Summary of Contents for InnoLux Yushan Series
- Page 1 Yushan Series X-Ray Flat Panel Detector Operation Manual INNOLUX Corporation -R y P ducts...
- Page 2 INNOLUX Yushan X the INNOLUX Yushan X-Ray Flat Panel Detector and cautions to be observed and cautions to be observed when operating it.
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Page 3: Table Of Contents
Table of Content Chapter 1 Introduction ..................... 6 Product Introduction ................7 Product Series ..................7 Product Intended Use ................7 Product Significant Performance Characteristics ....... 7 Product Intended Patient Population ..........8 Product Intended Part of the body or type of tissue applied to or interacted with .................... - Page 4 2.16.6 Safety Symbols ................27 3.1 How to Connect FPD ................28 3.2 Unit Names and the Functions ............. 29 3.2.1 Flat Panel Detector ............... 29 3.2.2 Accessories ..................30 3.3 LED indicators ................... 33 Chapter 4 Basic Operation ................... 34 4.1 Preparing the Flat Panel Detector ............
- Page 5 A.1.3 Power Supply to Battery Charger ..........57 A.1.4 Power Consumption and Battery Specification ....57 A.1.5 Environmental Conditions ............57 A.1.6 Image Performance ..............59 A.1.7 Radio Waves .................. 60 A.1.8 Reliability and Lifetime ............... 60 Appendix B Electromagnetic Compatibility (EMC) ........62 B.1 Yushan FPD ....................
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Page 6: Chapter 1 Introduction
This manual is intended to provide the operator with an overview of the operation and safety requirements for the operation and safety requirements for the INNOLUX Yushan X-Ray Flat Panel Ray Flat Panel Detector. This manual is not intended to provide instructions on actual Detector. -
Page 7: Product Introduction
The INNOLUX Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. INNOLUX Yushan series provide either raw X ray image or corrected image for system integrator to do further image process. 1.4 Product Significant Performance... -
Page 8: Product Intended Patient Population
0.11 @ 3 lp/mm 0.51 @ 0 lp/mm 0.48 @ 1 lp/mm 0.39 @ 2 lp/mm 0.29 @ 3 lp/mm DQE (Detector quantum efficiency) (Typical) 0.31 @ 0 lp/mm 0.27 @ 1 lp/mm 0.16 @ 2 lp/mm 0.09 @ 3 lp/mm Maximum linear dose (Typical) 88 uGy 574 lsb/uGy... -
Page 9: Product Intended User Profile
1.7 Product Intended user profile Considerations Requirement Description Minimum Graduate of radiology college Education Maximum No maximum Read and understand 'westernized Arabic' numerals when written in Arial Minimum font Knowledge Can distinguish of human body Understands hygiene Maximum No maximum Minimum Local language Language... -
Page 10: Product Features
(optional) are required. 1.10 Clinical Guide Users may require to attend the traning courses held by INNOLUX before using. A complete training should consist of the following elements: All safety precautions for practitioners and patients when using the device. -
Page 11: Chapter 2 Safety And Regulatory
Chapter 2 Safety and Regulatory This INNOLUX Yushan X-Ray Flat Panel Detector has been designed and tested to function in a safe and correct when used as indicated in this manual. Do not use this device before reading and completely understand this Operation Manual. -
Page 12: Classification
2.1.2 Classification Classification Type of protection against electrical shock: Class I Equipment Type of protection against electrical shock: Class I Equipment Type of protection against electrical shock: Class I Equipment Degree of protection a Degree of protection against electrical shock: Type B Equipment Equipment Degree of protection against harmful ingress of water: IPX6 Degree of protection against harmful ingress of water: IPX6... - Page 13 Observe the following precautions when using the cables: Do not touch the plug and connector with wet hands. Otherwise, electric shock may result causing death or severe injury. Hold the plug or connector when removing the cable. Pulling the cable or carrying by holding it may damage the cable, causing fire or electric shock.
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Page 14: Abnormalities Hazard
Make sure to use the optional parts and accessories the optional parts and accessories provided by innolux. provided by innolux. Failure to use the optional parts and accessories recommended by us may... -
Page 15: Connection Instructions
For veterinary or mobile applications, contact our official dealer or INNOLUX For veterinary or mobile applications, contact our official dealer or INNOLUX For veterinary or mobile applications, contact our official dealer or INNOLUX Representative. -
Page 16: System Isolation Instructions
Caution When a setting of the network to which the equipment is connected has been When a setting of the network to which the equipment is connected has been When a setting of the network to which the equipment is connected has been changed, check that the change does not affect the system operation and take check that the change does not affect the system operation and take check that the change does not affect the system operation and take... -
Page 17: Software Precautions
If you would like to receive such source codes, please contact INNOLUX If you would like to receive such source codes, please contact INNOLUX If you would like to receive such source codes, please contact INNOLUX... -
Page 18: Charging The Battery Pack
For details on the disinfectant, contact a INNOLUX dealer or th For details on the disinfectant, contact a INNOLUX dealer or th For details on the disinfectant, contact a INNOLUX dealer or the service representatives at the agency from which you purchased the disinfectant. -
Page 19: Battery Pack Instructions
To charge the battery pack, be sure to use the designated battery charger and battery charger and to observe the charging conditions specified by INNOLUX Corporation. If the charging conditions specified by INNOLUX Corporation. If the charging conditions specified by INNOLUX Corporation. If the... - Page 20 Use or store the battery pack only in the environmental conditions specified by INNOLUX. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid.
- Page 21 pack may overheat, emit smoke, explode or ignite. Do not pierce the battery pack with a nail, hit it with a hammer, or step on it. Otherwise, the battery pack may be damaged or deformed and short-circuit, causing it to overheat, emit smoke, explode or ignite. Do not subject the battery pack to strong impact or throw it.
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Page 22: Other Precautions
Wash the eyes immediately with Wash the eyes immediately with clean water such as tap water, and consult a clean water such as tap water, and consult a doctor. Otherwise, eye injury may result. doctor. Otherwise, eye injury may result. Do not use the battery pack in combination with a primary battery such as a dry Do not use the battery pack in combination with a primary battery such as a dry Do not use the battery pack in combination with a primary battery such as a dry... - Page 23 For information on systematically perform maintenance and inspection. For information on maintenance and inspection, contact our official dealer or INNOLUX maintenance and inspection, contact our official dealer or INNOLUX maintenance and inspection, contact our official dealer or INNOLUX Representative.
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Page 24: Disposal Of Waste
2.16 Product Labels The information of each label can be found in this section and the corresponding location are also presented as the following figure. The following labels are adhered to the INNOLUX Yushan X-Ray Flat Panel Detector. -R y P ducts... -
Page 25: Identification Label
2.16.1 Identification Label Yushan V14C Yushan V14G 2.16.2 Battery Polarity Label -R y P ducts... -
Page 26: Battery Label
2.16.3 Battery Label 2.16.4 Packing Carton Label 2.16.5 Adapter Specification Label -R y P ducts... -
Page 27: Safety Symbols
2.16.6 Safety Symbols The following safety symbols are used in the labels or on its body. -R y P ducts... -
Page 28: How To Connect Fpd
FPD to network switch hub or to PC. User can also User can also connect back-up cable to the adapter provid up cable to the adapter provided by INNOLUX to give the power ed by INNOLUX to give the power to operate or charging its battery. If the ad to operate or charging its battery. -
Page 29: Unit Names And The Functions
3.2 Unit Names and the Functions 3.2.1 Flat Panel Detector Unit names and the functions of the Yushan FPD are described below. -R y P ducts... -
Page 30: Accessories
3.2.2 Accessories Back-up cable Description: A cable which one side connects the flat panel detector and the other side spilt into two cable, one is RJ45 connector to connect with ethernet port, and the other side is DC Jack 5.5x2.5 to connect with the output of AC/DC adapter. - Page 31 Battery (Optional) Description: Rechargable Li-Ion battery designed for Yushan FPD. Capacity: 4212 mAh Rating voltage: 11.4V, TYP:4212mAh/48Wh Weight: ~260g UL certified Safety -R y P ducts...
- Page 32 Every accessory can’t be sale or used as an independent product, which is not compatible with other devices. Therefore, every provided accessory is identified to have not received prior 510(k) clearance. Do not use parts or accessories which are not certified by INNOLUX Corporation or not approved by CE or FDA. _____________________________________________________________...
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Page 33: Led Indicators
3.3 LED indicators 4 LED indicator are on the side of Yushan series FPD. The behavior and the relations to the FPD status are described in the table below. -R y P ducts... -
Page 34: Chapter 4 Basic Operation
Chapter 4 Basic Operation 4.1 Preparing the Flat Panel Detector This section describes how to prepare the flat panel detector. 4.1.1 Type of Flat Panel Detector Yushan V14C, Yushan V14G 4.1.2 Number of the Connectable Flat Panel Detector Up to 5 panels can connect to system at the same time. 4.1.3 Connecting/Disconnecting the Flat Panel Detector -R y P ducts... -
Page 35: Charging The Battery Pack For The Flat Panel Detector
Use the battery charger recommended by INNOLUX Corporation. Use the battery charger recommended by INNOLUX Corporation. Use the battery charger recommended by INNOLUX Corporation. For details on operations, refer to the instruction manual for the battery charger. to the instruction manual for the battery charger. -
Page 36: Led Indicator To Show Battery Capacity
Remove the battery pack Step Slide the arrow switch toward right side and hold it. Step Pick up the edge of battery by finger, then lift it. Install the battery pack Step Following the picture and install the battery. Step Push the battery pack and make sure the battery is tightly installed. -
Page 37: Detector Connection
4.2 Detector Connection Yushan detector can be connected to system either by wireless or by wire cable.Yushan FPD use Dynamic Host Configuration Protocol (DHCP) to assign IP address automatically. 4.2.1 Wire connection The default address of Yushan is 192.168.11.100. User need to set the computer to the same domain as Yushan. -
Page 38: Wireless Connection
4.2.2 Wireless connection SDK command is used to setup SSID and password of wireless access point. This setup to FPD need to be done first before wireless connection. Users can set client mode parameters through the software interface. Choose wireless in configuration interface. Choose the “Client”. -
Page 39: Ap Mode Connection
4.2.3 AP mode connection Users can set AP mode parameters through the software interface. Choose wireless in configuration interface. Choose the “AP”. -R y P ducts... - Page 40 Set the SSID and pass phrase of product. User needs to set the computer to the same domain as Yushan (Wifi). First, open the IPV4 of computer's local network management interface, and change the IP address to 192.168.11.1 and subnet mask to 255.255. 255.0. -R y P ducts...
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Page 41: Starting Up And Shutting Down The Yushan Fpd
4.3 Starting Up and Shutting Down the Yushan FPD This section explains how to start up and shut down the Yushan. 4.3.1 Starting Up the Yushan Press the power button for more than 2 second to start the FPD. 1. Make sure that the power LED light in green. 2. -
Page 42: Search And Connect Fpd
Message: The area is Message: The area is used to display important message to users. used to display important message to users. Diagnosis: The area lists several diagnostic messages of FPD that is Diagnosis: The area lists several diagnostic messages of FPD that is Diagnosis: The area lists several diagnostic messages of FPD that is currently connected. - Page 43 4.3.3.1 Wireless connection Expand the selected entry of the list, and select connection by Ethernet. Then click to connect the specified FPD. Note: Please make sure the host PC is connected to the specified AP. After establishing the connection, you can check the diagnosis field on the right to confirm the information of Yushan products.
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Page 44: Enter The Operation And Select The Mode
4.3.4 Enter the operation and select the mode .4 Enter the operation and select the mode .4 Enter the operation and select the mode Enter operation mode / Exit operation mode: Enter operation mode / Exit operation mode: The FPD must enter operation mode before take The FPD must enter operation mode before take exposure or dark or dark image. -
Page 45: Performing An Exposure And Image Acquistion
4.3.5 Performing an Exposure and Image Acquistion When performing an exposure, make sure that the STATUS LED light in green and not flashing. Otherwise image may loss. 4.3.5.1 AED one shot mode After selecting the AED one shot mode, press Start. When FPD is in AED one shot mode, it returns to operation mode after each X-Ray exposure is detected. - Page 46 4.3.5.2 Software sync mode (Emulation of two-stage exposure button) This group only serves as emulation of two-stage exposure button, and verifies the API functionality. After selecting the Software sync mode, press Start. When performing an exposure, make sure that the STATUS LED light in green and not flashing.
- Page 47 The steps of downloading exposure images are The steps of downloading exposure images are a. Exit the AED repeat AED repeat mode b. Use the Get Image List to update the Image List (Optional) Use the Get Image List to update the Image List (Optional) Use the Get Image List to update the Image List (Optional) c.
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Page 48: Download Image From Fpd
4.3.5.4 Other Operations Discharge: Discharge panel. Acquisition: Discharge panel and acquire image immediately. Reset operation mode: If errors occur in the exposure workflow, user must use this button to reset. 4.3.6 Download image from FPD Auto download The software has an automatic download function, as long as the automatic download is checked, the image can be automatically downloaded in modes other than AED repeat mode. -
Page 49: Shutting Down The Yushan
The image data is first stored in the DDR SDRAM and then transferred to the PC. When the status of image has been show “ready”, it means the images is already stored in the DDR SDRAM. Image download OK When the status of image has been show “OK”, it means the images is already stored in the PC. -
Page 50: Correction Procedure
4.4 Correction procedure 4.4.1 Collect images When the program is executed, the corrected images are collected in sequence. First, 16 dark images were collected, then the X-ray energy was set to 20 uGy and the X ray window and offset window were both set to 200 ms and collected 16 times. -
Page 51: Correction Process
4.4.2 Correction process First get 16 dark images and 16 light images, sort and store the images in the same folder, and create another folder named "calib".And store the image to be corrected in the same folder and fill in the name of the folder. Click “... - Page 52 Click “Gen Map”: Will output the map to be calculated Click “Correction” The Detector has been successfully corrected if a “correction of all raw images is complete” appears in the windows as seen in the figure. -R y P ducts...
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Page 53: Storage Of Calibration Data
4.4.3 Storage of calibration data 4.4.3 Storage of calibration data 10 sets of calibration data can be stored inside Yushan. Users can update or calibration data can be stored inside Yushan. Users can update or calibration data can be stored inside Yushan. Users can update or get calibration data for the product. -
Page 54: Daily User Inspection And Maintenance
Authorized Personnel Authorized Personnel There are no parts/components that needed to be replaced by Innolux or any There are no parts/components that needed to be replaced by Innolux or any There are no parts/components that needed to be replaced by Innolux or any authorized personnel. -
Page 55: Chapter 6 Troubleshooting
INNOLUX service engineer or local representative In case of abnormal image, calibrate detector by standard method. Contact INNOLUX service engineer or local representative if error is not removed by calibration. Other technical issue, contact INNOLUX service engineer or local representative. -
Page 56: Appendix A Specifications Of Fpd
Appendix A Specifications of A.1 Specifications Specifications of the Yushan are shown below. A.1.1 Reduced Equivalent Peak reduced equivalent on the front panel of the flat panel detector: 0.57 mmAl A.1.2 Power Supply Conditions when Using Back-up Cable The DC power supply to Yushan FPD is delivered with its AC/DC adapter. Item Typ. -
Page 57: Power Supply To Battery Charger
A.1.3 Power Supply to Battery Charger A 2-slot battery charger is provided along with the Yushan V14C/V14G. The battery charger is delivered with its AC/DC adapter which is the same as A.1.2. A.1.4 Power Consumption and Battery Specification Item Specification (typical) Unit Power (Operating) Power (Stand-by) - Page 58 means that, except if mentioned explicitly, any perturbation occurring within means that, except if mentioned explicitly, any perturbation occurring within means that, except if mentioned explicitly, any perturbation occurring within those conditions are reversible and not existing anymore when the detector is conditions are reversible and not existing anymore when the detector is conditions are reversible and not existing anymore when the detector is turned back within the performance operating conditions.
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Page 59: Image Performance
When the flat panel detector is used in high temperature condition for long period of time, it may cause image artifacts and/or failure of the device. _____________________________________________________________ A.1.6 Image Performance Each flat panel detector complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES) as a general X-ray radiography equipment. -
Page 60: Radio Waves
DQE @ 3 lp / mm 0.04 0.09 0.14 Sensitivity @2uGy LSB/uGy Dark noise Maximun linear dose Maximun clipping dose A.1.7 Radio Waves Wireless specifications for the flat panel detector and the access point are as follows. Item Specification Wireless specification IEEE802.11 ac / a/g/n Transmit frequency 5.2, 5.3, 5.6, 2.4 GHz... - Page 61 A.2 External View and Weight Item Width Length (mm) Height (mm) Weight (Kg) Yushan V14C Yushan V14G -R y P ducts...
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Page 62: Appendix B Electromagnetic Compatibility (Emc)
INNOLUX equipment and consult the manufacturer, our official dealer or INNOLUX equipment and consult the manufacturer, our official dealer or INNOLUX Representative for help. -
Page 63: Further Information For Iec 60601-1-2 (En 60601-1-2)
4. The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by INNOLUX Corporation as replacement parts for internal components, may result in increased emissions or decreased immunity of the Yushan. -
Page 64: Appendix C Radio Frequency (Rf) Compliance Information
Appendix C Radio Frequency (RF) Compliance Information Federal Communications Commission (FCC) Statement You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 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. - Page 65 with a minimum distance of 0 cm between the radiator and your body. -R y P ducts...
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