Whitening Lase Light Plus
Contents
1. ST Ono Whitening Lase 22 222 BRRGRRRERREREEE CE A Whitening Lase Light Plus is a device manufactured with the highest technology and all the devices are tested individually The device has the registration at the National Health Surveillance Agency Ag ncia Nacional de Vigilancia Sanitaria assuring this way the fulfillment of the national regula tions This device also fulfills the requirements established by the European Community being able to be commercialized in the European market Whitening Lase Light Plus was developed to be used by professionals of the dental area The dentist must be qualified to the application of the equipment s related techniques The inadequate usage may cause irreversible damages A the manufacturer recommends all manual reading before using the product DEVICE FUNCTIONS The Whitening Lase Light Plus device presents the following function Emits infrared laser light and blue or violet light for dental whitening DEVICE FUNCTIONING The whitening handpiece has infrared lasers and blue or violet LEDs The infrared lasers are used in the dental whitening in order to diminish the sensibility after the whitening and in order to activate the whitening gel by2. IEC 60601 1 2 2007 subcl 6 8 The Whitening Lase Light Plus is designated for the usage in electromagnetic environment specified below The client or user of the Whitening Lase Light Plus must assure that he she is using it in such environment Level of the Level of ears Immunity Trial 60601 ccordance Electromagnetic Environment Guideline Portable and mobile RF communi cation devices should not be used nearby any part of the Whitening Lase Light Plus including cables with separation shorter than the recommended calculates from the equation applicable to he trans mitter frequency Separation distance recommended D 10 10 m D 10 10 m 80 MHz up to 800 MHz D 20 20m Conducted RF 3 Vrms 800 MHz up to 2 5 GHz IEC 61000 4 6 150 kHz up to 80 MHz 3V Where P is the maximum output nominal power of the ransmitter in watts W according to the manufacturer of Radiated RF 3 3 V m he transmitter and D 15 the recommended sepa ration IEC 61000 4 3 80 MHz up to 2 5 GHz distance in meters m t is recommended that the intensi ty of the field establi shed by the RF transmitter as determined by an electro magnetic inspection at the locala is smaller than the ac cordance level in each frequency rangeb Interference may happen around the device marked with the follow ing symbol NOTE 1 80 MHz and 800 MHz applies to the higher frequency range NOTE 2 These guidelin
3. Caution Protected against solid stran ge objects of 12 5 mm of diameter and not protected against water drain On with voltage Off without Voltage Date of Manufacture Manufacturer Alternate Current Serial Number 40 C 10 C Fragile handle with care Indicates the position for transport Keep away from sunlight Protect from heat and radioactive sources Keep dry Do not overturn Maximum Pilling Humidity Limitation Authorized Represen tative in the European Community Temperature limits ALLL LLL TI E i a a m BERE ATLL EE ETIT ALLL LE E T OT MDI Europa GMBH Langenhagener Strage 71 30855 Langenhagen Germany DMC EQUIPAMENTOS LTDA Rua Sebasti o de Moraes 831 Jardim Alvorada Sao Carlos SP Zip Code 13562 030 CNPJ 02 827 605 0001 86 Tec Resp Renaldo Massini Jr CREA 0601706815 ANVISA Registry 80030810015 Technical Name Laser appliance for odontologic treatment Technical assistance DMC EQUIPAMENTOS LTDA Phone 16 2107 2323 Fax 16 2107 2320 21 MAN 132
4. Emissions Class A pel erent Whitening Lase Light Plus is convenient for using in Harmonic Emissions all the places that are not designated to domestic use 61000 3 2 or that not directly connected to a public power Emissions due to voltage supply of low voltage that powers buildings used for the domestic matter loating scintillation Not applicable EC 61000 3 3 Table 1 Accordance information to the electromagnetic emission requirements based in the table 201 60601 1 2 2007 Guidelines and manufacturer statement Electromagnetic Immunity for all Whitening Lase Light Plus 60601 1 2 2007 subcl 6 8 3 201 a 6 The Whitening Lase Light user of the Whitening Lase Plus is designated for the usage in electromagnetic environment specified below The client or Light Plus must assure that he she is using it in such environment Level of Accor Electromagnetic Environment Immunity Trial Level of the 60601 trial dance Guideline Floors must be made of wood concrete or Electrostatics discharge 6 kV per contact Actotdin ceramic If the floors are covered with syn ESD IEC 61000 4 2 8 kV through the air g thetic material the relative humidity must be at least 30 Fast electric transitory 2 kV in the power lines Quality of the energy must be the one pulse train Burst IEC 1 kV in
5. The emission of beeps and display of LEDs turned on with intermittent emission indicate that the handpiece is activated Important Remarks If the user wishes to stop the laser emission and LEDs at any time of the application simply press the button on the handpiece Caution Use of controls or adjustments or execution of other procedures not specified herein may result in hazardous radiation exposure FINALIZATION PROCEDURE In order to turn off the device the user must use the On Off switch located at the command box ISOLATION FROM THE SUPPLY MAINS In case of emergency or for maintenance purposes the A C Cable must be disconnected from sup ply mains by removing it from the sockets FUSE VERIFICATION AND CHANGE PROCEDURE Disconnect the A C cable from the supply mains and from the device By using a screwdriver undock both edges of the fuse hold er lid see picture below until it is possible to remove it with the hands Remove each one of the fuses and check if they are burnt observe if the fuse is dark of with the thread broken e If necessary replace the fuse using a spare fuse provided or another from the same value and features see the item Push the fuse holder with the hands until it locks 12 WHITENING LASE LIGHT PLUS User Manual PREVENTIVE MAINTENANCE The device must be calibrated at least every two years by t
6. the handpiece by optical fiber not replace able The blue or violet light is transmitted directly through the LEDs The optical power emitted is controlled through the electrical current that passes through the diodes and through the LEDs WHITENING LASE LIGHT PLUS User Manual Hand Piece Laser Optical Output Fiber 4 Signal Laser Driver eine Blue Light Output LED Driver Control Current Monitor Signal Conditioner Power Supply CALCULATION OF BEAM DIVERGENCE Standard 60825 1 2007 The beam divergence is 0 45 rad 0 03 rad ELECTROMAGNETIC SAFETY STANDARD OF THE DEVICE Below there are tables that represent the adjustment to the regulation of electromagnetic immunity and emission Guidelines and manufacturer statement Electromagnetic emission for all the device and System IEC 60601 1 2 2007 subcl 6 8 3 201 a 3 The Whitening Lase Light Plus is designated for the usage in electromagnetic environment specified below The client or user of the Whitening Lase Light Plus must assure that he she is using it in such environment Immunity Trial Accordance Electromagnetic Environment Guideline Whitening Lase Light Plus uses RF energy only for its RF Emissions Group 1 internal functions Thus its RF emissions are very low ABNT NBR IEC CISPR 11 According which is not likely that cause any interference in the electronic devices nearby RF
7. the input output According from a hospital environment or typical 610004 4 lines commerce ote 61000 4 5 1 kV line 5 to line 9 lt 5 U gt 95 of voltage drop Ut per 0 5 cycles Quality of the energy must be the one 40 Ut from a hospital environment or typical Voltage drops SiO in 60 of voltage drops in Ut commerce If the user of the Whitening terruptions and voltage s per 5 cycles 3 Lase Light Plus demands continuous variations in the input According 4 supply line 70 Ut ration during the energy interruption It is 61000 4 11 30 Of voltage drops in Ut recommended that the Whitening Lase per 25 cycles Light Plus is supplied by a uninterruptable lt 5 Ut power supply or a battery gt 95 of voltage drops in Ut per 5 seconds Magnetic field in the su Magnetic fields in the supply frequency pply frequency must be in specific levels of a typical pla 50 60 2 3AM hospital environment or typical IEC 61000 4 8 commerce NOTE Ut is the supply voltage c a before the applicati on of the trial level Table 2 Accordance Information to the electrom agnetic immuni 202 60601 1 2 2007 ty requirements based on the table 15 WHITENING LASE LIGHT PLUS User Manual Guidelines and manufacturer statement Electromagnetic Immunity Device that is not from LIFE SUPPORT
8. Review 05 Review Date 01 04 2013
9. by the following parts PARTS Whitening Lase Light Plus Handpiece Support AIC Cable 02 Fuses ACCESSORIES 22 USER WARRANTY MANUAL AGREEMENT 03 Protection Transportation User s Manual and Electronic Media goggles Briefcase Warranty If the acquisition of any accessory is necessary it must be bought at DMC Equipment through the following codes A C Cable 010130037 Manufacturer STO Model Cabo PP 3 x 0 75 2 e Goggles 050020001 Manufacturer Piramex Model ESB460SF Handpiece Support 110010418 Manufacturer DMC Model 110010418 A All the accessories and parts described above are for exclusive use in the Whitening Lase Light Plus device COMMAND BOX PARAMETERS 1 Cable A C connector Place where the cable A C must be connected 2 Fuseholder Place where the device fuses are inserted 3 On Off Switch Turns on and off the command box WHITENING LASE LIGHT PLUS User Manual WARNING LASERS Warnings in the Command Box The label below illustrates the laser radiation The label below illustrates the exposition laser radiation warning Invisible laser radiation Avoid direct eye exposure Class 3R Laser Product Maximum Output 0 1 W Wavelength 808nm 10nm Classification according to IEC 60825 1 2007 HANDPIECE A Activation Button Quick act
10. es cannot be applied in all the situations The electromagnetic propagation is affected by the structure absorption and reflection objects and people a The intensities of the field established by the fixed transmitters such as radio stations base telephone cell Phone wireless and mobile terrestrial radios amateur radio radio transmission AM and FM and TV transmitters do cannot be accurately foreseen theoretically In order to evaluate the electromagnetic environment due to the fixed RF transmitters it is recommended an electromagnetic inspection at the local If the measurement of the field intensity at the local in which Whitening Lase Light Plus is used exceeds the accordance level used above the Whitening Lase Light Plus should be obser ved to check if the operation is normal If an abnormal development if observed additional procedures may be necessary such as a reorienting or rearranging of the Whitening Lase Light Plus b Over the frequency range of 150 kHz up to 80 MHz the field intensity should be lower than 3 V m Table 3 Accordance information to the electromagnetic immunity requirements for devices which aims at LIFE SUPPORT based on the Table 204 60601 1 2 2007 mo Distance and minimum separation recommended between the RF portable and mobile communication devices and the Whitening Lase Light Plus The Whitening Lase Light Plus is designated for using at the electromagnetic environment in which radia
11. he manufacturer If this maintenance is not performed the manufacturer does not take any responsibility for its safety All the assistance services such as changes repairs calibration etc can only be performed by the manufacturer The circuit schemas components lists descriptions instructions for calibration and measurement are not available for people who are not qualified by the manufacturer If the maintenance or any other kind of assistance service if performed by unauthorized personnel the manufacturer do not take any responsibility for the safety of the device functioning In order to assure the safe usage of the product the user must inspect the integrity of the A C cable command box and the handpiece in a daily basis that is check if this parts are not broken torn dirty etc Never open the command box the handpiece At any problem contact the technical assistance of the DMC Equipment STORAGE AND TRANSPORTATION Store the device away from dust solar direct exposure near chemical products and cleaning agents device must be stored transported and used in the following environmental conditions Temperature from 100C to 400C Humidity from 30 to 75 Atmospheric Pressure from 700hPa to 1060hPa Avoid the device falling Keep the device safe place avoiding hits and vibrations PROBLEMS AND POSSIBLE SOLUTIONS Error Error Indication Solutio
12. heating The blue or violet LEDs have the function of activating the whitening gel thorough the interaction of the light dye INDICATION Dental Whitening CONTRAINDICATIONS Pregnant or lactating women Patients with predisposition to or who have cancer Patients with periodontal pathologies e Minimum age of 17 Patients with sensitive teeth WHITENING LASE LIGHT PLUS User Manual LIMITATION Restorations prosthesis and exposed root are not eligible for whitening SPECIFICATIONS Infrared Laser Characteristics Wavelength 808 nm 10nm Emitter useful power 100 mW 20 Blue or violet LED Characteristics Wavelength 450 nm 10 nm blue or 405 nm 5 nm violet Emitter useful power 400 mW 20 AX The parameters specified are not likely changes due to time General Characteristics Characteristics Specifications Voltage 90 240 V Power Input 50 VA Operation Mode Continuous Frequency Power 50 60 Hz Level of protection to the water and solid 20 objects penetration Nominal Current 2 A Type T Fuse Voltage 250 V Breaking Capacity 35 A or L Size 19 cm depth x 09 cm width x 10 cm height Weight 0 700 Kg Fiber Diameter 600 um Type of Current Alternating Current Software version 2 1 Applied Part Not Applicable Protection against electric shock C
13. ivation turn the device on off Continually press alternates between the laser option enabled and disabled B Handpiece fan C LD and LS Leds LEDs f EESE Equipment Situation LD LS Led on with Equipment in readiness with infrared me Led o continuous emission lasers disabled Led on with Handpiece activated with blue or violet LEDs Led intermittent emission in operation and infrared lasers disabled Led on with Led on with Equipment on in readiness with infrared continuous emission continuous emission lasers enabled Led on with Led on with Handpiece activated with blue or violet intermittent emission intermittent emission LEDs and infrared lasers in operation D Laser aperture localization Handpiece LEDs and lasers This handpiece has three infrared lasers and six blue or violet LEDs When it is not being used it is important to keep it in its holder in order to not get damaged How to apply the handpiece can be seen below PATIENT OPERATOR POSITION Below it follows the image with the patient Whitening Lase Light Plus device operator position Distance from the device for the operator patient 2cm from the target tissue WHITENING LASE LIGHT PLUS User Manual DESINFECTION Command box Handpiece device must be disconnected from the power supply before cleaning in order to avoid the user exposition to electrical
14. lass SAFETY IMPORTANT CAUTION A If any component present damage it must not be used AX The use of any part accessory or material not specified it is the user s entire responsibility AX The laser light is harmful to the eyes so the goggles must be used in order to protect them for everybody in the place where the session is happening The DMC provides three goggles along with the Whitening Lase Light Plus Only the goggles provided by the DMC may be used along with the device The model of the before mentioned goggle can be seen below Goggles Green lenses Never look directly to the laser light and more importantly do not direct the light to anybody unless he she is under treatment Reflexive surfaces may reflect the laser beam in the eyes direction Z the usage of flammable or oxidizable anesthetic gases such as the nitrous oxide N20 and oxygen must be avoided Some materials for example cotton when saturated with oxy gen may inflame by the high temperatures produced The adhesive solvents and flammable solutions used for cleaning and disinfection must evaporate before the device is used AX Only trained people can operate the device The inadequate usage can cause irreversible damages AX Only the components mentioned in this manual can be used together with the device It is not allowed the usage of the device by unauthorized and not qualified people aiming at avoiding the incorrect or inappropriate
15. ns Causes Possible Check whether the A C cable is well connected Check with the A C cable un With on off switch on I plugged from the grid if the fuse is on no indicator LD blown as item PROCEDURE FOR LS lights up CHANGE AND CHECKING OF FUSE Check if the outlet is working properly Activate the technical assistance of DMC Equipamentos The equipment does not turn on Clear the air outlet of the handpiece Check if the micro fan is locked Restart the equipment Activate the technical assistance of DMC Equipamentos nterruption of operation Excessive heating of hand and audible alarm with piece flashing hand piece switched off nterruption of operation and audible alarm with Restart Mie equipment Uncalibrated emissions Activate the technical assistance of flashing handpiece switched off DMC Equipamentos DISCARDING After the product and its accessories life has expired it can cause environmental harm or can be used incorrectly In order to minimize these risks the client must discard the device according to what the local legislation determines BIOCOMPATIBILITY The equipment has no applied part Therefore this topic is not applicable LASER LEDS SUPPLY SYSTEM The dental whitening handpiece is composed by three infrared diode lasers and six blue or violet LEDs For the lasers the light is conduced to the edge of
16. only manufacturing defects or of material used in the manufacturing of the products The warranty DO NOT covers shipping expenses C The warranty is automatically cancelled in case of any electrical or physical abuse happen if the parts were altered or if applications different from those the device is developed for happened D In case of repaired devices out of the warranty period it will only be extended to the replaced parts E The causes of the defects more common come from physical shock applied to the device in these cases the warranty is cancelled F The DMC does not take any responsibility for personal or material damages from the misusage of the devices they manufacture and or commercialize it is the user s responsibility to provide safety procedures in order to avoid such problems G The DMC responsibility concerning to the use of the device and its consequences limits to the replacement of the amount of the device The device will only be under the manufacturer warranty regulations if assembling extensions adjusts modification or repair operations were performed by people authorized by them 17 WHITENING LASE LIGHT PLUS User Manual electrical installation of the environment in focus is in accordance with the appropriate requirement device is used according to the instructions SYMBOLS USED SN J E O feo 18 Laser Radiation Check the user s manual
17. shock command box must not be washed it will imply in warranty loss cleaning consists of using a soft cloth moistened with alcohol 70 Do not allow liquids to drain into the command box because it will damage it A the device can be cleaned disinfected multiple times with no damage INSTALL Fix the support of the handpiece in the appropriate place clean flat surface near the point of use Position the dental whitening handpiece in the handpiece support while not being used Connect the A C in the command box of the equipment e Then insert the A C cable in the mains BEFORE USAGE INSPECTION Check if all the items mentioned in the INSTALL are connected SEQUENCE OF OPERATION e With the A C cable inserted into the mains according to item Install activate on off switch located on the command box e Direct the handpiece to the target tissue as item patient operator position Follow the instructions in the section How to Use for activation of handpiece USE METHOD Selection of Laser in Teeth Whitening To enable or disable emitting lasers with handpiece switched off the user must hold the button until the LS indicator of handpiece is off disabled or until it turns on enabled Handpiece Activation To activate deactivate the handpiece just quickly press the power button Whitening Lase Light Plus is configured for one minute cycles
18. ted RF disturbances are controlled The client or user of Whitening Lase II may help to prevent the electromagnetic interference keeping the minimum distance between the portable or mobile RF communication transmitters and the Whitening Lase Light Plus as recommended below according to the maximum output power of the communication devices Nominal maximum power of Separation distance according to the transmitter frequency m the transmitter W 150 kHz to 80 MHz 80 800MHz 800 MHz up to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters with an output nominal maximum power not listed above the separation distance recommended meters can be determined by the equation applicable for the transmitter frequency Note 1 80 MHz up to 800 MHz the separation distance is applied for the highest frequency range Note 2 these guidelines cannot be applied in all situations The electromagnetic propagations are affected by the structure absorption and reflection objects and people Table 4 separation distance between the device and the RF emission sources recommendations based on the Table 206 60601 1 2 2007 WARRANTY A The devices manufactured and or commercialized by DMC have a 24 twenty four months war ranty from the date of the purchase against any manufacturing defect B The warranty covers
19. usage WHITENING LASE LIGHT PLUS User Manual The device must not be used with wires and accessories that are not provided by DMC be cause it can result in increase of the emissions or decrease of the immunity of the device A the device must not be used too close of pilled over other devices If it is necessary we recom mend that the device is observed in order to check the normal operation in the setup in which it is going to be used The patient must be at least 18 years old to realize the dental whitening AX The device is not designated to be used in an environment full of oxygen AX n order to avoid the risk of electrical shock this device must be connected to only one power supply with grounding for protection A The user must not connect the Cable A C plug in places that are difficult to access because it can make the device disconnection difficult A None modification in this device is allowed A The manufacturer does not take any responsibility if the user uses a fuse and an A C cable different from the ones specified in this manual The user must be exposed to the noise the device does during the maximum period of 8 hours day The air inputs and outputs must not be obstructed not apply any protective film in the handpiece SECURITY ITEMS OF THE DEVICE The device emites sound signal emission while the handpiece is active COMPONENT LIST Whitening Lase Light Plus is constituted
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