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6. Regulatory Information

6.1.

Medical Equipment Safety Standards



Medical equipment classification

Protection type against electrical

shock

Class I equipment, using medically approved

adaptor supply

Internally powered equipment, using battery

power supply

Protection degree against electrical

shock

B Type

Protection degree against water

penetration

IP56 (Detector)
IP20 (Charger-Combo)

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)



Safety standards reference

Wireless detector safety standards cover the detector, charger, battery pack and other accessories.

IEC 60601-1:2005/AMD1:2012

Medical electrical equipment -- Part 1: General

requirements for basic safety and essential
performance

IEC 60601-1-2:2014/EN60601-1-2:2015

Medical electrical equipment – Part 1-2:

General requirements for basic safety and essential
performance – Collateral standard: Electromagnetic
disturbances – Requirements and tests

IEC 60601-2-54:2015/EN 60601-2-54:2015

Medical electrical equipment -- Part 2-54:

Particular requirements for the basic safety and
essential performance of X ray equipment for
radiography and radioscopy

IEC 62133-2:2017

Secondary cells and batteries containing alkaline

or other non-acid electrolytes - Safety requirements
for portable sealed secondary lithium cells, and for
batteries made from them, for use in portable
applications - Part 2: Lithium systems

ANSI/AAMI ES60601-

1:2005/(R)2012+A1:2012+C1:2009/(R)2012+A2:20
10/(R)2012

Medical electrical equipment - Part 1: General

requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)

CAN/CSA-C22.2No.60601-1:14

Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance

6.2.

Guidance and Manufacture’s Declaration for EMC

6.2.1.

EMI Compliance Table



Emissions

Phenomenon

Compliance

Electromagnetic environment

RF emissions

CISPR 11

Professional healthcare facility environment

User Manual of Mars1417X 69

Содержание Mars1417X

Страница 1: ...ase Date 2020 10 13 Before operating please read this user manual and pay attention to all safety precautions Please ensure that this user manual is properly maintained so that it can be accessed at any time reserve Please use it correctly based on full understanding of the content E ...

Страница 2: ......

Страница 3: ...ent of the equipment 1 Read all of the instructions in the user guide before your operation Give particular attention to all safety precautions 2 Only a physician or a legally certified operator should use this product 3 The equipment should be maintained in a safe and operable condition by maintenance personnel 4 Use only computers and image display monitors complying with IEC 60601 1 or IEC 6095...

Страница 4: ...or any damage loss or injury incurred by purchaser or third parties as a result of fire earthquake any accident misuse or abuse of this product 2 iRay shall not be liable to any damage loss or injury arising from unauthorized modifications repairs or alterations to this product or failure to strictly comply with iRay s operating and maintenance instructions 3 iRay shall not be liable for any damag...

Страница 5: ...be reproduced in any form or by any means without the written permission of iRay The information contained herein is designed only for use with iRay Mars1417X Trademarks The iRay name and iRay logo are registered trademarks of iRay Technology Co Ltd User Manual of Mars1417X 3 ...

Страница 6: ...Wireless Digital Flat Panel Detector Mars1417X Symbols and Conventions 4 User Manual of Mars1417X ...

Страница 7: ...ry Identify conditions under which improper use of the product may cause minor personal injury Identify conditions under which improper use of the product may cause property damage Indicate a prohibited operation Indicate an action that must be performed Indicate important operations and restrictions Indicate operations for reference and complementary information User Manual of Mars1417X 5 ...

Страница 8: ...E testing and the CE Notified Body number follows it Serial number of the product Name and address of the manufacturer Manufacturing date of this product Expiring date of this product This symbol is used to indicate non ionized electromagnetic radiation Name and address of iRay authorized representative in the European region Consultation of the user guide for general information This product is n...

Страница 9: ...limit Central area Handled with care Operational temperature limits Storage temperature limits Fragile Keep away from sunlight Keep dry Humidity limits Keep the equipment up right Do not roll the transportation package Stacking limit number IP56 IP56 for the detector User Manual of Mars1417X 7 ...

Страница 10: ...Wireless Digital Flat Panel Detector Mars1417X Detector symbol device is for prescription use only 8 User Manual of Mars1417X ...

Страница 11: ...US SITUATIONS resulting from a failure of the IT NETWORK 60 5 OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION 61 5 1 Steps for acquiring image 62 5 2 Software Mode 62 5 3 AED Mode 64 5 4 After use 65 5 5 Firmware Upgrade 65 6 REGULATORY INFORMATION 68 6 1 Medical Equipment Safety Standards 69 6 2 Guidance and Manufacture s Declaration for EMC 69 6 3 Radio Frequency Compliance Information 72 6 4 Batte...

Страница 12: ...Wireless Digital Wireless Digital Flat Panel Detector Mars1417X 1 Safety Information 1 1 Safety Precautions 11 1 2 Notes for Using 20 10 User Manual of Mars1417X ...

Страница 13: ...hol thinner benzene etc If chemicals are spilled or evaporate it may result in fire or electric shock through contact with electric parts inside the equipment Also some disinfectants are flammable Be sure to take care when using them Do not connect the equipment with anything other than specified Doing so may result in fire or electric shock All the patients with active implantable medical devices...

Страница 14: ... being damaged and do not alter them neither Doing so may damage the cords which could result in fire or electric shock Do not supply power to more than one piece of equipment using the same AC outlet Doing so may result in fire or electric shock Do not turn ON the system power when condensation has formed on the equipment Doing so may result in fire or electric shock Power supply Do not connect a...

Страница 15: ...ric shock may result Be sure to turn OFF the power to each piece of equipment before connecting or disconnecting the cords Otherwise you may get an electric shock that could result in death or serious injury Be sure to hold the plug or connector to disconnect the cord If you pull the cord the core wire may be damaged resulting in fire or electric shock WARNING User Manual of Mars1417X 13 ...

Страница 16: ... drop the equipment The equipment may be damaged if it receives a strong jolt which may result in fire or electric shock if the equipment is used without being repaired Do not put the equipment and pointed objects together The equipment may be damaged If so the equipment should be used in bucky Have the patient take a fixed posture and do not let the patient touch parts unnecessarily If the patien...

Страница 17: ...urning ON Otherwise it may result in fire or electric shock Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug its periphery and AC outlet with a dry cloth If the cord is kept plugged in for a long time in a dusty humid or sooty place dust around the plug will attract moisture this could cause insulation failure that may result...

Страница 18: ...an air conditioner or ventilation equipment Close to heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where temperature or humidity is high Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area Take care that cables do not become tangled during use Also be careful not to ge...

Страница 19: ...not use any power source other than the one provided with this equipment Otherwise fire or electric shock may be caused due to leakage Handling Do not spill liquid or chemicals onto the equipment In case the patient is injured it is not allowed to contact with blood or other body fluids Doing so may result in fire or electric shock In such a situation protect the equipment with a disposable cover ...

Страница 20: ...injury to the user or patient or may flip over resulting in damage to the inner device Keep the same load same pressure on the detector when acquiring the image Or the image will be incorrect Do not place excessive weight on the panel Otherwise the internal image sensor may be damaged and image may be incorrect Patients stand on the product temporarily and the intended weight can be 150kg Based on...

Страница 21: ...1 Safety Information CAUTION Do not close to fire do not use in high temperature Do not invert positive and negative pole Do not contact with metal in case of short circuit User Manual of Mars1417X 19 ...

Страница 22: ... is formed problems may occur in the quality of captured images When an air conditioner is used be sure to raise lower the temperature gradually to prevent condensation The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map Make sure wave form of the energy going to the X ray tube is square not pulse Be cautious with circumstance that someone has rad...

Страница 23: ...t a specialist Do not spray the product directly with disinfectants or detergents Wipe it with a cloth slightly damped with a neutral detergent Do not use solvents such as alcohol benzene and acid Doing so may damage the surface of the product It s recommended to use a waterproof non woven cover as the isolated layer between product and the blooding patient User Manual of Mars1417X 21 ...

Страница 24: ...Panel Detector Mars1417X 2 General Description 2 1 Product Description 23 2 2 Principle 23 2 3 Scope 23 2 4 Characteristics 24 2 5 Intended Use 24 2 6 Environment 29 2 7 Product Components 29 2 8 Specification 31 22 User Manual of Mars1417X ...

Страница 25: ...tiple trigger modes it can satisfy both of the general DR system and retrofit DR system 11 Rows 15 Rows 12 Columns 30 Columns 2 2 Principle Detectors contain a layer of scintillator material which converts the x rays into light Directly behind the scintillator layer is an amorphous silicon pixel array contains a photodiode which generates an electrical signal in proportion to the light produced by...

Страница 26: ...X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients It is intended to replace film screen systems in all general purpose diagnostic procedures The device is not intended for mammography or dental applications Suitable patient It is suitable for providing digital X ray imaging for DR system to ...

Страница 27: ...o 2 years of age Child Greater than 2 to 12 years of age Adolescent Greater than 12 through 21 years of age Exposure to ionizing radiation is of particular concern in pediatric patients because 1 for certain organs and tumor types younger patients are more radiosensitive than adults the cancer risk per unit dose of ionizing radiation is higher for younger patients 2 use of equipment and exposure s...

Страница 28: ... www imagegently org Table 1 Techniques for Typical Body Parts Body Parts Patient Size kVp mAs SID Grid Abdomen AP PA Very Low Birth Weight Less than 1 5Kg 55 1 1m No Low Birth Weight Between 1 5 and 2 5Kg 55 1 6 1m No Newborn Age is less than 1 month and Weight above than 2 5Kg 70 1 6 1m No 26 User Manual of Mars1417X ...

Страница 29: ...h Weight 55 1 1m No Newborn 65 1 1m No Infant 70 1 6 1m No Child 70 1 6 1m No Preadolescent 90 2 1m Yes Adolescent 90 2 1m Yes Adult Small 110 1 8 1 8m Yes Adult Medium 110 2 8 1 8m Yes Adult Large 120 4 1 8m Yes Extremities AP PA Very Low Birth Weight 50 1 1m no Low Birth Weight 55 1 1m no Newborn 57 1 1m no Infant 57 1 2 1m no Child 58 1 2 1m no Preadolescent 62 1 6 1m no Adolescent 62 2 1m no A...

Страница 30: ...According to the Mars1417X INTENDED USE and the result of risk management image acquisition and data transmission are defined as ESSENTIAL PERFORMANCE Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE Method for getting dark image in detail refers to section installation and operation Intended OPERATOR All of use maintenance and operation steps should be carried ...

Страница 31: ...ture Humidity Atmospheric Pressure Operating 10 35 5 90 RH 700 1060mbar Storage 20 55 5 95 RH 600 1060mbar 2 7 Product Components Item Picture Description Mars1417X Detector 1pcs Medical Adapter 1pcs AC Power Cable 1pcs User Manual of Mars1417X 19 ...

Страница 32: ...Wireless Digital Flat Panel Detector Mars1417X Gigabit Ethernet Cable 1pcs 2 7 1 Detector iRay Technology Co ...

Страница 33: ...tion 2 7 2 Indicator 2 8 Specification 2 8 1 Basic Item Specification Model Mars1417X Image Sensor a Si Amorphous Silicon TFT Scintillator CsI Pixel Size 100um Fill Factor 60 Effective Array 3500x4300 iRay Technology Co ...

Страница 34: ...3 lp mm Image Transfer WIFI Full Image Time 5s with 1s XWin from end of XWin Cycle Time 6s Power Consumption 35W Full Running 7 5W Idle Dimension L W H 460mmx384mmx15mm typ Weight 2 8kg with battery X ray Energy 40 150kV Panel protection IP56 Trigger Mode Software AED SID 90 180cm iRay Technology Co ...

Страница 35: ...2 General Description 3 Basic Operation 3 1 Preparation 34 3 2 Routine Operation 35 3 3 Battery Charger Installation 37 iRay Technology Co ...

Страница 36: ...ttery installation Make sure that connectors on the battery pack are pointed to the opening in the battery compartment Slide battery package into battery compartment Make sure battery capacity overpass is 15 Slide the battery lock lever 3 1 2 Adapter Detector supports an external adapter powered It gets CB certificate No SG PSB MD 00005 and NRTL certificate No U8V 093768 0016 The ports defined as ...

Страница 37: ...arting Up On the control panel users can press the power button to turn on When the detector is powered down the user presses the button for 4 seconds to turn on the detector if the battery is inserted and the capacity is not less than 15 or DC power is connected After booting up users can check the indicator of the detector Power indicator Power Indicator Lighting Status Status Battery Capacity D...

Страница 38: ...ctor is turned off Wired connection broken and wireless connection not ready Blue ON Wireless connection is enabled Green ON Wired connection is enabled Service Mode Mode indicator Mode Indicator Lighting Status Description ON Client connection is built ON AP mode is enabled OFF Detector is off Client connection is not built Status indicator Mode Indicator Lighting Status Description OFF Detector ...

Страница 39: ... Charger Installation Operation Figure Unload Battery from battery charger Insert battery into battery charger Note the interface position as figure Press the battery to the bottom of battery compartment User Manual of Mars1417X 37 ...

Страница 40: ...tup 4 1 System requirement 39 4 2 Environment setup 39 4 3 Wired Connection for setting maintenance 39 4 4 Software UI 42 4 5 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT NETWORK 60 54 User Manual of Mars1417X ...

Страница 41: ...y can install V4 0 Download from Microsoft web site please 2 Visual C redistributed package need to be installed vcredist_x86_2013 or vcredist_x64_vs2013 3 For Windows XP full path should be used in file bind txt The wifi information should be configured for first use with wired connection The configuration can be changed when needed 4 3 Wired Connection for setting maintenance Figure 3 3 1 Connec...

Страница 42: ...2 The default IP address IPv4 of the detector is 192 168 8 8 the PC address IPv4 should be configured as 192 168 8 xxx which should be the same as the value of parameter Cfg_HostIP in file work_dir Mars1417X config ini Wireless Configuration iRay Technology Co ...

Страница 43: ...d use the Connect button the build the connection Figure 3 3 4 After finishing building the connection click Read Config button on the Wifi tab of Detector pag to get the current wifi configuration User can set the mode of the wifi for detector AP or Client Figure 3 3 5 User Manual of Mars1417X 41 ...

Страница 44: ...o the access point when the data cable is removed What needs to be noticed is the wifi frequency set on the AP interface will also be valid for Client mode 4 4 Software UI SDK supply iDetector as tool softwore 32 bits iDetector exe Tools iDetector w32 64 bits iDetector exe Tools iDetector x64 Double click iDetector exe to run the software For different software version the UI maybe has little diff...

Страница 45: ...n files and manage the calibration files Local File Open and view local images 4 4 1 HomePage The main function in this page is to connect detector Item Function description Name Display the name of detector SN Display the SN of detector Product Type Display the type of detector State Display the connection state Bind Unknown Ready etc Button Function description Connect Click this button to conne...

Страница 46: ...e raw images will be shown The propertities of image is displayed on the left of image window And on the right of image window there is a list to show thumbnail of images User can select it and double click to see for detail User can rotate reverse or mirror image User can get the value of AVG and SNR by ROI tool The acquired images can be save as raw tiff or dicom formats Both raw and tiff format...

Страница 47: ...ingleAcq Acquire once PrepAcq Clear and acquire Acquire Acquire once Sleep Make the detector enter sleep mode not supported for samples Save Save the current image the format is raw and tiff PowerOff Turn off the detector via command Image Properties Image Process Description WW window width WL window level PosX X coordinates of the current cursor at the point PosY Y coordinates of the current cur...

Страница 48: ...mouse button movie playback function operation area display 2 Double click the left mouse button the image display in center and with maximum size 3 Double click the right mouse button restore the window level and width for WL 32767 WW 65535 4 Drag the left mouse button to drag the image display 5 Lateral drag the right mouse button to adjust the window width and vertical drag the right mouse butt...

Страница 49: ...regions in this page 2 Parameter name region lists the paramters 3 Parameter read region read the parameters the values of the parameters are displayed in this area by Read 4 Parameter write region write parameter Entered value of the corresponding parameter in this area can be write to detector 5 Operation region functional operation buttons area 6 Status bar region status bar for detector state ...

Страница 50: ...ion Firmware version number of the MCU N Arm Version Version number of the ARM App N Kernel Version Version number of ARM Kernel N Trigger Mode Tirgger mode of the detector Y Set Delay Time ms Exposure window for AED mode which use a fixed window Y Exp Window Time ms Max exposure window for command trigger which use a dynamic window Y Src IP Detector IP Y Src MAC Detector MAC Y WLAN DHCP Enable DH...

Страница 51: ...or Read Read parameters Write Write parameters Write RAM Write parameters into RAM will lost changes after reset Upgrade Firmware Upgrade firmware L Upload detector log to the specified directory Sensor The mainly function in this page is to probe the temperature and humidity of the detector Click Read button to get the value of the temperature or humidity User Manual of Mars1417X 49 ...

Страница 52: ...tion Temperature Read detector temperature Humidity Read detector humidity Battery Read the capacity of the battery Wifi User can config the wireless connect parameters on this tab Images You can Query and upload Images from detector to Workstation iRay Technology Co ...

Страница 53: ...oftware Setup 4 4 5 Calibrate Page Offset Gain Defect calibrate files can be generated and managed in this page Click Start Generate Templates to enter generating templates page User Manual of Mars1417X 51 ...

Страница 54: ...rst Then click this button to download selected template file s into detector UpLoad to Workdir Select one item in Fpd template file control and select one item in Subset settings control Click this button to upload selected template from detector into specified calibration directory Upload Lag Upload Lag into SDK current directory Active Select one item in list Click this button to activate selec...

Страница 55: ...emplate file 1 Enter Create Gain page Click Start button to start process the offset type should be selected then start to get the images 2 Click PREP button then exposure after Acquire button enable After receving the PREP request the detector needs some time to be ready the decounting bar will apear when the exposure window is opened After exposure user can click Acquire button to acquire the X ...

Страница 56: ...epting the current image the Stage will turn to 2 5 3 5 and so on The current value box will show different colors the definitons are as below Yellow The current value is higher or lower than the expected one user decides if acceptable For example the expected value is 20000 and user needs 40000 as the gain piont the yellow warning can be ignored and the value can be accepted still iRay Technology...

Страница 57: ...on and the process can be exited from at anytime by using Cancel button If Download to FPD after generation is checked then the download UI will appear after finishing generating User can refer to the part of Generate Defect Template File 4 When the generating process is finished the UI will give the message of successful User Manual of Mars1417X 55 ...

Страница 58: ... need to be acquired the UI gives the recommend KV and expected image value user should refer with them 3 If the option Download to FPD after generation is checked the download UI will appear after finishing generating the defect map which will takes a little time The field of Index in FPD means that the detector can store several correction maps and choose one set to active as user wants The Down...

Страница 59: ...on user should wait the process until it is finished 5 The correction map also can be managed at anytime on the page of Mode Files Choose the item of Default in the Subset settings part and click Download to FPD to finish downloading the maps into the detector Upload the correction files User Manual of Mars1417X 57 ...

Страница 60: ...d template files and the Default directory in the Subset settings then click the Upload to workdir 2 When the upload process is finished the UI will give the message The correction maps should be enabled before using hardware correction read status first then choose the gain or defect enable the map by clicking Active button iRay Technology Co ...

Страница 61: ...is not correct user will get an error message The pixel matrix is defined as below Active area 3500 4300 TFT includes active area and dummy pixels 3524 4330 Full image inlcudes TFT matrix and empty ROIC channels 3584 4352 What needs to be notice is only the active area pixels will be displayed when use load file funtion the value of dummy pixels and empty channels will be filled by 65535 This page...

Страница 62: ...ockwise 90 degrees every time Mirror Open or close mirror ROI ROI tool to view the image of the AVG SV SNR and other parameters Press ctrl key can create several ROI area WW WL Auto adjust WW WL based on selected area by right button of mouse 4 5 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT NETWORK a The operating system is not compatibility b Change or update the software f...

Страница 63: ...s Digital Flat Panel Detector Mars1417X 5 Operation Instructions for Image Acquisition 5 1 Steps for acquiring image 62 5 2 Software Mode 62 5 3 AED Mode 64 5 4 After use 65 5 5 Firmware Upgrade 65 54 User Manual of Mars1417X ...

Страница 64: ... the detector reaches thermal equilibrium Acquire images in the selected mode To Acquire X ray image is the main operation of Mars1417X Most importantly detector should build synchronization with X ray generator Mars1417X has one synchronization modes to acquire X ray image which is Software Mode 5 2 Software Mode 5 2 1 Block Diagram Software mode is the basic way to acquire X ray image Please see...

Страница 65: ...XWIN will be started 3 The XWIN is configured by parameter Clear Acq Delay Time on SDK page the unit is ms 4 User needs to make sure the X Ray ends within the XWIN 5 The detector will send the images after the XWIN closed 6 The preview image will be always sent which is 4x4 averaging the raw X Ray image will be sent if the HW correction is disabled with the raw offset image follows otherwise the X...

Страница 66: ...fo RAW Preview RAW X Ray image If HW offset is disabled RAW Offset Or corrected image Low power Prep Ack 1 The detector is in low power state user needs to send Cmd Prep to make the detector exit to idle state which indicated by the acknowledge to Cmd Prep 2 When the detector is in idle state user can start the X Ray any time 3 When the X Ray starts the detector will sense the X Ray automaticlly t...

Страница 67: ...page Parameter tab the unit is ms user needs to make sure that the XWIN is larger than the X Ray time 4 After the XWIN is end then the detector will start the acquisition flow 5 The preview image will be always sent which is 4x4 averaging the raw X Ray image will be sent if the HW correction is disabled with the raw offset image follows otherwise the X Ray image will not be sent and only the corre...

Страница 68: ...units Mars1417X_IMAGE_44_ARM_20XX_XX_XX ifrm Word ARM indicates the file is only for ARM Mars1417X_IMAGE_44_FPGA_20XX_XX_XX ifrm Word FPGA indicates the file is only for FPGA Mars1417X_IMAGE_44_MCU_20XX_XX_XX ifrm Word MCU indicates the file is only for MCU User can choose one of these files as required to start the upgrade Choose the file that needs to be upgraded and must check the package info ...

Страница 69: ...5 Operation Instructions for Image Acquisition User Manual of Mars1417X 67 ...

Страница 70: ...ry Information 6 1 Medical Equipment Safety Standards 69 6 2 Guidance and Manufacture s Declaration for EMC 69 6 3 Radio Frequency Compliance Information 72 6 4 Battery Safety Standards 75 6 5 Product Label 75 User Manual of Mars1417X 61 ...

Страница 71: ...1 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 60601 2 54 2015 EN 60601 2 54 2015 Medical electrical equipment Part 2 54 Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy IEC 62133 2 2017...

Страница 72: ...diated RF EM field IEC 61000 4 3 3V m 80MHz 2 7GHz 80 AM at 1kHz Near fields from RF wireless communications equipment IEC 61000 4 3 Refer to table Near fields from RF wireless communications equipment Rated power frequency magnetic fields IEC 61000 4 8 30A m 50Hz or 60Hz Near fields from RF wireless communications equipment Test frequency MHz Band MHz Immunity test levels Professional healthcare ...

Страница 73: ...nt including antennas can effect medical electrical equipment The warning should include a use distance such as be used no closer than 30 cm 12 inches to any part of the ME EQUIPMENT or ME SYSTEM including cables specified by the manufacturer Cable provided for EMC Cable Recommended length Shielded Unshielded Number Cable classification AC power cable 1 8m Unshielded 1 piece AC power DC power cabl...

Страница 74: ...art 15 subpart C 15 407 47 CFR 2 1091 KDB447498 D01 General Exposure Guidance v06 European Union ETSTEN 300 328 V2 2 2 ETST EN 301 893 V2 1 1 ETST EN 300 440 V2 1 1 ETSTEN 301 489 1 V2 2 3 ETSTEN 301 489 3 V2 1 1 ETSTEN 301 489 17 V3 2 4 EN 55032 2015 A11 2020 EN 55035 2017 A11 2020 EN 61000 3 2 2014 EN 61000 3 3 2013 EN 50566 2017 EN 62209 2 2010 A1 2019 IEC 62479 2010 6 3 1 FCC Compliance Contai...

Страница 75: ...tenna Increase the separation between the panel and receiver Connect the panel into an outlet different from the receiver is connected Consult the distributor or an experienced radio TV technician for help This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interfe...

Страница 76: ...ssue and is 1 6W kg Averaged over one gram of tissue by IEEE Std 1528 The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in compliance with the FCC RF exposure guidelines While there may be differences between the SAR levels of various product and at various positions they all meet the government requirements SAR compliance for body worn opera...

Страница 77: ...lytes Safety requirements for portable sealed secondary lithium cells and for batteries made from them for use in portable applications Part 2 Lithium systems UN38 3 United Nations Recommendations on the Transport of dangerous goods Manual of tests and Criteria ST SG AC 10 11 Rev 6 Amend 1 Amend 1 6 5 Product Label Mars1417X Detector Label User Manual of Mars1417X 75 ...

Страница 78: ...Flat Panel Detector Mars1717X 6 6 Battery Charger Label 62 User Manual of Mars1417X ...

Страница 79: ...6 Regulatory Information Battery Label User Manual of Mars1417X 77 ...

Страница 80: ...ing 7 Trouble Shooting Please refer to service manual If the problem persists turn off the panel and contact iRay service department service iraygroup com We would provide the best service User Manual of Mars1417X 71 ...

Страница 81: ...ital Flat Panel Detector Mars1417X 8 Service Information 8 1 Service Office Information 80 8 2 Product Lifetime 80 8 3 Regular Inspection and Maintenance 80 8 4 Repair 80 8 5 Replacement Parts Support 80 79 User Manual of Mars1417X ...

Страница 82: ...least once a year If necessary clean up the panel make adjustments or replace consumables such as fuses etc There may be cases where overhaul is recommended depending on conditions Contact iRay service office or local iRay dealer for regular inspection or maintenance 8 4 Repair If problem cannot be solved contact your sales representative or local iRay dealer for repairs Please refer to the label ...

Страница 83: ...ervice Information Main parts parts required to maintain the function of the product of this product will be stocked for 7 years after discontinuance of production for repairing User Manual of Mars1417X 81 ...

Страница 84: ...Wireless Digital Wireless Digital Flat Panel Detector Mars1417X APPENDIX A INFORMATION OF MANUFACTURES 76 APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE 77 76 User Manual of Mars1417X ...

Страница 85: ...nufactures COMPANY iRay Technology Co Ltd ADDRESS RM202 Building 7 No 590 Ruiqing RD Zhangjiang East Podong Shanghai China ZIP CODE 201201 TELEPHONE 86 021 50780560 FAX 86 021 50780560 HOMEPAGE WWW IRAYGROUP COM User Manual of Mars1417X 83 ...

Страница 86: ...r Mars1417X Appendix B Information of Europe Representative COMPANY iRay Europe GmbH ADDRESS IN DEN DORFWIESEN 14 71720 OBERSTENFELD GERMANY ZIP CODE TELEPHONE 49 7062 977 88 00 FAX 49 7062 976 0571 HOMEPAGE WWW IRAYEUROPE COM 76 User Manual of Mars1417X ...

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