Yushan Series X-Ray Flat Panel Detector Operation Manual INNOLUX Corporation 1 © INNOLUX Corpora on │ X-Ray Products
Radiologist or any other practitioners licensed should ensure that they have adequate knowledge of the operation prior using the INNOLUX Yushan Y X-Ray Flat Panel Detector. This Operation Manual should be studied and understood before proceeding to operate erate the equipment on patients; it describes details deta on how to operate the INNOLUX Yushan X-Ray X Flat Panel Detector and cautions to be observed when operating it.
Table of Content Chapter 1 Introduction............................................................................................. 6 1.1 1.2 Product Introduction ............................................................................ 7 Product Series ....................................................................................... 7 1.3 1.4 1.5 Product Intended Use .......................................................................... 7 Product Significant Performance Characteristics ...
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 ....................................................................................
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 ............................
Chapter 1 Introduction This manual is intended to provide the operator with an overview of the operation and safety requirements for the INNOLUX Yushan X-Ray Ray Flat Panel Detector. This manual is not intended to provide instructions on actual treatment procedures and it is expected that users should have official radiologist or any other practitioners license prior to using the device. The Manufacturer and Distribution stribution organization assume no liability through thro the use of the device.
1.1 Product Introduction INNOLUX Yushan X-Ray Flat Panel Detector is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Each X ray photon will be converted to electronic signal by scintillator and the sensor array. Electronic signal in the pixel will be readout by driver IC and then become an image before send to PC. 1.
0.11 @ 3 lp/mm CsI DQE (Detector quantum efficiency) (Typical) GOS Maximum linear dose (Typical) 0.51 @ 0 lp/mm 0.48 @ 1 lp/mm 0.39 @ 2 lp/mm 0.29 @ 3 lp/mm 0.31 @ 0 lp/mm 0.27 @ 1 lp/mm 0.16 @ 2 lp/mm 0.09 @ 3 lp/mm 88 uGy Sensitivity (Typical) Dark noise (Typical) CsI 574 lsb/uGy GOS 592 lsb/uGy CsI 4.5 LSB GOS 7.9 LSB Lag <0.5% after 1 minute 1.
1.
1.9 Product Features - 140 micron pixel pitch - Wide image - 16-bit dynamic range output - Exposure times up to 3.0 seconds - Wireless communication mode or wired communication mode is available. When used in wireless communication mode, an access point and battery pack (optional) are required. 1.10 Clinical Guide Users may require to attend the traning courses held by INNOLUX before using.
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. Always observe precautions for safety and only operates the device in a qualified room that provides protection. 2.1 Compliance Standards and Classification 2.1.1 Compliance Standards - FDA Standards 21 CFR 1020.
2.1.2 Classification - Type of protection against electrical shock: Class I Equipment Degree of protection against a electrical shock: Type B Equipment - Degree of protection against harmful ingress of water: IPX6 (An IPX6 rating does not indicate compliance with, and the detectors have not been tested for compliance with, any other IPX_ ratings.) ratings.
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. - Do not damage or remodel the cable. Do not place a heavy object on the cable or lay it under the flat panel detector.
packs are not attached, an electric shock may result. Make sure to use the optional parts and accessories provided by innolux. Failure to use the optional parts and accessories recommended by us may result in damage to the equipment and/or electric shock and injury. Keep the equipment away from patient’s body fluids, chemicals, chemical water, etc. Otherwise, it may be damaged, causing fire or electric shock. If necessary, protect the flat panel detector by covering it with a disposable bag.
Use the equipment on a flat place. If the equipment falls, it may cause damage to the equipment or personal injury. When you move the equipment, place it in the cassette storage box of a mobile X-ray ray unit or hold it by hand to prevent it from falling. falling. If the cart is used to move the equipment, place it horizontally. For veterinary or mobile applications, contact our official dealer or INNOLUX Representative.
Caution 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 measures if necessary. The setting change may include the following: - Change of connection destination - Addition of devices Removal of devices Update of devices Upgrade of devices After connecting this system to the network with other systems, confirm that the other systems are not affected. affected.
contact our official dealer or INNOLUX Representative. Keep equipment other than those those used for patients out of their reach to ensure appropriate system isolation. In normal use, have a patient take a proper positioning for exposure. The operator should operate the system in a place where safety from radiation is ensured. The operator should should also make sure before exposure that no one but the patient is in the exposure area and the operating area of the system.
which the quality, performance and safety of the equipment cannot be assured. - Chloric disinfectant which is strongly corrosive to metals and rubber parts. Disinfectant whose uses on metals, plastics, and coating are forbidden according to the instructions supplied with the disinfectant. - Formalin gas and disinfectant sprays that may get inside the equipment. Ultraviolet sterilizers. sterilizers Disinfectant ethanol is recommended for disinfection.
To charge the battery pack, be sure to use the designated battery charger and to observe the charging conditions specified by INNOLUX Corporation. If the battery pack is charged in other conditions (temperature or voltage/current higher than an specified, remodeled battery charger, etc.), the battery pack may be overcharged ercharged or charged charg with extremely high current, and abnormal chemical reactions may occur inside the battery battery pack, causing it to overheat, emit smoke, explode or ignite.
Do not leave the removed battery pack in the car or other places exposed to high temperature. 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. 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.
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.
Wash the eyes immediately with clean water such as tap water, and consult a doctor. Otherwise, eye injury may result. Do not use the battery pack in combination with a primary battery such as a dry battery or other battery of a different capacity, type and/or brand. Otherwise, the battery ry pack may be overcharged during charging, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.
Because this equipment is not explosion-proof, explosion proof, do not use combustible and explosive gases near the equipment. Caution Do not hit or drop the equipment. Otherwise, injury or damage to images, etc. may result. Be sure to inspect the system periodically. To assure optimum performance of the equipment, it is necessary to systematically perform maintenance and inspection. For information on maintenance and inspection, contact our official dealer or INNOLUX Representative.
outside the patient environment i.e. at least 1.5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents. Any person who connects external equipment to signal inputs, signal outputs or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative.
2.16.1 Identification Label Yushan V14C Yushan V14G 2.16.
2.16.3 Battery Label 2.16.4 Packing Carton Label 2.16.
2.16.6 Safety Symbols The following safety symbols are used in the labels or on its body.
Chapter 3 System Configuration onfiguration 3.1 How to o Connect C FPD Yushan FPD can be operated either in wireless connection mode or wired connection mode. When using wired mode, back-up back up cable is necessary to provide the link from FPD to network switch hub or to PC. User can also connect back-up up cable to the adapter provided provided by INNOLUX to give the power to operate or charging its battery. If the adapter ad is not connected, FPD will be powered by its own battery.
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.
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. Cable length: 2.5m Adapter Description: Medical grade AC/DC adapter which is used to provide power either to detector or use to charge the battery installed on FPD. Input : 100-250V ~ 1.5-0.75A 50-60Hz Output : 24V ⎓ 2.
Battery (Optional) Description: Rechargable Li-Ion battery designed for Yushan FPD. - Capacity: 4212 mAh - Rating voltage: 11.
Power Cord Description: Connection between AC inlet and adapter input. EU - PLUG : 6A/250V, CONNECTOR: 10A/250V Length : 3M - PLUG : 10A/125V, CONNECTOR: 10A/125V Length : 2.5M US _____________________________________________________________ Note: 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.
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.
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.
_____________________________________________________________ Caution Do not place the connector on a hard surface such as the edge of a bed. Make sure that the connector does not protrude from the edge of a bed. Do not raise the flat panel sensor by holding only the connector connector. _____________________________________________________________ 4.1.4 Charging the Battery Pack for the Flat Panel Detector Use the battery charger recommended by INNOLUX Corporation.
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 Step Following the picture and install the battery. Push the battery pack and make sure the battery is tightly installed. 4.1.6 LED Indicator to show battery capacity By short press LED at any time, even when power is off. LED will show current remaining capacity.
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. 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.
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”. Set the SSID and pass phrase of AP to be connected to the product.
4.2.3 AP mode connection Users can set AP mode parameters through the software interface. Choose wireless in configuration interface. Choose the “AP”.
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.
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. Wait Status LED stop flashing 3. Wait Link LED light in green 4. Wait Status LED light in green (ready for exposure) 4.3.2 Overview of User Interface - Discover: The area is used to list all FPD those are discovered and reachable.
- Message: The area is used to display important message to users. - Diagnosis: The area lists several diagnostic messages of FPD that is currently connected. - Image List: The area lists the images created by exposure operations. 4.3.3 Search and connect FPD Click 1 to discover all reachable FPDs Expand the selected entry of the list, and select connection by Ethernet or Wifi. Then click 2 to connect the specified FPD.
4.3.3.1 Wireless connection Expand the selected entry of the list, and select connection by Ethernet. Then click 2 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. The message appears to indicate a successful connection. After connection is established, you can use 3 to disconnect the FPD.
4.3.4 .4 Enter the operation and select the mode Enter operation mode / Exit operation mode: The FPD must enter operation mode before take exposure or dark image. After FPD enters operations mode, user can perform several exposure mode.
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. User can use Stop to exit AED one shot mode before X-Ray exposure is detected.
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. 4.3.5.3 AED repeat mode - After selecting the AED repeat mode, press Start. - When FPD is in AED repeat mode, it stays in AED repeat mode after each X-Ray exposure is detected.
The steps of downloading exposure images are a. Exit the AED repeat mode b. Use the Get Image List to update the Image List (Optional) c.
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.
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. Archive after continuous image taking If the automatic download function is not checked, the image will be stored in the DDR SDRAM.
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. The LSB average of the light image is obtained. It needs to fall within the range of 15,000 to 20,000. According to the above image, the offset map (D) and the gain map (G) are calculated.
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 “ Noise ”: The “mode” represents the level of noise. The “ ()” represents the number of pixels.
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.
4.4.3 Storage of calibration data 10 sets of calibration data can be stored inside Yushan. Users can update or get calibration data for the product. After selecting the class of the map, click “File to send”. Click on the file to be updated to the inside of the product. Click “Set” and complete the update. _____________________________________________________________ Caution These actions are carried out by Authorized Personnels not End Users.
Chapter 5 Daily Inspection and Maintenance 5.1 .1 Daily User Inspection and Maintenance During maintenance and inspection, strictly observe precautions contained in “Chapter Chapter 2 Safety and Regulatory” Regulatory” in this manual for you to use the device under best conditions. 5.1.1 .1.
Chapter 6 Troubleshooting - In case of smoke, fire, abnormal high temperature, remove battery and power supply and turn off detector imediately. - In case of yellow error LED on, it may trigger the impact. Please read the manual to release the status and restart the power; if the yellow light cannot be removed, contact INNOLUX service engineer or local representative - In case of abnormal image, calibrate detector by standard method.
Appendix A Specifications of FPD 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 Min Input Voltage Range Typ. Max unit 80 264 VAC Nominal Input Frequency 50 60 hz Input Frequency 47 63 hz Range Output voltage 24 Output current VDC 2.
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) 16 W Power (Stand-by) 10 W Battery voltage 11.
means that, except if mentioned explicitly, any perturbation occurring within those conditions are reversible and not existing anymore when the detector is turned back within the performance operating conditions. Item Min Temperature 5°C Humidity 15% Pressure 700mBar Typ.
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.
DQE @ 3 lp / mm 0.04 0.09 0.14 Sensitivity @2uGy 503 592 681 LSB/uGy 7.9 10 LSB 75 88 101 uGy 100 120 140 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 Antenna 2 Date rate 866Mbps (802.11ac) Authentication WPA/WPA2-PSK AP mode Work only in 2.
A.2 External View and Weight Item Width Length (mm) Height (mm) Weight (Kg) Yushan V14C 460 383 15 2.7 Yushan V14G 460 383 15 2.
Appendix B Electromagnetic Compatibility (EMC) B.1 Yushan FPD This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2014/EN 60601 60601-1-2:2015. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
B.2 Further Information for IEC 60601-1-2 (EN 60601-1-2) 1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. 2. Portable and mobile RF communications equipment can affect medical electrical equipment. 3. Information regarding the cable affecting EMC is as follows.
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.
with a minimum distance of 0 cm between the radiator and your body.
