MLED Blue ray 3 I05 221 U2 V1:Mise en page 1.qxd
Contents
1. U 297 3 3 V Pp MICROFLASH LED User s manual AO AMERICAN lt RTHODONTICS Light guide 2 Handpiece 1 Handpiece holder 9 Battery 8 AC power adapter 12 Not shown base 11 Fig 1 ON OFF button 3 Two color LED Error Indicator Light 4 LCD screen 5 Alert Mode Button 6 Timing Configuration Button 7 Power verification window 10 INTRODUCTION Il WARNINGS III DESCRIPTION IV INSTALLATION STARTUP V ROUTINE OPERATION VI CONFIGURATION VII INTERLOCKS VIII MAINTENANCE IX TROUBLESHOOTING X ELECTROMAGNETIC XI DISPOSAL AND RECYCLING XII LIABILITY XIII ACCESSORIES XIV REGULATIONS XV SYMBOLS AND ABBREVIATIONS XVI CUSTOMER RELATIONS ENGLISH SUMMARY INTRODUCTION You have just taken possession of your Blue Ray 3 unit congratulations Created by SATELEC the Blue Ray 3 is a photopolymerizer allowing dental care to be given using the suitable light guide supplied with the unit To take full advantage of the technology of this product we request that you read carefully the chapter covering all safety recommendations The manufacturer s warranty is applicable only if these indications relating to the unit s operation and safety have been correctly applied All of these safety measures require a sound knowledge of dentistry photopolymerization and2. 22 Time counter Fast Mode Battery charge indicator M y The LCD comprises from top to bottom Display of time counter for polymerization light emission time expressed in seconds A pictogram indicating the Fast mode Display of the battery charge level status battery being most charged when all of the pictogram s round symbols are displayed and the least charged when all of the round symbols have disappeared from the LCD screen Control buttons fig 2 3 6 7 The handpiece comprises three buttons On Off button fig 2 3 Press to start or stop the polymerization cycle Left button fig 2 6 Press to select alert mode see Types of alerts below Right button fig 2 7 Press and hold to toggle between 3 and 5 second curing interval modes Press and release to cycle through the timing options available in each curing interval mode see Curing intervals below Types of alerts Blue Ray 3 offers two alert signals to mark each 3 or 5 sec curing interval Press the left button fig 2 6 to select the following alert combinations Beep only Microflash only Beep and microflash No alert continuous On Curing intervals Blue Ray 3 offers either a 3 second or 5 second curing interval mode depending on your needs and preferences Press and hold the Right button fig 2 7 to toggle between 3 and 5 sec modes Press and release the Right button repeatedly to cycle throug
3. Protection 5 A T fuse non accessible 125 V Protection index IPX0 AC power adapter Input voltage 100 V AC to 240 V AC Frequency 50 Hz to 60 Hz Output voltage 12 V DC Output current 0 8 Category ll Protection index IP 41 Charging base Input voltage 12 V DC Protection 3 A T fuse non accessible 125 V Category Continuous operation Protection index IPX0 Battery Type Lithium lon Dimensions 024 x 88 mm Capacity 2500 mAh Optical specifications LED for polymerization Wavelength range 420 480 nm Peak wavelength 455 465 nm Intensity 3000 mW cm 10 for opalescent light guide diameter of 5 5 mm Class la according to European directive 93 42 CEE Maximum exposure time 100 seconds Mode Fast 99 Temperatures Operation 10 C to 40 C Storage 20 C to 70 C Humidity Operation 30 to 75 Storage 10 to 100 condensation included IV INSTALLATION STARTUP 4 1 UNPACKING THE UNIT On reception of the unit look for any damage that may have occurred during transportation If necessary contact your supplier 4 2 RECOMMENDATIONS Check that the environmental conditions have been complied with ambient temperature between 10 C and 40 C and humidity between 30 and 75 4 3 INSTALLATION A Ensure that the unit is not installed adjacent to or on top of any other equipment Do not place the power cord in a cable feedthrough or cable cover R
4. environment etc repairs have been performed by persons not authorized by the manufacturer the device has been used in an electrical installation which does not comply with current standards the device has been used in a way which is not stipulated in this Manual accessories other than those supplied by SATELEC have been used the instructions in this document have not been followed The manufacturer reserves the right to modify the unit and or the Operating Manual without notice XIII ACCESSORIES The following accessories are available from American Orthodontics for the Blue Ray 3 Opalescent light guide 5 5 mm Ref 852 913F Opalescent light guide 7 5 Ref 852 915F Molar shaped eye shield Ref 852 933 Oval eye shield Ref 852 934 Power cord Ref 852 936 Battery Ref 852 932 XIV REGULATIONS This medical device is classified as class lla according to European Directive 93 42 This equipment is manufactured in compliance with the current IEC 60601 1 standard This equipment has been designed and manufactured according to an ISO 13485 certified quality assurance system XV SYMBOLS AND ABBREVIATIONS SYMBOL DEFINITION Direct current A Follow operating instructions ON OFF pushbutton o YN Type B Class Note Technical personnel of the Satelec authorized dealer network can obtain from ACTEON Group on request all the information they need
5. E mail info me acteongroup com CHINA ACTEON CHINA Office 401 12 Xinyuanxili Zhong Street Chaoyang District BEIJING 100027 CHINA Tel 86 10 646 570 11 2 3 Fax 86 10 646 580 15 E mail beijing cn acteongroup com PHILIPPINES ACTEON PHILIPPINES 4 Floor Alco Building No 391 Sen Gil Puyat Avenue Makati City 1200 PHILIPPINES Tel 632 899 78 66 or 67 Fax 632 899 78 43 E mail info ph acteongroup com THAILAND ACTEON THAILAND 23 45 Sorachai Building 16th floor Sukumvit 63 Road Klongton Nua Wattana BANGKOK 10110 THAILAND Tel 66 2 714 3295 Fax 66 2 714 3296 E mail info th acteongroup com KOREA ACTEON KOREA 8F Hanil B D 132 4 16 Bongrae dong JOONG GU SEOUL KOREA Tel 82 2 753 41 91 Fax 82 2 753 41 93 E mail info kr acteongroup com INDIA ACTEON INDIA B 94 G I D C Electronic Estate Sector 25 GANDHINAGAR 382044 Gujarat INDIA Tel 91 79 2328 7473 Fax 91 79 2328 7480 E mail info in acteongroup com COSTA RICA ACTEON LATIN MERICA Del Cristo Sabanilla 2 6 km arriba 100 mts Este del Taller Autotransmisiones Residencial El Refugio San Ramon de Tres Rios COSTA RICA Tel 506 2273 4033 Fax 506 2273 4033 E mail am latina es acteongroup com RUSSIA ACTEON RUSSIA Valdajski Proezd 16 Building 1 125445 Moscow RUSSIA Tel Fax 7 495 451 80 50 sergey kobloveru acteongroup com office 253 AUSTRALIA
6. for repair of the parts of the curing light that Satelec has identified as repairable XVI CUSTOMER RELATIONS 16 1 MANUFACTURER IDENTIFICATION SATELEC 17 avenue Gustave Eiffel BP 30216 33708 MERIGNAC cedex France T l 33 0 556 34 06 07 Fax 33 0 556 34 92 92 E mail satelec acteongroup com www acteongroup com 16 2 SUBSIDIARIES FRANCE SATELEC A Company of ACTEON Group 17 av Gustave Eiffel BP 30216 33708 MERIGNAC cedex France T l 33 0 556 34 06 07 Fax 33 0 556 34 92 92 E mail satelec acteongroup com www acteongroup com U S A ACTEON NORTH AMERICA 124 Gaither Drive Suite 140 Mt Laurel NJ 08054 USA Tel 1 856 222 9988 Fax 1 856 222 4726 E mail info us acteongroup com GERMANY ACTEON GERMANY Industriestrasse 9 40822 METTMANN GERMANY Tel 49 21 04 95 65 10 Fax 49 21 04 95 65 11 E mail info de acteongroup com SPAIN ACTEON Avda Principal n 11 H Poligono Industrial Can Clapers 08181 SENTMENAT BARCELONA SPAIN Tel 34 93 715 45 20 Fax 34 93 715 32 29 E mail info es acteongroup com U K SATELEC UK LIMITED Unit 1B Steel Close Eaton Socon St Neots CAMBS PE19 8TT UK Tel 44 1480 477 307 Fax 44 1480 477 381 E mail info uk acteongroup com MIDDLE EAST ACTEON MIDDLE EAST Numan Center 1st Floor N 111 Gardens Street PO Box 468 AMMAN 11953 JORDAN Tel 962 6 553 4401 Fax 962 6 553 7833
7. 0 seconds shows 30 60 seconds shows 60 Available timing in 5 sec interval mode 5 seconds shows 05 10 seconds shows 10 30 seconds shows 30 100 seconds shows 99 4 6 ALERTS OFFERED Blue Ray 3 offers two alert signals to mark each 3 or 5 sec curing interval Press the left button fig 2 6 to select the following alert combinations Beep only shows b Microflash only shows F Beep and microflash shows Fb No alert continuous On shows F Fb V ROUTINE OPERATION Blue Ray 3 is normally placed on its holder The first time you plug it into the battery it will default to the 3 sec fast curing mode and the beep alert Your Blue Ray 3 is ready to operate once the curing time and the kind of alert have been selected Place the light guide as close as possible to the surface of the material to be polymerized without touching it as this may adversely affect the quality of the polymerization The polymerization starts by pushing the ON OFF button The setting will be confirmed by an audible signal beep A countdown on the LCD screen shows you how much time remains and the selected alert method signals each timing interval either every 3 or 5 sec depending on mode chosen When the polymerization cycle is completed the time that was applied is displayed You can press the ON OFF button at any time to interrupt the current polymerization cycle After 3 minutes without use the unit goes in
8. NEW ZEALAND ACTEON AUSTRALIA NEW ZEALAND L3 Suite 23 6 8 Crewe Place 2018 Rosebery NSW Australia Tel 612 966 24400 Fax 612 966 24600 E mail sandy junior au acteongroup com 105 221 U2 V1 o Z 7 Ref GT ACTEON C sss SATELEC A Company of ACTEON Group 17 av Gustave Eiffel BP 30216 33708 MERIGNAC cedex France Tel 33 0 556 34 06 07 Fax 33 0 556 349292 E mail satelec acteongroup com www acteongroup com
9. andpiece holder base is red check if the LED light guide and verification window are clean In the event of dust being present clean using a dry air jet If the problem persists or if the light guide or the verification window is damaged the unit must be returned to the after sales service A In the event of an anomaly contact the supplier of the unit rather than just any repairer who may return your unit in a hazardous state for both you and your patients The technical service of your supplier is available for any technical problems encountered on your unit Anomaly observed Possible causes Solutions Battery completely discharged Recharge battery No operation LCD screen off Battery defective Return to SATELEC after sales department Blue Ray 3 defective Return to SATELEC after sales department No operation Blue Ray 3 defective Return to SATELEC after sales department LCD screen on Check cleanliness of verification window and or LED Crees and ordirty Return to SATELEC after sales department Blue Ray 3 defective Return to SATELEC after sales department Light power defect Defective buttons rn to SATELEC after sales department or no light power 3 Light guide defective and or dirty Clean light guide and or Return to SATELEC after sales department Clean reflector dry air jet and or Return to id after sales department AC power wall outlet defective Contact your electrician AC po
10. e conditions of use must be checked beforehand The use of accessories other than those specified or sold by SATELEC or American Orthodontics as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the Blue Ray 3 10 1 Electromagnetic emissions Blue Ray 3 is intended for use in the electromagnetic environment specified in the table below The user and or installer must ensure that the Blue Ray 3 is used in such an environment Emission test Compliance Electromagnetic environment guidance Blue Ray 3 uses RF energy for internal operation Therefore its radiofrequency emissions ery low and are not likely to cause any interference in nearby equipment Blue Ray 3 is suitable for use in all establishments including domestic establishments hose directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emission CISPR 11 10 2 Magnetic and electromagnetic immunity Blue Ray 3 is intended for use in the electromagnetic environment specified in the table below The user and or installer must ensure that the Blue Ray 3 is used in such an electromagnetic environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance agnetic field at 50Hz bA m bA m he intensity of the magnetic field should be equivalent to that of 61000 4 8 typical commercial hospital environme
11. emove the protective caps from the handpiece screw the battery onto the handpiece and insert the sterilized light guide into the handpiece Ensure that the light guide is properly inserted confirmed by a click Ensure that all sections of the LCD screen are illuminated once the battery has been properly screwed on Place the base on a hard and stable surface that is not inclined by more than 5 Connect the AC adapter after ensuring that the voltage indicated corresponds to the electrical installation available in the dental practice Two audible beeps confirm that the unit has been correctly placed on its holder The translucent holder base lights up blue and starts flashing indicating that the battery is charging As soon as the battery is charged the translucent holder base stops flashing and the blue light remains illuminated continuously 4 4 OPERATING FOR THE FIRST TIME Before operating it is essential that the sterilizable accessories light guide be sterilized and that the Blue Ray 3 be disinfected see chapter VIII MAINTENANCE 4 5 EXPOSURE TIMES AVAILABLE Blue Ray 3 offers either a 3 second or 5 second curing interval mode depending on your needs and preferences Press and hold the Right button to toggle between 3 and 5 sec modes Press and release the Right button to cycle through available timing in each mode Available timing in 3 sec interval mode 3 seconds shows 03 6 seconds shows 06 3
12. gain and the screen once again displays the selected time cycle 7 2 BATTERY CHARGE LEVEL When the LCD screen displays the last remaining round battery charge indicator the audible alert beep sounds twice You then have about 500 sec remaining before the unit becomes completely discharged It is then recommended if possible to charge the battery for further use When the battery becomes completely discharged the letters Lb Low Battery are displayed on the screen the audible alert beep sounds 4 times and the indicator light two color LED becomes red Lb The user must return the handpiece to its charging base to recharge the unit s battery see chapter 4 3 INSTALLATION VIII MAINTENANCE A Before conducting any maintenance on the Blue Ray 3 check that The Blue Ray 3 is not on its charging base The battery has been unscrewed from the handpiece The charging base has been disconnected from the AC supply Before cleaning the handpiece insert the protective cap in the place of the light guide supplied to ensure that liquid does not enter the handpiece Avoid using cleaning and disinfection products containing flammable agents or other corrosive agents such as acetone chlorine or bleach Otherwise ensure that the product completely evaporates and that there are no combustibles on the unit and its accessories before operation Do not use abrasive products to clean the unit Do not im
13. h the timing options in each mode Available timing in 3 sec interval mode 3 6 30 60 sec Available timing in 5 sec interval mode 5 10 30 100 sec Note 100 sec cycle will read 99 on LCD screen Charge time Battery charge time is about 3 hours Battery charge level indicator When only one element of the pictogram remains the one farthest to the right on the LCD screen two beeps warn you that there are about 500 seconds of polymerization remaining The Blue Ray 3 should then be returned to the charging base When the battery is completely discharged the LCD screen displays the message Lb Low battery and no round symbols are shown the handpiece then beeps 4 times and the error indicator light becomes red Error Indicator light An error indicator light fig 2 4 is located below the On Off button The indicator light shines red when the unit detects error and shines green when the unit is in good working condition The indicator light is unlit when the handpiece is in standby mode Charging base The charging base is used to recharge the battery and also includes a translucent handpiece holder fig 1 9 and a power level verification window fig 2 10 The translucent handpiece holder holds the unit in the charging base and also lights up to indicate charging status The power level verification window is located on the front of the charging base and serves to verify the power output of the
14. harging base When handling the AC power adapter and or the battery disconnected from the handpiece avoid contact with the patients or other persons Do not touch the accessible battery and charging base connectors spring loaded contacts To disconnect the AC power supply adapter grip the AC adapter plug and hold the wall socket During dental care the Blue Ray 3 must not be connected to its charging base In the event that the unit is not in use or stored or in the case of a prolonged absence disconnect the AC adapter from the AC power supply and remove the battery from the body of the unit to protect it from a slow and detrimental discharge Do not exert excessive pressure on the unit s LCD screen Do not change the battery during use Do not short circuit the battery Do not short circuit the charging spring loaded contacts on the charging base Do not incinerate the battery risk of explosion Environment Do not immerse and do not use outside Place the charging base on a level surface Do not place the unit close to a heat source The use of solvents detergents or flammable substances can result in damage or even short circuits 6 Ensure that the power cord connecting the AC adapter to the charging base does not prevent persons from moving freely The unit must be stored in its original packaging in an appropriate place without danger for persons For unit transportation unscrew the battery and protec
15. ible on the LCD screen before pressing the ON OFF button In the event of a faulty battery see VII INTERLOCKS an automatic interlock system will prevent the unit from operating If this is the case recharge the battery by placing the curing light on its holder or by using a second fully charged battery Intensive use of the curing light can result in high temperatures inside the unit If this happens an automatic interlock system prevents the unit from operating see VII INTERLOCKS Leave the unit at rest for a few minutes to allow it to cool down After each use check that there is no composite residue adhering to the light guide If this is the case immediately remove the residues and check that the surface of the light guide has not been damaged If damage is visible replace the light guide as the unit s power could be significantly reduced Under normal conditions of use the unit s power does not vary if the battery is properly charged Consequently it is not necessary to check power as with ordinary polymerization lamps Nevertheless in case of doubt check its power using the verification window The battery located at the bottom of the handpiece can be removed by unscrewing it After removing the light guide check that the LED is clean and undamaged If necessary clean it using a medical quality dry air jet free from compressor oil During verification of the power level of the handpiece if the translucent h
16. ions without the prior authorization of SATELEC In the event of an anomaly immediately disconnect the unit s base and ensure that nobody can use the unit before verification by the manufacturer or the supplier This anomaly may be due to noncompliance with safety rules or because of technical damage to the unit In the event of an anomaly contact the supplier of the unit rather than just any repairer which may return your unit in hazardous state for both you and your patients www acteongroup com Email satelec acteongroup com or American Orthodontics www americanortho com Email info americanortho com DESCRIPTION 3 1 PHYSICAL DESCRIPTION The Blue Ray 3 includes the following components Handpiece fig 1 1 Lithium ion battery fig 1 8 Opalescent light guide 45 curve 0 5 5mm sterilizable fig 1 2 Charging base with handpiece holder fig 1 9 and 11 AC adapter fig 1 12 not shown Thow rigid eye shields Accompanying documentation Optional Multi fiber light guide 45 curve 0 7 5mm sterilizable 3 2 TECHNICAL DESCRIPTION The Blue Ray 3 is equipped with a Light Emitting Diode LED that emits blue visible light of a wavelength between 420 and 480 nm for the photopolymerization of dental materials LCD Liquid Crystal Display screen fig 2 5 The LCD screen is backlit and allows the display of the different pieces of information required by the user
17. ld strength in the immediate environment where the product is used exceeds the compliance level specified above the performance of the product must be tested to verify whether it conforms to the specifications If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the product b In the 150 kHz to 80 MHz frequency range the electromagnetic field strengths must be less than 3 V m 10 4 Recommended separation distances Blue Ray 3 is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled Blue Ray 3 user and or installer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment emitters and the Blue Ray 3 according to the maximum output power of the equipment as recommended in the table below Separation distance in meters m according to emitter frequency Rated max power 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of the emitter W d 1 2 VP d 1 2 VP d 2 3 VP at a p VJ m um m m For emitters rated at max power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the emitter where P is the max power rating of the emitter in watts W according the manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency ra
18. light curing unit Place the charging base on a hard level stable surface with an inclination of no more than 5 When the charging base s AC power is plugged in the translucent handpiece holder beeps and flashes red green and blue Place the curing light on the holder ensuring that there is good contact between the spring loaded contacts on the charging base and the copper contacts on the bottom of the battery Two beeps confirm that the unit is correctly positioned on the charging base and the translucent holder flashes blue indicating that the battery is charging When the battery completely charged the translucent holder will shine steady blue Power level verification window The procedure for using the power level verification window is as follows Check that the power level verification window is intact and clean Ensure that the light guide is intact and clean and insert it into the handpiece Place the tip of the light guide flat against the power level verification window and activate the curing light The translucent handpiece holder will shine green if compliant power level is detected or red if the power is insufficient If the power level is low please refer to chapter TROUBLESHOOTING Technical specifications Model name Blue Ray 3 Medical category lla Dimensions without light guide Weight 160 g Dimensions 024 x 201 mm Operation Continuous operation Protection Category Type B
19. merse the unit Never use ultrasonic cleaning whether for the Blue Ray 3 or its accessories None of the accessories is delivered in a sterilized state Only the light guide is sterilizable Before sterilization check the cleanliness of your autoclave and the quality of the water used After each sterilization cycle immediately remove the items from the autoclave to reduce the risk of corrosion of metallic parts It is necessary to leave the sterilized items to cool down to the ambient temperature and dry before re using them It is recommended to sterilize the items identified as sterilizable individually in the sterilization bags foreseen for this purpose To maintain the sterile and aseptic state of accessories make sure that they are kept in hermetically sealed bags or containers suited for use in dentistry The maintenance and or sterilization instructions that follow must be applied before each use of the unit 8 1 Pre disinfection cleaning_ Clean and disinfect the body light guide eye shield and the charging base of the Blue Ray 3 using ready to use cleaning disinfecting wipes based alcohol amphoteric disinfectant and biguanide of the type SEPTOL WIPE refer to the manufacturer s instructions for at least two minutes Leave the product to act for at least 15 minutes Use wipes with CE marking or compliant with any standard that may be required by national regulations 8 2 Drying Dry usi
20. ng a clean single use non woven cloth to remove any liquid traces 8 3 Packing Pack in single use sterilization bags or sleeves compliant with the requirements defined in the EN ISO 11607 1 standard or compliant with any standard that may be required by national regulations 8 4 Sterilization The fiber optic light guide for the Blue Ray 3 must be sterilized an autoclave according to the following parameters Autoclave Type B compliant with the EN 13060 standard Sterilization temperature 134 C Sterilization steady state 18 minutes Pressure 2 bar minimum CAUTION Not all autoclaves can reach 134 C Not all autoclaves perform a pre depressurization For further information on the applicable sterilization instructions consult the autoclave manufacturer 8 5 Storage After this store the sterilized items in a dry dust free place Before re use in the event of nonconforming packaging integrity re package and re sterilize according to the defined protocol IX TROUBLESHOOTING In the event of a problem before contacting the after sales service of SATELEC or the supplier Ensure that the base is correctly connected to the AC supply to ensure that the battery is charged normally If the Blue Ray 3 holder is not lit despite being correctly connected contact the after sales service of SATELEC or the supplier Check that at least one of the four round battery charge level indicators is vis
21. nge applies Note 2 These specifications may not be applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and persons 14 10 5 Cable lengths Cables and Maximum TET Complies with accessories length RF emission CISPR 1 Class B Immunity to magnetic fields IEC61000 4 8 Immunity to electrostatic discharge IEC61000 4 2 Immunity to electrical fast transients bursts IEC61000 4 4 Immunity to surges IEC61000 4 5 Immunity to voltage dips short interruptions and voltage variations 61000 4 11 Immunity to conducted disturbances induced by radiofrequency fields IEC61000 4 6 Immunity to radiated radiofrequency electromagnetic fields IEC61000 4 3 charger power cord DISPOSAL AND RECYCLING As electrical and electronic equipment the device must be disposed of according to a specialized procedure for collection pick up and recycling or destruction in particular on the European market with reference to Directive 2002 96 EC of 23 01 2003 When your device reaches the end of its life we consequently recommend that you contact your dental equipment dealer or failing this the nearest ACTEON GROUP office the list of which is given in chapter 16 for information on how to proceed LIABILITY The manufacturer is not liable if the manufacturer s installation recommendations have not been followed supply voltage electromagnetic
22. nt hospital clinic Electrostatic discharge 6KV contact 6KV contact Floors must be wood concrete cement or tiled ESD N 8KV air N 8KV air If floors are covered with synthetic material carpet etc the IEC 61000 4 2 relative humidity must be at least 30 Electrical fast transients 2KV for power supply 2KV for power supply Power quality should be that of a typical commercial or hospital IEC 61000 4 4 lines lines environment Surges 1KV differential mode 1KV differential mode Power quality should be that of a typical commercial or hospital IEC 61000 4 5 2KV common mode 2KV common mode environment lt 5 Ur gt 95 dip in Ur for 0 5 He 40 Ur 60 dip in Ur for 5 04 ys ycles 0 Ur 30 dip in Ur for hould be that of a typical commercial or hospital the Blue Ray 3 requires continued operation during a power cut it is recommended that the product be powered from separate power supply generator etc 10 3 Electromagnetic immunity mobile radiofrequency equipment Blue Ray 3 is intended for use in the electromagnetic environment specified in the table below The user and or installer must ensure that the device is used in such an electromagnetic environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile radiofrequency communications devices must not be used near the Blue Ray 3 including its cables at a dis
23. of the specific instructions regarding the operation of the Blue Ray 3 given in this operating manual Sections with the symbol A are points to which we would like to attract your attention Il WARNINGS A United States Federal Law restricts on its territory the use of this unit exclusively to trained capable and qualified dental healthcare professionals or under their control To reduce the risk of accidents it is imperative to comply with the following precautions Users of the unit Use of the Blue Ray 3 is limited exclusively to trained dental healthcare professionals apt and qualified in the usual context of their activity If you have received this unit in error contact the unit s supplier to arrange for its return Interactions contraindications Do not use on persons currently suffering from or that have suffered from in the past photo biological reactions including solar urticaria or erythropoietic protoporphyria or on persons undergoing treatment using photosensitizing medications including methoxsalen or chlortetracycline Any person practitioners or patients who have previously suffered from a retina or lens condition or who have undergone eye surgery in particular cataract surgery must consult their ophthalmologist before using this unit Even in the event of agreement it is strongly recommended to be prudent as the light intensity may cause accidents It is particularly recommended to continu
24. ommended to carry out polymerization in intermittent intervals of 10 sec for the 5 sec menu 30 sec for the 10 sec menu 2 minutes for the 30 sec menu and 10 minutes for the 100 sec menu For the orthodontic clinical menus 30 sec 60 sec and 100 sec menus can remain on at the condition of not staying on the same tooth segment This condition complies with the state of the orthodontic dental art the medical device must be exclusively settled and used by qualified and graduated dental health professionals Connection to power supply Ensure that your equipment is connected to the AC power supply by an authorized dentistry installation technician Before connecting the unit check that the AC voltage is compatible with that indicated on the AC power adapter allowing unit charging A different voltage would result in damage to the unit and could injure the patient and or the user The AC power supply used to power the unit must comply with the applicable standards of your country Any fluctuation of the voltage of the AC power supply or electromagnetic field noncompliant with the applicable limits may affect the unit s operation Unit operation Do not use the unit if it appears to be damaged or defective Do not use the unit if the light guide is damaged injury hazard Before each use check that light intensity is compliant see section 3 2 TECHNICAL DESCRIPTION using the power verification window on the c
25. ously wear protective glasses suited to the use of equipment emitting radiation of wavelengths less than 500 nm The light radiation produced by this type of equipment can be dangerous and must never be directed towards the eyes even if the practitioner or the patient is wearing protective glasses suited to the use of equipment emitting radiation of wavelengths less than 500 nm The light produced by this unit must be directed only at the part to be treated in the oral cavity The equipment must not be used if the patient and or the operator has a pacemaker or any other active implant cochlear implant The equipment has not been designed to withstand shocks from an electrical defibrillator The unit complies with current electromagnetic compatibility standards nevertheless the user shall ensure that any electromagnetic interference does not create an additional risk presence of radiofrequency emitters electronic equipment A Overexposure to light radiation of the pulp and soft tissues can result in the release of heat and can result in injury to the patient To use your equipment in the best possible conditions it is important to comply with the specifications given in sections 11 WARNINGS Equipment users and V ROUTINE USE As far as possible avoid the accumulation of heat due to a dental dam The use of 30 seconds 60 sec and 100 sec on the same tooth segment is forbidden To prevent a feeling of heat it is rec
26. t the light guide from any unexpected shocks Any condensation inside electrical equipment can be dangerous If the unit must be transported from a cold place to a warm place it must not be used immediately but only after reaching the ambient temperature To avoid an electric shock or short circuit hazard never insert or try to insert metallic objects into the equipment The unit is not designed for operation in the presence of anesthetic gas or any other flammable gas Do not expose the unit to water mist or water splashing The unit is not designed for operation close to ionizing radiation Maintenance Before and after each use it is essential that the unit be disinfected with the products recommended by SATELEC Before each use it is essential that a cleaned and disinfected rigid eye shield be used Before each use it is essential that a cleaned disinfected and sterilized light guide be used Before each use check the integrity of the unit and its accessories Accessories Do not use accessories other than those supplied by SATELEC or American Orthodontics The manufacturer refuses to accept any responsibility if damaged parts or accessories are not replaced exclusively by those supplied by the manufacturer In particular the use of light guides AC adapters or batteries other than those supplied by the manufacturer may be dangerous for the patient and the user Repair Do not perform equipment repairs or modificat
27. tance less than that recommended and calculated according to the frequency and power of the emitter 2 3V m Recommended separation distance radiofrequency fields 3 V m Em 150 KHz to 80 MHz EP d 1 2 VP 80MHz to 800MHz Radiated radiofrequency m electromagnetic field 3V m d 2 3 VP 800MHz to 2 5GHz IEC61000 4 3 80 MHz to 2 5 GHz here P is the maximum power rating of the emitter in watts W according to the manufacturer s specifications and d is the recommended minimum separation distance in meters m e electromagnetic field strengths of fixed radiofrequency emitters as determined by an electromagnetic environment measurement a must be less than the compliance level in each frequency range b Ke Interference may occur near equipment marked with the symbol at right Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These specifications may not be applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and persons a The electromagnetic field strengths of fixed radiofrequency emitters such as base stations for mobile telephones cellular cordless mobile radios amateur radios AM FM radio broadcasts and TV broadcasts cannot be determined exactly by theory To assess the electromagnetic environment due to fixed radiofrequency emitters an electromagnetic environment measurement must be made If the measured radiofrequency fie
28. to standby mode low consumption green indicator light and the LCD screen backlighting switch off The unit can be taken out of standby mode by simply pressing one of the three buttons which will not activate that function when coming out of standby mode VI CONFIGURATION 6 1 START UP On start up the unit performs an automatic test sequence auto check The device automatically recalls the settings used for the previous dental treatment 6 2 EXPOSURE TIMES Select 3 or 5 second mode by pressing and holding the Right button fig 2 7 on the handpiece Then select the desired exposure time by pressing and releasing the Right button repeatedly to cycle through the available timing options within each mode 6 3 ALERTS Combinations are chosen by pushing the left button fig 2 6 Then this selection is validated by waiting 3 sec by pushing the ON OFF button fig 2 3 or by pushing the button on the right fig 2 7 VII INTERLOCKS Blue Ray 3 is equipped with a system for the detection of possible unit operation anomalies 7 1 EXCESSIVE TEMPERATURE During intensive use an excessive temperature may be detected and the screen then displays the letters OH Over Heat the audible alert beep sounds 4 times and the error indicator light two color LED becomes red It is then recommended that the user leave the handpiece to cool for a few minutes until the indicator light becomes green a
29. wer adaptor defective Return to SATELEC after sales department Charger does Light and or audible alerts defective Return to SATELEC after sales department not operate Contact failure on Jack connector socket Return to SATELEC after sales department Error indicator light defective Return to SATELEC after sales department Light guide defective and or dirty Clean light guide and or Return to SATELEC after sales department Dysfunction of power LED defective and or dirty Clean LED dry air jet and or Return to SATELEC level verification after sales department i Clean reflector dry air jet and or Return to Reflector defective and or dirty SATELEC after sales department Clean window and or Return to SATELEC after sales department 0 Fusedefective rn to SATELEC after sales department Window defective and or dirty X ELECTROMAGNETIC COMPATIBILITY Warning The charger power cord must be kept apart from those of any nearby devices Blue Ray 3 requires special precautions to be taken with regard to electromagnetic compatibility It must be installed and prepared for use as described in chapter IV Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the Blue 12 Ray 3 The recommended separation distances in this paragraph must therefore be complied with Blue Ray 3 must not be used near or on top of another device If this cannot be avoided its operation under th
Download Pdf Manuals
Related Search