InnoLux Yushan Series, Operation Manual

Page 1: ...1 INNOLUX Corpora on X Ray Products Yushan Series X Ray Flat Panel Detector Operation Manual INNOLUX Corporation ...

Page 2: ... on how to operate the INNOLUX Yushan X Ray Flat Panel Detector and cautions to be observed After reading this manual store it nearby the INNOLUX Yushan X so that you can see it whenever necessary ral Law restricts this device to sale by or on the order of a radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device ...

Page 3: ...ompliance Standards and Classification 11 2 1 1 Compliance Standards 11 2 1 2 Classification 12 2 2 Contraindications 12 2 3 Power Supply Hazard 12 2 4 Electric Shock Hazard 12 2 5 Abnormalities Hazard 14 2 6 Installation Precautions 14 2 7 Connection Instructions 15 2 8 External Network Connection 15 2 9 System Isolation Instructions 16 2 10 Software Precautions 17 2 11 Disinfection Instructions ...

Page 4: ...36 4 2 Detector Connection 37 4 2 1 Wire connection 37 4 2 2 Wireless connection 38 4 2 3 AP mode connection 39 4 3 Starting Up and Shutting Down the Yushan FPD 41 4 3 1 Starting Up the Yushan 41 4 3 2 Overview of User Interface 41 4 3 3 Search and connect FPD 42 4 3 4 Enter the operation and select the mode 44 4 3 5 Performing an Exposure and Image Acquistion 45 4 3 6 Download image from FPD 48 4...

Page 5: ... 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 62 B 2 Further Information for IEC 60601 1 2 EN 60601 1 2 63 Appendix C Radio Frequency RF Compliance Information 64 ...

Page 6: ...tallation may only be conducted by authorized service Some maintenance and service work also must be carried out by authorized service agents and only those procedures outlined in the operator and service manual are allowed Any service work carried out by unauthorized person will void all warranties No circuit diagrams or component part lists are be provided for this device If you require technica...

Page 7: ...rsion 14 x 17 FPD with GOS 1 3 Product Intended Use The Wireless Wired INNOLUX Yushan X Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film screen or CR systems may be used The INNOLUX Yushan X Ray Flat Panel Detector i...

Page 8: ...SB GOS 7 9 LSB Lag 0 5 after 1 minute 1 5 Product Intended Patient Population Considerations Requirement Description Age Not restricted Height Not restricted Weight The uniform load of the device is 300kg The local load on 4 cm diameter of the device is 120kg Note Please evaluate the patient s condition before using Health Not restricted Nationality Multiple Sex Not restricted 1 6 Product Intended...

Page 9: ...ysician or legally certified operator Maximum No maximum _____________________________________________________________ Note Patient should not operate the device by its own in case result in malfunction of the equipment _____________________________________________________________ 1 8 Product Intended conditions of use Considerations Condition Environment including hygienic requirements Non steril...

Page 10: ...ld by INNOLUX before using A complete training should consist of the following elements All safety precautions for practitioners and patients when using the device A review of published clinical literature should be conducted to understand the indications and effects of the X Ray Flat Panel Detector _____________________________________________________________ Note It is strongly recommended for I...

Page 11: ... 1 Compliance Standards FDA Standards 21 CFR 1020 31 for ionizing radiation emitting products FDA Standards 21 CFR 892 1680 for stationary x ray system European Medical Devices Directive 93 42 EEC EN ISO 13485 2016 EN ISO 14971 2012 EN 60601 1 2006 A1 2013 A12 2014 ANSI AAMI ES60601 1 2005 R 2012 and A1 2012 C1 2009 R 2012 and A2 2010 R 2012 CAN CSA C22 2 No 60601 1 14 EN 60601 1 2 2015 IEC 62304 ...

Page 12: ...ompliance with any other IPX_ ratings Degree of safety of application in the presence of a flammable anesthetics mixture with air or with oxygen or nitrous oxide Equipment not suitable for e in the presence of a flammable anesthetics mixture with air or with oxygen or nitrous oxide 2 2 Contraindications No contraindications present 2 3 Power Supply Hazard __________________________________________...

Page 13: ...or malfunction of the equipment Do not use the equipment in a location where metal particles could come into the equipment This may cause an electric shock Do not disassemble or remodel the equipment Otherwise fire or electric shock may result Keep away from the parts inside the product which may cause electric shock If you touch them accidentally death or severe injury may result Do not hit or dr...

Page 14: ...ect the flat panel detector by covering it with a disposable bag _____________________________________________________________ 2 5 Abnormalities Hazard _____________________________________________________________ If any of the following occurs immediately turn off the power of each unit unplug the power cable from the outlet and then contact our official dealer or INNOLUX Representative hen smoke...

Page 15: ... devices are used outdoors in wireless communication mode contact aler or INNOLUX Representative Do not place any object in a place where removal of the power cable is To ensure optimal image quality it is recommended that you do not use the flat near devices motor transformer switching supply etc that generate electromagnetic noise To ensure optimal image quality it is recommended that you do not...

Page 16: ...tems confirm that the other systems are not affected If they are affected take countermeasures such as network separation Make sure to use the optional parts accessories and networks recommended by us Failure to use the optional parts accessories and networks recommended by us may result in damage to the equipment and or electric Connect to the Ethernet Network of 100BASE TX or 10BASE T prescribed...

Page 17: ...Precautions _____________________________________________________________ Do not install additional software to the system Do not uninstall any of the preinstalled in the system The system is preinstalled with the appropriate software If other software is installed or if the existing software is uninstalled various operational errors may result Source Software Contained in This Product This produc...

Page 18: ... the disinfectant before use For details on the disinfectant contact a INNOLUX dealer or th representatives at the agency from which you purchased the disinfectant is not disinfected it may lead secondary infection Be sure to disinfect with ethanol after use detector with ethanol for disinfection etc for each patient _____________________________________________________________ Charging the Batter...

Page 19: ...causing it to overheat emit smoke explode or ignite Immediately stop charging the battery pack if charging is not completed within time Otherwise the battery pack may overheat emit smoke Do not use the flat panel detector near the power cable Do not use a faulty or broken battery charger or AC adapter _____________________________________________________________ Battery Pack Instructions _________...

Page 20: ... battery pack directly There is a risk of electric shock Do not connect the positive and negative terminals with a wire or any metal object Do not carry or store the battery pack together with metal objects such as necklaces or hairpins Otherwise the battery pack may short circuit and overcurrent may flow causing the battery pack to overheat emit smoke explode or ignite Metal objects such as neckl...

Page 21: ...a result abnormal chemical reactions may occur inside the battery pack or extremely high current may flow during discharging causing it to overheat emit smoke explode or ignite The battery pack has a predetermined polarity If you cannot connect the battery pack to the battery charger or other equipment do not connect the battery pack forcefully Make sure that the terminals are correctly oriented I...

Page 22: ...ignite Do not put the battery pack in a microwave oven or high pressure container battery pack may be rapidly heated or damaged causing it to overheat emit smoke explode or ignite If the battery pack leaks or emits an unusual odor remove it from fire Otherwise the leaked electrolyte may catch fire causing the y pack to overheat emit smoke explode or ignite If you notice an unusual odor heat discol...

Page 23: ...enance In addition this equipment should not be used by persons other than doctors or suitably trained staff Be careful not to expose the flat panel detector to X ray without a subject Although the flat panel detector conforms to IPX6 no warranty is given as to the prevention of water intrusion in the flat panel detector If the flat panel is splashed with water wipe off moisture and ensure that th...

Page 24: ... requirements If in doubt contact qualified medical technician or your local representative _____________________________________________________________ 2 15 Disposal of Waste It is illegal to place the device in the trash Please contact the qualified local recycling provides before disposing the device The disposal procedure should comply with local law 2 16 Product Labels The information of eac...

Page 25: ...25 INNOLUX Corpora on X Ray Products 2 16 1 Identification Label Yushan V14C Yushan V14G 2 16 2 Battery Polarity Label ...

Page 26: ...26 INNOLUX Corpora on X Ray Products 2 16 3 Battery Label 2 16 4 Packing Carton Label 2 16 5 Adapter Specification Label ...

Page 27: ...27 INNOLUX Corpora on X Ray Products 2 16 6 Safety Symbols The following safety symbols are used in the labels or on its body ...

Page 28: ...mode When using wired mode back up cable is necessary to provide the link from FPD to network switch hub or to PC User can also up cable to the adapter provided by INNOLUX to give the power to operate or charging its battery If the adapter is not connected FPD will be powered by its own battery _____________________________________________________________ up cable connector of Yushan when in wirel...

Page 29: ...29 INNOLUX Corpora on X Ray Products 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 ...

Page 30: ... 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 5A Length 1 5M ...

Page 31: ...1 INNOLUX Corpora on X Ray Products 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 ...

Page 32: ...____________________________________________ 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 Do not use parts or accessories which are not certified by INNOLUX Corporation or not approved by CE or FDA ___________________________________________...

Page 33: ...33 INNOLUX Corpora on X Ray Products 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 ...

Page 34: ...l 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 ...

Page 35: ...tery charger recommended by INNOLUX Corporation to the instruction manual for the battery charger Installing Removing the Battery Pack for the Flat Follow the procedure below to install remove the battery pack for the flat panel When installing removing the battery pack place the flat panel Do not remove the battery pack until a processed image appears in the window of the image processing unit af...

Page 36: ...stall the battery pack Step Following the picture and install the battery Step 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 If the main battery is not exist it will show the second battery capacity by flashing light ...

Page 37: ...y 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 After connection established open Cmd exe and enter ping 192 168 11 100 then press enter to check the network If success ther...

Page 38: ...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 ...

Page 39: ...39 INNOLUX Corpora on X Ray Products 4 2 3 AP mode connection Users can set AP mode parameters through the software interface Choose wireless in configuration interface Choose the AP ...

Page 40: ...he 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 ...

Page 41: ... 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 Operations The tool bar contains different exposure mode ...

Page 42: ...lists several diagnostic messages of FPD that is currently connected Image List The area lists the images created by exposure operations Search and connect FPD 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 Note Please make sure the IP of Host PC and the selected connection is in the same local area netwo...

Page 43: ...se 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 Note Connecting to other FPD disconnect the currently connected FPD automatically ...

Page 44: ... several exposure mode INNOLUX Corpora on X Ray Products 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 After FPD enters operations mode user can perform several exposure mode 44 4 Enter the operation and select the mode or dark image After FPD enters operations mode user can perform several exposure...

Page 45: ...PD 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 If the X Ray exposure is successfully detected by FPD the newly created image is listed in the Image List area This utility application will try to download the image to local storage and the file name is the image key If the wo...

Page 46: ... 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 User can use Stop to exit AED repeat mode The utility doesn t not download the exposure image after each exposure it only updates the information...

Page 47: ... Image List Optional c Select the image and click Download Raw button INNOLUX Corpora on X Ray Products The steps of downloading exposure images are AED repeat mode Use the Get Image List to update the Image List Optional Select the image and click Download Raw button 47 Use the Get Image List to update the Image List Optional ...

Page 48: ...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 Image ready ...

Page 49: ...y 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 First press 3 to list all the information of the image and then press the arrow of 1 to output the original image to the PC In addition if there is an image with offset set at the beginning of the exposure press the 2 arrow to output the offset image ...

Page 50: ...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 And use the following algorithm to correct for raw images C corrected image R raw image F flat field image D dark field or dark frame...

Page 51: ...ages 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 ...

Page 52: ...on X Ray Products 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 ...

Page 53: ...ata 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 complete the update _____________________________________________________________ These actions are carried out by Authorized Personnels not End Users __________________________...

Page 54: ... you to use the 1 1 Periodical Inspection End User emove any dirt or dust accumulated in each part of the equipment using a vacuum cleaner or air duster clean each part with a slightly moistened soft cloth and then wipe off any moisture See 3 2 Unit Names and the Functions Authorized Personnel There are no parts components that needed to be replaced by Innolux or any ______________________________...

Page 55: ...ntact INNOLUX service engineer or local representative if error is not removed by calibration Other technical issue contact INNOLUX service engineer or local representative When Yushan cannot be turned on please check if the battery has power or if the DC power supply is connected When the software shows that the network can t connect please confirm the signal of Yushan first If it is wireless net...

Page 56: ...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 Typ Max unit Input Voltage Range 80 264 VAC Nominal Input Frequency 50 60 hz Input Frequency Range 47 63 hz Output voltage 24 VDC Output current 2 5 A Input connector AC inlet Standard IEC 62320 C14 Output connector type DC JACK ...

Page 57: ...rs Battery operating time in Operating mode 4 hours Charging time by cable 4 hours A 1 5 Environmental Conditions A 1 5 1 Storage and Transport Item Min Max Temperature 10 C 50 C Humidity1 10 90 Pressure2 700mBar 1060mBar Battery storage temperature 3 10 C 50 C note1 Non condensing note2 700mBar is equivalant to 3000m in altitude note3 Less than 1 month at 50 C A 1 5 2 Functional Operating Within ...

Page 58: ...roducts means that except if mentioned explicitly any perturbation occurring within conditions are reversible and not existing anymore when the detector is turned back within the performance operating conditions Min Typ 5 C 25 C 35 15 80 700mBar 1013mBar 1060mBar 300 kg Weight local load on 4 cm 120 kg 200 Hz 3 2 g Drop height the reversibility not guaranteed for this item 70 cm 3 Performance Oper...

Page 59: ...e the flat panel detector near devices motor transformer switching supply etc that generate electromagnetic noise V14C CsI Version Performance at RQA5 Item Min Typ Max unit MTF 1 lp mm 0 62 0 69 0 76 MTF 2 lp mm 0 35 0 39 0 43 MTF 3 lp mm 0 18 0 22 0 26 DQE 0 lp mm 0 45 0 51 0 56 DQE 1 lp mm 0 43 0 48 0 53 DQE 2 lp mm 0 35 0 39 0 44 DQE 3 lp mm 0 23 0 29 0 35 Sensitivity 2uGy 488 574 660 LSB uGy D...

Page 60: ... Europe ETSI Transmit frequencies available vary depending on the country Radio waves available outdoors vary depending on the country where the system is used When the Yushan and any other wireless equipment are operating on the same frequency channel in a hospital it may take time to show an image on the image processing unit monitor This equipment uses wireless LAN WLAN radios for transferring ...

Page 61: ...61 INNOLUX Corpora on X Ray Products 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 7 ...

Page 62: ...ions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular If this equipment does cause harmful interference to other devices which can be determined by tuning 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 re...

Page 63: ...utlet Use a hospital grade power cord 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 5 The Yushan should not be used adjacent to or stacked with other equipment If adjacent or stacked ...

Page 64: ...use 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 th...

Page 65: ...65 INNOLUX Corpora on X Ray Products with a minimum distance of 0 cm between the radiator and your body ...