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COUVERTURE SOPROLIFE par langue:Mise en page 1.qxd
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1. b 0582 output Disposal of electric and electronic equipment marketed after 13 August 2005 This symbol indicates that the product cannot be treated with domestic waste For medical devices this symbol is associated to the manufacturing year expressed with four digits For medical devices this symbol is associated to the manufacturer name and address Product compliance according to the European directive 93 42 EEC relative to medical devices zb Grounding The devices that connect to video or USB outputs should comply with IEC 60950 standard 20 SOPROLIFE User s manual Bo I S H INTRA ORAL TIP AND LIGHT SHIELD STERILIZATION Intra oral tip and light shield must be clean before sterilization Intra oral tip and light shield can be immersed in a disinfection bath and be subjected to a manual or automatic cleaning device ultrasonic cleaner It must then be rinsed dried and packaged before sterilization in an autoclave It can be sterilized at 134 C and two bars 200 KPa in an autoclave for 18 minutes Nevertheless it is important to note that sterilization of intra oral tips and light shields in an autoclave will cause wear on these accessories Therefore it is recommended to replace the intra oral tip and light shield on average every fifteen sterilization cycles to avoid distorted diagnosis NOTE The tips can be cleaned with a disinfecting wipe e g Sept
2. connection box with integrated image memory Power supply A2 5 metre cable to connect the handpiece to the connection box 5 metres and 7 metres optionally An S video Y C cable An RCA video cable USB cable SOPROLIFE User s manual 3 ENGLISH DOCK M USB2 A connection box with integrated image memory and USB2 digital output Power supply A2 5 metre cable to connect the handpiece to the connection box 5 metres and 7 metres optionally An S video Y C cable An RCA video cable A USB cable DOCK MU_VIDEO e A connection box with integrated image memory A2 5 metre cable to connect the handpiece to the connection box 5 metres and 7 metres optionally An installation manual DOCK MU_USB2 A connection box with integrated image memory and USB2 digital output A2 5 metre cable to connect the handpiece to the connection box 5 metres and 7 metres optionally An installation manual DOCK USB2 USB2 connection box with a 3 5 metre connecting cable This device has been packaged in a custom carton This carton should be kept for future possible transportation As complement to the dental camera we provide some dental barriers necessary for intra oral use of SOPROLIFE For more details about these products please refer to our catalogue or contact our commercial service NOTE The device was designed and developed with its ac
3. SOPRWLIFE Light Induced Fluorescence Evaluator USER MANUAL R Imaging ENGLISH Contents FOREWORD wii rt rm ab a iwi E Rue ERES 2 SOPROLIFE INTRODUCTION 3 SAFETY INSTRUCTIONS 22519944 UR ER 5 REGULATORY REQUIREMENTS 6 INSTALLATION 225659 RR 11 CONNECTING VIDEO SCREEN 12 CONNECTING TOACOMPUTER 13 OPERATION PROTOCOL OF SOPROLIFE 16 DESCRIPTION OF THE CONNECTION BOXES 19 INTRA ORAL AND LIGHT SHIELD STERILIZATION 21 MAINTENANCE Ge hehe Roni eg ere 22 AFTER SALES SERVICE cores me REO Ere ds 24 TECHNICAL FEATURES rr y Uem ee s 27 SOPROLIFE User s manual ENG I S H FOREWORD To optimize the use of this device whilst taking all the necessary precautions we recommended you read carefully and follow the owner s manual Please carefully consider 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
4. 06 model The power supply automatically adapts to the electric networks 115 V 230 V 60 Hz 50 Hz 0 5 SOPROLIFE voltage is powered by 6V of a continuous low voltage type 9 2 DOCK MU USB2 AND DOCK VIDEO POWER SUPPLY The electrical connection of this connection box should be performed by the installer SOPROLIFE power supply is performed through the connection box that should be connected 24 V 50 Hz 60 Hz 10 VA 9 3 DOCK USB2 POWER SUPPLY The dental camera electrical supply is directly performed through the computer USB port The voltage powering the camera is of continuous 5 V low voltage type 0 5 A 9 4 VIDEO AND USB OUTPUTS These connection boxes has two independent video outputs a composite one and a Y C S Video one One of these two outputs should be connected to the monitor video input preferably Y C S Video This connection box has a digital USB 2 0 output that can be connected to a computer USB2 port Except on Dock USB2 9 5 FOOTSWITCH The footswitch should be connected here zt you have selected it to freeze the image SOPROLIFE User s manual 19 ENGLISH 9 5 IDENTIFICATION The indications born on the boxes identify the SOPROLIFE according to the international standards CEI 601 1 and 417 Video output Handpiece connection Footswitch connection Continuous voltage BF type camera Caution please consult the ACCOMPANYING DOCUMENTS
5. compliance levels above applicable the good operation of SOPROLIFE device 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 SOPRO device SOPROLIFE device is intended to be used in an electromagnetic environment in which the irradiated RF disturbances are checked The user of SOPROLIFE device can help to avoid electromagnetic interference by maintaining a minimal distance between the portable and mobile RF communication devices transmitters and the recommended SOPROLIFE device such as recommended below depending on the maximum 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 16 d 1 16 2 33 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 frequen
6. imperative to send in everything so that the defective parts can be replaced When your material is returned to you you should check its condition and note any discrepancies on the delivery slip if necessary You will then have 48 hours to confirm by registered letter sent to the carrier After 48 hours the carrier will be able to deny these discrepancies If any material we sent was damaged during transportation the repair charges will be billed either to the carrier if the discrepancies were made within the period or to the recipient Check as soon as possible that all material is correctly working 26 SOPROLIFE User s manual TECHNICAL FEATURES SOPROLIFE High sensitivity CCD 1 4 e Resolution 752 x 582 PAL 768 x 494 NTSC e Definition 470 lines Sensitivity 2 lux e Lighting eight LEDs e Adjustment four preset positions Extra oral Intra oral LIFE Macro Two positions diagnostic and treatment Non inverted image Image capture through SoproTouch or footswitch optional Angle of view 70 e Cable length 2 5m Handpiece dimensions L 200 W 28 24 mm Usable part dimensions W 13 x H 8 mm Handpiece weight 78 DOCK M_USB2 Memory one and four images e Power supply 115 V 230 V 60 Hz 50 Hz 1 PAL or NTSC video output 1 PAL or NTSC S video output 1 digital USB output 2 0 Controller dimensio
7. or to clarify important information 2 SOPROLIFE User s manual ENGLISH SOPROLIFE INTRODUCTION Congratulations on your purchase of the Soprolife Caries Detection Aid System the latest product from Sopro Acteon Imaging in the aid of detection of caries Soprolife system provides the following benefits Motivates the patient to carry out a professional tooth cleaning Aids in the detection of caries Ideal complement to an X ray imaging system for patient care In mode 1 diagnosis aid mode SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution In mode Il treatment aid mode SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect In daylight mode SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror It allows the dentist to show the difference between before and after care This fluorescence Imaging device is composed of a handpiece SOPROLIFE and a connection box DOCK M USB2 DOCK M VIDEO DOCK MU USB2 DOCK VIDEO DOCK USB2 as well as various accessories necessary for it to work SOPROLIFE 1 handpiece integrating the camera electronics and lighting 1 handpiece holder 4 intra oral tips 2 light shields 10 dental barriers A quick start e Imaging software in demo version including documentations DOCK M VIDEO
8. the handpiece In order to do this please refer to the maintenance chapter SOPROLIFE User s manual 5 ENG I S H REGULATORY REQUIREMENTS 4 1 COMPLIANCE WITH STANDARDS AND REGULATIONS This product was designed and manufactured by a company having an authorized quality system It meets the European directive 93 42 EEC requirements relative to medical devices Therefore it particularly meets electrical safety and electromagnetic compatibility standards IEC CEM 4 2 ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES Electromagnetic compatibility CEM is the ability of electronic device elements to correctly interact in an electronic environment Although SOPROLIFE system was designed according to this compatibility and complies with the electromagnetic interference thresholds established by the regulatory agency there is no guarantee about interference likely to occur on a particular installation If the device generates interference with radio communication services which can be determined by switching it off and on it is recommended to try to correct this phenomenon by taking whole or part of the following measures Change the receiving antenna orientation Reposition the product according to the receiver Take the computer away from the receiver SOPROLIFE is designed and tested to be used in a home environment class B Group 1 according to CISPR11 standard 4 3 MEDICAL DEVICE VIGILANCE As with a
9. QUIRED CONFIGURATION FOR THE COMPUTER To use the SOPROLIFE system you must make sure the computer and its peripherals do not have any usage limitation that could concern personal safety It should also meet the following requirements Minimal configuration Recommended configuration Processor Intel Pentium III 500 MHz Intel Core 2 Memory 512 MB 2 GB Hard disk 20 GB 160 GB USB ports 2 x USB2 0 Hi Speed ports 4 x UB 2 0 Hi Speed ports Video board Graphic board 32 MB of unshared Graphic board with Nvidia chipset or exclusive video RAM compatible with DirectX 9 video 256 MB of unshared video RAM compatible with DirectX 9 or higher USB Chipset Intel or NEC Intel or NEC Screen resolution 1024 x 768 1024 x 768 or higher IEC 60950 IEC 60601 1 7 2 DOCK M USB2 CONNECTION e Connect the USB cable between the connection box and one of the computer USB ports Connect the connecting cable between the connection box and the handpiece e If you prefer using a footswitch rather than SoproTouch to freeze the image you just have to connect the footswitch optional to the connection box With this configuration SoproTouch is inhibited e Connect the power supply to the outlet and then to the connection box the green indicator light should be on 7 3 DOCK MU USB2 CONNECTION Refer to DOCK MU USB 2 integration manual e Connect the connecting cable to the handpiece e Connect the USB cabl
10. ance calculated with the applicable formulas depending on the emitter frequency Recommended separation distance Conducted RF 3 Vrms 1 16 JP 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 1 16 80 MHz to 800 MHz EN 61000 4 3 80 MHz to 2 5 d 2 33 800 MHz to 2 5 GHz 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 site should be lower than the compliance level in each frequency band Interference may occur in the vicinity of the devices bearing the following symbol 4 Note 1 At 80 MHz and 800 MHz the higher frequency band applies Note 2 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 SOPROLIFE User s manual 9 ENGLISH The fixed transmitter field levels such as the base stations of the radio telephones cellular wireless and the terrestrial mobile radios domestic 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 SOPROLIFE device exceeds the
11. cessories in order to guarantee to you safety and performance maximum The use of different origin accessories can represent a risk for you your patients and your device 4 SOPROLIFE User s manual ENG I S H SAFETY INSTRUCTIONS DO NOT expose SOPROLIFE to water spray and do not store it in a humid environment to prevent risk of electrocution e Install SOPROLIFE in a clean dry and well ventilated place e Disconnect the connection box from the power supply if you are not going to use it for several days Do not pull on the cable DO NOT compress or nip the handpiece cable DO NOT expose the product to high vibrations DO NOT drop the handpiece e Handpiece should NEVER be immersed in any liquid NOR should it be autoclaved e For each new patient it is essential to use the dental barriers provided with the handpiece Before using the SOPROLIFE make sure it does not have any sharp edges The surface temperature in the light emission area can reach above 41 C after several minutes of use Therefore avoid maintaining this emission area in contact with the patient s mouth SOPROLIFE is a product using class Il LEDs according to IEC 60825 To avoid any ocular risk do not look directly at the light NOTE If the hygienic protection is torn while examining a patient or if the handpiece was infected while withdrawing the hygienic protector it is essential to totally disinfect
12. cy 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 10 SOPROLIFE User s manual E N G gt INSTALLATION 5 1 CONNECTING Fastening the handpiece holder 1 Choose a plain area that can be easily accessible for use 2 Use the wipe provided to clean the surface on which you are going to fasten the holder 3 Remove the double sided adhesive tape protection that is on the support place it and then press it into place several times The maximum sticking performances are obtained after two hours so avoid any stress on the holder during this two hour period N CAUTION CAUTION This holder is equipped with magnets that can damage devices sensitive to magnetic fields Make sure you do not install this holder near these devices cathode ray tube video screen magnetic videotapes etc 5 2 FURTHER CONNECTION BOXES optional You can install a connection box near each dental chair no limitation You will just have to transport the handpiece from one chair to the other The handpiece holder is intended to maintain the connecting cable connector when the cable is not linked to the handpiece When you disconnect the handpiece connecting cable to take it to another chair or when you put the handpiece on its holder the last stored image is displayed on the screen or t
13. e between the connection box and one of the computer USB ports 7 4 DOCK USB2 CONNECTION Connect the USB cable to one of the computer USB ports e Connect the connecting cable to the handpiece SOPROLIFE User s manual 13 ENGLISH 7 5 SOPRO IMAGING SOFTWARE INSTALLATION elnsert the SOPRO Imaging CD ROM into the driver It will be executed 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 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 dialog box opens it is the main menu window allowing the installation of a certain number of programs related to SOPRO Imaging application 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 the files allowing an automatic launch and or a manual setup Located in the directory Document and its subdirectories are all the documents about the Sopro Imaging software digital x ray systems intra oral cameras and SOPROLIFE system These documents in PDF format Be sure to correctly install Acrobat Reader in case of reading difficulties The Drivers directo
14. ean directive 93 42 EEC Complies with EC60601 1 standard Complies with IEC60601 2 18 standard Complies with UL 60601 1 et CSA 60601 1 standard 28 SOPROLIFE User s manual y ce ACTEON Imaging ZAC Ath lia IV Avenue des Gen vriers 13705 LA CIOTAT cedex FRANCE T l 33 0 442 98 01 01 e Fax 33 0 442 71 76 90 E mail info sopro acteongroup com www sopro acteongroup com Non contractual document Ref 011274A Copyright 0 2009 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
15. green or blue displayed in the image should direct the dental professional to examine that area using Gold Standard techniques The Soprolife image information together with results of visual Gold Standard examination and X ray image inspections can be used to identify any caries and to formulate an appropriate treatment plan NOTE The Soprolife is an aid in the detection of caries by providing additional information to supplement the dentist s visual observations patient history and information from other diagnostic techniques resulting in an overall treatment determination The Soprolife does not provide a diagnosis Diagnosis subsequent to the use of the Soprolife is performed and provided by the dental practitioner Any use that is not described in this manual as correct usage is considered as incorrect usage The manufacturer is not to be held liable for any damage caused as a result of incorrect usage The operator bears all risks Soprolife today has not been proven to detect incipient or just beginnings caries SOPROLIFE needs to be used with a distal tip or a light shield in both diagnosis aid mode and treatment aid mode These accessories provided with SOPROLIFE enable displacement of ambient lighting light shield must be threaded on the camera distal part with this accessory the dental light can be kept in position distal tip must be put on the camera s head when using this accessory it is
16. he last four if you were in four image mode or the colour bar pattern if no image was stored Except on Dock USB2 5 3 FOCUSING ADJUSTMENT On the handpiece there is a rotating ring used to focus from 0 to infinite To simplify handling we have pre set four positions corresponding to the main SOPROLIFE uses Extra oral Portrait ntra Oral 1 to 5 teeth LIFE cavities and pulp chamber observation Macro details that cannot be seen with naked eye SOPROLIFE User s manual 11 ENG I S H CONNECTING TO A VIDEO SCREEN 6 1 CONNECTION OF DOCK M USB2 OR DOCK M VIDEO e Connect the video cable preferably Y C S video between the connection box and the monitor video input Connect the connecting cable between the connection box and the handpiece e If you prefer using a footswitch rather than SoproTouch to freeze the image you just have to connect the footswitch optional to the connection box With this configuration SoproTouch is inhibited Connect the power supply to the outlet and then to the connection box the green indicator light should be on Only use the power supply provided with the connection box 6 2 CONNECTION OF DOCK MU USB2 OR DOCK MU VIDEO Please refer to DOCK USB2 or DOCK MU VIDEO integration manual for its connections Connect the connecting cable to the handpiece e Connect the video cable preferably Y C S video between the connection box and the m
17. in power supply quality should be one of a traditional commercial or hospital environment Dips brief outages and power voltage variation EN 61000 4 11 lt 5 U for 10 ms 40 U 100 ms 70 U 500 ms lt 5 U 5s for for for lt 5 Ur 10 ms lt 40 Ur 100 ms lt 70 500 ms lt 5 Ur 55 The main power supply quality should be one of a traditional commercial or hospital environment If the user of SOPROLIFE device requires it to continue to operate during main power supply outages it is recommended SOPROLIFE device is fed by an inverter or a battery Magnetic field with the network frequency 50 60 Hz 3A m 3A m The magnetic field with the network frequency should be at a characteristic level of a location in a traditional commercial or hospital environment Note Uz is the power voltage nominal value applied during the trial 8 SOPROLIFE User s manual ENGLISH Guide and declaration of the manufacturer electromagnetic immunity SOPROLIFE device 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 SOPROLIFE device including the cables lower than the recommended separation dist
18. ion 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 24 SOPROLIFE User s manual 12 2 IN CASE OF FAILURE PROBLEMS With a video monitor No image displays on the screen and SOPROLIFE LEDs are not on CAUSES ENGLISH SOLUTIONS Defective power supply connection problem 1 Check the power supply is correctly connected to the network and to the connection box 2 Check the connecting cable is correctly connected to the handpiece and to the connection box SOPROLIFE switches on but no image displays on the screen An image displays on the screen but the quality is not satisfactory e Defective monitor power supply Connection problem Monitor configuration 1 Check the video cable is correctly connected to the monitor and to the connection box 2 Check the monitor is switched on Check the video monitor configuration is correctly set up brightness contrast saturation etc An image displays but it is not really clear blurry With a computer No image displays on the screen and the SOPROLIFE LEDs are not on Rotating ring Hygienic protector Defective power supply connection problem 1 Check the rotating ring is correctly positioned Extra oral Intra oral LIFE macro 2 Check the hygienic protector is co
19. necessary to move the dental light in order to avoid light in the patient s mouth 16 SOPROLIFE User s manual ENGLISH 8 1 DIAGNOSIS AID MODE In mode 1 diagnosis aid mode SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution DIAGNOSIS AID MODE is used to view the fluorescence of the tooth surfaces in order to quickly identify areas for the dentist to examine using Gold Standard methods The images provided are displayed with colors than can be interpreted following the tab bellow Alert signal Displayed color Acid green Light green to blue according Green black or Bright red or to the thickness of the enamel black red or miss of color grey area Supposed state of tissue Healthy dentine Healthy dentine Suspicious area Examine for Healthy tooth Healthy tooth Use Gold Standard techniques to examine for potential caries In case of alert signal always perform a professional cleaning using a prophy brush powder jet cleaner or other acceptable means to remove any debris meal deposits dental tartar plaque detection agents and preventative materials such as fluor paste that can interfere with caries detection Then process to a new examination 8 2 TREATMENT AID MODE In mode Il treatment aid mode SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect It helps to check the exeresis quality of damage tis
20. ngly recommended to follow a disinfecting process First of all clean the handpiece with disinfecting wipes then wrap the handpiece in several disinfecting wipes and leave for 15 minutes SOPROLIFE User s manual 23 ENG I S H AFTER SALES SERVICE 12 1 WARRANTIES SOPRO ensures its products to be free from material and manufacturing defects for a period of one 1 year from the date of purchase 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 an extended warranty period on behalf of SOPRO The entire liability of SOPRO is limited to its convenience when replacing or repairing free of charge the defective product if it has been sent to SOPRO After Sales Service This applies for the warranty period Outside of France access to the warranty is only possible if the product was bought at a point of sale by an authorized SOPRO dealer in the country where it will be used THIS WARRANTY APPLIES ONLY TO THIS UNIQUE REMEDY IT REPLACES ANY OTHER WARRANTY FOR EXAMPLE A WARRANTY OF ADEQUACY TO A PARTICULAR AIM SHOULD IT BE EXPLICIT OR IMPLICIT SOPRO SHALL NOT BE LIABLE FOR ANY PARTICULAR DAMAGE INDIRECT ACCIDENTAL OR CONSEQUENTIAL NOR FOR ANY DETERIORATION OR DATA LOSS ON A CONTRACTUAL NON CONTRACTUAL OR OTHER BASIS The liability exclus
21. ns L 145 W 130 H 35 mm Controller weight 245 DOCK M VIDEO Memory one and four images e Power supply 115 V 230 V 60 Hz 50 Hz 1 PAL or NTSC video output 1 PAL or NTSC S video output Controller dimensions L 145 W 130 35 mm Controller weight 245 SOPROLIFE User s manual 27 ENGLISH DOCK MU USB2 Memory one and four images e Power supply 24 V 50 Hz 60 Hz Consumption 10 VA 1 PAL or NTSC video output 1 PAL or NTSC S video output 1 digital USB output 2 0 Controller dimensions L 100 W 72 36 mm Dock weight 190 DOCK MU VIDEO Memory one and four images Power supply 24 V 50 Hz 60 Hz Consumption 10 VA 1 PAL or NTSC video output 1 PAL or NTSC S video output Controller dimensions L 100 W 72 36 mm Dock weight 190 g DOCK USB2 e Cable length 3 5 m 1 digital USB output 2 0 Controller dimensions L 100 l 46 H 20 mm Dock weight 165 g BF type applied part Operating temperature 10 to 40 Storage temperature 20 C 45 e Relative humidity 10 to 90 e Atmospheric pressure 900 hPa to 1 060 hPa Continuous service Not protected against water chutes Not adapted to the use in presence of an anaesthetic mixture flammable with air oxygen or dinitrogen monoxide Complies with the Europ
22. ny medical device this device is subjected to 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 6 SOPROLIFE User s manual ENGLISH 4 4 END OF LIFE 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 contribute to avoiding any damage to the environment and human health The symbol 2 on the device or on the accompanying documentation indicates this product cannot be in any case treated as household waste Therefore it should be transferred to a waste collection centre that handles electric and electronic equipment recycling Please respect the standards relative to waste disposal in force in the installation country For more details about the device treatment recuperation and recycling please contact your dental device distributor or failing that the group ACTEON site www acteongroup com so that you can be informed of the procedure 4 5 ELECTROMAGNETIC COMPTABILITY Guide and declaration of the manufacturer electromagnetic emissions SOPROLIFE device is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment Emission trial Compliance Electromagnetic envir
23. ol Wipes from Pierre Rolland SOPROLIFE User s manual 21 ENG I S H MAINTENANCE The SOPROLIFE does not need any maintenance if it is used according to the manufacturer s use and cleaning instructions Before first using it it is imperative to follow the complete disinfecting procedure Any SOPROLIFE returned from servicing or maintenance should be completely disinfected before being used WARNING Do not use products containing Ammoniac trichloroethylene Dichloroethylene Ammonium hydrochlorid Chlorinated and aromatic hydrocarbon Ethylene dichloride Methylene chloride Ketones Use of these chemicals subject plastic parts to risk of deterioration WARNING Do not directly spray disinfecting products on SOPRO products 22 SOPROLIFE User s manual ENGLISH 11 1 HANDPIECE OR CONNECTION BOX MAINTENANCE DESCRIPTION RECOMMENDATIONS USE INSTRUCTIONS AND PRECAUTIONS x Disinfecting Surface cleaning and Take the wipe remove X Do not scrub disinfecting wipes e g excess moisture and then X Do not rinse Septol Wipes from wipe the equipment until X Do not immerse in Pierre Rolland visible cleanliness is a disinfecting obtained liquid v Allow to dry in the open air v Carefully close the packaging box NOTE In case of contact with blood or excessive soiling it is stro
24. ompany can be read with the 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 7 6 SOPRO IMAGING SOFTWARE CONFIGURATION WITH A SOPROLIFE SYSTEM Refer to the Sopro Imaging owner s manual that is on the Sopro Imaging CD ROM in the document directory 7 7 USING SOPRO IMAGING SOFTWARE WITH LIFE FUNCTION Refer to the Sopro Imaging owner s manual that is on the Sopro Imaging CD ROM in the document directory SOPROLIFE User s manual 15 OPERATION PROTOCOL OF SOPROLIFE IN DIAGNOSIS AID MODE AND TREATMENT AID MODE The Soprolife is used as an aid in the detection of caries The light emitting diode LED lamps in the Soprolife emit blue light In diagnosis aid mode and treatment aid mode which causes healthy dentin to fluoresce with a green color The optics and the charged coupled device CCD sensor in the Soprolife picks up the images containing this fluorescence highlights it and converts them to an video signal that is sent to a video monitor or computer monitor The result image can be used to aid the dental practitioner to perform diagnosis As an aid in the detection of caries any color other than acid green light
25. onitor video input 6 3 OPERATION OF SOPROTOUCH IMAGE FREEZE ON SOPROLIFE When powering on the soprolife automatically selects the one image mode switch to four image mode press SoproTouch lt for more than three seconds until a black flash appears on the screen or if you have chosen to use a footswitch press it for more than three seconds Perform the same procedure to switch back to one image mode In one image mode you just have to slightly touch SoproTouch or briefly press the footswitch once as Soon as the desired image appears on the monitor The image is automatically stored in the SOPROLIFE and displayed on the screen If you want to return to direct mode you just have to slightly touch SoproTouch lt once more or press the footswitch e Another little gentle touch on SoproTouch lt or press on the footswitch will freeze another image by deleting the previous one n four image mode the image is stored in one of the quarters of the screen when you slightly touch SoproTouch lt or press the footswitch and remains displayed on the screen Another little slight touch SoproTouch or press of the footswitch will return the image to direct mode A third little slight touch or press will store a second image in another quarter of the screen and so on until obtaining the four images 12 SOPROLIFE User s manual EN GJ gt CONNECTING TO A COMPUTER 7 1 RE
26. onment Guide RF emissions SOPROLIFE device only uses radio energy for its CISPR 11 internal functions Therefore its RF emissions are very low and are unlikely to cause interference with nearby electronic devices RF emissions Class B SOPROLIFE device may be used in all domestic CISPR 11 environments including the ones directly connected to the public low voltage power distribution network used to supply household buildings Harmonic emissions Not applicable EN 61000 3 2 Voltage fluctuations Applicable Flicker EN 61000 3 3 SOPROLIFE User s manual 7 ENGLISH Guide and declaration of the manufacturer electromagnetic immunity SSOPROLIFE device is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment Immunity trial Electrostatic discharges EN 61000 4 2 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 one of a traditional commercial or hospital environment Voltage shocks EN 61000 4 5 Differential mode x 1 kV Common mode 2 kV The ma
27. ries contain the drivers necessary for the use of 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 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 SOPRO Imaging software will automatically install in 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 14 SOPROLIFE User s manual ENGLISH NOTE To obtain the best performance possible when using the SOPRO Imaging 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 amp 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 C
28. rrectly positioned on the camera head 1 Check the power supply is correctly connected to the network and to the connection box 2 Check the connecting cable is correctly connected to the handpiece and to the connection box SOPROLIFE switches on but no image displays on the screen Configuration Driver Connection problem 1 Check the SOPROLIFE is correctly set up in Sopro Imaging please refer to Sopro lmaging user s manual 2 Check the camera is correctly detected in the device driver correct installation of its driver 3 Check the USB cable coming from the DOCK is correctly connected to the HUB An image displays on the screen but the quality is not satisfactory SOPROLIFE driver configuration Check the camera configuration in the Sopro Imaging software brightness contrast saturation etc Please refer to Sopro Imaging user s manual An image displays but it is not really clear blurry Rotating ring Hygienic protector 1 Check the rotating ring is correctly positioned Extra oral Intra oral LIFE macro 2 Check the hygienic protector is correctly positioned on the camera head SOPROLIFE User s manual 25 ENGLISH The SOPROLIFE should be sent to us in its totality connection box handpiece cables Please enclose your packing list with a brief explanatory note relative to the noticed defect If some parts constituting SOPROLIFE happen to break it is
29. sue during or at the end of the preparation in several clinical situations common in general practice Diagnosis subsequent to the use of the Soprolife is performed and provided by the dental practitioner The images provided are displayed with colors than can be interpreted following the tab bellow In case of quick carious processus Alert signal Alert signal Alert signal Displayed Acid green or Light green black or dark green dark green with red shadow color green to blue Bright red according to the thickness of the enamel Supposed Healthy dentine Completely Affected Affected dentine end of treatment state of decayed infected dentine end of there can still be a red shadow at the tissue dentine or affected treatment bottom of the cavity linked to a very Interface hard tissue It represents the tertiary dentine and testifies of the answer of the pulp to the carious attack Examine Healthy tooth Suspicious area Presumed end Presumed end of treatment for of treatment SOPROLIFE User s manual 17 ENGLISH Diagnosis subsequent to the use of the Soprolife is performed and provided by the dental practitioner Alert signal is only an indication the dental practitioner is the only expert to judge and adapt his treatment s option to the situation and also decide to stop treatment based on his clinical sense In case of slow carious processus Alert signal Alert signal Displa
30. yed color Acid green Light green to blue green black or Bright red and dark green veil according to the thickness of the red enamel Supposed state Healthy dentine Completely decayed Affected dentine end of of tissue infected dentine treatment affected Interface Examine for Healthy tooth Suspicious area Presumed end of treatment Diagnosis subsequent to the use of the Soprolife is performed and provided by the dental practitioner Alert signal is only an indication the dental practitioner is the only expert to judge and adapt his treatment s option to the situation and also decide to stop treatment based on his clinical sense 8 3 MODE SELECTION Button Pressing on button I makes it possible to switch from daylight mode to diagnosis aid mode and inversely Button 11 Pressing on the button makes it possible to switch from daylight mode to treatment aid mode and inversely NOTE An alternated push on the button I then on the button II makes it possible to switch from diagnosis aid mode to treatment aid mode 18 SOPROLIFE User s manual ENG I S H DESCRIPTION OF THE CONNECTION BOXES 9 1 DOCK M USB2 AND DOCK M VIDEO POWER SUPPLY SOPROLIFE power supply is connected to the power outlet The other end of the cord is connected to the connection box where the symbol 6 is located PHIHONG PSA 10R 060 Model or FRIWO MPP15 FW 7555M
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