Sopix2
Contents
1. SODIX USER MANUAL ACTEON Imaging ENGLISH Contents FOREWORD iea cect ia pe ER aoe aoe S 2 X RAY SYSTEM INTRODUCTION 2 PRECAUTIONS USE ae eee ee GAs es ale 4 STANDARDS AND REGULATIONS 7 SYSTEM CONFIGURATION cesses we gis Sei ow 13 INSTALLATION AND CONNECTION 14 USE ieai a i Bisco ane a tise A 17 MAINTENANCE scion e i ater eee aides ahd eee ee 19 AFTER SALES SERVICE sisi adenda gah doh 21 TECHNICAL FEATURES vad wae gees 23 Sopix User manual ENGLISH FOREWORD Before using the Sopix digital x ray system it is recommended to carefully read and follow the instruction manual in order to use this device at its best Always be aware of the messages CAUTION WARNING and NOTE when using the system CAUTION the term CAUTION describes potential incidents likely to jeopardize safety WARNING the term WARNING refers to the incidents likely to disturb the smooth running of the imaging system NOTE the term NOTE highlights particular points in order to facilitate the system maintenance or to clarify important information X RAY SYSTEM INTRODUCTION 2 1 FUNCTIONS AND PERFORMANCE The Sopix medical device is a digit2. OR OTHER BASIS The liability exclusion or limitation for direct or indirect damages does not apply under the regulatory or legal rules in force in some countries and the present exclusion may not apply to a purchaser in those countries Sopix2 User manual 21 ENGLISH 9 3 IN CASE OF FAILURE PROBLEMES CAUSES SOLUTIONS After the timer was activated no image appears on the screen 1 The sensor is positioned generator cone 2 Exposure time is too short incorrectly relation to the 3 Failure of the generator 4 Sensor or Controller 5 USB cable 1 Use a KERR type positioning kit for the sensor 2 Slightly increase the exposure time 3 Check for proper generator operation 4 Check the sensor is correctly connected to the computer 5 Avoid using a port on the front plate The TWAIN window has a red spot Wire connection problem 1 Check the sensor is correctly connected to the computer 2 The USB port may be put in standby by Windows Some white areas appear on the image The sensor is incorrectly positioned in relation to the generator cone Use a KERR type positioning kit for the sensor The image is blurry stretched or scratched 1 The sensor is incorrectly positioned 2 The patient moved when the image was taken 3 The generator head was not stabilized when the timer was activated 1 Use a KERR type positioning kit of the sensor 2
3. The patient should be still when the image is taken 3 Stabilize the generator head In case of failure not mentioned above please send back the Sopix2 system to the SOPRO dealer or after sales department WARNING No maintenance should be performed by a third party 22 Sopix2 User manual ENGLISH TECHNICAL FEATURES USB CONTROLLER Power supply Non power fed via the USB port 5V Consumption 200 mA USB cable length 3m Dimensions 27 5 x 98 x 13 mm Total weight 118 g Liquid penetration Size 1 SENSOR protection index Resolution 25 pl mm Pixel size 20 x 20 um Technology CMOS Optical fiber scintillator Liquid penetration IP67 temporal immersion Cable length 70 cm External dimensions Active area dimensions Pixel number 38 9 x 24 9 x 5 3 mm 20 x 30 mm 600 mm 1 5 Million 1000 x 1500 System operation environment Temperature Humidity rate from 5 to 40 C from 20 to 60 RH Atmospheric pressure no noticeable influence of the environmental conditions System transport and or storage environment Storage temperature from 40 to 70 C Humidity rate from 10 to 95 RH Atmospheric pressure 500 hPa to 1060 hPa Not protected against water chutes e Not adapted for use in presence of a flammable anaesthetic mixture with air oxygen or dinitrogen monoxide Complies with the European directive 93 42 EE
4. it is used in this environment Immunity trial Electrostatic discharges EN 61000 4 2 CEI 60601 Severity level 6 kV when in Contact 8 kV in the air Compliance level Electromagnetic environment Guide The floor should be wooden concrete or tile If the floor is covered with a synthetic material the relative humidity should be at least 30 Far transient bursts EN 61000 4 4 2 kV for the feed cables 1 kV for the input output cables The main power supply quality should be the one of traditional commercial or hospital environment Voltage shocks EN 61000 4 5 Differential mode 1 kV Common mode 2 kV The main power supply quality should be one of a traditional commercial or hospital environment Dips brief outages and power voltage variation EN 61000 4 11 Magnetic field with the network frequency 50 60 Hz lt 5 U for 10 ms 40 U 100 ms 70 U 500 ms lt 5 U 55 for for for lt 5 UT 10 ms lt 40 UT 100 ms lt 70 UT 500 ms lt 5 UT 55 The main power supply quality should be of a traditional commercial or hospital environment If the user of the standard device Sopix dental digital x ray system requires it to continue to operate during main power supply outages it is recommended the standard device Sopix dental digital x ray system is fed by an inverter or a battery The magne
5. reading difficulties The Drivers directories contain the drivers necessary to the use of the hardware accepted by Sopro Imaging Sopix system SOPRO cameras in USB 1 and USB 2 Hasp protection key The directory Sopro Imaging contains the Sopro Imaging installation program The directory Tools contains the Microsoft Direct X 9 0 c and ADOBE Acrobat Reader installation programs To obtain the best performance possible when using the Imaging SOPRO software it is recommended to install DirectX 9 0c In order to do this click on the key Install DirectX 9 0c and then follow the displayed instructions DirectX 9 0c is a Microsoft product In case of difficulties when installing this product consult the information provided by this editor In order to ensure maximal compatibility with all the installed systems computers Windows and word processing version it was decided to provide the documents available on the CD ROM in PDF format This format developed by ADOBE Company can be read thanks to Acrobat Reader service program If Acrobat Reader is not installed on the computer or the version is not recent enough click on the key Install Acrobat Reader and then follow the instructions Acrobat Reader is an ADOBE product In case of difficulties when installing this product consult the information provided by this editor 14 Sopix User manual ENGLISH A dialog box opens it is the main menu win
6. ACQUISITION OF AN X RAY IMAGE First switch on the PC on which the Sopix system is installed and launch the imaging software Sopro Imaging Set your generator and the timer Slip the sensor into a hygienic protector NOTE For further information please refer to chapter 7 2 Using sensor protectors Place the sensor in the patient s mouth parallel to the long axis of the tooth with the active face against the tooth NOTE If using a positioning kit refer to the instructions provided with this kit e Move the generator closer to the patient s head Make sure the generator cone is parallel to the sensor positioning e Activate the timer trigger Once the exposure is finished the imaging software downloads the x ray image onto the screen Sopix2 User manual 17 ENGLISH 7 2 USING SENSOR PROTECTORS In order to ensure maximal hygienic safety for the patient it is imperative to cover the Sopix sensor with a disposable sensor protector WARNING Place the sensor protector with gloves Change the sensor protector for each new patient Preferably use the sensor protectors especially designed for Sopix sensors Keep the sensor protectors in a dry and clean place Dispose of the used sensor protectors with the other biologically and potentially hazardous infected wastes Do not use finger cots It is recommended to b
7. C relative to medical devices Complies with the standard IEC60601 1 User manual 23 Sopix 0459 ACTEON imaging ZAC lV e Avenue des Gen vriers 13705 cedex FRANCE T l 33 0 442 98 01 01 Fax 33 0 442 71 76 90 E mail info sopro acteongroup com www sopro acteongroup com Non contractual document Ref 011271 B Copyright 2008 SOPRO All rights reserved No information or part of this document may be reproduced or transmitted in any form without the prior permission of SOPRO
8. MUST put the sensor on its support DO NOT put the sensor in an autoclave DO NOT drop the sensor DO NOT hold the sensor with clamp forceps DO NOT hold the sensor with the connecting cable DO NOT roll over or walk on the connecting cable DO NOT ask the patient to bite the sensor or the connecting cable DO NOT immerse the sensor DO NOT open the sensor or controller in case of failure DO NOT use protections other than the SOPRO sensor protectors DO NOT use abrasive product to clean the sensor 3 5 PRECAUTIONS TO TAKE FOR THE USB PORT Most of current motherboards are equipped with two USB channels Each channel has two USB ports to connect various peripherals WARNING It is recommended to dedicate a USB channel for the imaging system This will ensure the performance and the transmission speed of Sopix system data will not be affected by the fact that another peripheral is on the same channel Sopix2 User manual 5 ENGLISH 3 6 ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES Electromagnetic compatibility CEM is the ability of electronic device elements to correctly interact in an electronic environment Although this digital X ray system was designed according to this compatibility and complies with the electromagnetic interference thresholds established by the regulatory agency there is no guarantee about the interference likely to occur on a pa
9. al dental x ray imaging system The sensor located in the patient s mouth just like a silver film captures thanks to the CMOS sensor the X rays produced by the generator Then it will transmit this data to the control box to which it is connected and in turn transmits the information to the computer to display the x ray onto the screen All the images captured with the Sopix system can be recalled onto the screen with the Sopro Imaging software provided with the system This software displays processes and stores the images captured with the Sopix system Exclusive technology A C E Automatic Control Exposure developed by SOPRO provides the system with prominent functionalities Thus Sopix analyzes radiation in real time upon every acquisition thus avoiding any risk of overexposure 2 Sopix2 User manual ENGLISH 2 2 PARTS LIST The Sopix dental digital x ray system is composed of the following elements A sensor size 1 integrating the controller and a cable of 3 70 meter total length A sensor holder 10 sensor protectors An active extension USB2 0 booster 5 meters long ACD of Imaging SOPRO software Multilingual operating instructions incorporated in the Sopro Imaging software CD ROM A quick startup guide e Optional the angulation set 1 NOTE The device was designed and developed for use with SOPRO accessories only In order to guarantee patient
10. dard and that it supplies a cleaning and or disinfecting procedure These elements should be placed more than 1 50m from the chair so that they are not part of the patient s environment No peripherals other than the ones specified should be connected to the system No mobile stand with multiple plugs and no additional or extension cord other than that supplied by SOPRO should be connected to the system Check the electric installation compliance with the standards in force in the country where the system is Sopix2 User manual 15 ENGLISH Once the box is connected to the PC Windows detects the Sopix system and indicates it is ready to install the drivers A window displays Keep the option install automatically the software and click on Next WARNING Insert the Sopro Imaging software into the CD driver in order to install the drivers e During the installation of the drivers and hardware a dialog box displays click on Continue gt to continue installing the system without taking into consideration the Windows message After a few moments the installation is completed A window opens Click on Finish The Sopix system is ready to receive the sensor NOTE Please refer to the use instructions of the used imaging software to determine know the installation mode of Sopix system inside it 16 Sopix User manual ENGLISH Q USE 7 1
11. dow for installing a certain number of programs related to Sopro Imaging application e Click on Install Sopro Imaging A window displays select the desired language during the installation process A dialog box opens It displays the software license to be entirely read to continue the installation Once the terms are read click on Next By default the Imaging SOPRO software will automatically install the directory C Program Files Sopro Imaging To start installing the software click on Next Once the installation is completed a dialog box displays Click on Finish Once the software installation is completed you just have to connect the Sopix system to the computer 6 2 SOPIX SYSTEM INSTALLATION Before installing the Sopix system make sure the computer is connected to an outlet correctly grounded Now follow the below indications e Connect the Sopix system USB connector to the computer WARNING Never connect the USB cable to the port found on the computer front plate Indeed the connectors present on the computer front plate are much more sensitive to the various USB signal interference and this may cause a dysfunction of our x ray system For electrical safety reasons the computer on which the imaging system will be connected as well as the printer should comply with IEC 60950 standard Be sure their respective manual indicates the compliance with this stan
12. e and declaration of the manufacturer electromagnetic emissions The standard device Sopix dental digital x ray system is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment Emission trial RF emissions CISPR 11 Compliance Electromagnetic environment Guide The standard device Sopix dental digital x ray system only uses radio energy for its internal functions therefore its RF emissions are very low and are not likely to cause interference with near electronic devices RF emissions CISPR 11 Harmonic emissions EN 61000 3 2 Voltage fluctuations Flicker EN 61000 3 3 Applicable 8 Sopix User manual The standard device Sopix dental digital x ray system may be used in every domestic premises including the ones directly connected to the public low voltage power distribution network used to supply household buildings The standard device Sopix dental digital x ray system may be used in every premises other than household premises and the ones directly connected to the public low voltage power distribution network used to supply household buildings ENGLISH Guide and declaration of the manufacturer electromagnetic immunity The standard device Sopix dental digital x ray system is intended to be used in the electromagnetic environment specified below The user should make sure
13. e far sighted and have plenty of disposable hygienic protectors because the Sopix system should not be used without them NOTE If the sensor cap is torn when examining a patient or if the Sopix sensor has been infected by withdrawing the sensor protector it is essential to totally disinfect the Sopix sensor and the first 40cm of cable In order to do this please refer to the table in chapter sensor maintenance 18 Sopix2 User manual ENGLISH MAINTENANCE The Sopix digital x ray system does not need any maintenance if it is used according to the manufacturer use and cleaning instructions Before first using any device from the Sopix range it is imperative to follow the complete disinfecting procedure Any device from the Sopix range returned to the manufacturer or distributor for servicing or maintenance should have been carefully disinfected before shipping Any device of the Sopix range coming back from servicing or maintenance operation should follow the complete disinfecting procedure before being used 8 1 CONTROLLER MAINTENANCE DESCRIPTION RECOMMENDATIONS USE INSTRUCTIONS AND PRECAUTIONS V x WARNING Decontamination and disinfecting e Surface disinfectant spray of Septol type Spray Surface without Aldehyde Pierre Rolland X Do not scrub Spray at 40 from the surface and allow to dry e Surface cleaning and disinfecting wipes of Wip
14. ent in which the irradiated RF disturbances are checked The user of the standard device Sopix dental digital x ray system can help to avoid electromagnetic interference by maintaining a minimal distance between the portable and mobile RF communication devices transmitters and the recommended device Sopix dental digital x ray system such as recommended below depending on the maximal output power of the communication device Rated maximal output Separation distance depending on the transmitter frequency power of the m transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 16VP d 1 16VP 4 2 33 VP For the transmitters whose maximal output is not listed above the recommended separation distance d in metres m can be determined by using the equation applicable to the transmitter frequency where P is the maximal output of the transmitter in watts W rated by the transmitter manufacturer Note 1 At 80 MHz and at 800 MHz the separation distance given in the higher frequency band applies Note 2 These recommendations may not apply in every situation The electromagnetic wave propagation is modified by absorption and reflection due to the structures objects and persons Sopix2 User manual 11 ENGLISH 4 2 SIGNIFICATION OF THE STANDARDISED SYMBOLS Indications born on the controller identifying the Sopix digital x ray system according to the international standards Th
15. es Septol type Pierre Rolland X Do not rinse the wipe wring it and then scrub until obtaining visible cleanliness v Allow to dry in the open air v Carefully close the packaging box Sopix User manual Do not use products containing Ammoniac trichloroethylene Dichloroethylene Ammonium hydrochlorid e Chlorinated and aromatic hydrocarbon Ethylene dichloride Methylene chloride Ketones Deterioration risks of the plastic parts 19 ENGLISH 8 2 SENSOR MAINTENANCE DESCRIPTION RECOMMENDATIONS USE INSTRUCTIONS AND PRECAUTIONS V x WARNING Decontamination and disinfecting of the sensor and of the first 40 cm of cable WARNING Surface cleaning and disinfecting wipes of Wipes Septol type Pierre Rolland v Take the wipe wring it and then scrub until obtaining visible cleanliness v Allow to dry in the open air v Carefully close the packaging box X Do not rinse Do not immerse the sensor in a disinfecting liquid It is imperative to respect the sensor precautions for use Please refer to chapter 3 of this manual Precautions for use 20 Sopix2 User manual ENGLISH AFTER SALES SERVICE 9 1 LIMITED LIABILITY The Sopix digital x ray system was designed to ensure the acquisition of dental x ray images their transfer in
16. ether with the imaging software of the management software of the practice For more information please contact your distributor 5 3 COMPATIBILITY WITH X RAY GENERATORS The Sopix digital x ray system is potentially compatible with all intraoral x ray generators Nevertheless we recommend X Mind AC DC generators which are perfectly adapted to Sopix system and provide very good performance to the system Sopix2 User manual 13 ENGLISH INSTALLATION AND CONNECTION 6 1 IMAGING SOPRO SOFTWARE INSTALLATION Insert the Sopro Imaging CD ROM in the drive it will run automatically WARNING If the CD ROM does not execute automatically or if the operating system is prior to Windows XP SP1 follow the following instructions Go to the Start menu gt Execute Type D setup exe replace D by the letter of the CD ROM driver And then click on OK The file instantly executes Then follow the steps from the below point NOTE Clicking on the key Browse this CD ROM accesses a Windows browse window from which it is possible to consult the whole content of the CD ROM At the CD ROM root there are files to automatically and or manually launch the setup In the directory Document and its subdirectories there are all the documents about the Imaging SOPRO software and the Sopix system these documents are in PDF format Make sure to correctly install Acrobat Reader in case of
17. is symbol indicates the device protection degree against indirect and direct electric contacts is BF type Read the use instructions Manufacture date 2 Electric and electronic equipment marketed after 01 August 2005 Manufacturer Complying with the European directive 93 42 EEC relative to medical devices 12 Sopix2 User manual ENGLISH SYSTEM CONFIGURATION 5 1 REQUIRED CONFIGURATION FOR THE COMPUTER To use the Sopix system you must make sure the computer and its peripherals do not have any use limitation that could concern life safety It should also meet the following requirements Minimal system configuration Recommended configuration Operating system Windows XP Pro SP2 Windows XP SP2 VISTA SP1 Processor Intel Pentium IV 1 3 GHz Intel Core 2 Memory 512 MB 2 GB Hard disk 80 GB 320 GB USB ports 2 x USB2 0 Hi Speed ports 4 x UB 2 0 Hi Speed ports Video board Graphic board 32 MB RAM Graphic board with Nvidia chipset or exclusive video ATI 256 MB RAM USB Chipset Intel or NEC Intel or NEC Screen resolution 1024 x 768 1024 x 768 or higher Standard IEC 60950 IEC 60601 1 5 2 IMAGING SOFTWARE The Sopix system is provided with the dental imaging software Sopro Imaging running in Windows It is a versatile software that captures processes and files the x rays taken with the Sopix system but also to share your data in network Sopro Imaging may also link tog
18. medical devices IEC 60601 1 and of electromagnetic compatibility IEC 60601 1 2 Medical device vigilance As any medical device this device is subjected to the medical device vigilance dispositions any serious dysfunction should then be the subject of a description to the competent authorities and to the manufacturer as soon as possible and as precisely as possible Scrapping the system This device bears the recycling symbol according to the European directive 2002 96 EC about electric and electronic equipment waste DEEE or WEEE By correctly disposing of this device you will avoid damaging the environment and human health The symbol 2 present on the device or on the accompanying documentation indicates that this product cannot be in any case treated as household waste Therefore it should be given to a waste collection centre that handles electric and electronic equipment recycling Standards in force in the installation country must be respected relative to waste disposal To have more details about this device treatment recuperation and recycling please contact your dental device distributor or failing that the group ACTEON site regarding the indicated procedure NOTE To avoid any environment contamination risk likely to cause mild or serious injuries be sure to dispose of the device and its accessories as special waste Sopix2 User manual 7 ENGLISH Electromagnetic compatibility Guid
19. nce may occur in the vicinity of the devices bearing the following symbol 2 At 80 MHz and 800 MHz the higher frequency band applies These recommendations may not apply in every situation Electromagnetic wave propagation is modified by the absorption and reflection due to the structures objects and persons 10 Sopix User manual ENGLISH The fixed transmitter field levels such as the base stations of the radio telephones cellular wireless and the terrestrial mobile radios amateur radio AM FM and TV radio communication cannot be theoretically assessed precisely To obtain the electromagnetic environment due to the fixed RF transmitters a site measurement should be performed If a field level measured in the use environment of the standard device Sopix dental digital x ray system exceeds the compliance levels above applicable the good operation of the standard device Sopix dental digital x ray system should be checked If abnormal operations are proved some further measures should be taken such as reorientation or relocation of the standard device b Above the 150 kHz to 80 MHz frequency band the field level should be lower than 3 V m Recommended separation distances between the portable and mobile RF communication devices and the standard device Sopix dental digital x ray system The standard device Sopix dental digital x ray system is intended to be used in an electromagnetic environm
20. rticular installation If the device generates interference with radio communication services which can be determined by switching it off and on the user is recommended to try to correct this phenomenon by taking whole or part of the following measures Change the receiving antenna orientation e Reposition the product according to the receiver Take away the computer from the receiver The Sopix digital x ray system is designed and tested to be used in a home environment class B Group 1 according to CISPR11 standard 3 7 ELECTROSTATIC INTERFERENCE A strong electrostatic discharge may logically disconnect the Sopix system from the computer USB Universal Serial Bus port In most cases the Sopix system recovers itself Thereafter it will be judicious to implement the sensor cap before setting the Sopix system to hold an image acquisition and or e dissipate your static charge by touching for example a metallic part of the dental chair before taking a digital x ray 6 Sopix User manual ENGLISH STANDARDS AND REGULATIONS 4 1 COMPLIANCE WITH STANDARDS AND REGULATIONS Compliance with European Community directives The Sopix system design manufacturing and distribution comply with the European directive 93 42 EEC requirements relative to medical devices SOPRO certifies this device went through audit tests and was declared complying with the restrictions imposed by the safety standards of electro
21. safety and maximum performance The use of any other manufactures accessories can result in risk or harm to a patient and a malfunction to your device Sopix2 User manual 3 ENGLISH PRECAUTIONS FOR USE 3 1 SAFETY INSTRUCTIONS e Comply with the operating and storage requirements and avoid exposing the Sopix system to excessive dust Do not open the device and do not try to take it apart or to modify it e Never insert any metallic object into the device in order to avoid any electric shock fire short circuit or hazardous discharge risk Do not put the device in a humid environment or where it could be water sprayed e Always unplug from the outlet the computer on which Sopix system is connected in case of storm or when it will not be used for a certain period e Only use the connecting cable s supplied with the Sopix system 3 2 SYSTEM OPERATING ENVIRONMENT Refer to chapter 10 Technical features 3 3 TRANSPORT AND OR STORAGE ENVIRONMENT OF THE SYSTEM Refer to chapter 10 Technical features 4 Sopix2 User manual ENGLISH 3 4 PRECAUTIONS TO TAKE FOR THE SENSOR S It is imperative to take some precautions for use of the sensors particularly e YOU MUST handle the sensor with much care e YOU MUST use a SOPRO sensor protector for each patient YOU MUST use a positioning kit to correctly place the sensor YOU MUST use a disinfecting wipe to clean the sensor YOU
22. the form of computer data as well as their storage Nevertheless SOPRO Company shall not be liable for inappropriate use of this materiel or for any loss of stored data in the computer system due to a use issue or any possible technical problem 9 2 WARRANTIES SOPRO Company ensures the absence of material and manufacturing defects for its products during a period of one 1 year coming into force at the purchase date This warranty does not apply to misused modified untended or accidentally damaged products or products subject to abnormal use and handling conditions The distributors other than ACTEON Group s subsidiaries are not authorized to apply a warranty further extended on behalf of SOPRO The entire liability of SOPRO is limited to its convenience either when replacing or when repairing free of charge the defective product if it has been sent to SOPRO After Sales Service And this applies for the warranty period Outside of France access to the warranty is only possible if the product was bought in one of the points of sale authorized by SOPRO in the country where it will be used THIS WARRANTY CONSTITUTES THE ONLY AND UNIQUE REMEDY IT REPLACES ANY OTHER WARRANTY FOR EXAMPLE WARRANTY OF ADEQUACY TO A PARTICULAR AIM WHETHER IT BE EXPLICIT OR IMPLICIT SOPRO SHALL NOT BE LIABLE FOR ANY PARTICULAR DAMAGE INDIRECT ACCIDENTAL OR CONSEQUENTIAL OR FOR ANY DETERIORATION OR DATA LOSS ON A CONTRACTUAL NON CONTRACTUAL
23. tic field with the network frequency should be at a characteristic level of a location in a traditional commercial or hospital environment Note UT is the power voltage nominal value applied during the trial Sopix2 User manual 9 ENGLISH Guide and declaration of the manufacturer electromagnetic immunity The standard device Sopix dental digital x ray system is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment CEI 60601 Compliance Electromagnetic environment Immunity trial Severity level level Guide Portable and mobile RF communication devices should not be used at a distance from the standard device Sopix dental digital x ray system including the cables lower than the recommended separation distance calculated with the applicable formulas depending on the emitter frequency Recommended separation distance Conducted RF 3 Vrms d 1 16VP EN 61000 4 6 150 kHz to 80 MHz d 1 16 80 MHz to 800 MHz Radiated RF 3 V m d 2 33 800 MHz to 2 5 GHz EN 61000 4 3 80 MHz to 2 5 GHz where P is the maximum rated output of the transmitter in watts W by the transmitter manufacturer and d the recommended separation distance in metres m The field levels emitted by the fixed RF transmitters determined by an electromagnetic measurement of the sitea should be lower than the compliance level in each frequency band Interfere
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