14 3 Installation Panel Installation............................................................................................................................ 3-1 Install the Detector Battery...................................................................................................... 3-1 Power on the Detector............................................................................................................. 3-2 Install the Detector Battery Charger............................................................................................. 3-8 Detector Battery Lock and Activation........................................................................................... 3-9 4 Operation Notes for Using............................................................................................................................... 4-1 Detector Position............................................................................................................................ 4-3 Appendix (For Service Personnel Only) Software and Settings.....................................................................................................................A-I Operating Modes...........................................................................................................................A-V Software Mode........................................................................................................................ A-V Inner2 Mode............................................................................................................................A-VI Freesync Mode........................................................................................................................ A-VI Software Installation.................................................................................................................. A-VIII AJ4312 | 2020-02-10 i Contents Set the Connection Mode............................................................................................................ A-IX Wireless Client Mode.............................................................................................................. A-IX Wireless AP Mode.................................................................................................................... A-X Shortcuts.......................................................................................................................................A-XII Establish a Connection with the Detector.................................................................................A-XIII Configure the Detector..............................................................................................................A-XIV Correction and Calibration Template Generation.....................................................................A-XV Pre-offset Template Generation........................................................................................... A-XV Gain Calibration Template Generation................................................................................ A-XV Defect Correction Template Generation..............................................................................A-XV Image Check and Upload..........................................................................................................A-XVII Local Image Check............................................................................................................... A-XVII Panel Image Upload............................................................................................................ A-XVII Defect Template Check and Modification.............................................................................. A-XVIII Defect Template Check...................................................................................................... A-XVIII Defect Template Modification...........................................................................................A-XVIII Correction and Calibration Management.................................................................................A-XIX Correction and Calibration Template Synchronization......................................................A-XIX Correction and Calibration Management...........................................................................A-XIX Update the Firmware.................................................................................................................. A-XX Publication History ii AJ4312 | 2020-02-10 1 Safety and Regulatory Information Symbols Symbols and Conventions WARNING:

This is used to identify conditions under which improper use of the product may cause death or serious personal injury. This is used to indicate a prohibited operation. This is used to indicate an action that must be performed. Labels and Markings on the Equipment This indicates that the product has passed CE certification and is followed by the CE number. AJ4312 | 2020-02-10 1-1 Safety and Regulatory Information This is used to identify the manufacturers series number, which is after, below, or adjacent to the symbol. The series number usually consists of 19 digits as shown in the following example:

1A2A3A4 B1B2 C1C2 L M1M2 D1D2 Y1Y2 X1X2X3X4 L - Production site 1A2A3A4 - Product code B1B2 - Derived classes C1C2 - Version M1M2 - Month D1D2 - Day Y1Y2 - Year X1X2X3X4 - Numerical order This indicates the name and address of the manufacturer. This indicates the name and address of a Carestream authorized representative in the European region. This indicates consulting the user guide for general information. Safety sign: Dangerous Voltage Handle with care. This indicates operational temperature limits. 1-2 AJ4312 | 2020-02-10 Safety and Regulatory Information This indicates storage temperature limits. This indicates the product radiates a wireless signal. Package symbol: Fragile Package symbol: Keep away from sunlight. Package symbol: Keep dry. This indicates the humidity limits. Keep the product upright. Do not roll the transportation packaging. This indicates the stacking limit number. FDP is allowed to withstand 100 kg on its surface. Rx only IP Device is for prescription use only. IPX1 for working surface only. AJ4312 | 2020-02-10 1-3 Safety and Regulatory Information Cautions Environment for Installation and Use WARNING:

Do not use or store the product near flammable chemicals such as alcohol, thinner, benzene, etc. Chemicals that are spilled or evaporated may result in fire or electric shock through contact with electric parts inside the product. Also, some disinfectants are flammable. Be sure to take care when using them. Environment for Installation and Use WARNING:

Do not connect the equipment with anything other than the specified connectors to avoid fire or electric shock. WARNING:

Keep all patients with active implantable medical devices away from the product. CAUTION:

Do not install the product in any of the locations listed below to avoid failure, malfunction, falling, fire, or injury. Installation and Environment of Use Close to facilities where water is used Where there is exposure to direct sunlight Close to the air outlet of an air conditioner or ventilation equipment Close to a heat source such as a heater Where the power supply is unstable Where temperature or humidity is high Where there is freezing or condensation On an incline or in an unstable area In a dusty environment In a saline or sulfurous environment In areas prone to vibration 1-4 AJ4312 | 2020-02-10 Safety and Regulatory Information Installation and Environment of Use CAUTION:

Do not allow cables to become tangled to avoid a malfunction of the product. Do not get your feet caught by a cable to avoid tripping and injury. CAUTION:

Non-medical equipment such as battery chargers and access point and infrared register tools cannot be used in the vicinity of a patient. Power Supply AJ4312 | 2020-02-10 1-5 Safety and Regulatory Information WARNING:

Do not operate the product with a power supply other than the one indicated on the rating label to avoid fire or electric shock. WARNING:

Do not handle the product with wet hands to avoid electric shock that could result in death or serious injury. Power Supply WARNING:

Do not place heavy object on cables and cords. Co not pull, bend, bundle, or step on them to prevent damage to the sheath. Do not alter them. Avoid damage to the cords, which could result in fire or electric shock. WARNING:

Do not supply power from the same AC outlet to more than one product to avoid fire or electric shock. WARNING:

Do not turn on system power when condensation has formed on the equipment to avoid fire or electric shock. WARNING:

Do not connect multiple portable socket outlets or extension cords to the system to avoid fire or electric shock. Power Supply WARNING:

Connect this product only to a power supply with protective earth to avoid fire or electric shock. WARNING:

Do not use the adapter cord when connecting the panel to a patient. 1-6 AJ4312 | 2020-02-10 Safety and Regulatory Information Power Supply WARNING:

Securely insert the power cord into the AC outlet to avoid a contact failure. If a contact failure occurs or if metal objects come in contact with the exposed metal prongs of the plug, fire or electric shock may result. WARNING:

Be sure to turn off the power before connecting or disconnecting the cords to avoid an electric shock that could result in death or serious injury. WARNING:

Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the core wire may be damaged, resulting in fire or electric shock. Power Supply CAUTION:

Always connect a three-core power cord plug to a grounded AC power outlet. Keep the outlet free of obstacles for easy access to disconnect the plug at any time and in an emergency. Be sure to ground the product to an indoor grounded connector. Be sure to connect all the grounds of the system to common ground. CAUTION:

Do not use any power source other than the one provided with the product to prevent leakage that could result in fire or electric shock. AJ4312 | 2020-02-10 1-7 Safety and Regulatory Information Handling Handling WARNING:

No modification is allowed. Never disassemble or modify the product to avoid fire or electric shock. The product incorporates parts that may be hazardous or cause electric shock Touching them may cause death or serious injury. WARNING:

Do not place an object on top of the product. The object may fall and cause an injury. Metal objects such as needles or clips that fall into the product or spilled liquid may result in fire or electric shock. WARNING:

Do not strike, drop, or cause a strong jolt to the product to prevent damage and avoid fire or electric shock. WARNING:

Do not place the product and pointed objects together to prevent damage. Handling If so, it should be used in Bucky. WARNING:

Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction. 1-8 AJ4312 | 2020-02-10 Safety and Regulatory Information CAUTION:

Do not spill liquid or chemicals onto the equipment. Do not allow an injured patients blood or body fluids contact with the equipment. Doing so may result in fire or electric shock. Handling In such a situation, protect the equipment with a disposable cover as necessary. CAUTION:

For safety Turn OFF the power and remove the plug for all equipment when not used. CAUTION:

Handle the product carefully. Do not submerge the product in water. CAUTION:

The internal image sensor may be damaged if struck or dropped. If the product is dropped, the drop sensor inside would record and the product would not be under warranty. Handling AJ4312 | 2020-02-10 1-9 Safety and Regulatory Information CAUTION:

Do not place excessive weight on the panel to avoid damage to the internal image sensor and an incorrect image. Patients stand on the product temporarily, and the intended weight can be 135 kg. Based on the internal TFT character, cannot load the dynamic forces due to loading from persons Load Limit Handling Uniform load:150 kg over the whole area of the surface Local load:100 kg on an area 4 cm diameter 1-10 AJ4312 | 2020-02-10 Safety and Regulatory Information CAUTION:

Be sure to use the product on a flat surface to prevent the product from bending and doing damage to the internal image sensor. Be sure to securely hold the product while using it in an upright positions to prevent the product from tipping or flipping over, resulting in injury to the user or patient damage to the inner device. Handling Keep the same pressure on the product when acquiring an image to avoid an incorrect image. AJ4312 | 2020-02-10 1-11 Safety and Regulatory Information Handling CAUTION:

Do not use the product close to fire or in high temperature. Do not invert the positive and negative poles. Do not allow the product to make contact with metal to avoid a short circuit. Do not insert sharp objects into the battery. Do not strike the battery. Do not stand on the battery. Do not use the battery outside of the guidelines. Do not dispose of the battery or change the inner structure. Do not submerge the battery in water. When in use, do not allow the battery to have contact with water. Store the battery in a dry place. Use a charger to charge the battery following the GB 9706.1 Standards provided. Do not replace the battery provided with one from another company. Do not use a damaged charger to charge the battery. Only qualified personnel may replace the battery inside the main unit. Do not touch the output connector for the adapter. Do not remove the battery when the detector is powered on only with the battery. Replace the DC power cable if either of the following occurs:

An arc occurs at the detector interface when connecting the cable The power indicator is not illuminated after connecting the cable 1-12 AJ4312 | 2020-02-10 Maintenance and Inspection Safety and Regulatory Information WARNING:

Turn off the power of the product and disconnect the power cord of the adapter before cleaning. Never use alcohol, ether, and other flammable cleaning agent for safety. Never use methanol, benzene, and acid to avoid corrosion on the equipment. Do not place the product in liquid. Maintenance and Inspection WARNING:

Make sure that the surface and connectors are dry before turning on the product to avoid fire or electric shock. WARNING:

Clean the power cord connector periodically. Disconnect the connector from the AC outlet. Use a dry cloth to remove dust or dirt from the connector, its periphery, and the AC outlet. If the cord is kept plugged in for a long time in a dusty, humid, or sooty place, dust around the plug will attract moisture; this could cause insulation failure that may result in a fire. WARNING:

For safety reasons, be sure to turn off the power when performing the inspections indicated in this manual to avoid electrical shock. When a Problem Occurs When a Problem Occurs WARNING:

If any one of the following occurs, immediately disconnect the power cord of the adapter or battery, and contact your sales representative or local dealer:

When there is smoke, an odd odor, or abnormal sound When liquid has spilled into the equipment or a metal object has entered through an opening When the product has been dropped and damaged AJ4312 | 2020-02-10 1-13 Safety and Regulatory Information Medical Equipment Classification Type of protection against electrical shock External electrical power source equipment Class I Equipment (medical approved adapter) Internal electrical power source equipment (battery) Degree of protection against electrical shock Type-B applied part Degree of protection against ingress of water IPX1 Mode of operation Flammable anesthetics Continuous operation Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Not suitable for use in an oxygen-rich environment 1-14 AJ4312 | 2020-02-10 Standards ISO 13485:2016 IEC 60601-1:2005/AMD1:2012 IEC 60601-1-2:2014/EN60601-1-2:2015 IEC 60601-2-54:2018/EN 60601-2-54:2019 IEC 62133-2:2017 IEC 62220-1-1:2015/EN 62220-1-1:2015 IEC 62304:2006/AMD1:2015 Safety and Regulatory Information Medical devices Quality management systems Requirements for regulatory purposes Medical electrical equipment Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard:

Electromagnetic disturbances v Requirements and tests Medical electrical equipment Part 2-54:

Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy Secondary cells and batteries containing alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-1:

Determination of the detective quantum efficiency

- Detectors used in radiographic imaging Medical device software Software life-cycle processes IEC 62366-1:2015/IEC 62366:2007/EN62366:2008 Medical devices Part 1: Application of usability IEC 60601-1-6:2010+A1:2013 EN ISO14971:2012 engineering to medical devices Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Medical device Application of risk management to medical devices ANSI/AAMI ES60601-1:2005/

(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/

(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) AJ4312 | 2020-02-10 1-15 Safety and Regulatory Information CAN/CSA-C22.2 No.60601-1:14 ISO 15223-1:2016/ EN ISO 15223-1:2016 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Medical devices Symbols to be used with medical device labels, labeling and information to be supplied-Part 1: General requirements 1-16 AJ4312 | 2020-02-10 Safety and Regulatory Information Emissions and Immunity Compliance to the IEC60601-1-2 Standard Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment RF emissions Harmonic distortion Voltage fluctuations and flicker CISPR 11 Group 1, Class B IEC 61000-3-2 Class A IEC 61000-3-3 Compliance The TRIMAX 43C Detector uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The TRIMAX 43C Detector is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic Immunity Emissions Test EMC Standard Test Levels Professional healthcare facility environment Electrostatic discharge IEC 61000-4-2 8 kV contact Radiated RF EM field IEC 61000-4-3 2 kV, 4 kV, 8 kV, 15 kV air 3 V/m 80 MHz2.7 GHz 80 % AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 Refer to Proximity Fields From RF Wireless Communications Equipment Rated power frequency magnetic fields IEC 61000-4-8 30 A/m 50 Hz or 60 Hz AJ4312 | 2020-02-10 1-17 Safety and Regulatory Information Proximity Fields From RF Wireless Communications Equipment Test Frequency

(MHz) 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 Band (MHz) 380390 430470 Test Levels Professional healthcare facility environment Pulse modulation 18 Hz, 27 V/m FM, 5kHz deviation, 1 kHz sine, 28 V/m 704787 Pulse modulation 217 Hz, 9 V/m 800-960 Pulse modulation 18 Hz, 28 V/m 17001990 Pulse modulation 217 Hz, 28 V/m 24002570 Pulse modulation 217 Hz, 28 V/m 51005800 Pulse modulation 217 Hz, 9 V/m Input AC Power Port Emissions Test EMC Standard Test Levels Professional healthcare facility environment Electrical fast transients/burst IEC 61000-4-4 2 kV 100 kHz repetition frequency 1-18 AJ4312 | 2020-02-10 Emissions Test EMC Standard Professional healthcare facility environment Safety and Regulatory Information Test Levels Surges Line-to-line Surges Line-to-ground Conducted disturbances induced by RF fields Voltage dips IEC 61000-4-5 0.5 kV, 1kV IEC 61000-4-5 0.5 kV, 1kV, 2 kV IEC 61000-4-6 3 V, 0.15 MHz80MHz 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz 0 % UT; 0.5 cycle IEC 61000-4-11 At 0 , 45 , 90 , 135 , 180 , 225 , 270 and 315 Voltage dips IEC 61000-4-11 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0 Voltage interruptions IEC 61000-4-11 0 % UT; 250/300 cycles Signal Input/Output Parts Port Emissions Test EMC Standard Test Levels Professional healthcare facility environment Electrostatic Discharge IEC 61000-4-2 8 kV contact 2kV, 4kV, 8kV, 15kV air Electrical fast transients/burst IEC 61000-4-4 1 kV 100 kHz repetition frequency AJ4312 | 2020-02-10 1-19 Safety and Regulatory Information Emissions Test EMC Standard Test Levels Professional healthcare facility environment Conducted disturbances induced by RF fields IEC 61000-4-6 3 V, 0.15 MHz80 MHz 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz Reference Cables Provided Against EMC Cable Recommended Cable Length AC Power Cable DC Power Cable LAN Cable

(configuration mode) 3 m 3.5 m 3 m Shielded or Unshielded Unshielded Unshielded Shielded Number Cable Classification 1 pcs 1 pcs 1 pcs AC Power DC Power Signal Important Information Regarding Electromagnetic Compatibility (EMC) TRIMAX 43C requires special precautions regarding EMC and needs to be installed only by Carestream or authorized personnel and put into service according to EMC information provided in the user manual. TRIMAX 43C in use may be susceptible to electromagnetic interference from portable and mobile RF communications such as mobile (cellular) telephones. Electromagnetic interference may result in incorrect operation of the system and create a potentially unsafe situation. The minimum distance between the panel and other equipment should be larger than 12 inch. TRIMAX 43C conforms to this EN60601-1-2:2015 standard for both immunity and emissions. Nevertheless, special precautions need to be observed. The use of accessories, transmitters, and cables other than those specified by this user manual, with the exception of accessories and cables sold by Carestream as TRIMAX 43C replacement parts for inner components, may result in increased emission or decreased immunity. 1-20 AJ4312 | 2020-02-10 Safety and Regulatory Information Radio Frequency Compliance Country Item U.S.A FCC Code CFR47 Part15B (2018) ANSI C63.4(2014) FCC CFR47 Part 15C (2018)Radio Frequency Devices ANSI C63.10(2013) KDB 558074 D01 15.247 Meas Guidance v05r02 FCC CFR47 Part 15E (2018) Unlicensed National information infrastructure devices ANSI C63.10(2013) KDB 789033 D02 General UNII Test Procedures New Rules v02r01 KDB 662911 D01 Multiple Transmitter Output v02r01 248227 D01 802.11 Wi-Fi SAR v02r02 447498 D01 General RF Exposure Guidance v06 648474 D04 Handset SAR v01r03 865664 D01 SAR measurement 100MHz to 6GHz v01r04 865664 D02 RF Exposure Reporting v01r02 941225 D06 Hotspot Mode v02r01 616217 D04 SAR for laptop and tablets v01r02 AJ4312 | 2020-02-10 1-21 Safety and Regulatory Information Country Item European Union ETSI EN 300 328 V2.1.1 ETSI EN 301 893 V2.1.1 ETSI EN 300 440 V2.1.1 ETSI EN 301 489-3 V2.1.1 Draft ETSI EN 301 489-1 V2.2.1 Draft ETSI EN 301 489-17 V3.2.0 EN 55032: 2015 EN 55035: 2017 EN 61000-3-2: 2014 EN 61000-3-3: 2013 EN 50566: 2017 EN 62209-2: 2010 EN 62479: 2010 FCC Compliance The panel has been tested to comply with limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Operation is subject to the following two conditions. The panel may not cause harmful interference. The panel must accept any interference received, including interference that may cause undesired operation. The panel generates, uses, and radiates radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If the panel does cause harmful interference to radio or television reception, which can be determined by turning the panel off and on, the user is encouraged to correct the interference by one or more of the following measure. Increase the separation between the panel and receiver. Reorient or relocate the antenna. Connect the panel into an outlet different from the receiver is connected. Consult the distributor or an experienced radio/TV technician for help. 1-22 AJ4312 | 2020-02-10 Correction and Calibration Template Generation Correction and calibration should be performed after installation and every six months. The new correction and calibration should be performed after any major change on the system settings and hardware configuration. Safety and Regulatory Information AJ4312 | 2020-02-10 1-23 Safety and Regulatory Information Battery Safety Standards Standards Description CAN/CSA E62133:13 1st Ed. Rev. UL 62133, 1st Ed. Rev. Secondary cells and batteries containing alkaline or other non-

acid electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications First Edition Secondary cells and batteries containing alkaline or other non-

acid electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications First Edition UL 2054 Household and commercial batteries IEC 62133-2:2017 UN38.3 Secondary cells and batteries containing alkaline or other non-

acid electrolytes Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems United Nations Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria ST/SG/

AC.10/11/Rev.5/Amend.1 and Amend.2 1-24 AJ4312 | 2020-02-10 Safety and Regulatory Information Intended Use and Essential Performance Intended Use These devices are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. Essential Performance For TRIMAX 43C, the intended use and the result of risk management, getting imaging and function of data transmission is defined as essential performance. Getting qualified dark image proves that essential performance does not influence the intended use. For the method of getting dark image, see the Installation and Operation sections. Application Specification Patient Population Adult and pediatric patients Weight: not relevant Health: not relevant Nationality: multiple Gender: except for pregnant women Patient state: patient is not user Pediatric Use: Guidance & Considerations Special care should be exercised when imaging patients outside the typical adult size range, especially smaller pediatric patients whose size does not overlap the adult size range (e.g.less than 50 kg (110 lb) in weight and 150 cm (59 in) in height, measurements which approximately correspond to that of an average 12 year old. The following ranges of pediatric subpopulations are to be used as a guide for manufacturers in developing medical devices:

Pediatric Subgroup Approximate Age Range Newborn (Neonate) From birth to 1 month of age Infant Child Adolescent Greater than 1 month to 2 years of age Greater than 2 to 12 years of age Greater than 12 through 21 years of age AJ4312 | 2020-02-10 1-25 Safety and Regulatory Information Exposure to ionizing radiation is of particular concern in pediatric patients because:

1. For certain organs and tumor types, younger patients are more radio sensitive than adults (the cancer risk per unit dose of ionizing radiation is higher for younger patients);

2. Use of equipment and exposure settings designed for adults of average size can result in excessive and unnecessary radiation exposure of smaller patients;

3. Younger patients have a longer expected lifetime putting them at higher risk of cancer from the effects of radiation exposure. To help reduce the risk of excessive radiation exposure, you should follow the ALARA

(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only the amount necessary to obtain images that are adequate clinically. Additional guidance and recommendation are provided by the Alliance for Radiation Safety in Pediatric Imaging (Image Gently Alliance) https://www.imagegently.org/

Table 1: Techniques for Typical Body Parts Body Parts Patient Size Very Low Birth Weight (Less than 1.5 Kg) Low Birth Weight (Between 1.5 and 2.5 Kg) Newborn (Age is less than 1 month and Weight above than 2.5 Kg) Infant (Age is between 1 month and 2 years) Abdomen AP/PA Child (Age is between 2 years and 12 years) Preadolescent (Age is between 12 years and 13 years) Adolescent (Age is between 12 years and 21 years) Adult Small Adult Medium Adult Large kVp 55 mAs 1 55 70 73 75 75 75 75 80 85 1.6 1.6 2 7.1 14 20 18 22 32 SID 1m 1m 1m 1m 1m 1m 1m 1m 1m 1m Grid no no no no yes yes yes yes yes yes 1-26 AJ4312 | 2020-02-10 Body Parts Patient Size kVp mAs Safety and Regulatory Information Very Low Birth Weight Low Birth Weight Newborn Infant Child Preadolescent Adolescent Adult Small Adult Medium Adult Large Very Low Birth Weight Low Birth Weight Newborn Infant Child Preadolescent Adolescent Adult Chest PA/AP Extremities AP/PA 50 55 65 70 70 90 90 110 110 120 50 55 57 57 58 62 62 1 1 1 1.6 1.6 2 2 1.8 2.8 4 1 1 1 1.2 1.2 1.6 2 SID 1m 1m 1m 1m 1m 1m 1m 1.8m 1.8m 1.8m 1m 1m 1m 1m 1m 1m 1m Regarding adult details techniques of Extremities, please refer to the table of Techniques for Adult Extremities Grid no no no no no yes yes yes yes yes no no no no no no no no 1-27 Table 2: Techniques for Adult Extremities Adult Extremities List Ankle - AP Ankle - Lateral AJ4312 | 2020-02-10 kVp 58 58 mAs 4 4 SID 1 1 Grid no no Safety and Regulatory Information Adult Extremities List kVp mAs SID Grid Femur - AP Femur - Lateral Hand - PA Hand - oblique Humerus - AP Humerus - Lateral Knee - AP Knee - Lateral Wrist - PA Wrist - Lateral 70 70 53 53 75 70 65 65 55 55 16 10 1.8 1.8 7.1 3.2 10 10 1.8 1.8 1 1 1 1 1 1 1 1 1 1 yes yes no no yes yes yes yes no no Intended Operator All procedures should be carried out by an operator who has completed the professional training offered by the companys customer service staff. Life Time Lifetime: 7 years without frequency limit 1-28 AJ4312 | 2020-02-10 2 Overview The TRIMAX 43C Detector is a cassette-size, wireless x-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It is developed to provide the highest quality of radiographic images with an active matrix of 30723072 with 139 um pixel pitch. The detector supports wireless communication between the panel and the workstation and is powered by an internal battery. Scope This manual contains information about the TRIMAX 43C. Information in the manual, including the illustrations, is based on a prototype. If your system configuration does not have features described in this manual, the information does not apply to your detector. Features Sync-shot exposure trigger Wireless static flat panel detector used for general radiography Cassette-size CsI scintillation screen Battery recycling Easy-to-change cable and easy-to-update firmware AJ4312 | 2020-02-10 2-1 Overview Components and Specifications Product Components Component Description Detector Item Description Notes For optional power input For service DC jack Ethernet port B A C D E Detector indicator Detector indicator of control panel Power button Mode button Power button of control panel Mode switch 2-2 AJ4312 | 2020-02-10 Item Description F G Power indicator Handle Battery Overview Notes The other Power indicator Optional Item Description Notes A B C D Battery label Battery interface Pilot pin Indicator Battery Charger 8 pin battery connector Installation direction indicator AJ4312 | 2020-02-10 2-3 Overview Item Description Notes A B C D E F G Battery Interface A Battery Interface B Battery Interface C Indicator The limit ball plug Hand Pull Position AC Jack Battery Charger Indicator 8 pin battery connector Not used Not used The indicator definition is as follow

220V (ac) input Name Item A B C Power Indicator Charging Indicator Charge Full Indicator 2-4 AJ4312 | 2020-02-10 X Indicator All off A indicator on A indicator on B and C alternately blink 2 times Overview Operating Status No power input AC power input Multiple batteries inserted Battery insertion self test A and B indicator on Battery charging A and C indicator on A indicator on B and C alternately blinking Battery capacity full, charging stops Battery is not charging properly Two or more batteries charging cannot be charged at the same time. Charging will automatically stop if more than one battery is inserted. AJ4312 | 2020-02-10 2-5 Overview Product Specifications Detector Item Specifications Model Image Sensor Pixel Size Active Array Active Area (H x V) Gray Scales Spatial Resolution Cycle Time Power Consumption Dimension (L W H) TRIMAX 43C a-Si (amorphous silicon) TFT 139 m 3072 x 3072 427.0 x 427.0 mm (16.8 x 16.8 in.) 16 bit 3.6 Lp/mm Min. 8.5 sec. Max. 20 W 460.0 x 460.0 x 15.0 mm (18.1 x 18.1 x 0.6 in.) Weight (with one battery) 4.68 kg (10.32 lb) Image Transfer Wireless: IEEE802.11a/b/g/n/ac 2-6 AJ4312 | 2020-02-10 Item Specifications Overview Data Transmission Rate (Wireless) 802.11b: Max. 11 Mbps 802.11a/g: Max. 54 Mbps 802.11n: Max. 300 Mbps (MIMO 2 x 2) 802.11ac: Max. 867 Mbps(MIMO 2 x 2) Battery Item Specifications Model Rated capacity Nominal voltage Charge voltage Discharged end voltage Charging method Battery-KV Typ. 4180 mAh @ Discharge 0.2C 10.8 V 12.6 0.05 V 9 V CC-CV AJ4312 | 2020-02-10 2-7 Overview Item Specifications Operating temperature Storage temperature Charge 060 C (32140 F) Discharge 060 C (32140 F) 3 month -20 - +45 (-4113 F) 6 month -20- +35 (-495 F) Relative humidity 5 %~95 %

Dimension (L W H) 210.0 x 115 x 7.5 mm (8.3 x 4.5 x 0.30in.) Weight 0.28 kg (0.62 lb) Battery Charger Item Specifications Model Simultaneous Charging Full Charging Time Rated Power Supply Dimension (L W H) Charger-Combo 1 Battery Pack 3 hr 90~264 V (ac) 240.0 x 184.0 x 38.0 mm

(9.4 x 7.2 x 1.52 in.) Weight 0.55 kg (1.2 lb) 2-8 AJ4312 | 2020-02-10 Overview Power Supply Item Specifications DC Power (Optional) Battery Package CAUTION:

24V (dc), 0.8A 10.8V (dc), 1.78A The charging cable can only be used in areas not are accessible to the patient, such as in the Bucky. The product must be used with the approved adapter and CB certificate number SG PSB-MD-00191. Wireless Communication Item Specifications Wireless Standard Frequency Range Data Transmission Rate Modulation IEEE 802.11 a/b/g/n/ac 2.412~2.472 GHz: ch1~ch13 5.18~5.24 GHz: ch36~ch48 5.745~5.85 GHz: ch149~ch165 802.11b: Max. 11 Mbps 802.11a/g: Max. 54 Mbps 802.11n: Max. 300 Mbps (MIMO 2x2) 802.11ac: Max. 867 Mbps(MIMO 2x2) 802.11b:

CCK, DQPSK, DBPSK 802.11a/g/n:

64 QAM, 16 QAM, QPSK, BPSK 802.11ac:

256 QAM, 64 QAM, 16 QAM, QPSK, BPSK Transmission Power Max.17 dBm AJ4312 | 2020-02-10 2-9 Overview Item Specifications Security Antenna Mechanical Outlines WPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64 bit & 128 bit 2 dual band inner antenna Use Environment Temperature Temperature Change Humidity Atmospheric Pressure Pressure Change Operating Storage 535 C

(4195 F)

-2055 C

(-4131 F)

< 1k/min 10 %90 %

RH 7001060 hPa

<10 kp/min

(1 kp=1.0197E-5Pa)

< 1k/min 5 %95 % RH 7001060 hPa

<10 kp/min

(1 kp=1.0197E-5Pa) 2-10 AJ4312 | 2020-02-10 Temperature Temperature Change Humidity Atmospheric Pressure Pressure Change TRIMAX 43 detectors shall operate at a specified altitude of not more than 3000.0 m (9842.5 ft). The environment specific is only for the detector. Overview IT Network Purpose for IT-network Transmission of image data and command/status communication between the detector and the workstation. Required Features Wireless communication follows IEEE 802.11a/b/g/n/ac protocol. It works on 2.4 GHz and 5 GHz. It supports at least 2 routers. Hazardous Situations from Failure of the IT Network Incompatibility of the operating system is not compatible Inability to update or change software Incompatibility of the interface Inconsistency of interface or format leads to data distortion Data transfer protocol error Data output failure Required Configuration The wireless card and the detector must work on the same IP segment such as 192.168.8.XXX. They must support IEEE 802.11a/b/g/n/ac. Technical Specifications Item Specifications Wireless Standard IEEE 802.11a/b/g/n/ac Frequency Range 2.412-2.472 GHz: ch1-ch13 5.18-5.24 GHz: ch36-ch48 5.745-5.85 GHz: ch149-ch165 AJ4312 | 2020-02-10 2-11 Overview Item Specifications Data Transmission Rate 802.11b: Max. 11 Mbps 802.11a/g: Max. 54 Mbps 802.11n: Max. 300 Mbps (MIMO 2x2) 802.11ac: Max. 867 Mbps (MIMO 2x2) Modulation 802.11b: CCK, DQPSK, DBPSK 802.11a/g/n: 64 QAM, 16 QAM, QPSK, BPSK 802.11ac: 256 QAM, 64 QAM, 16 QAM, QPSK, BPSK Security WPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64 bit, and 128 bit Intended Information Flow The detector sends the acquired image data to the workstation. The workstation sends the user's commands to the detector. Please refer to the operation manual of the console for detail. Hazardous Situations Resulting From Failure of the IT-network Failure of completing essential performance Failure of finishing configuration of product Incompatibility of operating system Failure of change or update to software Compatibility of interface Data transfer protocol error Data output failed Inconsistency of interface or format leads to data distortion Warning Connection of the main unit to an IT network that includes other equipment could result in previously unidentified risks. The manufacturer of the x-ray machine should identify, analyze, evaluate, and control these risks; subsequent changes to the IT-network could introduce new risks and require additional analysis. Changes to the IT-Network Changes in the IT-network configuration Connection of additional items to the IT-network Disconnecting of items from the IT-network Update of equipment connected to the IT-network 2-12 AJ4312 | 2020-02-10 Service Information Product Lifespan Overview The estimated product lifetime is up to 7 years under appropriate regular inspection and maintenance (battery 5 years). Regular Inspection and Maintenance In order to ensure the safety of patients and operator, and to maintain the performance and reliability of the panel, be sure to perform regular inspections at least once a year. If necessary, clean the panel, make adjustments, or replace consumables such as fuses etc. There may be cases where an overhaul is recommended depending on conditions. Contact Carestream service or your local dealer for regular inspection or maintenance. Repair If the problem cannot be solved, contact Carestream service or your local dealer for repairs. Please refer to the label and provide the following information:

Product Name:

Series Number:

Description of Problem: (as clearly as possible) Replacement Parts Support Main parts (those required to maintain the function of the product) needed to repair the product will be stocked for 5 years after discontinuance of production. AJ4312 | 2020-02-10 2-13 Overview Disposal CAUTION:

Do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste. Contact your local authorities for information about dropping off waste products for recycling. If collection systems are not available, call Carestream Customer Service for assistance. In the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to appropriate facilities for recovery and recycling. See http://recycle.carestreamhealth.com for additional information on the collection and recovery programs available for this product. 2-14 AJ4312 | 2020-02-10 3 Installation Panel Installation Install the Detector Battery The detector can be powered by the battery package or DC power. The detector will be activated as soon as power is supplied and will power off as soon as power is removed. AJ4312 | 2020-02-10 3-1 Installation 1. Make sure that the connectors for the battery and battery compartment are aligned. 2. Slide the battery into the battery compartment. Note:

Make sure the battery level is >10 % of full capacity. 3. Slide the two battery lock levers toward the center of the detector.. Power on the Detector On the control panel, the power button is used to power the detector on and off. 3-2 AJ4312 | 2020-02-10 To power on the detector, press and hold the power button for 4 seconds. The detector must either have a battery installed with >10 % charge or have the DC power connected. To power off the detector, press and hold the power button for 4 seconds. To reset the detector, press and hold the power button for 8 seconds. Installation Power Indicator After booting up, the user can check the status LED indicator. Power Indicator Lighting Status OFF Orange ON Green ON Operating Status Operating Battery Capacity DC Input Power OFF

Power ON 20%

No Power ON Battery capacity 20 %, no DC input DC input (Optional) Orange Blinking Power OFF

<20 %

Yes Green and Orange Blinking Power OFF 20 % and <95 %

Yes AJ4312 | 2020-02-10 3-3 Installation Power Indicator Lighting Status Operating Status Operating Battery Capacity DC Input Green Fast Blinking Power OFF 95 % and <100 %

Yes OFF Power OFF

=100 %

Yes Link Indicator Power Indicator Lighting Status Description Off Green On Blue On Blue Blinking Green and Blue Blinking Shut down Wired connection broken and wireless connection not ready Wired connection is built Client mode, wireless connection is built AP mode, wireless AP is ready (Not used) Client mode, no connection is built Initialization Status Indicator Power Indicator Lighting Status Description Off 3-4 Shut down Exposure prohibit AJ4312 | 2020-02-10 Power Indicator Lighting Status Description Green On Exposure enable Installation Green Blinking Image transmission Orange On Error Orange Blinking Safety mode Mode Indicator Power Indicator Lighting Status Description Off Green On Blue On Shut down Wired connection is built AP mode, wireless AP is ready (Not used) Client mode, wireless client is ready Blue and Green Blinking Initialization AJ4312 | 2020-02-10 3-5 Installation Button Function Action FPD Status Power Mode Note Power ON Short hold No action Hold for 4 seconds Forced restart Long hold No action Exit the battery from ship mode Power OFF Press 3 times No action Enter safety mode Short hold Long hold Forced restart Power ON Long hold No action Enter/exit sleep mode Double click No action Power OFF Short hold No action Restore default configuration Triple check Short hold Long hold Hold for more than 7 seconds. Release the power button when the power indicator is ON. Release after two short presses (interval < 1second). Power button: hold for 4 seconds Mode button: hold for 7 seconds Hold for more than 7 seconds, when the Power indicator is OFF and then ON, release Power button. Release after two short presses (interval <1second) Hold for 4 seconds, Release the Power button when the power indicator is OFF. 1. Hold the Mode button hold for 7 seconds. 2. Press the Power button 3 times. 3. Short hold the Power button for 4 seconds. 3-6 AJ4312 | 2020-02-10 Action FPD Status Power Mode Note Installation Wireless ConnectionMode Switch Power ON No action Long hold and then short click 1. Hold the Mode button hold for 7 seconds. 2. Release the Mode button after Mode indicator starts blinking, and then press again in 5 seconds. The mode starts switching. 3. Press the Mode button to switch modes. The Mode indicator blinks at the corresponding color. 4. Wait at intended mode, the Mode indicator will switch color after several seconds. Blue = client Green = AP (Not used) AJ4312 | 2020-02-10 3-7 Installation Install the Detector Battery Charger 1. Remove the battery from the battery charger. 2. Insert battery into battery charger in the orientation shown below. 3. Press the battery down into the battery compartment. 3-8 AJ4312 | 2020-02-10 Installation Detector Battery Lock and Activation To ensure the safety of the battery during transportation or storage, the battery can be set to ship mode where it is locked and will not provide any voltage output. Enter Ship Mode Method Steps Factory configuration Web write in 1. Connect the adapter to the detector and power it on. 2. Connect the other end of the adapter to the PC. 3. Insert the battery into the detector. 4. Open a web browser and enter the following address: http://10.0.1.150/

cgi-bin/shipmode.cgi?action=on The battery is placed in ship mode. Exit Ship Mode Web exit Adapter + FPD Method Steps 1. Connect the adapter to the detector and power it on. 2. Connect the other end of the adapter to the PC. 3. Insert the battery into the detector. 4. Open a web browser and enter the following address: http://10.0.1.150/

cgi-bin/shipmode.cgi?action=off The detector exits ship mode. 1. Connect the adapter to the detector and power it on. Insert the battery into the detector. 2. 3. Press the power button for approximately 4. 4 seconds to shut down the detector. In the shutdown state, press the power button 3 times to exit ship mode. AJ4312 | 2020-02-10 3-9 Installation Charger Method Steps 1. Power on the charger. 2. Insert the battery into the charger for 3 to 5 seconds to exit ship mode. 3-10 AJ4312 | 2020-02-10 4 Operation Notes for Using Do the following to ensure that the detector functions correctly. Before Exposure Inspect the detector daily and confirm it is working properly. Check that there is no condensation on the any of the surfaces of the detector. Condensation can be caused by the sudden heating of the room in cold areas. If this occurs, wait until the condensation evaporates before performing an exposure or problems may occur with the quality of captured images. When changing the temperature in an air-conditioner environment, be sure to raise or lower the temperature gradually. The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map. Make sure exposure rate is over 900 nGy/s @70 KV. Make sure the wave form of the energy going to the x-ray tube is square and not pulse. Check if the patient has recently been injected with a radio isotope; this may cause the detector to transmit an image without performing an x-ray. During Exposure Important:

To prevent image noise, artifacts, or incorrect images, do not use the product near equipment generating a strong magnetic field.:

After Usage Remove the battery from the detector if the detector will not be used for more than 5 days. If the battery is stored for an extended time, it should be charged (30 % to 50 %) every 3 months or charged (50 % to 70 %) every 6 months. Cleaning, Disinfection, and Sterilization of Patient Contact Surfaces To prevent the risk of infection, wipe the patient contact surfaces after every examination with a nonflammable disinfectant, such as benzalkonium chloride or benzalkonium bromide. For details on how to sterilize, consult a specialist. AJ4312 | 2020-02-10 4-1 Operation CAUTION:

Do not spray disinfectants or detergents directly onto the detector. To prevent damage to the surface of the detector, wipe with a cloth slightly dampened with a neutral detergent. Do not use solvents such as benzene and acid. It is recommended to use a waterproof non-woven cover as the isolated layer between the detector and a patient who is bleeding. Applied Part The front and back of the detector is an application part. 4-2 AJ4312 | 2020-02-10 Detector Position To prevent abnormal light lines, place the detector behind the patient in the orientation shown below. Operation AJ4312 | 2020-02-10 4-3 Operation 4-4 AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Software and Settings Main Interface Button Function Home page, shows the list of the detectors Acquire images, free for use after connecting the detector Configure UI for SDK, free for use after connecting the detector Configure UI for detector, free for use after connecting the detector Calibrate UI, for generation and management of the calibration template Image management, free for use at any time Connect the detector Disconnect the detector Manage the syncbox Message Box Status Box Tab Description Serial number of the detector Status of the detector, busy or ready The task that is currently being executed Home Acquire SDK Detector Calibrate Local File Connect Close Syncbox SN Status Task Message Information AJ4312 | 2020-02-10 I Appendix (For Service Personnel Only) Tab Description Remaining power of the battery, shown as a percentage Progress Bar If the progress bar Is green while taking an x-ray, the image quality is acceptable Is not green while taking an x-ray, the image quality will be degraded General Settings Parameter Description Can be Modified Product No. Type number of the detector Sub Product No. Sub-type of the detector Serial No. Serial number of the panel Main Version Version of the firmware of Main FPGA Main MB CPU Version Version of the MB CPU of Main FPGA MCU Version Version of the firmware of MCU Arm Version Version of the App of ARM Kernel Version Version of the Kernel of ARM Inner Subflow Sub work-flow Prep CapMode Self CapEnable Reserved Reserved Self Cap Span Time Should not be modified; keep the original value Trigger Mode Trigger mode Sequence Interval Time Should not be modified; keep the original value Set Delay Time Exposure window for Freesync mode Exp Window Time Exposure Window for Software/Inner mode, the value should not be larger than 10s Acquire Delay Time Reserved No No No No No No No No Yes No Yes Yes Yes Yes Yes Yes Yes II AJ4312 | 2020-02-10 Parameter Description Can be Modified Appendix (For Service Personnel Only) Integrate Time Should not be modified; keep the original value Src Port Src IP Src MAC Dest Port Dest IP Self Clear Enable Port number for detector IP address for detector MAC address for detector Port number for PC IP address for detector Related to Prep CapMode, the value should be configured as On if Prep CapMode is configured as PrepCapMode_ClearAcq. Otherwise, the value should be Off If the Trigger Mode is Software/Inner, the value should be On Self Clear Span Time Should not be modified; keep the original value Hvg Prep On Hvg XRay Enable Hvg XRay On Reserved Reserved Reserved Tube Ready Time Reserved Image Pkg Gap Time Reserved Out Mode Cap Trigger Reserved SDK Settings Yes No No Yes No No Yes Yes Yes Yes Yes Yes Yes Yes Parameter Description Can be Modified Host IP Host Port IP Address of local workstation Port of local workstation Ftp Download Host IP FTP download server IP; keep the same as Host IP Ftp Download Host Port FTP download server Port; keep the same as Host Port Yes Yes Yes Yes AJ4312 | 2020-02-10 III Appendix (For Service Personnel Only) Parameter Description Can be Modified Ftp Upload Host IP FTP upload server IP; keep the same as Host IP Ftp Upload Host Port FTP upload server Port; keep the same as Host Port Yes Yes Network Settings Button Description Add Del Up Down Select Read Config Write Config Add the information of SSID and the AP Key Delete the information of SSID and the AP Key Move up the AP information Move down the AP information Select the AP Read the parameters of the AP information when the detector is set as AP Write the parameters of the AP information when the detector is set as AP Read Wifi Status Read the WIFI status of the current detector Scan from FPD Scan the AP IV AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Operating Modes Software Mode Block Diagram Software mode is the basic way to acquire an x-ray image. The workstation is a host device installed with iDetector and SDK. Installation describes how to establish connections between the panel and workstation. In software mode, the workstation does not control the x-ray generator. Users decide when to take x-rays. Work Flow 1. Workstation receives prep request and sends clear command to the panel. 2. Panel receives clear from the workstation and starts clearing leakage from the panel. Meanwhile, the panel sends an Exposure Prohibited message to the workstation. 3. Panel finishes clear and sends an Exposure Enable message to the workstation. 4. Workstation shows Exposure Enable on the iDetectors message bar to tell the user to take the x-ray now. 5. User triggers the x-ray generator to initialize and do an anode rotation to prepare for taking x-rays. 6. X-ray generator finishes preparation for taking x-rays and reminds the user to take the x-ray. 7. X-ray generator starts releasing the x-ray. 8. X-ray generator finishes taking the x-ray. 9. Workstation receives acquire request and sends Data Acquisition command to the panel. 10. Panel receives Data Acquisition from the workstation and starts data acquisition operation. 11. Panel completes image acquisition and begins to send data to the workstation. 12. Workstation receives all image data from the panel after calibration if hardware calibration is on. Time Setting To set a clear scenario for programming, see the diagram below. AJ4312 | 2020-02-10 V Appendix (For Service Personnel Only) Inner2 Mode Block Diagram The workstation is a host PC device installed with iDetector and SDK. Installation describes how to establish connections between the panel and workstation. In inner2 mode, the workstation does not control the x-ray generator. Users decide when to take x-rays. Work Flow 1. Workstation receives prep request. 2. X-ray generator is ready to take x-rays and starts releasing the x-ray. 3. Panel starts uploading a Pre-dark image and a Light image to the workstation for preview. If hardware offset is selected, panel first performs an offset and then uploads the preview image. 4. Panel starts uploading Post-dark image to the workstation. If hardware offset is selected, panel first performs correction and calibration and then uploads the processed image to the workstation. 5. Workstation enters exposure prohibit state. Time Setting To set a clear scenario for program, see the diagram below. Freesync Mode Block Diagram The workstation is a host PC device installed with iDetector and SDK. Installation describes how to establish connections between the panel and workstation. In FreeSync VI AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) mode, the user does not interact with the workstation. After taking x-rays, images immediately appear on the screen. Work Flow 1. X-ray generator is ready to take x-rays and starts releasing the x-ray. 2. Workstation receives Exposure Prohibited from the panel. 3. Panel starts uploading a Pre-dark image and a Light image to the workstation for preview. If hardware offset is selected, panel first performs an offset and then uploads the preview image. 4. Panel starts uploading Post-dark image to the workstation. If hardware offset is selected, panel first performs correction and calibration and then uploads the processed image to the workstation. 5. Workstation receives Exposure Enable from the panel. Time Setting AJ4312 | 2020-02-10 VII Appendix (For Service Personnel Only) Software Installation Do the following if the iDetector application is not working:

1. 2. Install MICROSOFT .NET Framework 4.5. Install vcredist_x86_2013 (or vcredist_x64_vs2013). Important:

The iDetector application should not be used for a hospital terminal. VIII AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Set the Connection Mode The detector supports the following two connection modes and should be configured per site requirements. Wireless Client Mode 1. Connect one end of the Gigabit Ethernet cable to the workstation. 2. Connect another end to the LAN port of external wireless AP. 3. From the workstation, open the Control Panel and then the Network and Sharing Center. In the Connections: field, click on Local Network. 4. 5. Open the IPV4 settings. 6. For the IP and network mask setting, select Obtain an IP address automatically. 7. Open the browser and type 10.0.1.1 and log into external wireless AP. 8. Do the wireless setup. 9. Configure 2.4 GHz wireless network. SSID: NETGEAR_BIG_24 Security: WPA2-PSK Password: 12345678 Channel: Check the current Wi-Fi environment, and choose a relatively clean channel. 10. Configure 5G Hz wireless network. SSID: NETGEAR_BIG_50 Security: WPA2-PSK Password: 12345678 Channel: Check the current Wi-Fi environment, and choose a relatively clean channel. 11. Configure LAN IP address. IP address: 10.0.1.1 Subnet Mask: 255.255.255.0 12. Do an external wireless AP reboot: Apply the above settings and reboot your wireless router. 13. Recover the local network IPV4 setting. IP settingIP address: 10.0.1.251 Network mask settingSubnet mask: 255.255.255.0 14. Connect the panel to the workstation with the Ethernet cable. AJ4312 | 2020-02-10 IX Appendix (For Service Personnel Only) 15. Select:

Detector Wifi Read Config Client 16. Select Add and enter the SSID and Password. Select Apply. 17. Choose SSID and select the one with a check mark. Select Write Config to save the parameters. 18. Turn on the wireless router. a. Make sure there is a wired connection between the outer, work station, and IP 10.0.1.251. b. Select Read Wifi Status to check wireless transmission status, numerical value occurred means the link is up and available. The detector will connect to the wireless AP the next time it is powered on. Wireless AP Mode A wired cable can also be used to configure detector in wireless client mode. The wired connection should only be used by the service operator.To start configuration with wired cable, it is necessary to complete this procedure. 1. Connect the panel to the workstation with the Ethernet cable. 2. Select the Detector tab and then Wifi. 3. 4. Select Read Config to display the default settings. 5. Change the settings for SSID and password. In the Mode field, select AP. Important:

6. 7. Make sure that the SSID is different from others already used. In the Frequency field, click on the arrow and select a value from the drop-down list.. In the Country field, click on the arrow and select a country from the drop-down list. In the Channel field, click on the arrow and select a clean frequency and channel. 8. 9. Select Write Config to save the settings. Note:

Do not remove the wired cable until the FPD status is Ready. X AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) The detector will connect to the wireless AP the next time it is powered on. 10. Configure the external wireless card. a. Open the local wireless signal list. b. Select the SSID that belongs to the detectors. Enter the password and select OK. c. Open the wireless card configuration. d. Open the IPV4 setting and set the following values:. IP settingIP address: 10.0.1.251 Network mask settingSubnet mask: 255.255.255.0 e. Open SDK and select the detector. f. Select Connect. AJ4312 | 2020-02-10 XI Appendix (For Service Personnel Only) Shortcuts Shortcut Result Double-click the window using the left mouse button. The image is centered and displayed at the maximum size. Double-click the window using the right mouse button. The window level and width are adjusted to WL: 32767/WW: 65535. Drag the left mouse button to move the displayed image. Drag the right mouse button horizontally to adjust the window width, and drag the right mouse button vertically to adjust the window level. F3 key Quickly adjust the image window width and window level. XII AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Establish a Connection with the Detector 1. Open SDK, select the detector, and select Connect. 2. Confirm that the values for IP address and Port are the same as the values in config.ini. Note:

The value for Cfg_HostPort should be the default of 28000. Note:

When the connection is changed to a different network card, the user must reconnect the detector using a different IP address. The rule of Multi-Share control is based on the IP address. The second terminal with a different IP address is not allowed to operate a detector after the first one is connected. If there is no command transmission between the detector and workstation after 5 minutes, the detector releases access authority. AJ4312 | 2020-02-10 XIII Appendix (For Service Personnel Only) Configure the Detector 1. From the iDetector menu, select the Acquire tab. 2. Acquire the module related setting, such as loading correction and calibration template, acquiring images. 3. See the SDK module-related settings, such as IP address. 4. See the Detector module related settings, such as trigger module, wireless signal. 5. Calibrate the module related setting, such as making correction and calibration template. The template in the panel could be uploaded to a workstation, and the template in a workstation could also be downloaded to panel. 6. See the Local File module related setting, such as import a Raw or DCM image. XIV AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Correction and Calibration Template Generation Correction and calibration should be performed after installation and every six months. The new correction and calibration should be performed after any major change on the system settings and hardware configuration. Pre-offset Template Generation If panel is configured to do Pre-offset correction, Pre-offset Template is necessary. 1. Select Calibrate. 2. Select Start Generate Templates. 3. Select Create Offset. 4. Select Start create offset template file. The screen will display Offset Map Generating. 5. When complete, the screen will display Offset MAP Generated!

Gain Calibration Template Generation Before doing this procedure, make sure SID1.2m, no copper is required. Actual screens may be different from those shown in this procedure. Note:

Use software post offset correction. 1. On the gain template generating page, five images need to be created. 2. Select Start. 3. Select PREP and start the exposure. 4. When completed, select Acquire to get the light image. 5. If the value meets the expected value, select Accept, and then acquire the other four images. If the value does not meet the expected value, do not click Accept. Adjust the exposure dose, and then click PREP to acquire the light image again. 6. When all five images are created, select Generate to generate the gain template. Defect Correction Template Generation Before doing this procedure, make sure SID1.2m, no copper is required. Actual screens may be different from those shown in this procedure. Note:

Use software post offset mode. AJ4312 | 2020-02-10 XV Appendix (For Service Personnel Only) 1. On the Defect Calibration page, start the exposure. Eight images need to be captured. 2. Select Start. 3. Select PREP and start the exposure. 4. When completed, select Acquire to get the light image. 5. If the value meets the expected value, select Accept, and then acquire the other seven images. If the value does not meet the expected value, do not select Acquire. Adjust the exposure dose, then select PREP to acquire the light image again. 6. When all eight images are created, select Generate to generate the gain template. Note:

Make sure your x-ray dose is correct. If your dose is out of the range, iDetector will remind you to adjust the dose. Then you can select start creating and try again. If users operate with two panels, SDK has a probability of automatically quitting. XVI AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Image Check and Upload OPEN provides two features for image check and uploading: Local Image Check and Panel Image Upload. Local Image Check is used to check images saved in the workstation. Panel Image Upload is used to upload images stored in the panel. Local Image Check 1. From the Local File tab, select Load File. Choose the specified file. 2. Choose the images stored in the workstation. The screen will display the images. Panel Image Upload Prerequisites:

Make sure the firewall is closed. 1. Select the Images tab from the Detector interface. 2. Select Query Images. The images stored on the detector will be listed. 3. Select Upload Images and choose the specified image. Select OK. When the state changes to Success, the image has been uploaded. The upload process can be canceled by selecting Stop Upload. The uploaded images are saved in the path of the detector serial number. AJ4312 | 2020-02-10 XVII Appendix (For Service Personnel Only) Defect Template Check and Modification The iDetector software provides the ability to check the defect template. If the template has updates, the user can add and delete pixels or defective lines by modifying the opened defect template. Defect Template Check 1. From the Local File page, select Load File. 2. Select the specified defect template, and select Open. The defect template will be displayed. Defect Template Modification 1. Open the specified defect template. The defect management dialog box will be displayed. 2. Locate the pixel that needs to be managed, type the coordinates of the pixel, and select Add. The information will be added to the template. Note:

If Delete is selected, the information will be removed from the template. 3. Select Save. 4. It is similar to manage the defect pixel. If the user needs to add the defect line, type the coordinates of the line, and select Add. If the information needs to be deleted, select Delete. XVIII AJ4312 | 2020-02-10 Appendix (For Service Personnel Only) Correction and Calibration Management Correction and Calibration Template Synchronization The detector supports correction and calibration template storage. Templates in the detector can be uploaded to a workstation, and templates in a workstation can be downloaded to a detector. 1. After generating the offset, gain, and defect templates, select the templates and select Download to FPD. 2. Select Download. 3. Select Read Status. 4. If the Activity column shows disable, select the row and select Active to enable it. Correction and Calibration Management The detector supports the following ways to do correction and calibration:

In software correction and calibration, the workstation completes all correction and calibration. In hardware correction and calibration, the panel completes all correction and calibration. 1. User can set the calibration method on the Detector page. Note:

The hardware-based calibration is on. 2. Select:

HWPostOffset HWGain HWDefect Note:

The hardware-based calibration is on. 3. Select:

SWPostOffset SWGain SWDefect Note:

The software-based calibration is on. AJ4312 | 2020-02-10 XIX Appendix (For Service Personnel Only) Update the Firmware The Internet can be used to upgrade the detector firmware. This procedure applies to MCU, FPGA, and ARM. 1. Connect the panel to a PC. 2. Open a browser, type detector IP in the search bar, and then press Enter. 3. Enter the following and select login. User name: admin Password: admin 4. Click on the three squares located on the left side of the screen. 5. Select Upgrade and then Browse. 6. Select one the firmware files from the list and select Open. 1717V3TISA07_IMAGE_MCU_xxxx_xx_13.ifm 1717V3TISA07_FPGA_xxxx_xx_13.ifm 1717V3TISA07_IMAGE_ARM_xxxx_xx_13.ifm Important:

Selecting 1717V3TISA07_IMAGE_ALL_xxxx_xx_13.ifm will allow all three versions of firmware to be updated at the same time. 7. When the selected file name is displayed on the interface, select Upgrade. 8. Select Close when the Notice box is displayed. The progress bar will be displayed. If the upgrade is successful, the following interface screen will be displayed. 9. Note:

If the screen is not displayed, the upgrade has failed. XX AJ4312 | 2020-02-10 Publication History Version A Date Changes 2020-02-10 Initial release AJ4312 | 2020-02-10 I Carestream Health, Inc. 150 Verona Street Rochester, NY, USA 14608 Carestream Health, Inc., 2020 Made in China for Carestream Health, Inc. TRIMAX is a trademark of Carestream Health. Pub. No. AJ4312 Rev A. FCC Regulations:

Contains modules FCC ID2ACHK-01070189 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/ TV technician for help. Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment. W52/UNII I is in door use only Radio Frequency (RF) Energy This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the United States. During SAR testing, this device was set to transmit at its highest certified power level in all tested frequency bands, and placed in positions that simulate RF exposure in usage against the body with no separation. Although the SAR is determined at the highest certified power level, the actual SAR level of the device while operating can be well below 1

..................................................................................................................................................KONICA MINOLTA, INC. the maximum value. This is because the device is designed to operate at multiple power levels so as to use only the power required to reach the network. In general, the closer you are to a wireless Base station antenna, the lower the power output. The exposure standard for wireless devices employing a unit of measurement is known as the Specific Absorption Rate, or SAR. The SAR limit recommended by the ICNIRP used by the general public is 2.0W/kg averaged over ten grams of tissue and, is 1,6W/kg Averaged over one gram of tissue by IEEE Std 1528. The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in compliance with the FCC RF exposure guidelines. For this device, the highest FCC reported SAR value for usage is 0.042W/kg. While there may be differences between the SAR levels of various product and at various positions, they all meet the government requirements. SAR compliance for body-worn operation is based on a separation distance of 0 mm between the unit and the human body. Carry this device at least 0 mm away from your body to ensure RF exposure level compliant or lower to the reported level. To support body-worn operation, choose the belt clips or holsters, which do not contain metallic components, to maintain a separation of 0 mm between this device and your body. RF exposure compliance with any body-worn accessory, which contains metal, was not tested and certified, and using such body-worn accessory should be avoided. IC Notice This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

(1) this device may not cause interference, and

(2) this device must accept any interference, including interference that may cause undesired operation of the device. This Class B digital apparatus complies with Canadian ICES-003. IC:25116-01070189 IC Radiation Exposure Statement This EUT is in compliance with SAR for general population/uncontrolled exposure limits in IC RSS-102 and had been tested in accordance with the measurement methods and procedures specified in IEEE 1528 and IEC 62209. This equipment should be installed and operated with minimum distance of 0 cm between the radiator and your body. This device and its antenna(s) must not be co-located or operating in conjunction with any other antenna or transmitter. Cet appareil est conforme aux Normes RSS d'Industy Canada. Son utilisation est soumise deux conditions:

(1) Ce dispositif ne peut pas provoquer d'interfrences, et

(2) Ce dispositif doit accepter toutes les interfrences reues, y compris les interfrences susceptibles de provoquer un fonctionnement non souhait. Cet appareil de classe B est conforme la norme canadienne ICES-003. IC:25116-01070189 Dclaration d'exposition IC Cet EUT est conforme aux valeurs SAR la norme SAR pour le grand public ainsi qu'aux limites d'exposition non rglemente IC RSS-102 et a t test selon les mthodes et procdures spcifies par les Normes IEEE 1528 et IEC 62209. Cet appareil devrait tre install et utilis en respectant une distance minimale de 0 cm avec votre corps. Cet appareil et son (ses) antenne (s) ne doivent pas tre situs proximit l'un de l'autre et ne doivent pas fonctionner en mme temps qu'une autre antenne ou qu'un autre metteur. UNII I is in door use only Les dispositifs RL- EL sont restreints une utilisation lintrieur seulement dans la ba nde de 5 150 5 250 MHz. Cet appareil est conu et fabriqu de faon ne pas dpasser les limites d'mission pour l'exposition l'nergie de radiofrquence (RF) fixes par la Federal Communications Commission des tats-Unis et Industrie Canada. Au cours des essais SAR, cet appareil est configur pour transmettre des donnes son niveau de puissance le plus lev toutes les bandes de frquences testes et places dans l'ensemble des positions simulant l'exposition aux radiofrquences contre la tte et prs du corps, avec une sparation de 0 mm. Bien que le DAS soit dtermin par le niveau de puissance le plus lev, le niveau SAR rel de l'appareil en fonctionnement peut tre bien infrieur la valeur maximale indique. Cela est d au fait que l'appareil est conu pour fonctionner plusieurs niveaux d'alimentation, pour s'adapter aux capacits des diffrents rseaux lectriques. De manire gnral, plus vous vous trouverez ps d'une station sans fil, plus la frquence de transmission sera basse. La norme d'exposition pour les dispositifs sans fil employant une unit de mesure est connue sous le nom de taux d'absorption spcifique (SAR). La limite SAR fixe par la FCC est de 1,6 W / kg et de 1,6 W / kg par Industry Canada. Cet appareil est conforme la norme SAR pour le grand public ainsi qu'aux limites d'exposition non rglementes ANSI / IEEE C95.1-1992 et Canada RSS 102, et a t test conformment aux mthodes et procdures spcifies par les Normes IEEE1528 et Canada RSS 102. Ce dispositif a t test et respecte les directives FCC et IC sur l'exposition aux radiofrquences lorsqu'il est test en contact direct avec le corps. Pour cet appareil, la valeur SAR la plus leve pour une utilisation prs du corps est de 0.042 W/kg. Bien qu'il puisse exister des diffrences entre les niveaux de SAR selon les dispositifs et les emplacements o ils sont utiliss, tous rpondent aux exigences Gouvernementales. La valeur SAR dclare conforme est une distance de 0 mm entre l'unit et le corps humain. Eloignez cet appareil une distance d'au moins 0 mm de votre corps pour vous assurer que le niveau d'exposition aux RF est conforme ou infrieur au niveau indiqu. Vous pouvez galement opter pour un tui ne contenant aucun composant mtallique, pour maintenir une sparation de 0 mm entre cet appareil et votre corps. Pour tout appareil contenant du mtal, la conformit de l'exposition aux radiofrquences n'a pas encore t teste / certifie de manire prcise.

TRB

#15: NDT1417MA AKU: ERB 24V:

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ARR Wireless Digital Flat Panel Detector Model: NDT1417MA Power: Adapter Port Input 24V==1. Battery Port Input 11.1V==2.2A Ray Technology Taicang Lid. No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Jiangsu, China www.iraygroup.com iRay Europe GmbH EC |REP| in den Dorfwiesen 14, 71720 Oberstenfeld Germany Contains FCC ID: 2ACHK-01070189 Contains IC: 25116-01070189

. Portable X-ray System ) ;

Power Input: Adapter Port Input 24V DC Battery Port Input 18V DC iRayrechnology onal iRay Imaging Technology (Haining) Limited No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China 20XX-XX-%*

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of L965 | 597 Pr 2 752 184 5 4-R3.9 290.05 129.5 105 R0.6(4 PLS) OPTIONAL Focus HD 35 Detector Focus HD 35 ABR MZ MoDEL | #5: Focus HD 35 sc | 5935 Rx only SN CMIIT ID: 2021AJ9970 DC Port Input: 18 VDC, 1.954 HMA: HRIEKI, 1.953218 Battery Port Input: 11.55 VDC,1.6A HajthiA: E11. 554K, 1. OSeHe Manufactured in China for:

EF WRH: Carestream Heath, Inc. PALSEAHBLE: 150 Verona Street, Rochester, NY, USA 14608

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() This product complies with 21 CFR chapter |, subchapter J. PIN AL9539 REVA.

Focus 43C Detector Rx only Focus 43C ARM 2 Mobet | 823: Focus 43C sc 77 SN CMIIT ID:

Adapter Port Input: 24 VDC, 0.8A BARBRA: HLZAIKHS, 0. oI Battery Port input 10.8VDC,1.78A iti: EURO. BHR, 1. 7805 Manufactured in China for:

EPG Carestream Heath pe BAEEAUNL: 160 Verona Steet Rochester NY, USA 14008 PmiAl4200 REVA

() Manufactured: Radio M/N: 01070189 Contains FCC ID: 2ACHK-01070189 Contains IC: 25116-01070189 This product complies with 21 CFR chapter 1, subchapter J PIN AJ4290 REV A TRIMAX 43C Detector Rx only TRIMAX 43C ARM ES MODEL | #2: TRIMAX 43C = [SC] 2278 SN CMIIT ID:

Adapter Port Input: 24VDC,0.8A iSBCBHHA: BPR, 0. 8zRt8 Battery Port Input: 10.8.VDC,1.78A Ab A: ABEI0. BER, 1. 78818 Manufactured in China for:

eFdelb#h- Carestream Health Inc. PMEABIBHE: 150 Verona Street, Rochester, NY, USA 14608 Ci] FRA PIN AJ4293 REVA

() Manufactured: Radio M/N: 01070189 Contains FCC ID: 2ACHK-01070189 Contains IC: 25116-01070189 This product complies with 21 CFR chapter 1, subchapter J PIN AJ4290 REV A

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Battery Port Input 11.55V 2a 6A iRay Technology Co. Lid ul Fm202, Building 7 No. $90, Ruiging RO. Zhangiang East, Pudong 201201 Shanghai, PLR. China 201-04 wor raygroup.com FE corse roc10-2acrxcororore9 SN IIL UI VUE TE IL

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( A ) PINAL9540 REVA. 105 | R 0.6 (4 PLS) Lo OPTIONAL Focus HD 43 Detector Rx only Focus HD 43 ARM mobeL | #5: Focus HD 43 SC | 5936 SN CMIIT ID: 2021AJ9791 DC Port Input: 18 VDC, 2.3. HMA: Avett, 2.3908 Battery Port Input: 11.55 VDC,1.8A ith A: Hit1. S5ikHF, 1.830 Manufactured in China for:

PEW AR: Carestream Health, Inc. EWSEABIBLE- 150 Verona Street, Rochester, NY, USA 14608

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: Mars1717VS

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Wireless Digital Flat Panel Detector Model: Mars1717VS

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Rx only CMIIT ID:

Contains FCC ID: 2ACHK-01070189 Contains IC:25116-01070189 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:(1) this device may not cause hamful interference;

(2) this deviece must accept any interference received, including interference that may cause undesired operation. 126.95 11 368.6 22.5 1.(20XX-XX) 2.;

3.SNSNBarcode Material (or approved equivalent):

Sabic 8B35+3M6615 Finishing. Treatment. A0 ITEM Release CONTENTS OF CHANGE 11 11 19 180~315 M D Y 315~800 0.2 0.3 0.5 0.8 0.6 0.6 1.2 1.1 0.8 1.5 A B TOL

RANGE 0~6 6~30 30~80 80~180 M1 M2 S2 P1 P2 C B 0.05 0.1 0.15 0.2 0.05 0.1 0.5 0.15 Description 0.1 0.2 0.15 0.25 0.1 0.15 0.15 0.25 0.2 0.3 0.2 0.4 0.15 0.3 0.25 0.45 0.4 0.8 General Tolerances to:

S1 1 2 3 3 4 0.15 0.25 0.25 0.3 0.5 v S1 0.4 0.7 C model name:

D Mars1717VS Part No. Drawn Checked Standard Process Approved Doc.No. 01186847 2019-11-11 2019-11-11 2019-11-11 2019-11-11 2019-11-11 119-321-22 Third Angle Projection E 2019-11-11 Doc.Type Mod.No Scale Rev. 1:1 A0 F file name:

Mars1717VS_ SHEET NO. OF 1 1

iRay Technology Co. Ltd. POWER OF ATTORNEY DATE:December 19, 2023 To:

Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 We, the undersigned, hereby authorize TA Technology (Shanghai) Co., Ltd./Michelle Qu on our behalf, to apply to FCC on our equipment for FCC ID: 2ACHK-01070189. Any and all acts carried out by TA Technology (Shanghai) Co., Ltd. on our behalf shall have the same effect as acts of our own. Sincerely, Print name: Wei Pan Signature:

iRay Technology Co. Ltd. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: December 19, 2023 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: 2ACHK-01070189 iRay Technology Co. Ltd.(the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Sincerely, Wei Pan Rev 1/26/2023 iRay Technology Co. Ltd. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: December 19, 2023 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID:2ACHK-01070189 iRay Technology Co. Ltd. (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, Wei Pan Rev 1/26/2023

iRay Technology Co. Ltd. RM 202, Building 7, No. 590, Ruiqing RD.,Pudong, Shanghai, China Date: May 25, 2023,Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2ACHK-01070189 US Agent Attestation Statement / Part 2.911(d)(7) iRay Technology Co. Ltd. certifies, FRN:0023535727, that as of May 25, 2023, we have designated FCC US Agent, LLC to accept service of process on our behalf for FCC ID: 2ACHK-

01070189. iRay Technology Co. Ltd., accepts to maintain an agent of service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-

related administrative or judicial proceeding involving the equipment, whichever is later. FCC US Agent, LLC, accepts as of the date of the filing of this application, the obligation of being the designated agent for the purpose of accepting service of process on behalf of iRay Technology Co. Ltd. for FCC ID: 2ACHK-01070189. Designated Agent Information:

Company Name: FCC US Agent, LLC FRN: 0033402884 Address: 3722 Illinois Avenue, Saint Charles, IL, 60174, USA Contact Person: Tim Payne Phone: 708-571-3148 Email: Support@FCCUSAgent.com Sincerely, Company: iRay Technology Co. Ltd. Designated Agent: FCC US Agent, LLC Company Representative:Wei Pan Designated Agent Representative: Tim Payne Signature:

Signature:

Date:June 21, 2023 iRay Technology Co. Ltd. Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class I] permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018.This is the twelfth C2PC. 1. The subject approved module is being used in a specific host (model: Lunal012X) 2. SAR Testing is performed to demonstrate RF Compliance 3. Software security remains unchanged form original application 4. There were no hardware changes to the module Mars1013X (Granted on 06/09/2023 ) KF FBR Lunal012X Flexible Amorphous Silicon TFT Panel

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iRay Technology Co. Ltd. Request for Confidentiality Date:

_June 26, 2023_ Subject: Confidentiality Request for:

FCC ID: 2ACHK-01070189 Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Permanent Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent*1 Permanent Permanent Permanent Permanent Permanent Permanent Permanent*

Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics NII Software Security Info Test Setup Photos Users Manual

*Note:

______(Insert Explanation as Necessary)______ ______ iRay Technology Co. Ltd. first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. _____ has spent substantial effort in developing this product and it is one of the Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of _____ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TCB in the event information regarding the product or the product is made available to the public. TCB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Sincerely, Company:

iRay Technology Co. Ltd. Print Name: Wei Pan Signature:

iRay Technology Co. Ltd. Date: May 24, 2023 Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class II permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018. The major change filed under this application is:

1. The subject approved module is being used in a specific host (model: Mars1013X) 2. SAR Testing is performed to demonstrate RF Compliance. 3. Software security remains unchanged form original application 4. There were no hardware changes to the module Sincerely yours, Name: Wei Pan Title: RA Director Company: iRay Technology Co. Ltd.

C5266091_X10_Ed.2 iRay Technology Co. Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: Request for Confidentiality FCC ID: 2ACHK-01070189 To Whom It May Concern, Pursuant to the provisions of Sections 0.457 and 0.459 of Commission's rules

(47CFR0.457, 0.459), we are requesting the Commission to withhold the following attachment(s) as confidential document from public disclosure. Date: 2022-6-9 Exhibits ID Label/Location Attestation Statement External Photos Block Diagram Schematics Test Report Test Setup Photos Users Manual Internal Photos Parts List / Tune Up RF Exposure Info Operational Description Cover Letter(s) SDR Software / Security Info Long-Term Confidentiality No No No No No NOTE 1 NOTE 1 No No Short-Term Confidentiality NOTE 2 No No No No No No NOTE 1: Long-Term Confidentiality may be permitted under special conditions (See II. LONG-TERM CONFIDENTIALITY, Section 3 of KDB 726920, use last in force) NOTE 2: Short-Term Confidentiality can be requested for a maximum of 180 days from the date of the grant. Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In case of short-term Confidentiality, the applicant requests the exhibits selected above are withheld from public view for a period of ______ days from the date of the Grant of Equipment Authorization and prior to marketing. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Sincerely, 1/1 C5266091_X10_Ed.2 Signature:

Name: Wei Pan Title: RA Director 1/1

C5266091_X8_Ed.1 Letter of Authorization iRay Technology Co. Ltd. Company: iRay Technology Co. Ltd. Address: RM 202, Building 7, No. 590, Ruiqing RD., Pudong, Shanghai, China Product Name: Portable X-ray System Model Number: Canis014D07 FCC Identifier: 2ACHK-01070189 We authorize LGAI Technological Center S.A., Ronda de la Font del Carme, s/n, 08193 Bellaterra, Spain, to act on our behalf on all matters concerning the above named equipment. Any individual within LGAI Technological Center S.A. is authorized to act on our behalf and take action on the application. We declare that authorize LGAI Technological Center S.A., Ronda de la Font del Carme, s/n, 08193 Bellaterra, Spain, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by LGAI Technological Center S.A. on our behalf shall have the same effect as acts of our own. Name: Wei Pan Title: RA Director Date: 2022-6-9 Signature of applicant:

1/1

C5266091_X9_Ed.1 iRay Technology Co. Ltd. Modular Transmitter Approval Request Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Company name: iRay Technology Co. Ltd. FCC ID:

Gentlemen, In accordance with 47CFR 15.212 Modular Transmitters and KDB 996369 D01 Module Certification Guide v02 has been examined against the following requirements. 2ACHK-01070189 2ACHK-01070189

. FCC ID Requirement per 15.212 and KDB 996369 D01 Modular Certification Guide v02 The radio elements must have the radio frequency circuitry shielded. Physical components and tuning capacitor(s) may be located external to the shield, but must be on the module assembly The module must have buffered modulation/data inputs to ensure that the device will comply with Part 15 requirements with any type of input signal The module must contain power supply regulation on the module The module must contain a permanently attached antenna, or contain a unique antenna connector, and be marketed and operated only with specific antenna(s), per Sections 15.203, 15.204(b), 15.204(c), 15.212(a), 2.929(b) The module must demonstrate compliance in a stand-alone configuration The module must be labelled with its permanently affixed FCC ID label, or use an electronic display (See KDB Publication 784748 about labelling requirements) The module must comply with all specific rules applicable to the transmitter including all the conditions provided in the integration instructions by the grantee The module must comply with RF exposure requirements Explanation from Grantee

(do not write yes/no, but explain why product complies/how it is achieved) Shielding is provided by a metal cover over the circuitry. All modulation and data inputs are buffered by circuitry on the transmitter chip. Power supply regulation is provided by circuitry on the transmitter chip. The antenna is connected to the module with the means of unique coupling. Testing was performed with the module extended inside of the host on a as shown in the test setup photos. A sample of the host label is provided as an exhibit, showing the FCC identifier of the module. The module complies fully with the operating requirements of Part 15 section C &E as demonstrated in the test report exhibit. Yes, Please see the MPE report, the modular meets MPE calculation. Date:

2022-6-9 Name:

Wei Pan Title:

RA Director Signature of applicant 1/1

iRay Technology Co. Ltd. Date: June 22, 2022 Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 The third C2PC module Grant Date: 07/02/2019 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class II permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018.The third C2PC Granted on 07/02/2019. The major change filed under this application is:

1. The subject approved module is being used in a specific host (model: Canis014D07) 2. SAR Testing is performed to demonstrate RF Compliance. 3. There were no hardware changes to the module 4. Converting the combination of two antennas to the one antenna which is controled by software, and RF performance are exactly same with original. Sincerely yours, Name: Wei Pan Title: RA Director Company: iRay Technology Co. Ltd.

iRay Technology Co. Ltd. POWER OF ATTORNEY DATE:February 25, 2022 To:

Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 We, the undersigned, hereby authorize TA Technology (Shanghai) Co., Ltd./Yun Qu on our behalf, to apply to FCC on our equipment for FCC ID: 2ACHK-01070189. Any and all acts carried out by TA Technology (Shanghai) Co., Ltd. on our behalf shall have the same effect as acts of our own. Sincerely, Print name: Wei Pan Signature:

iRay Technology Co. Ltd. Date:February 25, 2022 Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class II permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018.This is the Ninth C2PC. 1. The subject approved module is being used in a specific host (model: Mars1417VS) 2. SAR Testing is performed to demonstrate RF Compliance 3. Software security remains unchanged form original application 4. There were no hardware changes to the module Different Prototype Model Mars1417V-TSI DC input port 3PIN+4PIN variant Mars1417VS None, 8PIN is service wired port and cant charge IND Board Hall Board Others Powered by adapter and battery Powered by battery Sincerely yours, Name: Wei Pan Title: RA manager Company: iRay Technology Co. Ltd.

iRay Technology Co. Ltd. Date:September 30, 2021 Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class II permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018.This is the Tenth C2PC. 1. The subject approved module is being used in a specific host (model: Focus HD 43) 2. SAR Testing is performed to demonstrate RF Compliance 3. Software security remains unchanged form original application 4. There were no hardware changes to the module Different Prototype variant Model Mars1717X(Granted on 12/03/2020) Focus HD 43 Product name Wireless Digital Flat Panel Detector Focus HD 43 detector Brand name iRaytechnology 4PIN Carestream 10PIN DC input port Based on Mars1717X, unwanted emission and SAR have been retested for Focus HD 43 detector. Sincerely yours, Name: Wei Pan Title: RA Deputy director Company: iRay Technology Co. Ltd.

iRay Technology Co. Ltd. POWER OF ATTORNEY DATE:August 27, 2021 To:

Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 We, the undersigned, hereby authorize TA Technology (Shanghai) Co., Ltd./Yun Qu on our behalf, to apply to FCC on our equipment for FCC ID: 2ACHK-01070189. Any and all acts carried out by TA Technology (Shanghai) Co., Ltd. on our behalf shall have the same effect as acts of our own. Sincerely, Print name: Wei Pan Signature:

Date: 2020-11-27 Oe Shanghai Name: Wei Pan Function: Regulatory Affairs Department manager Signature: ...... es an Notes:

(1): Required for FCC application

(2): For FCC it must be the Grantee Code owner or the authorized agent. Declaration of Authorization Ate Name: iRay Technology Co. Ltd. Address: RM 202, Building 7, No. 590, Ruiging RD., Pudong, City: Shanghai Country: China Declare that:

Name Representative of agent: Ms. Riley Wei Agent Company name: BTL Inc. Address: No. 29, Jintang Road, Tangzhen Industry Park Pudong New Area City: Shanghai Country: China is authorized to apply for Certification and signing related documents of the following product(s), including 731 form(s):

Product description: Wireless Digital Flat Panel Detector Type designation: Luna1013XE, NDT1013LA, Luna1012X Brand: iRay Technology FCC ID: 2ACHK-01070189 on our behalf. RF_ 160, Issue 02

We, the undersigning company Company Name: iRay Technology Co. Ltd. Address: RM 202, Building 7, No. 590, Ruiging RD., Pudong, Shanghai, China Hereby confirm that the following products:

Product description: Wireless Digital Flat Panel Detector Type designation: Luna1013XE, NDT1013LA, Luna1012X That Date: 2020-11-27 Name: Wei Pan Telephone: 0086 021 50720560 E-mail: Wei.pan iraychina.com Signature: A All versions of the Model Luna1013XE and NDT1013LA, Luna1012X are electrically equal except the naming and using environments are different. Model Declaration Letter

__ Subject: Requesting Class II permissive change for FCC ID: 2ACHK-01070189 To Whom It May Concern:

The purpose of this letter is to request a Class II Permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018. There is no other hardware or electrical modification made to the applying modular transmitter itself except below:

1. The subject approved module is being used in a specific host

(Brand name/model: iRay Technology / Lunal013XE, NDT1013LA, Lunai012X) 2. SAR Testing is performed to demonstrate RF Compliance, 3. Software security remains unchanged form original application 4, Radiated emission testing was not additionally performed due to the product with FCC ID: 2ACHK-01070189 module was assessed compliant to radiated emission limits per

15.247 and 15.407 in its initial FCC approval. 5. This application is to change from modular to non-modular. Please contact me if you have any questions or need further information regarding this application. er ISereec Tae Name: Wei Pan UEC ew mL UEC DLs reunion BNET ors Date: 2020-12-14 iRay Technology Co. Ltd. Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046

Confidentiality Request regarding application for certification of FCC ID: 2ACHK-01070189 Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below Date: 2020-11-27 Federal Communications Commission Authorization and Evaluation Division The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and Renee unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Ba Grantee Contacts Signature Wei Pan iRay Technology Co. Ltd. Block Diagram Schematics Operational Description

iRay Technology Co. Ltd. Date:December 3, 2020 Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 The seven C2PC module Grant Date: 12/02/2020 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class II permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018.The seven C2PC Granted on 12/02/2020. The major change filed under this application is:

1. Please refer to the below table. 2.There were no other hardware and software changes. Prototype Mars1417X Variant Mars1717X Product name Wireless Digital Flat Panel Detector Wireless Digital Flat Panel Detector Different Model Label Dimension 460 x 384 x 15 mm 460 x 460 x 15 mm Effective Array 3500x4300 Weight with one battery 3kg 4267x4267 3.4kg Sincerely yours, Name: Wei Pan Title: RA Deputy director Company: iRay Technology Co. Ltd.

iRay Technology Co. Ltd. Request for Confidentiality Date:

_November 30, 2020_ Subject: Confidentiality Request for: _FCC ID:2ACHK-01070189 Pursuant to FCC 47 CRF 0.457(d) and 0.459 , the applicant requests that a part of the subject FCC application be held confidential. Permanent Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent*1 Permanent Permanent Permanent Permanent Permanent Permanent Permanent*

Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics NII Software Security Info Test Setup Photos Users Manual

*Note:

______(Insert Explanation as Necessary)______ ______ iRay Technology Co. Ltd. first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. _____ has spent substantial effort in developing this product and it is one of the Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of _____ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TCB in the event information regarding the product or the product is made available to the public. TCB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Company:

iRay Technology Co. Ltd. Print Name: Wei Pan Sincerely, Signature:

iRay Technology Co. Ltd. Request for Confidentiality Date:

_November 12, 2020_ Subject: Confidentiality Request for: _FCC ID:2ACHK-01070189 Pursuant to FCC 47 CRF 0.457(d) and 0.459 , the applicant requests that a part of the subject FCC application be held confidential. Permanent Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent*1 Permanent Permanent Permanent Permanent Permanent Permanent Permanent*

Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics NII Software Security Info Test Setup Photos Users Manual

*Note:

______(Insert Explanation as Necessary)______ ______ iRay Technology Co. Ltd. first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. _____ has spent substantial effort in developing this product and it is one of the Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of _____ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TCB in the event information regarding the product or the product is made available to the public. TCB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Company:

iRay Technology Co. Ltd. Print Name: Wei Pan Sincerely, Signature:

iRay Technology Co. Ltd. Date:February 19, 2020 Federal Communications Commission Authorization and Evaluation Devision 7435 Oakland Mills Road Columbia, MD 21046 Attn: OET Dept. Ref: FCC Class II Permissive change for FCC ID:2ACHK-01070189 Original module Grant Date: 09/10/2018 The six C2PC module Grant Date: 02/14/2020 Applicant: iRay Technology Co. Ltd. Dear Examiner, This is to request a Class II permissive change for FCC ID: 2ACHK-01070189, originally granted on 09/10/2018.The six C2PC Granted on 02/14/2020. 3.There were no other hardware and software changes to the host other than the below. Focus 43C Detector,TRIMAX 43C Detector Wireless Digital Flat Panel Detector The major change filed under this application is:

1. Please refer to the below table. 2.There were no hardware changes to the module Different Prototype Focus 43C,TRIMAX 43C Model Product name Brand name Carestream,TRIMAX Color Grey Variant Mars1717VS iRayTechnology White 3PIN 2PIN DC input port DC input on backside Label iRay Technology Co. Ltd. Dimension 460 x 460 x 15 mm 461x 461 x 15.7 mm Core board: Mars1717VS add hall sensor functionality, the hardware circuit changed the bit Numbers D127, D128, R670 and R669 into the package 0402 0hm resistance. Gate board: Same Read board:Same 1 Spec&model

of the Gate board read board, Core board Number of the power light Sincerely yours, 2, on both sides of detector Name: Wei Pan Title: RA manager Company: iRay Technology Co. Ltd.

iRay Technology Co. Ltd. Request for Confidentiality Date:

_February 12, 2020_ Subject: Confidentiality Request for: _FCC ID:2ACHK-01070189/ IC:25116-01070189 Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Permanent Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent*1 Permanent Permanent Permanent Permanent Permanent Permanent Permanent*

Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics NII Software Security Info Test Setup Photos Users Manual

*Note:

______(Insert Explanation as Necessary)______ ______ iRay Technology Co. Ltd. first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. _____ has spent substantial effort in developing this product and it is one of the Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of _____ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TCB in the event information regarding the product or the product is made available to the public. TCB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Company:

iRay Technology Co. Ltd. Print Name: Wei Pan Sincerely, Signature: