User Manual F100 Digital intraoral x
Contents
1. lt 5 96 Ut gt 95 dip in Ur for 5 sec 5 Ur gt 95 96 dip in Ur for 0 5 cycle 40 96 Ut 60 dip in Ur for 5 cycles 70 96 Ur 30 96 dip in Ur for 25 cycles lt 5 96 Ut gt 95 dip in Ur for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the F100 requires continued operation during power mains interruptions it is recommended that the F100 be powered from an uninterruptible power supply or a battery Page 23 of 26 3 A m 3 A m Power frequency magnetic fields Power frequency should be at levels characteristic of a 50 60 Hz ce UM es a magnetic field typica pester a typical commercia or hospital environment IEC 61000 4 8 NOTE Uris the a c mains voltage prior to application of the test level Page 24 of 26 EMC Declaration Continued Guidance and manufacturer s declaration electromagnetic immunity The F100 is intended for use in the electromagnetic environment specified below The customer or the user of the F100 should ensure that it is used in such an environment li Immunity test IEC 60601 test level ae Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the F100 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmit2. size 1 universal sensor Use for regular periapical and retro coronary procedures The sensor is connected to the computer with USB 2 0 connector You do not need to start the ORFC Software before you connect the sensor However you can acquire the image only in the imaging module You can disconnect the sensor with the power on but do not disconnect the sensor when you are acquiring an image This can damage the sensor 6 2 X ray Generator The x ray generator has a significant impact on image quality Due to its high sensitivity and capacity to store an enormous quantity of information the sensor requires high energy rays generated over very short time periods This way the images are formed by a maximum number of gray levels and you can process the images digitally to assist in extracting the clinical information WARNING The power of a generator decreases over time Have the generator inspected annually to determine any difference between its nominal and effective power As a general rule the sensor is compatible with all generators provided the generator meets the current standard of intraoral radiology You can use a high frequency or conventional generator The generator must operate with a voltage of 60 to 70kV The generator head must have a long cone with a focal point film distance of at least 20 cm to concentrate the x rays toward the sensor Select a mechanism that supports the generator and provides stability to a
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4. Acquiring a Good Image To obtain a good image in digital radiology follow the rules that apply to classic radiology The same anatomy limitations determine the positioning of the sensor in the mouth You may require time to adapt to the new dimensions of the sensor Page 11 of 26 6 6 1 Preparing the Sensor To ensure maximum hygiene cover the sensor with a disposable protective sheath prior to using the sensor To prevent cross contamination use a new hygienic barrier for each new patient For optimum performance use protective sheaths specifically designed for the size of sensor Note 7 For the additional instructions on hygiene see Disinfecting the Sensor and Maintaining Hygiene 6 6 2 Positioning the Sensor An X ray image sensor is positioned in the patient s mouth just like intraoral film Figure 6 1 shows a positioning example Figure 6 1 Positioning Example 6 6 2 1 Positioning the Sensor for a Mandibular Image To position the sensor for a mandibular image follow these steps 1 Have the patient draw the tongue towards the back of the mouth Insert the sensor holding it horizontally 2 Then turn the sensor downward to place it in a vertical position 3 Center the sensor on the targeted tooth For premolars and incisors move the sensor towards the center of the mouth by compressing the tongue when the mouth closes to relax the muscles The rigidity of the sensor and the positioning system aids in
5. system EMI Limitations Possible EMI sources should be identified before the unit is installed Electrical and electronic equipment may produce EMI unintentionally due to one of the following defects High frequency electrotome Transformer Defibrillator Wireless LAN equipment Medical lasers Scanners Cauterizing guns Computers Monitors Fans Gel warmers Microwave ovens Light dimmers Portable phones The presence of a broadcast station or broadcast van may also cause interference If you find strong interference shows on the screen please check the sources Electromagnetic Compatibility EMC Operating the sensor in close proximity to sources of strong electromagnetic fields such as radio transmitter stations or similar installations may lead to interference visible on the monitor screen However the device has been designed and tested to withstand such interference and will not be permanently damaged 27 Do not modify this equipment without authorization of the manufacturer 28 The system is not serviced or maintained while in use with the patient Page 3 of 26 1 3 2 General Cautions CAUTION 1 Before use you must make sure that there is no visible evidence of damage on the equipment cables and probes which may affect patient safety or diagnostic capability The recommended inspection interval is once per week or less If damage is evident replacement is recommended before use 2 If the power cord of the
6. system is missing damaged or not provided please purchase the power cord meeting the specification requirements for the original one and complying with the local regulations 3 The device and accessories are to be disposed of according to local regulations Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal 4 Please use the standard power cord as the input line of the network power supply for the adapter to reduce risk 5 No user serviceable parts are inside the system All repairs on the system must be performed by Fussen certified service personnel NOTE To avoid damaging the system DO NOT use it in environment as below 1 Locations exposed to direct sunlight Locations subject to sudden changes in ambient temperature Dusty locations Locations subject to vibration Locations near heat sources Oyo UT uo UA c Locations with high humidity Page 4 of 26 1 4 List of Symbols Caution Follow Instructions for Use Type BF Device The sensor is a Type BF device He E Recycle P N Part Number SN Serial Number Date of Manufacture Manufacturer The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices Authorized Representative in the European Community The symbol indicates that the device should be sent to the special agencies according to
7. the generator is producing x rays have it checked by a certified technician Appendix C EMC Declaration Guidance and manufacturer s declaration electromagnetic immunity The F100 is intended for use in the electromagnetic environment specified below The customer or the user of the F100 should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge 1 kV differential 1 kV differential Mains power quality should be that of a ical ial or hospital IEC 61000 4 5 ode mod typical commercial or hospita 2 kV common mode 2 kV common mode environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 UT gt 95 dip in Ur for 0 5 cycle 40 Ut 60 dip in Ur for 5 cycles 70 96 Ur 30 dip in Ur for 25 cycles
8. the lower part of the sensor away from the incisive edge to place it parallel to the real axis of the teeth Lower Anterior Region For a narrow mouth move the sensor back parallel to the real axis of the teeth while pushing back the tongue slightly Use the blunt edges of the sensor to depress the floor of the mouth to better frame the apical area This product is recommended for use Rinn film holder is DENSPLY company s production of the following products Code Model 559900 XCP DS FIT Hygiene Kit 559908 XCP DS FIT Endo Kit 559909 XCP DS FIT Hygiene Kit plus Endodontic Holders 550771 XCP ORA Arm amp Ring l pk 550772 XCP ORA Arm amp Ring 2 pk 550773 XCP ORA Ring only l pk 550774 XCP ORA Arm only 1 pk 550598 XCP DS Endo Ring l pk 50597 XCP DS9 Endo Arm 1 pk 559901 XCP DS FIT Anterior Biteblock 2 pk 559902 XCP DS FIT Posterior Biteblock 2 pk 559903 XCP DS FIT H Bitewing Biteblock 2 pk 559904 XCP DS FIT V Bitewing Biteblock 2 pk Page 14 of 26 559905 eer FIT Endo Biteblock 2 pk 7 Software operating Guide About the software operating guide refer to the software manual 8 Disinfecting and Maintaining the Sensor 8 1 Disinfecting the Sensor and Maintaining Hygiene Carefully follow the procedure detailed earlier in this manual on how to prepare the sensor to ensure maximum hygienic safety for th
9. warnings especially safety warnings NOTE 1 This system is not intended for home use 2 The pictures and windows in this manual are for reference only 1 3 1 Safety Warnings WARNING 1 Failure to follow the safety instructions for operating the instrument and system could endanger the patient The manufacturer accepts no liability for damages resulting from improper use 2 System installation shall be in accordance with the requirements of IEC 60601 1 the Standard for Safety Requirements of Medical Electrical Systems Page 1 of 26 10 11 12 13 14 15 16 17 Only qualified and authorized personnel may operate this equipment observing all laws and regulations concerning radiation protection This system is not intended for treatment This equipment must only be used in rooms or areas that comply with all applicable laws and recommendations concerning electrical safety in rooms used for medical purposes The diagnosis and examination function of the system should be integrated with clinical situation of patients and the diagnostic results are only for physician s reference EXPLOSION HAZARD Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide The device is not waterproof Do not use it in locations where water or any liquid leakage may occur Do not use any fluid onto the system surface as fluid seepage into t
10. Acquisition button is active not grayed out If the button is grayed out check the connection of the sensor on the USB 2 0 port The acquisition function was not activated click on the Acquisition button The button turns green or use the button on the remote control take the X ray image within 90 seconds If the system is connected to the timer Check the connection with the timer Check that the hub is powered properly Contact your dealer The image is pale and grainy The exposure time is too short increase it The selected acquisition mode does not correspond to the x ray dose used The generator voltage is too low 60 kV rms have the generator checked The generator is too far from the patient with respect to the selected dose Check the monitor contrast and brightness settings and ensure there are no reflections on the screen The image is too dark The exposure time is too high lower it The selected acquisition mode does not correspond to the Page 22 of 26 x ray dose used Check the monitor settings contrast and brightness and ensure there are no reflections on the screen The image is blurred Patient moved during exposure Generator head was not stable Use an image filter The image is white Active face of sensor was not exposed to x rays X ray dose is insufficient Sensor is not connected or is improperly connected Ensure
11. O mb naa etai du 5 2 About the Mant l 5 e tree re tii be rere eed fei ie i e eg 6 2 1 Application of the Manual esee nennen nennen nennt 6 2 2 Applicable ODIBCL acaso te e etta eoa males Gu pur pube tt Re dt adapter pA ences 6 2 9 Legend and Name e ertet eee etie rd dre e e ee d 6 3 Product informatioh eoe eir ee ede e LEE He E Re e EE ede 7 Lag ic rM y 5 Installation ang EXIU rei eaedem 7 5 1 Installation ere t ah tee nte e e Re Ere D a e 7 SpA zi haa EE cap pate ccna aawtuce aasy ig staan terns a Gg ecaaare Saunas mae snares 8 6 Understanding the Imaging Chain eese ener enne 8 BP SONS Off ME 8 6 2 X ray GIerIGrator ee Had e UU E diddeliaisbnuinyndaa Ginseng Cipro 9 0 3 TITIO oce ma rte e o eet ma e te E RR 10 6 4 Computer and Monitor ziasi eere t tb eie ee eet mtus 10 6 5 Adjusting Exposure TMe ncssa enne enne 10 6 6 Acquiring a Good Image ertt tkt rtr itn th M n e o endis 11 6 6 1 Preparing the S8rnsor s oi eie reri a o RR II istae din S 12 6 6 2 Positioning the SerisOr ed e eie eA ente 12 7 Software operating Guides quia oou tue a ph D eM rx E REECRRR RR MERO I Ra TuS 15 8 Disinfecting and Maintaining the Sensor eee 15 8 1 Disinfecting the Sensor and Maintaining Hygiene see 15 8 2 Cleaning the Cable 5 dar pp NBN TOT NUI rus itis tmb NER rU 16 8 3 Storing the Sensor Aft
12. User Manual FUSSEN F100 Digital intraoral x ray imaging system Version 1 0 C About this Manual P N 11 54 0008 Release Date July 2013 Copyright Fussen Technology Co Ltd 2013 All rights reserved Authorized Representatives Well Kang Limited Statement The User Guide for F100 includes information on the devices as well as their usage We recommend that you thoroughly familiarize yourself with this Guide in order to make the most effective use of your system User s operation failing to comply with this manual may result in malfunction or accident for which Fussen Technology Co Ltd hereinafter called Fussen can not be held liable Fussen owns the copyrights of this manual Without prior written consent of Fussen any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of Fussen Fussen holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer Fussen only considers itself responsible for any effe
13. affected by the amount of RAM and storage memory available to the system for acquisition displaying storing and printing digital X Ray images The recommended requirements are listed as a guideline only NOTE Be aware that the patient volume and the specific demands of your practice may require adjusting these guidelines accordingly The system requirements of other programs operating on the same computer or network may affect these guidelines as well 5 Installation and Exit 5 1 Installation First pull USB connect of Sensor into PC USB 2 0 port NOTE Page 7 of 26 1 The USB calbe must be connected to USB sockers only Do not connect the cables to any other equipment 2 If the distance between the SENSOR and the PC exceeds 5M a HUB must be used E F100 N Fixed 2 or 5m USB HUB Then start ORFC console the software operating guide refer to the Software User Manual 5 2 EXIT 1 Close ORFC console 2 Pull out F100 from computer USB port 6 Understanding the Imaging Chain The imaging chain consists of the following components Sensor X ray generator Timer Computer and monitor 6 1 Sensor Page 8 of 26 r The sensor is radio sensitive zi The back of the sensor non reactive to x rays is rounded corner and contains the cable attachment Applied part is the sensor In the operating environment of 40 C the highest surface temperature of the sensor may reach the 42 C
14. chronized mode or during acquisition Do not force bend or pull the cable at the sensor side Do not immerse the sensor 8 5 Preventing Electrostatic Discharge To prevent electrostatic discharge do the following When the sensor is not connected store it in its case Do not touch the monitor s screen and the sensor simultaneously This can result in serious damage to the sensor Do not touch the contact points of the USB connector of the sensor 8 6 Protecting Computer Data Back up the database daily on several high capacity magnetic media streamer ZIP DAT used alternately Ask for advice from your computer dealer Store the copies in a secure location Page 17 of 26 9 Maintenance You should be familiar with all the operation methods of this system It is strongly recommended to understand the whole operation process before use it F100 digital intraoral x ray imaging system just needs simple maintenance during the operation process But only the right operation method can guarantee durable and stable working As a result you must comply with the notice and maintenance presented by the manufacturer strictly WARNING Turn off the power before cleaning CAUTION 1 Avoid pouring liquid on the equipment while cleaning 2 Never place the sensor in an autoclave This can damage the system 3 Never immerse the connector located on the other end of the cable nor the sensor 4 Immerse part of the cabl
15. ct on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by Fussen and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request Fussen may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which Fussen may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure Table of Contents WS ATC Ly OUI 6B so sono Yates neh yok tac obese isa D Babe aada darea aea dans aiana aiat 1 Tet Intended lsa pet rd rr rtr 1 1 2 Gontralrticatiols s seed eee a oo e n het i deans aiid 1 1 3 Warnings and Cautlons ue cidinto ttr i nl RR Rede eL EUR a RV Rete De rus 1 1 3 1 Safety MEDIO ato stitit d o e Doa tatiteq HATH MTM MEE 1 1 9 2 General Cautions aon coe te dd eA ae 4 1 4 LISt OL Symbols 3d on iive p ep o dn ep e
16. demark of Ecolab Paragerm Laboratories SEKUSEPT Easy trademark of Ecolab Paragerm Laboratories FD333 trademark of DURR Dental Laboratories FD332 trademark of DURR Dental Laboratories Caution 1 Do not place the sensor in an autoclave This can damage the system 2 Do not immerse the connector and the sensor Note Immerse part of the cable to guarantee a good disinfection 8 2 Cleaning the Cable Clean the cable carefully by using a disinfecting wipe When cleaning the cable with one hand holding the sensor the other hand has been wiped from the end of the sensor over the first twelve inches of the cable without pulling on the cable insulation Slide the wipe without force pinching the cable between the fingers with minimal pressure 8 3 Storing the Sensor After Use It is strongly recommended that you store the sensor in its case at the end of the day to prevent it from falling or from coming into contact with abrasive cleaning products Page 16 of 26 8 4 Maintaining the Sensor WARNING Follow these guidelines to prevent damage to the sensor In order to extend the life of the sensor do the following Do not place the sensor in a sterilizer or autoclave Do not pull on the cable even when removing the disposable protective sheath Do not walk on or roll objects over the cable Do not request the patient to bite on the sensor or the cable Do not disconnect the sensor during the 90 second delay in non syn
17. e patient Note Our sensors are supplied non sterile To disinfect the sensor and maintain proper hygiene follow these guidelines Use a new hygienic barrier for each new patient The barrier must be biocompatible following the standard ISO 10993 1 When selecting a disinfectant product check the list with the product manufacturer s information carefully Do not clean the sensor or cable with abrasive tools Do not use disinfectants that contain bleach or alcohol The sensor cable can be soaked in a disinfecting solution as long as there is no mechanical damage to the cable If mechanical damage is recognized consult with Fussen technical support before attempting to immerse the cable Thoroughly disinfect the sensor after each patient Remove the hygienic protective sheath and thoroughl y clean the sensor with a disinfecting wipe Use only cold disinfecting products that are authorized by local dental regulatory agencies Page 15 of 26 Follow the manufacturer s recommendations for safety precautions when using the disinfectant product Before the use of sensor clean the sensor and the first centimeters of the cable by using a disinfecting cloth Wipe down the sensor with a sterile solution and keep the sensor off of the floor at all times Preferred disinfecting liquids DENTASEPT trademark of ANIOS Laboratories Prohibiting the use of Alcohols Isopropyl Alcohol Methanol SEKUSID N tra
18. e to guarantee a good disinfection Do not immerse the sensor Maintenance of the Main Unit and the Monitor 1 Keep the main unit and the monitor clean The main unit case can be cleaned with a soft cloth dampened with water If necessary use a mild detergent but carefully remove any residue Use water very sparingly to prevent liquid from seeping into the equipment 2 The main unit and the monitor should be placed in a dry and well ventilated place Avoid placing them in a dusty and humid environment The air path for cooling the system should be kept well ventilated Maintenance of the CD 1 Do not bend or press the CD 2 Clean the CD with a disk cleaner Do not use organic solvents such as acetone 3 Do not handle the CD while smoking or eating 4 Keep the CD away from direct sunlight and high temperature Otherwise the CD may become deformed Page 18 of 26 5 Do not get the CD wet 6 Do not touch the disk surface of the recorded side If the surface becomes contaminated with any foreign substance such as fingerprints reading data may be impossible 10 Accessories WARNING Only accessories supplied by the manufacturer can be used Or else the performance cannot be guaranteed Table 1 Standard Accessory List Accessory Quantity USB Cable 1 Installation CD 1 Sensor 1 Table 2 Optional Accessory List Accessory Quantity Softdog 1 Computer 1 The F100 digital i
19. er S6 oo o esaet On DU E 16 8 4 Maintaining fhie Sensor e eit tei et e the er reb Ne 17 8 5 Preventing Electrostatic Discharge seen 17 8 6 Protecting Computer Data 2 entretien re ee trea e een ee da 17 9 Malhteharice ee D eet teret p ee to uot be dr eee pi E De ER dee 18 jeep EE 19 TT Warrarity and Servite ne veo aer a i D HOT dt ti n ORE Lens 20 11 1 Warranty uses eun ERR PEEN eges 20 WA AAS OMEACLUS acts tea Ash Rte tbe bot Aaa ra Calder M niaan 20 AppendixA SpSeOIICAllOrts soient tr hp Hos pi ben Pn eel ined I Green a eda s 21 Appendix B Troubleshooting Images eene 22 Appendix G EMCO Deolaraton c oca te ivoox ee adiu Mp RN RM rx UR OMS 23 1 Safety Guidance This chapter provides important safety information related to the use of Digital intraoral x ray imaging system 1 1 Intended Use The system is used by dentists and other legally qualified professionals for dental radiographic examination and diagnosis of diseases of the teeth jaw and oral structures in hospitals or clinics The system is intended for adult patients but paediatric and pregnant women with caution 1 2 Contraindications None known 1 3 Warnings and Cautions In order to use the system safely and effectively Please read this manual carefully and be familiar with the proper operation method of ORFC Software and sensor before starting to use the device paying particular attention to
20. g a minimum distance between portable and mobile RF communications equipment transmitters and the F100 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m jabai i 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz dl 35 ral d 9p d LWP E1 E1 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Page 26 of 26 P N 11 54 0008 FUSSEN Smile in your life EC REPRESENTATIVE Well Kang Limited The Black Church St Mary s Place Dublin 7 Ireland TEL 353 1 4433560 FAX 353 1 6864856 E mail AuthRep CE marking eu MANUFACTURE Fussen Technology Co Ltd 3F 10 Building Tongfuyu Industrial Zone Taoyuan Street Nanshan District Shenzhen China TEL 86 755 21670890 FAX 86
21. he electrical circuitry may cause excessive leakage current or system failure Do not spray cleansers on the system as this may force cleaning fluid into the system and damage electronic components It is also possible for the solvent fumes to build up and form flammable gases or damage internal components If the device breaks down please shut down the machine immediately and contact Fussen or authorized representatives Equipment connected to the sensor and located in the patient zone must be powered from a medically isolated power source or must be a medically isolated device Equipment powered from a non isolated source can cause your system to exceed leakage current limits Enclosure leakage current created by an accessory or device connected to a non isolated outlet may add to the enclosure leakage current of the imaging system When more than one medical device is connected to the patient leakage current of the devices is summed together Take caution SHOCK HAZARD Do not attempt to connect or disconnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord SHOCK HAZARD Don t connect non medical electrical equipment which has been supplied as a part of the system directly to the wall outlet when the non medical equipment is intended to be supplied by a multiple portable socket outlet with an isolation transformer SHOCK HAZARD Don t connect electrical equipment w
22. hich has not been supplied as a part of the system to the multiple portable socket outlets supplying the system Do not exceed the maximum permitted load when using multiple portable socket outlets to Page 2 of 26 18 19 20 21 22 23 24 25 26 supply the system Do not use the additional multiple portable socket outlet or extension cord in the medical electrical system unless it s specified as part of the system by manufacturer And the multiple portable socket outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system Do not touch accessible parts of non medical electrical equipment and the patient simultaneously To avoid the possibility of electrostatic shock and damage to the system avoid using aerosol spray cleansers on the monitor screens The computer and any other associated equipment like external printer shall be placed outside the patient s environment i e more than 2 meters away from the chair The operator shall not access the patient and such devices at the same time If the liquid crystal material leaks from the panel it should be kept away from the eye or mouth In case of contact with hands skin or clothes it has to be washed away thoroughly with soap Do not move the main unit or the monitor while working Only accessories supplied or recommended by the manufacturer can be connected to the
23. local regulations for separate collection after its useful life Page 5 of 26 2 About the Manual 2 1 Application of the Manual The manual mainly introduces functions of the system and the way to operate it 2 2 Applicable Object The manual is applicable to clinical professionals and other authorized users 2 3 Legend and Name All legends provided in the manual are just for examples All names shown in examples and legends are imaginary It is coincidence if somebody happens to have the same name with that in the manual Page 6 of 26 3 Product information Operation Temperature 5 C 40 C Relative Humidity lt 80 Non condensed Atmospheric Pressure 700 1060 mbar hPa Power Supply DC 5V 3 596 Power Consumption 350mW Anti electroshock degree BF Harmful Ingress of Water proof degree IP64 4 Overview Digital intraoral x ray imaging system is an intraoral digital sensor and an image acquisition software used with an intraoral X Ray generator to capture digital images of dentition and the surrounding skeletal structures The sensor is connected directly to a PC You must have a dedicated Computer with a 32 bit or 64 bit Windows operating system and have at least one High speed USB port available The computer requirements are listed in ORFC Software User Manual Image capture and management ORFC software must be installed on all computers that will host the sensors The performance of that software is
24. ntraoral x ray imaging system and accessories are available by contacting the manufacturer or your local distributor Page 19 of 26 11 Warranty and Service 11 1 Warranty Fussen warrants that Fussen s products meet the labeled specifications of the products and are free from defects in materials and workmanship that occur within warranty period The warranty period begins on the date the products are shipped to distributors for lyear The warranty is invalid in the case of a Damage caused by handling during shipping b Subsequent damage caused by improper use or maintenance c Damage caused by alteration or repair by anyone not authorized by Fussen d Damage caused by accidents e Replacement or removal of serial number label and manufacture label If a product covered by this warranty is found to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period Fussen will at its discretion repair or replace the defective part s free of charge Fussen will not provide a substitute product for use when the defective product is repaired 11 2 Contact us If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Page 20 of 26 Alternatively you can send an email to Fussen service department at info fussenct com Appendix A Specifications Product Categories Anti electr
25. obtaining the image Page 12 of 26 6 6 2 2 Positioning the Sensor for a Maxillary Image To position the sensor for a maxillary image follow these steps 1 Insert the sensor maintaining it horizontally 2 Turn the sensor upward so that it is vertical or parallel to the axis of the target tooth 3 Center the sensor on the tooth to be x rayed by sliding it distally 6 6 2 3 Using the Different Positioning Systems The sensor is positioned with the same principles of the conventional radiography Rigidity of sensor can avoid X ray imaging distortion easily You can use different systems for positioning intraoral sensor However none of them can fulfill all of its functions How you position the sensor is dictated by the morphology of the patient the habits of the practitioner and the information you need rather than the positioner itself You can switch from the paralleling technique to the bisecting technique from holding the sensor with the finger to use the holders Table 6 2 describes examples of positioning Table 6 2 Positioning Examples Example Description Upper posterior region Use the roundness of the palate to place the sensor to frame the apical area Use Rinn I ry i Wi yr 3 type positioners for paralleling technique Page 13 of 26 Maxillary Anterior region Use a bisecting technique Have the patient hold the sensor against the tooth with a finger For the paralleling technique move
26. oshock degree BF Harmful Ingress of Water proof degree IP64 Working mode Continuous working AP APG equipment Not category AP APG equipment Product Specifications Weight 0 1KG Size 39 5mm X 26 mm 5 Environmental Requirements Temperature Operation T5 C 40 C Transport and storage 20 C 55 C Relative Humidity Operation lt 80 Non condensed Transport and storage lt 93 Non condensed Atmospheric Pressure Operation 700hPa 1060hPa Transport and storage 700hPa 1060hPa Electrical Specifications DC 5V 5 Rated input power 350mW Page 21 of 26 Performance Parameters Spacial Resolution 2 12LP mm Effective imaging area 30mm X 20mm 596 Blur Artifacts NO Appendix B Troubleshooting Images When troubleshooting problems that you may encounter with images try to solve the problem by using the following instructions If the problem persists or if it is not outlined below contact Fussen dental imaging support Table A 1 outlines troubleshooting methods for resolving most problems that you may encounter Table A 1 Troubleshooting Tips Symptom Cause and Corrective Action After triggering the Make sure a patient record is open in imaging mode X rays no image is If the system is not connected to the timer displayed Check that the
27. re time depends on the following Generator type Patient s morphology Tooth which is x rayed Table 2 1 provides you guidelines of exposure times for an average generator at 70kV and 4mA These are approximate values Adjust the values for your generator If the images are displayed too dark reduce the exposure settings Page 10 of 26 If the images are displayed too light increase the exposure settings Add the values for corrections in the second column of Table 6 1 Table 6 1 Sensor Exposure Times High Resolution Acquisition Mode Seconds Correction Upper incisor canine 0 18 Upper premolar 0 24 Upper molar 0 40 Lower incisor canine 0 12 Lower premolar 0 18 Lower molar 0 24 Note The exposure times in Table 6 1 are suggested times Over time and with experience you can identify the settings specific to the configuration in your practice Operating tips and recommended exposure times are given for an average case representing an adult patient weighing approximately 80 kg The distance between the sensor and the generator s focal point is approximately 23 cm The exposure times varies according to the patient and the angle used to take the x ray Increase the dose proportionally to the square of the distance Note The programmed time varies as the square of the distance If the distance sensor focal point of the generator raised increase the dose 6 6
28. rved additional measures may be necessary such as reorienting or relocating the F100 Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m Page 25 of 26 EMC Declaration Continued Guidance and manufacturer s declaration electromagnetic emissions The F100 is intended for use in the electromagnetic environment specified below The customer or the user of the F100 should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance PM The F100 uses RF energy only for its RF emissions Grai internal function Therefore its RF emissions are very CISPR 11 P low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 The F100 is suitable for use in all Harmonic emissions Class A establishments including domestic establishments and those directly connected to the public low voltage IEC 61000 3 2 power supply network that supplies buildings used for Voltage fluctuations Complies domestic purposes flicker emissions IEC 61000 3 3 Recommended separation distances between portable and mobile RF communications equipment and the Medical F100 The F100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Medical F100 can help prevent electromagnetic interference by maintainin
29. ter Recommended separation distance d 1 2 P Conducted RF 3 Vrms iResipaiies Pees om d 1 24P 80MHz to 800MHz d 2 3 P 800MHz to 2 5 GHz Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t as NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the F100 is used exceeds the applicable RF compliance level above the Medical F100 should be observed to verify normal operation If abnormal performance is obse
30. void any motion blurring due to vibration of the x ray source WARNING The sensor is not compatible with generators of lesser specifications Page 9 of 26 6 3 Timer Use the timer to control exposure times The selected exposure time does not exactly represent the dose of x rays output by the generator since the variations in the mains current has not been taken into consideration Use a digital timer to compensate for current variations in conventional generators Remember that the image quality for short exposures is linked to the use of the physical synchronization function of the sensor and the timer in particular with the very high frequency Fussen intraoral x ray units 6 4 Computer and Monitor Place the computer and its monitor in or close to the operating area to ensure the visual field of the practitioner Provide visual access for the patient to encourage communication Use a monitor with proper technical display characteristics for the visualization of radiological images Select and set up the monitor according to the procedure described in the installation guide for the sensor Position the monitor to avoid direct light or reflections that could affect the reading of the clinical information Caution A poor monitor setting or a poor quality monitor can cause diagnostic errors due to the inability of the equipment to display the image properly 6 5 Adjusting Exposure Time As in conventional radiology the exposu
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