Digital Flat Panel Detector Mars1717XF User Manual Before operating, please read this user manual and pay attention to all safety precautions. Please ensure that the user manual is properly maintained so that it can be accessed at any time. Please use correctly on the basis of full understanding of the content. iRay Technology Co. Ltd.
To Customers About FCC This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device must not cause harmful interference; (2) This device must accept any interference received, including interference that may cause undesired operation. Attention must be paid to the fact that changes or modifications not expressly approved by the party responsible for compliance can void the user’s authority to operate the equipment.
To Customers maintenance personnel. 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 dealer. 5. Use dedicated cables. Do not use cables other than those supplied with the product. 6. Do not open the cover of the product without approval. 7. Request your sales representative or local dealer to install this product.
To Customers All rights reserved No part of this publication may be reproduced in any form or by any means without the written permission of manufacturer. The information included is designed only for use with product. Trademarks The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd. Symbols and Conventions The following symbols and conventions are used throughout the user guide.
To Customers Caution: please refer to instructions in the user manual. This symbol is used to indicate that equipment has passed CE testing, and it is followed by a CE number. This symbol is used to identify the manufacturing series number which is after, below or adjacent to the symbol.
To Customers FPD is allowed to withstand 100kg on its surface This symbol is used to indicate operation temperature range. This symbol is used to indicate storage temperature range. Non-ionizing radiation FCC Federal Communications Commission certificate Package symbol: fragile. Package symbol: keep away from sunlight. Package symbol: keep dry. Package symbol: this symbol is used to indicate humidity range. Package symbol: keep equipment upright. Package symbol: do not roll package.
To Customers Detector symbol: the device passes IPX4 test Rx Only iRay Technology Co. Ltd. Device is for prescription use only.
Contents 1 2 Safety Information ...................................................................................................................... 11 1.1 Safety Precautions 11 1.2 Notes for Use 15 General Description .................................................................................................................... 17 2.1 Scope 17 2.2 Lineup 17 2.3 Characteristics 18 2.4 Intended Use 18 2.5 Product Components 18 2.6 Components Description 20 2.7 3 Detector .
Contents 4.4 4.5 4.6 Correction Template Generation 38 4.4.1 Pre-offset Template Generation ........................................... 38 4.4.2 Gain Template Generation................................................... 40 4.4.3 Defect Template Generation ................................................ 43 Image Check and Upload 45 4.5.1 Local Image Check.............................................................. 45 4.5.2 Panel Image Upload ................................................
Contents 4.10.7 Warning ............................................................................... 71 4.10.8 Changes to IT Network Include: ......................................... 72 5 Charger Installation ..................................................................................................................... 73 6 Regulatory Information ............................................................................................................... 74 6.
Safety Information 1 Safety Information 1.1 Safety Precautions Follow these safety guides and properly use the device to prevent injury and damage. WARNING Installation and environment of use Do not use or store the device near flammable chemicals such as alcohol, thinner, benzene, etc. If chemical is spilled or evaporates, it may result in fire or electric shock through contact with electric parts inside the device. Also, some disinfectants are flammable. Be sure to take care when using them.
Safety Information Securely plug power cord into AC outlet. If contact failure occurs or metal objects contact with exposed metal prongs of the plug, this may result in fire or electric shock. Be sure to turn off power to each piece of the device before connecting or disconnecting cords. Otherwise, you may get electric shock that could result in death or serious injury. Be sure to hold plug or connector to disconnect cord.
Safety Information 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 fire. For safety reasons, be sure to turn off the power to each piece of the device when performing inspections indicated in this manual. Otherwise, an electric shock may occur. CAUTION Installation and environment of use Do not install the device in any of the locations listed below.
Safety Information CAUTION Handling Handle carefully. Do not submerge the device in water. The internal image sensor may be damaged if something hits it or is dropped. If it is dropped, the shock label inside will turn red and the device will not be warranted by Manufacturer. Do not place excessive weight on the device.
Safety Information Keep the same load (the same pressure) on the detector when acquiring an image, or the image will be incorrect.
Safety Information Sudden heating of the room in cold areas will cause condensation to form on the device. In this case, wait until condensation evaporates before performing an exposure. If it is used while 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 slowly so that a difference in temperature in the room and the device does not occur, to prevent condensation.
General Description 2 General Description The product is a cassette-size wireless X-ray flat panel detector based on amorphous silicon thinfilm transistor technologies. It is developed to provide the highest quality of radiographic images, and contains an active matrix of 2832×2836 with 150um pixel pitch. The detector’s scintillator has two options: GOS (Gadolinium Sulfoxylate) and CsI (Caesium Iodide). However, the greatest improvement is wireless communication between the detectors and PC.
General Description 2.3 Characteristics Wireless static Flat Panel Detector used for general radiography. 17 × 17 inch AED trigger Easy-to-change cable and charge in tray. Battery rechargeable IPX4 2.4 Intended Use Wireless Digital Flat Panel Detector is intended for digital imaging solutions and designed to provide general radiographic diagnosis of the human anatomy. It is intended to replace radiographic CR and DR systems in all general-purpose diagnostic procedures.
General Description Mars1717XF Detector Mars1717XF GSI/CSI Medical adapter for detector and battery charger 24V (DC) power adapter 7.6V battery pack Battery pack Gigabit ethernet cable Ethernet cable for wireless router AC power cable AC cable for adapter iRay Technology Co. Ltd.
General Description Battery charger Battery charger User Manual Paper print User Manual CD-ROM Service tool Note: The product package may be different based on requirements. 2.6 Components Description 2.6.1 Detector External Signals Input and Control Panel Control Panel iRay Technology Co. Ltd.
General Description NO. Item Description A DC Input Interface 24V DC input B Reserved Reserved C Status Indicator Detector Status indicator D Reserved Reserved E Link Indicator Detector Link indicator F Power Indicator Detector Power indicator G Power Button Power button 2.6.2 Battery Pack C D E B A NO. Item iRay Technology Co. Ltd.
General Description A Battery Label / B Battery Interface 7-pin battery connector C Guide Block / D Latch Attach the battery lock to the detector E Touch Display Show battery level after touching 2.6.3 Battery Charger A B C Item Item Description A Battery Slot 3 batteries inserted B Capacity Indicator The indicator definition is as below C DC Jack 24V DC input The battery charging capacity indicator definition: Indicator iRay Technology Co. Ltd.
General Description OFF No battery insert Green blinking Battery insert with capacity ≤95%, charging Green ON Battery insert with capacity >95% Orange blinking Battery slot malfunction 2.7 Product Specifications 2.7.1 Detector Item Specification Model Mars1717XF-GSI (GOS) Mars1717XF-CSI (CsI) Pixel Size 150 μm Effective Array 2832 x 2836 (Note) Effective Area (H x V) 424.8mm x 425.4mm Greyscales 16 bit Image Transfer Wireless: IEEE802.11a/b/g/n Wireless Frequency Range 2.412~2.
General Description 14dBm (Typ.) @802.11g 13dBm (Typ.) @802.11n HT20 11dBm (Typ.) @802.11n HT40 16dBm@2.4GHz 13dBm@5.8GHz Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK) 11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM) Wireless Band 2.4GHz≤40MHz 5.19GHz≤40MHz 5.8GHz≤40MHz Note: The Mars1717XF-GSI’s active area and defect calculation area is 2832 x 2836; the TFT module size is 2848 x 2840.
General Description The Mars1717XF-CSI defect calculation area is 2826 x 2818, the active area is 2832 x 2836 and the TFT module size is 2848 x 2840 iRay Technology Co. Ltd.
General Description 2.7.2 Battery Item Specifications Model Battery-KX Rated Capacity Min. 3500mAh, Typ.3800mAh @ Discharge 0.5C Rated Voltage 7.6V 2.7.3 Battery Charger Item Specifications Model Charger-KX iRay Technology Co. Ltd.
General Description Simultaneous Charging 3 battery packs Full Charging Time 2.5 hours 2.7.4 Environment Operating Temperature Temperature Variation Humidity Atmospheric Pressure Atmospheric Pressure Variation 5~30℃ <1k/min 10%~80% RH 700~1060hPa <10kp/min 10%~90% RH 700~1060hPa Storage (without battery) -20~50℃ <1k/min (1kp=1.0197E-5Pa) <10kp/min (1kp=1.0197E-5Pa) Detectors should operate at altitudes of not more than 3,000m; the requirement is only for the detector.
Operation 3 Preparation 3.1 Detector Installation 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.
Operation 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. When the detector is powered on, the user presses the button for 4 seconds to shut down the detector. On the other hand, it can also be used as a reset internal control IC when the button is activated for 8 seconds. After booting up, users can check the indicator of the detector.
Operation Blue ON Green ON Wired connection broken and wireless connection not ready Wireless connection is enabled Wired connection is enabled (Service Mode) Blue blinking Green blinking Detector Initialization Wireless configuration reset Wireless configuration reset Mode indicator: Mode Indicator Lighting Status Blue ON Description Default OFF Detector is turned off Status indicator: Status Indicator Lighting Status OFF Green ON Detector is turned off Exposure p
Operation Green blinking Wireless configuration reset 3.1.3 Adapter The detector supports an externally powered It gets CB certificate No. SG PSB-MD-00005 and NRTL certificate No. U8V 093768 0016. Port defined as bellowing: No. Definition Voltage Range Rated Current P1 DC Power Negative 0~0.5V 0~0.42A P2 DC Power Positive 23~25V 0~0.42A P3 DC Power Positive 23~25V 0~0.42A P4 DC Power Negative 0~0.5V 0~0.
Operation synchronization with the X-ray generator, i.e., Software Mode and AED Mode. 4.1.1 Software Mode 4.1.1.1 Block Diagram Software mode builds the first X-ray image acquisition step. Please see the figure below for general features. Software mode is configured by selecting “prep” in Trigger mode and “prepcapmode_acq2” in Prep capmode. The workstation hosts the PC device installed with FDR SE Console or iDetector. Chapter 3.
Operation 4.1.1.3 Timing Setting To get a clear view of the workflow, see the diagram below for details Process Clear Detector Workstation Xray Generator Exposure Prohibited 2 Exposure 3 1 5 Acquisition 10 4 Anode Rotate 6 11 9 Exposure Enable 7 X ray shooting 8 12 Exposure Prohibited 1. Workstation receives “Acquire” request, send command “Clear” to detector. 2. Detector receives “clear” from workstation and begins flushing panel.
Operation 4.1.2 AED Mode 4.1.2.1 Block Diagram Please see the figure below for general features. AED mode is configured by selecting “inner” in Trigger mode and “cycleacq” in inner trigger subflow. The workstation hosts the PC device installed with FDR SE Console or iDetector. Chapter 3.3 describes how to establish the connection between detectors and the workstation. In AED mode, the workstation does not control the X-ray generator; the user decides when to take the X-ray. 4.1.2.
Operation Process Clear Detector Workstation Xray Generator Exposure Prohibited 2 Exposure 3 1 5 Acquisition 9 10 4 Anode Rotate 6 11 7 Exposure Enable X ray shooting 8 12 Exposure Prohibited 1. Workstation receives “Acquire” request and sends “Clear” to detectors. 2. Detector receives “clear” from workstation and begins flushing panel. Meanwhile, replies to workstation “Exposure Prohibited”. 3. Detector finishes “Clear” and sends message “Exposure Enable”. 4.
Operation 4.1.2.4 Abnormal Action If users do not want to take an X-ray, it is possible to cancel the exposure window manually. 4.1.2.5 Exposure Window The exposure window can be configured with: 0.7s, 1.2s, 2.2s, 3.2s, 4.2s. 4.2 Connection Build Open iDetector and click “Connect” based on product name Notes: 1. Users must re-connect the detector with a different IP address when changing the connection from a different net card. 2.
Operation “Acquire” module: Choose offset mode, load gain and defect template Acquire images: “Prepacq”, “Acquire” and so on “SDK” module: IP address, MAC address and so on “Detector” module: Trigger module, wireless configuration and so on iRay Technology Co. Ltd.
Operation “Calibrate” module: Template generation and management. “Local File” module: Read raw or dcm image 4.4 Correction Template Generation Manufacturer recommends users correction template generation after installation, any major change on system settings or hardware configuration. On the other hand, it is also recommended to do template generation every 6 months. 4.4.1 Pre-offset Template Generation The pre-offset template is necessary for preview image. See below iRay Technology Co. Ltd.
Operation Go to “Acquire” module, choose “HWPostOffset” Go to “Calibrate” module, click “Start Generate Templates” Click “UpdateHWPreOffset”, wait until image acquisition ends iRay Technology Co. Ltd.
Operation 4.4.2 Gain Template Generation Before gain template generation, make sure SID=1.2m; no copper is required, Go to “Acquire” module, choose “HWPostoffset” Go to “Calibrate” module, click “Start Generate Templates” iRay Technology Co. Ltd.
Operation Click “ Create Gain” Click “Start” Set X-ray dose to meet the expected value. Click “PREP”, wait for exposure bar to count down. Before window ends, take X-ray. iRay Technology Co. Ltd.
Operation There will be a prompt in the region of the current value if the dosage is incorrect. (Note 1) Change dosage and exposure again until image is accepted. Click “Accept” if box is green, Click “PREP” to start another X-ray take. Gain calibration template needs 5 Xray images. After 5 images acquired, click “Generate”, wait until “Task succeed:FinishGenerationProcess” Note: 1. X-ray image has three states: green, yellow and red. Green means image meets requirements. iRay Technology Co. Ltd.
Operation Yellow means image does not meet requirements, but can generate template. Red means image does not meet requirements, cannot generate template, must be taken again. 4.4.3 Defect Template Generation Before defect template generation, make sure SID=1.2m, no copper is required, Click” Create Defect” Click “Start”, Defect template needs 8 X-ray images. iRay Technology Co. Ltd.
Operation Set X-ray dose according to expected value. Click “prep”, wait for exposure bar to count down. Before window ends, take X-ray. There will be a prompt in the box if the dosage is improper. (Note 1) Change dosage and exposure again until image is accepted. Click “Accept” if box is green, Click “PREP” to start another X-ray take. iRay Technology Co. Ltd.
Operation Calibration template needs 8 X-ray images. After images acquire, click “Generate”, wait until “Task succeed:FinishGenerationProcess” . Note: 1. X-ray image has three states: green, yellow and red. Green means image meets requirements. Yellow means image does not meet requirements, but template can be generated. Red means image does not meet requirements, template cannot be generated, must take another shot. 4.
Operation Click “Local File” to open dicom, Raw and tif file Click “Open” 4.5.2 / Panel Image Upload Double-check firewall is closed Panel Image is uploaded as below. iRay Technology Co. Ltd.
Operation Choose “Detector” -> “Images” Click “Query Images”, image info listed below Click “Upload Images” Input the index number of images Click “OK” Waiting for status from "Busy" into "Ready" Check upload images Click "Stop Uploading" to stop image upload Images uploaded is stored in "work_dir \ Mars1717XF_Client \ upload \serial number" iRay Technology Co. Ltd.
Operation 4.5.3 Defect Template Check and Modification iDetector provides function checking defect template. If the defect template has updates, the user can add and delete defect pixels or lines. 4.5.3.1 Defect Template Check Select “Local File” module Click “Local File” Choose template type “*.dft”, open it 4.5.3.2 Defect Template Modification Open defect template iRay Technology Co. Ltd.
Operation If there are new defect pixels, type in coordinates, click "Add". If defect templates have dummy lines, type in coordinates, click "Delete". If there are new defect lines, type in starting and ending coordinates, click "Add". If defect templates have dummy lines, type in coordinates, click "Delete". Click "Save" to save modified defect template. 4.6 Correction Template Management 4.6.
Operation Make sure the firewall is turned off Choose “Calibrate”, Click “Start Generate Templates” Click “Read Status” besides “Subset settings” iRay Technology Co. Ltd.
Operation Click the template to be downloaded Click “Download to FPD” Check whether information is right. Change Index in FPD if necessary. Click “Download”. Wait until “Task succeed: Download CaliFile” iRay Technology Co. Ltd.
Operation Click “Read Status” to read template Choose template number according to requirements Click “Active” to activate template Upload templates Make sure firewall is turned off iRay Technology Co. Ltd.
Operation Choose “Calibrate”, Click “Start Generate template” Click “Read status” besides FPD template file. Click template which needs to be uploaded. Click subset settings Click “upload to Workdir”. If information listed is right, click “OK”. Wait until “Upload FPD file succeed!” iRay Technology Co. Ltd.
Operation Check template uploaded in “work_dir\Mars1717XF_192.168.100.8\ Correct\Default” 4.6.2 Correction Activation The detector supports two ways to do corrections. Software correction defines a scenario in which the workstation(FDR SE Console or iDetector) finishes a correction. If the detector does itself, that is hardware correction and calibration. 4.6.2.1 Software Correction Make sure templates are saved in “work_dir\Mars1717XF_192.168.100.8\ Correct\Default” Choose “Acquire” iRay Technology C
Operation Offset mode “SWPostOffset”, Gain mode “SWGain”, Defect mode “SWDefect” 4.6.2.2 Hardware Correction Click “Read Status” to read template iRay Technology Co. Ltd.
Operation Choose template number according to requirements Click “Active” to activate template Offset mode “HWPostOffset” / Gain mode “HWGain” Defect mode “HWDefect” 4.7 Firmware Update The detector supports firmware updating with the website; if the user needs to update firmware, please follow the steps below Preparation before updating Go to page “Detector” iRay Technology Co. Ltd.
Operation Change Trigger mode to “TriggerMode_Prep” Change Prep Capmode to “PrepCapMode_Acq2” Click “Write” Firmware updating Open IE browser. Input 192.168.100.8 User name: admin Password: iray Click button in red box Choose “upgrade” iRay Technology Co. Ltd.
Operation Click “browse” on the right Choose” Mars1717XF_IMAGE_41_ALL_XXXX _XX_XX.ifrm” Click “upgrade” Click “close” when “upload image success” pops up Wait until upgrade is done. Note: 1. Please insert the battery (more than 25%) in the detector, in case power is down when upgrading. On the other hand, the detector should reboot after updating. 4.8 Short cut iDetector supports some shortcuts as follows: Double-click left mouse: image displayed in center with maximum size.
Operation 4.9 Software 4.9.1 Main GUI Double-click iDetector, main interface is shown on the screen. See the table below for a detailed function description. Item Home Acquire SDK Function description Connect detector, check connection status Image acquisition, correction mode, image storage and processing Config.ini setting and Log level setting Detector Detector configuration, synchronization methods, etc.
Operation Product Type State Product type Three states: Bind, Unknown, Ready Button Connect Build connection with specific detector Close Disconnect with specific detector Add Add additional working directory Remove 4.9.3 Function description Delete working directory Acquire Page This page works mainly for image acquisition. In the “operation” box, the user chooses the image correction method according to requirements. “image properties” shows simple information of the image acquired.
Operation State Detector status, such as Busy or Ready Task What detector is doing Message Feedback of detector action, such as succeeded or failed Image operation and property of SDK is shown below Correction Menu Function description SWPreOffset Reserved HWPreOffset Reserved SWPostOffset DR Software does post offset correction HWPostOffset Detector does post offset correction Offset SWGain DR Software does gain correction HWGain Detector does gain correction Gain SWDefect DR Softwa
Operation Height FPS Image height Frame rate Frames Frame number Rotate Rotate image 90 degrees in clockwise direction Reverse Mirror ROI Image List Rotate image 90 degrees in counterclockwise direction Mirror image horizontally Statistic of image such as AVG and SV Latest 5 images Image preview shortcut is stated below： • Double left click: image displayed in center with maximum size. • Double right click: window level and width adjusted to WL: 32767/WW: 65535.
Operation A B D 4.9.4 C A B D C SDK Page The page is used to configure config.ini and set log level in real time, as shown below iRay Technology Co. Ltd.
Operation 4.9.5 Detector Page 4.9.5.1 Parameters Parameter tab is activated in default. Five boxes on the page are defined as follows: Zone 1: parameters Zone 2: parameters reading from detector Zone 3: parameters written into detector Zone 4: function button Zone 5: simple message from detector and state iRay Technology Co. Ltd.
Operation Configuration parameter items ParmName Description Modifiable Main Version Detector FPGA version NO Read Version Detector Read version NO Product No Product number NO SN Serial number NO Trigger Mode Static X-ray synchronization mode YES Fluro Sync Dynamic X-ray synchronization mode YES Set Delay Time Delay time for “prepacq” YES Acquire Delay Reserved YES Integrate Time Reserved YES Tube Ready Reserved YES Function button description Function Button Description
Operation Read Read configuration Write Write configuration Upgrade Firmware Reserved 4.9.5.2 Sensor This page includes temperature and humidity information. Sensor Description Modifiable Temperature Read temperature in detector NO Humidity Read humidity in detector NO 4.9.5.3 Wireless configuration Mode should be checked with client. iRay Technology Co. Ltd.
Operation Parameters Description Client Add Add default SSID in wifi list Del Delete specified SSID in wifi list Up Move up Down Move down Select Set specified SSID as default one which means it will be loaded automatically after powering up SSID Key List 10 optional SSID names Others Read Config Read wireless configuration from detector Write Config Write wireless configuration to detector Read WiFi Status Check wireless link status in detector Scan from FPD Scan SSID in air with FPD
Operation 4.9.5.4 Images Parameters Description Query images Query image list in detector Upload images Upload specific images in detector Stop upload Index Filename Stop uploading accidently Item No. which is roll counting Image No. which is defined and saved in detector Create time Time image is saved Delay time Acquisition delay time Image attr Image type Note: 1. If “HWPostoffset” is chosen, the image saved in the detector will be the corrected one.
Operation 4.9.6 Calibrate Page This page works for template management and generation. Function Button Start to Generate Templates 4.9.7 Description Start template generation and template management Local File Page This page works for local image check. iRay Technology Co. Ltd.
Operation Function Button Rotate Reverse Mirror ROI Description Rotate image 90 degrees in a clockwise direction Rotate image 90 degrees in a counterclockwise direction Mirror image horizontally Region of interest image statistic such as AVG and SV Right press mouse, draw a box 4.10 IT-network 4.10.1 Purpose for IT-network Transmission between the detector and the workstation(FDR SE Console or iDetector) is image data and command/status communication. 4.10.
Operation 16dBm@2.4GHz 13dBm@5.8GHz Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK) 11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM) Wireless Band 2.4GHz≤40MHz 5.19GHz≤40MHz 5.8GHz≤40MHz 4.10.5 Intended information flow The detector sends image data acquired to the workstation (FDR SE Console or iDetector). The workstation(FDR SE Console or iDetector) sends users’ commands to the detector. 4.10.
Operation 4.10.8 Changes to IT Network Include: changes in IT network configuration; connection of additional items to IT network; disconnecting items from IT network; update of equipment connected to IT network. iRay Technology Co. Ltd.
Charger Installation 5 Charger Installation Insert battery into battery charger Note: Insert direction as in figure Make sure the battery is inserted to the bottom of the opening Unload battery from charger after charging completes. iRay Technology Co. Ltd.
Regulatory Information 6 Regulatory Information Product safety regulatory information includes safety of the detector, charger and other accessories. 6.1 Manufacturer’s Information COMPANY: iRay Technology Co., Ltd ADDRESS: Rm. 202, Building 7, No. 590, Ruiqing Rd., Zhangjiang East, Pudong, Shanghai, China ZIP CODE: 201201 TELEPHONE: +86-21-50720560 European Representative COMPANY: iRay Europe GmbH ADDRESS: In den Dorfwiesen 14, 71720 Oberstenfeld Germany www.irayeurope.
Regulatory Information Mode of operation 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) Note 1.
Regulatory Information Medical electrical equipment –Part 1: General requirements for basic safety and essential performance KS C IEC 60601-1 Medical electrical equipment– Part 1: General requirements for basic safety and essential performance JIS T0601-1:2012 SS-EN 60601-1:2006+A11:2011+A1:2013+AC1:2014+A12:2014 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-2-54:2009+A1:2015 Medical electrical equipment –Part 2-54: Particular requir
Regulatory Information performance — Collateral standard: Usability EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– Collateral standard: Electromagnetic disturbances– Requirements and tests IEC 62133:2012 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 EN 62220-1:2004 M
Regulatory Information Class A Voltage fluctuations and flicker 6.3.2 IEC 61000-3-3 Professional healthcare facility environment Compliance EMS Compliance Table Enclosure Port Phenomenon Basic EMC standard Immunity test levels Professional healthcare facility environment Electrostatic IEC 61000-4-2 ±8 kV contact Discharge ±2kV, ±4kV, ±8kV, ±15kV air Radiated RF EM field IEC 61000-4-3 3V/m 80MHz-2.
Regulatory Information 1720 1700-1990 Pulse modulation 217Hz, 28V/m 2450 2400-2570 Pulse modulation 217Hz, 28V/m 5240 5100-5800 Pulse modulation 217Hz, 9V/m 1845 1970 5500 5785 Input a.c. power port Phenomenon Basic EMC standard Electrical fast transients/burst IEC 61000-4-4 Surges Line-to-line Surges Line-to-ground Conducted disturbances induced by RF fields Immunity test levels Professional healthcare facility environment ±2 kV 100kHz repetition frequency IEC 61000-4-5 ±0.
Regulatory Information Cable provided for EMC Recommended Cable Shield/Unshielded Number Cable classification length AC power cable 1.8m Unshielded 1 piece AC power DC power cable 3m Unshielded 1 piece DC power Electromagnetic Compatibility (EMC) The Mars1717XF series wireless flat panel detector needs special precautions regarding EMC, and should be installed by authorized personnel and follow EMC guidance in the user manual.
Regulatory Information EN 300 328 V 2.1.1; EN 301 893 V 2.1.1 EN 62311:2008 EN 62209-2:2010 EN 50566:2017 EN 62476:2010 EN 55032:2015 EN 61000-3-2:2014 EN 61000-3-3:2013 6.5 Battery Safety Standards Standards Description UL1642 Component recognition on secondary Li-ion cells UL 2054:2004 R9.11 Household and commercial batteries IEC 62133:2012 Secondary cells and batteries containing alkaline or other nonacid electrolytes UN38.
Regulatory Information Mars1717XF CSI Detector Label Battery Charger Label iRay Technology Co. Ltd.
Regulatory Information Battery Label iRay Technology Co. Ltd.
Regulatory Information iRay Technology Co. Ltd.
Trouble shooting 7 Troubleshooting Please refer to the service manual. If the problem remains unsolved, turn off the detector and contact the Fujifilm service department. We will provide the best service possible. iRay Technology Co. Ltd.
Product Maintenance 8 Product Maintenance 8.1 Expected Service Life Estimated product lifetime is 7 years with regular inspection and maintenance. 8.2 Regular Inspection and Maintenance The detector needs regular inspection at least once a year not only for the safety of patients, the operator and third parties, but also for performance and reliability. If necessary, contact Fujifilm service office or local dealer for regular inspection or maintenance.
Appendix iRay Technology Co. Ltd.
