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WISER: User Manual

1. Verify the correct power cable has been connected Activate using the main switch on the rear of the machine see fig 2 4 b The system shows a start up screen like the follow wiser The Wireless laser x doctor smile VA Note the start message may be different of this one and may be modify by manufacturer without notification Thus the system asks for an access code after 5 seconds from the intro screen Insert the access code The initial default factory password is UP key for four time the first button at the top of the touch pad FIG 3 8 Access code requirement The access password can be changed at any time by using the appropriate function from the menu see Chap 4 After having inserted the correct password the system will activated and proceed in standby status showing on display the settings of the last treatment used see fig 2 2 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 38 3 3 LASER SOURCE ACTIVATION PROCEDURE After system start up the system will go to the STAND BY mode The laser source will not be active Emission parameters set depending on the last program used Finger switch or Footswitch in case optional is not enabled You can quickly modify the emission parameters using the function keys see Chap 4 To activate the laser carry the following actions out ar ca From the Stand By state push I 00 00 ready stand by
2. Brightness 10 Sleep Time 60 Screen Theme 1 FIG 4 7 System menu The green colour shows the selected entry The Light selection is disabled when used wireless a low light is automatically set to save battery charge When turned into wireless mode the display light will be reduced 4 6 1 How to enter escape system menu From Stand By state press twice the menu key it will display a screen as reported in Fig 4 6 TO ESC Press the Left key to escape from the setting menu and get back to the main menu avoiding the saving operation Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 57 4 6 2 Language Is possible to set the favourite language for displaying the messages and the words appearing on the display Use the Up and Down to select the language from the setting menu The selection become written in green Press the Stand By Ready Operate key to confirm the language choice the written start blinking Use the Up and Down to select the language required Press the Stand By Ready Operate key to confirm the language required OR Press the Left key to escape from the setting menu and get back to the main menu avoiding the saving operation After the procedure described has been carried out the display will be immediately updated with the words in the selected language and it will remain as the default language
3. WARNING Never direct the red pointer towards eyes eventough is a low level laser source eventough is selected ON in the main menu The switch of the aiming beam if activated from the main menu starts when there is the activation of the laser source and it remains active for all the time during the lasing AN WARNING in Stand By state the Aiming beam is always switch OFF Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 52 4 5 USE OF APPLICATIONS FIELDS The system can internally hold a list of programs appropriate for various types of application fields These programs have preset names that recall application fields that have been predefined and default values for various parameters These values are not absolute nor definitive but only indicative and are useful as a starting point for the operator given the responsibility to adapt as best they can and depending on single case the parameters of emission Starting with this list the operator can select the appropriate application to carry out The programs are collect in seven fields each one with a reserved key for a quick access of application fields menu and to the desidered operation see fig 4 3 1 Endodontics 1 Endodontics 2 Periodontics 3 Surgery 3 Surgery 4 Implant 4 Implant 5 Therapy 5 Therapy 6 Whitening 6 Whitening 7 User Treatments 7 User Treatments FIG 4 3 Treatment menu 4 5 1 Application field selection To s
4. the optic tips The parts that can not be sterilized are special lens for bleaching that works not in contact WARNING The components to be sterilised must be always be separated and prepared for sterilised removing any possible solid organic residue To sterilise the parts indicated the standard methodology in autoclave at 121 C for 20 min The number of cycles of sterilisation in autoclave is limited and we suggest that the operator make a careful inspection of the sterilised parts after each cycle to confirm its integrity In particular For the optic tips verify that covering does not show signs of deterioration breakages or holes For the accessories for the withening verify if there are signs of abrasions breakages or changes to the size the structure or coloring In the event a part has signs of deterioration or in case of doubt ensure that the component is substituted by a new one DISPOSAL Do not dispose the used or damaged tips in the environment Disposal must always conform to national and or regional laws in place Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 37 3 2 SYSTEM POWER ON PROCEDURE WARNING Before following the system start up procedure ensure that all safety measures described in this manual have been put into place After having carried out installation and system preparation see previous paragraphs you can start up the device by the following actions
5. d Right tip connection ready to be used in order to avoid damage to the tips it is important to verify a correct coupling between tip and handpiece Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 33 FIG 3 3 Optical tip inserting Remove 1 Twist and tear the tip 2 Handpiece without tip vce FIG 3 4 Optical tip removal 3 1 5 Tips preparation are supplied in a non sterilized making Thus sterilize them before each 1 CAUTION at delivery of the appliance the handpiece and the optical tips session The optical tips supplied are different in their length and purpose and marked with different colours Attenzione tutte le misure hanno una tolleranza di 1 5mm FIG 3 5 Dimension of Tip Quantity Tip CA O _ ei Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 34 A 25mm LATEN201 4 jii B 3mm 4 C 15mm D e LATSU401 4 SURGERY hi LATIM301 4 IMPLANT WHITE co LATHE401 4 THERAPY BLACK P LAACS043 1 WHITENING A LAACS042 1 WHITENING The end of the tip fitted with the handpiece connector and must be carefully plugged into the special socket lodged on the front side of the handpiece Never leave the tip connector socket unprotected Theparts lodged inside this port is very delicate and liable to easy breaking in case of penetration of fluids action of smoke steam or things of all kinds Absolutely avoid putting your fingers into th
6. WISER User Manual TT doctor smile dental laser LAMBDA SpA Table of contents TABLE OF CONTENTS 1 TABLE OF FIGURES 3 SYMBOLS 6 WARNING 7 DISPOSAL 8 CE CONFORMITY MARKING 8 CE CONFORMITY STATEMENT 9 INTRODUCTION 10 CAP 1 SAFETY INSTRUCTIONS 12 1 1 GENERAL SAFETY MEASURES 12 1 1 1 Working area 12 1 1 2 Safety labels 12 1 2 INDIVIDUAL SAFETY MEASURES 15 1 3 EMC REGULATIONS ELECTROMAGNETIC COMPATIBILITY 16 1 3 1 List and set up of linkable cables to the appliance 16 1 3 2 Emissions _ 17 1 3 3 Immunity 18 1 4 OCULAR RISKS__ _ 21 1 5 LASER BEAM ACTION PRICIPLE 22 1 5 1 Contraindications 22 1 5 2 Laser benefits with respect to traditional techniques 23 1 5 3 Collateral effects 23 CAP 2 VIEW OF DEVICE 24 2 1 INTRODUCTION 24 2 2 THE CONTROL PANEL 24 2 2 1 LCD colour display 25 2 3 FRONT SIDE 26 2 4 REAR SIDE 27 2 5 THE POWER SUPPLY 27 2 6 SUPPLIED ACCESSORIES 28 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 1 2 7 SYSTEM SWITCHES CAP 3 SYSTEM USE 3 1 PRE OPERATIVE INSTALLATION 1 1 External interlock network optional 1 2 Preparation of the handpiece 1 3 Tip bending 1 4 How to insert remove the tip 1 5 Tips preparation 1 6 Preparation of handpiece for bleaching Wide area 1 7 Preparation of handpiece for bleaching Small area 1 8 Sterilization of the tips and accessories SYSTEM POWER ON PROCEDURE 3 LASER SOURCE ACTIVATION PROCEDURE 3 3 1
7. Figure 2 3 illustrates these in detail A Display B Control panel C Handpiece holder D Indicator lamp E Handpiece FIG 2 2 Front side laser air change Do cnot cover even partially the ventialtion grilles during 1 Do not place the laser next to walls or other locations that could decrease the system in use Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 26 2 4 REARSIDE The sockets for several system accessories are positioned on the rear section of the appliance Figure 2 4 illustrates these in detail A A Emergency button within Ready indicator Led B Main switch C Footswitch socket D Power socket E Interlock socket F Fuse G Optic fiber output FIG 2 3 Rear side Ensure that the external power socket has a sufficient earth connection compatible with the system see Chap 7 The optic fiber is connect to the rear side and it is integrate to the laser device It is not allowed to unplug or remove the optic fiber for any reason AN Ensure that the electrical specifications of the electrical power circuit are 2 5 THE POWER SUPPLY The power supply provided with LA3D0001 1 fulfils the rules CEI EN 60601 1 Such power supply has the following characteristics Input voltage 100 240 AC Frequency rate 47 63 Hz Output voltage 12 VDC Max output current 8 33 A CAUTION never use a different power supply from the one provided We recomme
8. The system LA3D0001 1 allows three option for emission mode Pulse modality with fix parameters a b c d a Continuous emission CW Medium pulse MP Super pulse SP Super Supreme pulse SSP Manual Pulse modality Manual user The choice of emission mode set the parameters of laser pulse Ton pulse duration Toff time between two pulses _ lt __w Ton Toff FIG 4 2 Pulse parameters Ton and Toff vcan be modified with values from 20us until 30S included the CW mode Continuous Wave MP SP SSP By modifying Ton and Toff other parameters of the system also will change with the pulse shape like the frequency and the average power These parameters are displayed in the Window applications vedi fig 2 2 J where the accumulated energy during the treatment and the exposure time appear as well Therefore during the modification of either Ton or Toff it will be noticed that the figures displayed in Window applications have changed Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 49 4 3 4 Pulse modality with fix parameters The parameters Ton and Toff of the default treatments become fix values according to the CW MP SP SSP mode as shown on the display The following table shows the relative Ton and Toff values already set Toff Frequency related poo Continuous emission Pulse modality with fix parameters The power value shown at the top of the display
9. 10ms 20ms 30ms 40ms 50ms 60ms 70ms 80ms 90ms Values admitted in LOOmsec 1sec field 100ms 200ms 300ms 400ms 500ms 600ms 700ms 800ms 900ms Values admitted in 1sec 30sec field from 1 30 sec with steps of 1 sec Tab 4 4 Table of the Ton and Toff values admitted for the manual mode Procedure to set Ton and Toff parameters O BWM From the standby mode press the Enter Recall key Push 2 3 times the Right key Respectively background to select the Ton or Toff turn in red color Use Up and Down keys to set increase or decrease the Ton or Toff values See Tab 4 4 for the admitted values Press Enter key to esc from the setting functions OR Press directly the Stand By Ready Operate key to esc from the Ton o Toff setting Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 51 4 4 USE OF RED POINTER The unit is supply with an ausiliar light source as known as red pointer aiming laser beam It is a low level power unit visible in the red spectrum If activated it is visible in operate state only Procedure to set on off the red pointer From Stand By state push the Left key to ro activate Deactivated the laser beam A ofl The border of the red pointer Icone on display Fig 2 2 G become in red Press Stand By Ready Operate key to activate Deactivate the red pointer O iby Activate the red pointer Deactivate the red pointer
10. 2 Laser tissues interactive diagram The surgical treatments of the diode lasers are based for the majority of them on the conversion of the optical radiation mostly into thermal energy and partly in mechanical energy 8 3 3 Thermic interaction In a microscopic view the photothermic processes may be represented with the absorption of a photon by an organic molecule that bears it to an excited rotating vibrational state and with the successive disexcitment derived from anaelastic shock with a molecule of the surrounding medium that will have thus its kinetic energy This process of non radiative loss occurs within the shortest delay 1 100 psec and the subsequent fast heating will give a local temperature rise Macroscopically the biological effects of photothermic kind may be classified according to some different thermodynamic processes which the main histological changes summarized in the below table will be relevant to Tab 8 1 Histological changes induced by photothermic processes Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 73 Structure changes Shrinking Overheating cellular death Reduction of enzyme activity Protein degenerating Coagulation Collagen degenerating Permeabilizzazione delle membrane Low temperature effect 43 100 C Hypothermic regime 43 45 C hypothermic interval The first thermal effect put up with by the biomatter is the degenerating breaking of the hydrogen bon
11. 5 0W a 00 00 Brind the system to the Sstand by state pushing the Stand By Ready Operate button Implant Uncover y Ready Op PW Av 5 0W x Press the main switch see fig 2 4 f 3 5 1 Emergency stop Whenever there may be an emergency situation you can switch off the machine by simply pressing the emergency button see fig 2 1 A Any pressure applied to this button will instantaneously block the system and the eventual emission of radiation in progress After pressing the emergency button do not forget to press the main switch When danger ceased it is necessary to press the emergency button again In case of emergency stop the laser get instantly blocked in all operations in order to start and activate the machine again o Push stop button to block instantaneously the system and the eventual emission of radiation in progress x Press the main switch Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 41 3 6 BATTERY OPERATION The LA3D0001 1 laser contains an internal rechargeable battery and a storage battery that guarantee the functioning of the system and the power supply when used in the wireless mode The duration of use in the wireless mode depends on the battery level on the storage battery level and on the laser beam settings mode and power When either of batteries run below the operational minimum the system goes into the stand by mode and displays a low batt
12. Code LI3D0001 2 Date 25 09 2009 Pag 75 the different temperature values that locally develop after the laser radiation has penetrated into the tissue Using the laser on a continuous mode in particular beside the penetration depth another parameter basically to check in order to circumscribe the effects of the laser radiation into the volume of the tissue to be treated is the thermal relaxation time t in the tissue In fact if the laser radiation time is longer than t the heat has the way to scatter inside the tissue on a larger space than the typical penetration depth 8 3 4 Thermal relaxation time of the tissue The ength of scattering L bound to time t represents a very important parameter for the control of the thermal effects L 4Kt K being the thermal diffusivity of the material which is in relation with the thermal conductivity specific heat and density The water has K 1 43 10 cm s so within a second the heat scatters on a length of 0 8 mm Similarly the scattering time associated with an blood vessel of 10 um of diameter is about 100 us while for a vessel of 100 um this time will increase until about 18 ms If L is equalled to the penetration length of the optical radiation into the tissue the thermal relaxation time t in the tissue will be thus calculated ta YU KI representing then the time the heat will take to spread on an optical penetration length If the duration of the laser pulse is shorter than
13. Laser emission 3 4 PROCEDURE FOR DEACTIVATE LASER SOURCE 3 5 PROCEDURE FOR SWITCHING OFF THE SYSTEM 3 5 1 Emergency stop 3 6 BATTERY OPERATION 3 6 1 Battery level indication 3 6 2 Storage battery level 3 6 3 Battery Charge internal battery CAP 4 CONTROL PANEL 4 1 INTRODUCTION 4 2 MEANING OF GRAPHIC SYMBOLS 4 3 EMISSION PARAMETERS 4 3 1 Power settings 4 3 2 Treatment duration settings Timer 4 3 3 Emission mode settings 4 3 4 Pulse modality with fix parameters 4 3 5 Manual mode functioning 4 4 USE OF RED POINTER 4 5 USE OF APPLICATION FIELD 4 5 1 Application field selection 4 5 2 Application selection 4 5 3 How to save application field parameters 4 5 4 How to recall default parameters 4 6 SYSTEM MENU 4 6 1 How to enter escape system menu 4 6 2 Language 4 6 3 Password setting 4 6 4 Contrast settings 4 6 5 Setting display standby time 4 6 6 Main menu background setting 4 7 SOUND ALARM SETTING CAP 5 SYSTEM ERRORS 5 1 SYSTEM ERROR VISUALIZATION MODE 5 2 DESCRIPTION OF ERROR MESSAGES 5 2 1 Interlock not connected NW WWWW WW WD di 3 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 2 5 2 2 Overheating Temperature error _ 5 2 3 System error Electric failure CAP 6 CLEANING AND MAINTENANCE 6 1 GENERAL CLEANING INSTRUCTIONS 6 2 GENERAL MAINTENANCE INDICATIONS CAP 7 TECHNICAL SPECIFICATIONS 7 1 GENERAL SYSTEM FEATURES 7 2 LASER SOURCE SPECIFICATIONS 7 2 1 Diode laser source 7 3 OPERATI
14. Save the parameters only if an application field has been modified by the user an asterisk near the treatment will appear Recall key Into main menu e Select confirm value of selected parameters Into system menu e Not Active Into treatment menu e Not Active Into application field menu e Recall default parameters if an application field has been modified by the user an asterisk near the application field will appear Nel menu principale e Select value of selected parameters e Select the laser beam Into system menu Not Active Into treatment menu e Not Active Into application field menu e Not Active Left key Into main menu e Select value of selected parameters Select sound activation deactivation Into system menu Return to the main menu Into tretament menu Return to the main menu Into application field menu e Return to the treatment menu Tab 4 1 Meaning of graphic symbols Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 46 4 3 EMISSION PARAMETERS LA3D0001 1 system allows the operator to have a full control on the settings of the laser radiation The various parameters are Power Power of laser radiation 0 1 10 0W Timer control the duration of application field off 10 min Mode CW Continue Wave continuous emission MP Medium Pulse Ton 200ms Toff 500ms 1 5Hz SP Super Pulse Ton 10ms Toff 10ms 50Hz SSP Super Super Pu
15. Ur 60 dip in Ur for 5 cycle 70 Ur 30 dip in Ur for 25 cycle lt 5 Ur gt 95 dip in Ur for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative umidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of LA3D0001 1 requires continued operation during power mains interruptions it is recommended that LA3D0001 1 be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Ur is the a c mains voltage prior to treatment of the test level Model LA3D0001 1 Tab 1 2 Electromagnetic immunity Manual Code LI3D0001 2 Pag 18 Date 25 09 2009 Guidance and manufacturer s declaration electromagnetic immunity LA3D0001 1 is intended for use in the electromagnetic environment specified below The customer or the user of LA3D0001 1 should assure that it is used in such an environment test test level e level guidance Portable and mobile RF communications equipment should be used no closer to any part of LA3D0001 1 including cables than the recommended sep
16. according to the European standard applicable for medical devices CEE 93 42 The number 0476 reported under this label indicates the competent body that has issued this certification The office responsible for the product is 0 4 6 LAMBDA SpA Via dell Impresa 36040 Brendola VI ITALIA www lambdaspa com info lambdaspa com Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 8 CE Conformity Statement For the devices coded as follows LA 3DO 001 _ S n manufactured by LAMBDA SpA According to part II of standard 93 42 CEE issued with Law Decree 46 97 The writer LAMBDA SpA seated at Via dell impresa 36040 Brendola Vicenza manufacturer of the above mentioned devices takes responsibility to state that such devices do fulfil all necessary qualifications required by Standard 93 42 CEE Part I about the Medical Devices their design production and final check up are carried out according the relevant instructions taken from Quality Guarantee System certified on 31 01 2001 by CERMET according to the prescription from Standard 93 42 CEE part II The firm also does guarantee and takes responsibility to state that 1 The devices are to be considered as belonging to Class II B 2 The manufacturer engages himself in keeping and leaving at disposal of the Qualified Authority the following technical documents as specified in Part II paragraph 6 1 of Standard 93 42 CEE for a period of five years since the
17. and therefore with a very high directionality of great spectral purity with possibility to concentrate very high powers on very small surfaces In order to provoke the desired clinical effect the laser radiation must be absorbed by the target tissue The interaction laser tissue deriving from it depends on the characteristics of the laser used such as its wavelength its effective power on the irradiation forms such as the radiation intensity and application field duration and on the characteristics of the target tissue such as its colour and properties of absorption and reflection of the substances it contains water hemoglobin and pigments or chromophores The laser treatment in medicine and in particular in dentistry is based precisely on the absorption of radiation by water contained in the tissues by the hemoglobin contained in the blood and by pigments or chromophores normally present in some tissues In particular water absorbs in infrared with a maximum absorption around 3 000 nm hemoglobin presents an absorption spectrum that goes from the ultraviolet to the visible until a little less than 0 64 micrometers with fluctuations in the visible inferior to 10 per cent The pigments and or different chromophores present an absorption spectrum extended from the ultraviolet to the near infrared The radiation between 800nm and 1000nm is weakly absorbed by water and hemoglobin and presents a penetration depth of many hundreds of microm
18. communication appliances can affect the operation of the LA3D0001 1 device on or underneath other appliances AN WARNING the LA3D0001 1 device must not be used near or placed 1 3 1 List and set up of linkable cables to the appliance A Power cable 2mx0 75 C Interlock cable 5m P Footswitch cable 2 9m T Power supply EUT LA3D0001 1 device FIG 1 4 Set up cable during tests WARNING do not use cables or accessories different from those specified Use only cables and accessories supplied with the AN equipment or otherwise sold by the manufacturer Use of alternative cables may cause possible malfunction an increase in emissions or a reduction in immunity of the LA3D0001 1 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 16 1 3 2 Emissions Guidance and manufacturer s declaration electromagnetic emissions LA3D0001 1 is intended for use in the electromagnetic environment specified below The customer or the user of LA3D0001 1 should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance LA3D0001 1 uses RF energy only for its internal RF Emissions Group 1 function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment RF emissions TERESE LA3D0001 1 is suitable for use in all EE Class A establishments including domestic establishments IEC 610
19. lasers 190 350 nm are mainly absorbed by the main organic species A similar attitude is shown by the IR wavelengths such as those relevant to Ho YAG Er YAG and CO 2 10 um lasers that undergo a massive absorption mainly by the content of water in the tissues In these cases the penetration depth of the radiation formally defined as L 1 a where a is the coefficient of absorption in the tissue turns out to be of a few dozens of micrometers and the phenomenon of the scattering may be ignored about the propagation Absorption scattering In the optical portion of the spectrum where the emission lines lie of Argon duplicated Nd YAG and copper vapour 450 570 nm lasers the effects of absorption and scattering will turn out equally important with typical penetration depth of about one millimeter Part of the luminous radiation in the tissue will be tallied and surrounded by an area where the basis will put up with multi scattering Scattering prevailing In the spectral areas of IR and near IR typically between 600 nm and 1 5 m the tissue is provided with a transmission window for the electromagnetic transmission On this band which the emissions of diode laser Dye Nd YAG Alexandrite and He Ne lasers belong to the scattering is prevailing over the absorption and consequently the penetration depth of about 2 8 mm turns out to be determined by phenomena of multi scattering rather than absorption A portion of radiation not to neglect
20. noted so that they can Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 63 5 2 DESCRIPTION OF ERROR MESSAGES The errors like Interlock not connected or Overheating will shown only when user try to access ready state and only for few seconds If there are multiple errors the system shows once at time following a priority list 5 2 1 Interlock not connected The external interlock network aims to block the functioning of the machine once a specific event is confirmed for example at the opening of a door see Chap 3 paragraph 3 1 1 a Inthe event the external interlock network is present verify that the event is under control for example the opening of a door or check that the connections are correct b Inthe event that the external interlock network is not present verify that the interlock connector supplied is correctly inserted in the appropriate socket Call the help desk service if the error persists 5 2 2 Overheating Temperature error This type of error appears when system temperatures inside the machine is out of working range The system independently goes into a safeguard mode switching off all the power sections and going into stand by state Switch the machine off and leave it switched off in an climatised environment that are within the technical specifications for at least 5 minutes and then try switch on again The message is accompanied by a sound warning Call the help desk service if
21. occurs in the immediately inner layers of the tissue because of the back scattering of the radiation derived from the scattering nature of the tissue The damage that takes place in these conditions beside having purely thermal consequences will give mechanical effects as well The macroscopical bubbles vacuoles that form in the warmest areas of the tissue below the radiated surface will press the tissue because of the notable increase of the volume with respect to the conversion liquid vapor when the critical pressure is reached the thin walls of the vacuoles will break so these latter will gather to form larger sized conglomerates by radiating for a longer time the bubbles will spread until they cause kind of explosive breaks pop corn effect The break of the vacuoles on the surface will allow the vapor to get outside producing a temporary cooling of the surface The histological analysis of the effects induced by the pop corn effect indicate that the superficial craters thus produced are not due to any loss of tissue mass but to the formation expansion and break of vacuole agglomerates Differently the high and quick heating due to the radiation in pulsed mode will produce an explosive break of the vacuoles with explosion of tissue fragments It is important to notice that most of the previously described thermal effects may occur simultaneously on different areas of the radiated volume as a consequence of Model LA3D0001 1 Manual
22. of it easier Besides the external power supply included in the accessories package the unit has an internal rechargeable battery capable of providing a certain autonomy at full load It is provided with a display with a clear and intuitive interface which guarantees a quick learning of the use of the machine 2 2 THE CONTROL PANEL On the front side of the machine is housed the control panel with a led anda sequence of keys as shown in fig 2 1 being parts of it Multifunction button for selection and set up of parameters through menus Stand by Ready Operate key Multifunction button for application field selection and parameters set up through menus Orange led light indicator Multifunction button for parameters set up of selected application field FIG 2 1 The control panel Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 24 2 2 1 LCD colour display The LCD display is the communication interface between the appliance and the operator Display functions Allows you to see and modify energy values Allow you to see and modify pulse settings CW MP SP SSP or manual set up T on and T off Allows you to set the time for the treatment in use Allows you to see and modify the pre set treatment in use Allows you to see any system errors allows you to see the stored energy to use the device in wireless remote and the charging of the internal battery allows you see the freque
23. t the laser energy will stay trapped into the volume S S radiated surface The strong temperature rise and the relevant thermal harm will be localized on such area while the surrounding tissues will undergo a very moderate heating after the successive thermal scattering There are then great differences in the t depending on the scattering dispersion to be prevailing or not over the absorption These concepts are applied to selectively effect the coagulation and or the vaporization of the tissue by choosing the wavelength of excitement so that the penetration length is almost equalled with the size of the structure of the tissue to treat for example a blood vessel and adjusting the duration of the laser pulse this latter will turn out mostly confined into this structure By adjusting at last the repetition rate as well in an appropriate way the temperature may be kept to level in the surrounding tissues that are heated by the scattered heat generated in the absorption area for duration times longer than t with a value of specific harm selective photothermolisis Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 76 8 3 5 Photomechanical interaction Short duration pulses may give birth to mechanical shock waves enabled to damage the tissue where they propagate in The formation of the shock wave usually comes after a quick local expansion of the medium Such photomechanical interaction involves the processes
24. the target The importance of such harm is essentially determined by the Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 78 rates of energy on that tissue and its treatment time In most cases the harm is very light and well sustainable in comparison with the benefits We thus advise the user to very carefully check the following parameters so as to not cause any unwanted effects on the patient Power Diameter of the fiber Distance between the end of the fiber and the tissue spot Continuous or pulsed laser emission treatment time The variables diameter of fiber and distance from the fiber are used in order to decide the size of the section of the laser beam interacting with the tissue in fact the smaller the diameter of the fiber and distance from the fiber are the greater the power density will be The variable applied power is used along with the two previous ones in order to decide the power density The variable treatment time is used to decide the total energy or the total energy density to deliver for an treatment The more the treatment time is the greater the temperature rises into the tissue will be The variable of emission mode is a very important variable because it allows decide both the peak power and the average power delivered 8 7 LASER BENEFITS WITH RESPECT TO TRADITIONAL TECH The extreme tolerability of the treatment allows avoiding use of anesthesia in majority of int
25. the tissue a small portion of the radiation typically 5 is reflected back because of the refraction index jump between the outside environment and the tissue The remaining portion is transmitted to the tissue and will be subject to process of absorption and multi scattering The chemical species participating in the absorption of the light in the tissue are numerous and their effect very sensibly changes on a par with the wavelength of the radiation A very important part is covered by the water fig 8 1 being the main absorber in the IR spectrum Besides in the optic bands of the visible and the near IR the radiation is scattered because the cellular diameter comes similar to the wavelength Absorption of light by water and tissues Jase apoig Linear absorption coefficient Logarithmic scale 11mm 0 1 0 00001 100 1 000 10 000 Wavelength Logarithmic scale nanometers FIG 8 1 Absorption of light by water and tissues This process causes an effect over the light propagation reducing the real penetration depth of the radiation into the tissues Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 71 On the ground of these comments it may be advantageous to classify the features of the laser propagation inside the biological media in function of the wavelength of the radiation Absorption prevailing As one may watch on diagram of fig 8 1 the UV wavelengths including the emission lines of excimer
26. vaporization in the tissue may take place with ejection of biomaterials the recoil of which will generate elastic waves and the inertial confinement constant volume transferring of optical energy to the liquid contents of the tissue For very short laser volumes the heated volume has not time enough to spread during the pulse a sudden rise of the inside pressure follows and the successive quick local expansion produces acoustic waves of high intensity High intensity ionization and formation of plasma When either the energy density values are sufficiently high or the removal times sufficiently short the jonization of the radiated material may be induced and the successive creation of plasma Into the plasma extremely high values of pressure and temperature are reached thousands of C and atmospheres The expansion of plasma generates a shock wave that may cause fragment forming and local break in the tissue Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 77 8 3 7 Photochemical interaction The IR radiation that is that coming from the diode is little effective in producing the changes into the biological systems of non thermic nature Non thermic processes may occur in case of high power peaks through two or three photon transitions 8 3 8 Photoablate process The laser photoablate represents a complicated process where in different amounts a few photochemical breaks in molecular bonds photothermic acc
27. will be scattered back and have the effect of rising the temperature inside the tissue with respect to that in the surface Therefore the wave delivered by a diode laser will be propagated through the biological medium mainly by a process of multi scattering with a penetration depth of about 2 8 mm Since part of the radiation is reflected back a temperature rise will take place inside the tissue with respect to the radiated surface 8 3 2 Laser tissue interactive diagram The various kinds of laser tissue interaction may be schematically represented as regions of a diagram reporting the exposure times as abscisses and the power density of the radiation as ordinate where the diagonals stand as lines of constant fluency Though the various kinds of biological effect in this representation will appear in a rather tidy and distinctive way it must be considered however that in the practical treatment they will often appear overlapped both because the intensity of the may not be constant on the radiated area and because the portion transmitted may change during the propagation inside the tissues as described in the previous paragraph Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 72 Laser tissue interactive diagram 1 E 12 1 E 06 1 E 03 Densit di potenza W cm 1 E 00 FOTOCHIMICA 1 E 03 1 00E 12 1 00E 09 1 00E 06 1 00E 03 x 1 00E 00 1 00E 03 Tempo di esposizione sec FIG 8
28. 00 3 2 and those directly connected to the public low voltage power supply network that supplies Voltage fluctuation buildings used for domestic purposes flicker emissions Complies IEC 61000 3 3 Tab 1 1 Electromagnetic emissions Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 17 1 3 3 Immunity Guidance and manufacturer s declaration electromagnetic immunity LA3D0001 1 is intended for use in the electromagnetic environment specified below The customer or the user of LA3D0001 1 should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic Immunity test test level level environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 6kV contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycle 70 Ur 30 dip in Ur for 25 cycle lt 5 Ur gt 95 dip in Ur for 5 sec 6kV contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40
29. 0001 1 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orenting or relocating LA3D0001 1 b Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m Tab 1 3 Electromagnetic immunity recommended separation distance Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 19 Recommended separation distances between portable and mobile RF communications equipment and LA3D0001 1 LA3D0001 1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of LA3D0001 1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and LA3D0001 1 as recommended below according to the maximum output power of the communication equipment Rated maximum output power of Separation distance according to frequency of transmitter aro m 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz d 12 VO d 1 2 VE d 2 3 VO For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer Notes 1 At 80MHz and 800MHz the separati
30. HOLD K 4 6 3 Password setting The Change password function menu allows to modify the system access code To modify the password the old one is required The password is made by a sequence of five keys pressing The initial default factory password is press Up key five times x 5 Procedure to change password Use Up and Down to select the password the written code become in green color K Press Stand By Ready Operate key to start the password modification OR Press the Left key to escape from the password change and get back to the main menu avoiding the saving operation OD Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 58 Language English When old password appears Brightness 10 flashing insert the new system code Sleep Time 60 Screen Theme 1 SETTIN Language English When new password appears Brightness 10 flashing insert the new system code Sleep Time 60 Screen Theme 1 SETTI Language English When confirm password appears Brightness 10 flashing insert again the new system Sleep Time 60 code Screen Theme 1 At the end of procedure the display shows a message to confirm the good result While proceeding in this function if something goes wrong incorrect code inserted on display appears a message like operation failed and the procedure is closed without changing the code WARNING We suggest that the access
31. MENU FIG 4 4 APPLICATION FIELD MENU FIG 4 5 CONFIRMATION OF SAVING PARAMETERS OF MODIFIED APPLICATION FIELDS Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 4 26 26 27 28 30 31 34 34 34 36 36 38 39 39 43 43 44 49 53 54 55 FIG 4 6 CONFIRMATION SCREEN OF DEFAULT PARAMETRY RECALL 56 FIG 4 7 SYSTEM MENU 57 FIG 8 1 ABSORPTION OF LIGHT BY WATER AND TISSUES _ 71 FIG 8 2 LASER TISSUES INTERACTIVE DIAGRAM 73 TABLE OF TABLES TAB 1 1 ELECTROMAGNETIC EMISSIONS 17 TAB 1 2 ELECTROMAGNETIC IMMUNITY 18 TAB 1 3 ELECTROMAGNETIC IMMUNITY RECOMMENDED SEPARATION DISTANCE 19 TAB 1 4 RECOMMENDED SEPARATION DISTANCE EXAMPLES 20 TAB 4 1 MEANING OF GRAPHIC SYMBOLS 46 PULSE MODALITY WITH FIX PARAMETERS 50 TAB 4 3 TON AND TOFF SELECTION FIELDS FOR MANUAL MODE 50 TAB 4 4 TABLE OF THE TON AND TOFF VALUES ADMITTED FOR THE MANUAL MODE 51 TAB 7 1 SPECIFICATION TABLE 67 TAB 7 2 LASER SOURCE SPECIFICATIONS 68 TAB 7 3 OPERATING FEATURES 69 TAB 8 1 HISTOLOGICAL CHANGES INDUCED BY PHOTOTHERMIC PROCESSES 73 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 5 Symbols Symbol Caution the user to pay the utmost attention to the present indications that imply 1 The text enclosed in this space and sided by the symbol Caution warns danger Symbol Information The text enclosed in this space sided by the symbol Information
32. Manufacturer LAMBDA S p A www lambdaspa com Model Serial number Supply voltage 12V DC Class I B R Laser class 4 Working mode 3 2min on off O 4 7 amp ea ee tll FIG 1 3 Security label position Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 14 1 2 INDIVIDUAL SAFETY MEASURES scrupulously followed in order to avoid accidental exposures to laser radiation 1 All the safety measures reported in the following must be The personnel authorised to work inside the laser working area must wear the protection glasses at hand Never direct the laser beam towards eyes Never look at into the fiber connector The fiber connector must always be covered either by the fiber or the protection plug fig 2 3 c Eliminate from the operative area all reflecting and metallic objects including personal belongings such as watches and rings since these objects risk reflecting the laser beam In case of danger immediately press the emergency button see chapter 3 par 3 5 1 At the end of using the laser it is recommended to turn off the main switch The intrinsic characteristics of the diode laser ray if not correctly used could set some non metallic material on fire It is therefore advisable to follow these simple rules very carefully Model Do not point the laser ray towards any clothing We recommend that only appropriate light coloured and completely dry clothing be worn Remove all
33. NG FEATURES CAP 8 APPLICATIONS ERRORE IL SEGNALIBRO NON DEFINITO 8 1 INTRODUCTION 8 2 OPERATING AREA 8 3 LASER ACTION PRINCIPLE 8 3 1 The tissue as an optic conductor 8 3 2 Laser tissue interactive diagram 8 8 8 8 8 8 69 3 3 Thermic interaction 3 4 Thermal relaxation time of the tissue 3 5 Photomechanical interaction 3 6 Photomechanical processes 3 7 Photochemical interaction 3 8 Photoablate process 8 4 EXAMPLES OF TREATMENTS 8 5 CONTRAINDICATIONS 8 6 COLLATERAL EFFECTS 8 7 LASER BENEFITS WITH RESPECT TO TRADITIONAL TECH CAP 9 WARRANTY 69 Table of figures FIG FIG FIG FIG FIG 1 1 SAFETY LABEL 1 2 LIST OF SAFETY LABELS 1 3 SECURITY LABEL POSITION 1 4 SET UP CABLE DURING TESTS 2 1 THE CONTROL PANEL Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 3 12 14 14 16 24 FIG 2 2 LCD DISPLAY FIG 2 3 FRONT SIDE FIG 2 4 REAR SIDE FIG 2 5 SYSTEM SWITCHES FIG 3 1 INTERLOCK FIG 3 2 THE HANDPIECE FIG 3 3 OPTICAL TIP INSERTING FIG 3 4 OPTICAL TIP REMOVAL FIG 3 5 DIMENSION OF TIP FIG 3 6 PREPARATION OF HANDPIECE FOR BLEACHING FIG 3 7 PREPARATION OF HANDPIECE FOR BLEACHING FIG 3 8 ACCESS CODE REQUIREMENT FIG 3 9 LASER IN READY STATE FIG 3 10 LASER IN OPERATE STATE FIG 3 11 BATTERY LEVEL INDICATION FIG 3 12 STORAGE BATTERY LEVEL FIG 4 1 THE CONTROL PANEL FIG 4 2 PULSE PARAMETERS FIG 4 3 APPLICATION FIELD
34. STEM FEATURES Tab 7 1 Specification table Type Features LAMBDA SpA Origin Via dell impresa 36040 Brendola VI Italy L A 3DO 001 1 2 3 4 Input of power supply 100 240 VAC Network frequency 47 63Hz Maximum current absorbed by the 0 5A 230V network Output of power supply 12VDC 8 33A max Supply voltage for the system 12VDC Part applied Type B x This device is not suitable for use with a Protection against anaesthetics mixture of inflammable anaesthetic with air or oxygen or nitrogen dioxide Protection level IP IPXO Continuous with alternative load Procedural use active 3 min pause 2 min TEMP 10 30 C Working conditions HUMIDITY 30 75 ATM PRESSURE 700 1060 hPa 1 The model changes according to wavelength Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 67 TEMP 05 50 C Storage conditions HUMIDITY 30 75 ATM PRESSURE 700 1060 hPa External connections Footswitch optional interlock Weight 1 kg ca 7 2 LASER SOURCE SPECIFICATIONS 7 2 1 Diode laser source Tab 7 2 Laser source specifications Parameters Features gt 808 10 nm 940 10 nm 980 10 nm Wavelength 1064 10 nm Wavelength of aiming beam 635t10 nm 2 Different for the model 808nm for LA 3D0 001 1 980nm for LA 3D0 001 2 940nm for LA 3D0 001 3 1064nm for LA 3D0 001 4 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 68 7 3 OPERATING FEATURES Tab 7 3 Op
35. This ensures a better relationship with the patient especially with odontophobic patients and children n Lasing is thus a less invasive method if compared with the conventional techniques which reduces cells disruption as well as the bleeding thanks to the haemostasis The laser has then a strong antibacterial power so it encourages the sterilising and anti inflammatory effects while using it The application field with the laser requires the patient a shorter list of sessions let alone the short time dental operations for the most of applications 1 5 3 Collateral effects An inappropriate use of the laser device may cause unwanted and sometimes dangerous consequences The laser actually bears some huge and beneficial effects into the human tissue at the right rates of power frequency and treatment time On the other hand especially at high power rates may cause damage vaporising or even necrotizing the tissue that has been lased Therefore as this kind of consequence is unwanted the user must always be aware about the risks for the patient But when one actually plans necrotizing a particular site as in the photodinamic therapy or in the use as scalpel one cannot avoid to necrotizing part of tissue very beside the target The importance of such harm is essentially determined by the rates of energy on that tissue and its application time In most cases the harm is very light and well sustainable in comparison with the bene
36. able to remove all useless above all easily inflammable see paragraph 1 2 chap 1 material and verify the electric power panel is in conformity with the current safety norms Take careful attention that the support board is steady even and without irregularities of any kind Moreover check the electric powering matches the laser system electric requirements The laser place of use will have to be identified with the appropriate labels supplied together with laser accessories see chap 1 HANDLING ON LASER ARRIVAL The casing containing the laser system and all its equipment weighs about 1 kg observance or inadequacy of all the precautionary measures in the The manufacturer does not assume any responsibility in case of non AN handling of this type of device CHECK ON DELIVERY On arrival of the goods and in the presence of the carrier it is highly important to pay accurate attention that the shipped material is correct and intact These checks have to be particularly carried out Checking of the number of parcels and corresponding relative codes Checking of the outside packaging conditions and inside damaged parts It is important to immediately notify the carrier of all possible non conformities found during checking The manufacturer states that in accordance with national and international laws the customer always takes full responsibility for the shipped goods Moreover unless previously specified at the moment of stip
37. and each of these doors must visibly carry a safety label like the one shown in figure 1 1 FIG 1 1 Safety label system area of use Moreover the authorised personnel must follow all the individual safety measures see paragraph 1 2 1 1 2 Safety labels 1 No one other than the authorised personnel can have access to the laser Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 12 On the laser there are some safety labels including danger notes for the operator and information about the laser device characteristics The labels represented in the following must always be kept in good conditions and eventually replaced with the spare labels you will find in your accessories In order not to ruin these labels it is recommended to use non aggressive products as you clean the laser Figure 1 2 represents the type and figure 1 3 the position of safety labels Meaning of the different labels ET 1 warning label hazard symbol ET 2 emergency stop ET 3 explanatory label ET 4 information rear label with symbol laser aperture laser aperture at the end of the fiber a ET 5 information label with symbol ET 6 storage conditions information label N Caution Consult the user manual for additional information LAI Interlock connector gt Footswitch connector ps Recycling Use separate collection mm ps Fuse Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 13 ET 5
38. ansit transport or negligence is not covered by the warranty In the case of an indication of a fault a label has to be placed on the device container with a brief description of the faults encountered In order to speed up the return of the device indicate the name and telephone number area code and telephone number or direct number and or department extension of the client Under this warranty LAMBDA SpA will repair or exchange any product returned to the Client Service Department during the warranty period once the technical service has examined the product and found it to be defective at the fault of LAMBDA SpA All worn parts are not covered by the warranty LAMBDA SpA is not responsible or at fault or with good reason any damage or unforeseen direct indirect accidental or consequent delays of the equipment during the period necessary for repairs Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 80 LI 3DO 001 5 Azienda con Sistema di Gestione per la Qualit certificato secondo Pd UNI EN ISO 9001 2008 J AM 5 D A S A UNI EN ISO 13485 2004 he pr p Via dell Impresa 36040 Brendola Vi ITALY Ph 39 0444 349165 Fax 39 0444 349954 Web www lambdascientifica com E mail info lambdascientifica com Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 81
39. anually Procedure to set the treatment time Press Enter key in stand by status Press Right key The background of the timer window turn in red Use Up and Down keys to set the desired value The value can be changed from off state timer off to 10min with step of 1sec Press Enter key to esc from setting function or press Stand By Ready Operate key to esc setting function galge CAUTION the Timer indicates the time passing and is in no way bound to the time parameters of the pulse gt The emission laser starts in the ready state from the pressure of the footswitch and this operation starts the timer If the footswitch is released then the emission is immediately interrupted even if the timer has not finished counting down because the footswitch has total priority over the interruption Viceversa if the footswitch is kept pressed in which case it is the timer with the finished counter which interrupts the laser emission At this point to effect a new exposure you need to release the footswitch and then press the footswitch again At each pressure on the footswitch in the case of the anticipated interruption of exposure the timer restarts the counter from where it stopped During the treatment the value of the timer on the display is decreased allowing the operator to control the remaining time Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 48 4 3 3 Emission mode settings
40. aration distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3Veff IEC 61000 4 6 150kHz to 80MHz d 1 2 VP Radiated RF 3V m IEC 61000 4 3 80MHz to 2 5GHz d 1 2 Xp 80MHz to 800MHz d 2 3 Xp 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in Watt W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as 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 a Notes 1 At 80MHz and 800MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a 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 accurancy To assens the electromagnetic environment due to fixed RF transmitters an electromagnetic site survay should be considered If the measured field strength in the location in which LA3D0001 1 is used exceeds the applicable RF compliance level above LA3D
41. code be immediately modified to ensure that only authorised personnel are able to use the system In the event that the access code has been forgotten contact the help desk service to reset the system 4 6 4 Contrast settings The display is coloured with Led retrospective lighting The function in menu Settings gt LCD Contrast allows to display a lighter or darker side of the contents As for function Sound the setting is made by choosing the item in the menu then pressing key h Ok Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 59 Use the key Light into menu to change the display lightness Use Up and Down to select Light Lightness from the menu the entry turns green K Press Stand By Ready Operate to confirm the light choice the entry starts to flash Use Up and Down tkeys o select light lightness Press Stand By Ready Operate to confirm the light choice OR Press Left key to esc system menu and return to main menu with no changes Aq ODIO K The Light selection is disabled when used wireless a low light is automatically set to save battery charge When turned into wireless mode the display light will be reduced Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 60 4 6 5 Setting display standby time The standby time setting function permits to set the display time minutes before turning to the standby mode disabled laser
42. coectomy FIG 4 4 Treatment menu According to the application field selected in the menu the parameters displayed on the bottom of the screen vary see properties fig 4 4 The operator can therefore immediately verify the adequacy of the set levels for the application required The application field menu can scroll continuously once the last application of the list is displayed the first application of the list can be displayed by pressing the key once again How to select a treatment From the TREATMENT menu select the desired field then press the STAND BY READY OPERATE key the screen will display all the application contained in the selected field See fig 4 4 as an example Use the UP and DOWN keys to select the desired application The selected title will turn green O Press the STAND BY READY OPERATE key to select the application OR Press the LEFT key to exit the application field menu and return to the main menu without modifying the settings Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 54 4 5 3 How to save application field parameters For each application it is possible to change the values of emission parameters Refer to previous paragraphs in order to customizethe protocol The new values can be save for the application field in use in order to let them available for next time Procedure for saving the application field From application field menu select th
43. ds of the biomolecules and their aggregates proteins collagen lipids hemoglobin Around 45 C it may be noticed what follows structure changes bond breaking alteration of the membrane Every single cell and all the different tissues heated to a temperature of about 43 45 C can stand a temporary harm only the damage will become irriversible cell death after prolonged exposure times that may vary between 25 minutes and a few hours depending on the kind of tissue and conditions of radiation In case of tumoural nature cells the mortality is particularly high at this thermal regime These processes find treatment in the interstice hyperthermia techniques for the cure of tumors typically treated by diode lasers in continuous mode Coagulative regime When the temperature rises higher than the degenerating value processes of necrosis will take place cellular shaped as coagulation and vacuoles Between 50 C and 60 C the enzyme activity is modified reduced so a considerable degenerating of the macromolecules like proteins collagen lipids hemoglobin will begin standing as a ground for the coagulative process The degenerating of the collagen is important fibrous protein broadly spread among mammals made up of four polypeptic chains gathered to form a bi helicoidal structure The temperature rise destroys the space organization created by the macromelecular chains the spirals are distributed at random with strong changes in the sp
44. e compatibility with the absorption specifications as indicated in chapter 7 Ensure to switch off the laser equipment when not in use since a long period of time see par 2 7 1 WARNING Ensure that the external power socket has a sufficient earth Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 29 3 1 1 External interlock network optional The device has been fitted with a rear socket that allows you with an optional accessory to interrupt the emission upon confirmation of a particular event for example the opening of a door This accessory is not necessary if you foresee that the work area is inaccessible for example by locking all entrances interlock contatto di interlock Example of the location of an interlock Diagram of the interlock socket alarm on an entrance door contacts located on the back of the machine see fig 2 4 FIG 3 1 Interlock AN Do not apply any pressure to the interlock contacts In the event an external interlock network is used all contacts must be closed to enable the operation Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 30 3 1 2 Preparation of the handpiece non sterilized making Thus is preferable to sterilize them before each 1 WARNING at delivery of the appliance the optical tips are supplied in a session The handpiece supplied is made of several parts see picture below a Front tips b Removable cap c Central b
45. e importer consider themselves responsible for the safety reliability and performance of the device only if the points mentioned above are respected The manufacturer makes the technical details of design outlines and test instructions available prior to written request so that the qualified personnel authorized by LAMBDA SpA will be enabled to repair or maintain those parts of the system that the manufacturer consider as possible to repair Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 7 DISPOSAL Disposal of Old Electrical amp Electronic Equipment Applicable in the European Union and other European countries with separate collection system This Symbol on the product or on its packaging indicates that this product shall not be treated as household waste Instead it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product tHe recycling of materials will help to conserve natural resources For more detailed information about recycling of this product please contact your local city office your household waste disposal service or the shop where you purchased the product CE conformity marking This product is marked with the CE label
46. e protocol and press the Menu key The display shows a message like Saving to confirm the modified value In fig 4 5 is reported an example Use the Left and Right keys to select the voice Yes and to confirm the saving operation Press the Stand By Ready Operate key to confirma the saving OR Use the Left and Right keys to select the voice No and avoid the saving operation In application field menu beside the name of the application modified an Saving modified paramenters is possible only with applications with an icon will appear to indicate the parameters in the system have been modified compared with the default values pre set by the manufacturer G All the others cannot be saved _1 Endodontics FIG 4 5 Confirmation of saving parameters of modified application fields 4 5 4 How to recall default parameters Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 55 If an application has been modified it is possible to retrieve the parameters of the laser emission pre set for the application chosen Procedure to retrive the default application parameter From the application fields menu select the chosen application and press Recall the display shows the screen to load default parameters f the modified application Fig 4 6 shows an example Use Right and Left keys to select Yes to confirm default parameters Pres
47. ectra of absorption and scattering of the optical radiation causing a notable contraction in the collagen fibers The thermal degenerating and the contraction of the inter cell proteins alongwith a possible collapse of the cytoskeleton will produce the shrinking of the coagulated cells The breaking of the membranes becomes prevailing in all the cells when they turn out seriously damaged after a thermal action In the end in those tissues where a high standard spatial order stands like in the muscles the protein degenerating will upset this regular structure with a loss of the relevant optical features These processes of photocoagulation are used for example in ophtalmological surgery to reduce the retina coming off and in dermatology to treat the pigment vascular lesions Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 74 Besides laser welding techniques have been proposed on the skin vessels and urological ducts that are based on induced modifying of the collagen fibers through laser heating at low temperature 45 50 C Medium high temperature effects gt 100 C The prevailing effects within this range of temperature may be noticed in the water in fact very qualitatively assuming that the process of vaporization begins at 100 C namely due to the heating of the water running in the tissue the continuous radiation will determine a Energy absorption for the phase of transition liquid vapor b Drying u
48. elect a field of application just follow the indication at first pressure the display shows the first field of application At second pressure the display shows the second application field of menu and so on When you reach the end of list at next pressure restart with the first The selected application field is remarked and written in green colour see Fig 4 3 Procedure for the selection on application field From the Stand By state press the Menu key it will appear the screen shown in Fig 4 3 Use the key Up and Down to select the desidered application The selected application is remarked and written in green colour Press the Stand By Ready Operate to confirm the selected application field OR Press directly the Left key to esc from the treatment menu and get to the main menu without any modification OP ii Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 53 4 5 2 Application selection To select an application of a specific field just follow the indication at first pressure the display shows the first application field of menu At second pressure the display shows the second application field of menu and so on When you reach the end of list at next pressure restart with the first The selected application is remarked and written in green colour see Fig 4 3 1 Endodontres 1 1 Canal Sterilization 1 1 2 Canal Sterilization 2 1 3 Pulp Capping 1 5 Api
49. erating features Type Features MP Ton 200MS Tor 500ms Mee M D To j ni Ton 10Ms Tor 10ms Ton 25US Tor 25US CAP 8 TREATMENTS 8 1 INTRODUCTION LA3D0001 1 is a medical device capable of supplying light radiation at high energy to the treatment area via an optic fiber This device was idealised for use in the following medical fields surgery orthodontics and therapy In the following paragraphs the detailed clinical functionality will be defined as well as the operating area in which the device should be used it will also describe in general terms what the clinical action of the radiation laser is on human tissue 8 2 OPERATING AREA LA3DO001 1 is a medical device designed for use in surgeries situated in private and public structures hospitals clinics medical studies and exclusively by specialized medical personnel You must arrange for the removal of all extraneous material from the room where the machine is to be used and above all inflammable see paragraph 1 2 Chap 1 verify that the electrical power source is in accordance with safety regulations You must also check that the power supply satisfies the electrical requirements of the Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 69 equipment The voltage and current values are listed in the general system features table in Chap 7 You must ensure that the surface where the device is to be placed is stable and that there is no likeli
50. erventions This ensures a better relationship with the patient especially with odontophobic patients and children Lasing is thus a less invasive method if compared with the conventional techniques which reduces cells disruption as well as the bleeding thanks to the haemostasis The laser has then a strong antibacterial power so it encourages the sterilising and anti inflammatory effects while using it The treatment fields with the laser requires the patient a shorter list of sessions let alone the short time dental operations for the most of treatments Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 79 CAP 9 Warranty LAMBDA SpA guarantees its clients that the products are free of defects and are guaranteed for one year This warranty is not valid for any defect fault or damage caused by improper use or inadequate maintenance and care LAMBDA SpA is not obliged to provide assistance under warranty to repair damage caused by other personnel not authorised by LAMBDA SpA In order to obtain assistance under this warranty clients must contact LAMBDA SpA to advise the problem The client is responsible for transport and possible insurance expenses for the return of the products to the service provider LAMBDA SpA will repair the products under warranty with transport costs at customer s expense For shipping by post rail or courier we request that the client use the original packing Damage caused in tr
51. ery signal and an audio signal for about one minute If the machine is not shut down during this phase it will automatically turn off The control panel will not therefore allow any operation It is strongly recommended that the device be turned off when connecting or disconnecting the power supply cable Battery Characteristics Type 4 AA 1 2V 2000mAH rechargeable Maximum endurance 10 hours Minimum endurance 5 hours Charge time 5 hours Storage battery characteristics Endurance at maximum power in Cw 3 minutes Endurance at minimum power in Cw 1H 50 minutes Endurance at medium medium power 45 minutes Charge time 1 5 minutes Should the duration of the battery when fully charged last less than the indicated values or should the charge time last longer it is recommended that the battery be replaced declines any responsibility for the use of improper materials or 1 CAUTION use only battery types as specified LAMBDA SpA ncorrect placement of the battery polarit DISPOSAL damaged or used batteries must not be dispersed in the environment The disposal of batteries must be carried out according to national regional legislation The batteries can be substituted by LAMBDA SpA who will provide to their proper disposal Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 42 3 6 1 Battery level indication The level of the battery power is graphically displayed as in fig 3 9 Battery ind
52. eters Laser may be used as cutting tool for coagulation and tissue destruction but also as therapeutic instrument of bio stimulation decontamination and disinfections Such effects are normally due to a temperature rises that follow the laser tissue interaction When a laser beam is focused on a tissue the water included in high percentage in it absorbs the energy transforming it in heat With an intensity of a few watts per square millimeter the water present in the tissue rapidly begins boiling and evaporates If it is moved along the tissue the beam behaves as a scalpel forming an incision whose depth depends on the intensity of the beam and the speed of movement 1 5 1 Contraindications So far there are no contraindications known concerning the use of laser in surgery dentistry and therapy field It may be assumed though that in case of a coetaneous application some unwanted coetaneous reactions might occur on photosensitive or people with dark pigmentation like some Asian and Negroid races We suggest the user start with small dosages of energy and increase them if necessary but estimating how the subsequent effects noticed may be sustainable and less important than the benefit reached Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 22 1 5 2 Laser benefits with respect to traditional techniques The extreme tolerability of the application field allows avoiding use of anesthesia in majority of interventions
53. fits We thus advise the user to very carefully check the following parameters so as to not cause any unwanted effects on the patient n Power Diameter of the fiber Distance between the end of the fiber and the tissue spot Continuous or pulsed laser emission treatment time The variables diameter of fiber and distance from the fiber are used in order to decide the size of the section of the laser beam interacting with the tissue in fact the smaller the diameter of the fiber and distance from the fiber are the greater the power density will be The variable applied power is used along with the two previous ones in order to decide the power density The variable treatment time is used to decide the total energy or the total energy density to deliver for an treatment field The more the treatment time is the greater the temperature rises into the tissue will be The variable of emission mode is a very important variable because it allows decide both the peak power and the average power delivered Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 23 CAP 2 View of device This chapter describes the parts of the system which you should become familiar with before commencing use 2 1 INTRODUCTION LA3D0001 1 is a medical device enabled to deliver laser radiation being carried onto the application spot through an optical fiber and a tip The reduced size makes the carriage and the settling down
54. ght indicator E Multifunction button for parameters set up of selected application field FIG 4 1 The control panel Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 44 4 2 MEANING OF GRAPHIC SYMBOLS Description Emergency stop Stand By Ready Operate Multifunctional Button Stand By Ready Operate key Into main menu e Confirm value of selected parameters e Turn to standby ready operate desable the laser load shot paremetres enable the laser Into system menu e Confirm selected parameter Into treatment menu e Confirm the selected treatment Into application field menu e Confirm the selected application field Up key Into main menu e Increase value of selected parameters Into system menu e Move between the menu options Into treatment menu e Move between the treatment options Into application field menu e Move between the application field options DownUp key Into main menu e Decrease value of selected parameters Into system menu e Move between the menu options Into treatment menu e Move between the treatment options Into application field menu e Move between the application field options Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 45 Main menu key Into main menu e Select the application field menu Into system menu e Not Active Into treatment menu e Select the system menu Into application field menu e
55. gives useful information regarding the laser device Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 6 Warning The following manual has been written up referring to products LA3D0001 1 and LA3D0001 2 LA3D0001 3 LA3D0001 4 These products are different from one another only for their wavelength respectively 808nm 940nm 980nm and 1064nm If not differently specified by referring to LA3D0001 1 we will make reference also to the other device Where it is necessary to distinguish among the two products it will be suitably shown These laser equipment are medical devices and their application fields are e SURGERY e DENTISTRY e THERAPY The manufacturer is not responsible for the direct and indirect effects due to the use of the system These effects remain under the direct responsibility of the medical staff carrying out the operation We therefore recommend the user to respect the following instructions The system must be used in conformity with the instructions contained in this manual concerning both safety measures and use of the system The installation and any operation of alteration calibration and maintenance must be made only by qualified staff authorized by the manufacturer The electric system of the environment to which the laser is meant for must be in accordance both with the IEC regulations and the local prescriptions in force The manufacturer the assembler the installer and th
56. h FIG 2 4 System Switches Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 28 CAP 3 System use procedures different from those specified herewith can cause exposure to dangerous levels of radiation 1 WARNING The use of the commands the adjustments and execution of 3 1 PRE OPERATIVE INSTALLATION Before using the appliance it is necessary to prepare the machine by following these simple installation instructions Remove the system with extreme care from the transport container Insert the external interlock connector in the appropriate socket on the back of the device see fig 2 4 E or the connector supplied with the equipment a description of the interlock network is described in the following paragraph Insert the footswitch optional connector in the appropriate socket at the back of the laser see fig 2 4 C Skip this operation if using the finger swith in the handpiece Insert the power cable in the appropriate socket at the back see fig 2 4 D and connect to a power point Skip this operation if using the battery supply system Insert the optic tip appropriately prepared see par 3 1 2 3 1 3 into the handpiece after having removed the protection cap WARNING on delivery of the device the handpieces and the optic tips and all the other components supplied in the packaging have not been sterilised Before each use ensure that these parts are sterilised connection Also ensure th
57. he sound alarm is always ON enabled when turning on the device From standby mode press Right key to enable disable sound The icon edge borde turns red fig 2 2 F of laser emission Even though visible indications are always ON keeping 1 Warning when sound alarm is disabled the operator cannot be informed also sound alarm ON is safer for the user Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 62 CAP 5 System errors 5 1 SYSTEM ERROR VISUALIZATION MODE The device is constantly subjected to controls to internal parameters that guarantee the safety of the device during use WARNING Before following the system start up procedure ensure that all safety measures described in this manual have been put into place The systems advises the operator of any malfunction by a message on display and a warning sound see Fig 5 1 SYSTEM ERROR The system will then put itself automatically to a safe state the laser source will be automatically deactivate as well as the foot switch stand by state The system does not allow the operator to enter ready state until the causes of all the errors signalled have been resolved If there are multiple errors the system shows once at time following a priority list Once an error is signalled it is necessary to repeat the activation procedure to make the laser operative be referred to the help desk AN Ensure that the errors signalled by the system are
58. hood of uneven surfaces or disconnections from the power supply The laser operating environment must be identified by appropriate labels supplied with the laser accessories see chap 1 Position the appliance at a safe distance from other appliances where there may be possible electromagnetic interference The room in which the LA3D0001 1 will be used must respect the following environmental limits Temperature 10 30 C Relative humidity 30 75 Atmospheric pressure 700 1060hPa WARNING carefully follow all instructions for the safety measures reported individually parag 1 2 in Chap 1 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 70 8 3 LASER ACTION PRINCIPLE This paragraph will present the mode of interaction of the laser light with the biological tissue and the consequences produced by such interaction 8 3 1 The tissue as an optic conductor The interaction between an electromagnetic wave and a biological conductor depends on the wavelength of the radiation itself and the optic features of the tissue Despite the structural complexity and the morphological differences as first approximation the organic tissues may be seen optically as homogeneous and isotropic conductors into which the propagation of the luminous radiation is described according to very important optical variables such as absorption transmission scattering etc Considering then a laser beam perpendicularly turned to the surface of
59. icator Su 5 Implant Uncover I i _ 3 E PW Av 5 0W FREQ 0Hz FIG 3 11 Battery level indication 3 6 2 Storage battery level The level of the battery power is graphically displayed as in fig 3 10 nergy Accumulator coe Implant Uncover PW Av 5 0W FREQ 0Hz FIG 3 12 Storage battery level 3 6 3 Battery Charge internal battery Charging takes place only if the device is connected to an external power supply If the device is turned off see chapter 3 5 the external power supply will only charge the batteries and not the storage battery Turn on the laser chapter 3 2 to begin charging the storage battery Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 43 CAP 4 Control panel procedures different from those specified herewith can cause exposure to 1 WARNING The use of commands adjustments and execution of dangerous levels of radiation 4 1 INTRODUCTION The control panel is made up of a display and a keyboard which allows the intervention and modification of various machine parameters by the operator For best understanding illustrations and details are given here below see chap 2 with respect to the function of each key A Multifunction button for selection and set up of parameters through menus E B Stand by Ready Operate key doctor smile C Multifunction button for application field selection and parameters set up through menus D Orange led li
60. ice on It is advisable to keep the laser away from direct sun light avoiding possible system overheating Do not place the laser next to walls or other locations that could decrease laser air change While working do not cover the machine with things or clothes LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 11 CAP 1 Safety instructions This laser device has been projected respecting the present norms concerning safety for electric and medical devices Despite this it is necessary to adopt some important safety measures to avoid sometimes even mortal accidents The system LA3D0001 1 is a medical equipment Three are the treatments this equipment is designed for n Surgery n Dentistry Therapy 1 1 GENERAL SAFETY MEASURES During its normal use the laser LA3D0001 1 exposes the human body to laser light radiation therefore it is important to scrupulously read and follow all the safety dispositions listed in this chapter Never let the connector plug of the diode s optical fiber without protection The optics placed inside this port is very delicate and subject to break easily in case of penetration of liquids smoke steam or things of other kind Absolutely avoid putting fingers inside this port and looking directly inside 1 1 1 Working area After the device has been delivered and its content checked it is necessary to prepare the place where the laser will be used Doors must limit the working area
61. is port and watching straight in the inside see fig 2 3 The effectiveness and lifetime of the optical fiber often depend on a suitable preparation and a good cleaning The optical tips are very fragile We advise to avoid leaving the tips where it might be trampled or shocked gt gt Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 35 3 1 6 Preparation of handpiece for bleaching Wide area Insert the whitening set Wide area Handpiece ready for use see par 2 6 Supplied Accessories F FIG 3 6 Preparation of handpiece for bleaching Before to start the Whitening Application field in wireless mode be sure that the Wiser is totally charged see par 3 6 Battery operations 3 1 7 Preparation of handpiece for bleaching Small area Insert the whitening set Small area see par 2 6 Supplied Accessories G Handpiece ready for use FIG 3 7 Preparation of handpiece for bleaching that the Wiser is totally charged see par 3 6 Battery operations AN Before to start the Whitening Application field in wireless mode be sure Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 36 3 1 8 Sterilization of the tips and accessories All the parts that can come into contact with organic parts of the patient can and must be sterilised In particular the parts of the system that can be sterilised are the handpiece body ONLY COLD STERILIZATION
62. lse Ton 20us Toff 20us 20KHz Ton Toff manually customizable These parameters may be set manually or recalled from configurations stored on the system treatment programs 4 3 1 Power settings The system LA3D0001 1 allows to set the pulse power this means the power of laser radiation during Ton time only It must be specified that the peak power of the pulse and the average power delivered within the pulse time will both coincide in case of continuos operating only while in all other cases the average power delivered will be lower than the peak power The system displaysaccording tor each power setting see Fig 2 2 the average power in relation to the T on time selected Procedure to set the power From Stand by status press Enter key once The background of the power window turn in red Use Up and Down keys to set the desired value The value can be changed from 0 1W to 5 0W with step of 0 1W Press Enter key to esc from the setting function OF press Stand by Ready Operate key to esc setting function Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 47 4 3 2 Treatment duration settings Timer The system gives you the option to set a specific duration for an application field so that laser emission is automatically interrupted at a predetermined amount of time In this way it is possible to use the laser for single treatments and the operator does not need to block the laser emission m
63. ncy and the average power during the laser emission mode Allows you manage several functions such as language enablement disenablement of sound adjustment of display contrasts and modification of access password display brightness regulation The graphic display is easy to use and intuitive showing all useful parameters required by the operator It is divided into three sections The upper part of the display shows the value of power the stored energy to use in wireless remote battery power and the duration lasting In the middle is shows the name of the application field in use In the lower part is indicated the emission mode Fig 2 2 shows the display after the initial system startup and the use of the correct key software A Power setting value B Timer for the application field setting C Pre set application field indication D Pulse settings of T on or T off values manual selection of paramenters or fix indications CW MP SP SSP E Stand by Ready Operate status of device F Sound mode on off G Aiming beam pilot guide on off H Stored energy to use the device in wireless remote I Charge level of the internal battery J Frequency and the average power during the laser emission mode Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 25 PW Av 5 0W FREG 0Hz J E FIG 2 1 LCD display 2 3 FRONT SIDE The main commands are positioned on the front section of the appliance
64. nd in case of breaches or for any other needs to address the supplier and order a same power supply or at least compatible with the one provided with the equipment gt Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 27 2 6 SUPPLIED ACCESSORIES Beside the footswitch and the stem for fiber support you can find inside the package the following accessories C Set of optical tip D Interlock plug E Handpiece F Handpiece adapter for bleaching Wide area G Handpiece adapter for bleaching and Therapy H Power supply I Laser device LA3DO 001 1 L Protection glasses M Tip Bending N Manual O Supply Cable 2 7 SYSTEM SWITCHES The LA3D0001 1 laser device is set with two switches one for the power supply and one for the safety Emergency of the system General Switch Emergency Switch The general switch is placed on the rear side while the emergency button is placed on the top side at your convenience as shown in fig 2 4 The general switch see fig 2 5 has two positions n Posizion 0 the system is not power supplied Posizion 1 the system is power supplied but not connect to the net due to the presence of the battery Emergency switch see fig 2 5 has two positions a NOT pusched button device with power supplied and all functions enabled PUSHED button device with power supplied BUT with and all functions disabled General Switch Emergency Switc
65. ody d Lock nut FIG 3 2 The handpiece CAUTION There are potential hazards when inserting steeply bending or improperly securing the optical fibers stating that not following the recommendations of the manufacturer may lead to damage to the fiber or delivery system and or harm to the patient or user WARNING when the aiming beam uses the same method of transmission as the working beam it is a good means of verifying the system distribution integrity If the beam spot is missing from the distal extremity of the transmission and if the intensity is reduced or seems diffused this can indicate that the transmission system has deteriorated or is not working properly gt Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 31 3 1 3 Tip bending Insert the tip in the as illustrate hole TIP SHAPER Bend the Tip towards the right to obtain the desired shape TIP WARNING in the side SHAPER figures the exact procedure is represented for the tip bending Don t respect the procedure could bring to the definitive tip s breakup Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 32 Final Tip shape 3 1 4 How to insert remove the tip Insert a Hold tight the handpiece body b Select the size of the tip for the use c Insert the tips into the handpiece hole and push it till the end Be careful to bring the bottom of the plastic tip in contact with the handpiece
66. of a Thermoelastic expansion b Mechanical recoil due to the ejection of matter c Formation of plasma Depending on the type of interaction the pressure wave may be classified into I Acoustic wave that is low pressure wave that propagates at sound speed II Shock wave that is high pressure wave that propagates at supersonic speed The shock wave is characterized with a supersonic expansion speed and a very steep forehead where the pressure rises up onto thousands of atmospheres on distances of few nanometers creating temporary effects with rise delays of few picoseconds 8 3 6 Photomechanical processes According to the laser pulse intensity three borderline cases may be distinguished in absorbent media and below the optical breakdown threshold the generation of acoustic waves is dominated by thermoelastic effects and vaporization in transparent media the acoustic effects are bound to the formation of plasma that may join up with the above effects into the absorbent media as well Low intensity thermoelastic effect With low energy dosages transferred to the material the thermoelastic effect determines the thermic expansion of the layer of heated material to which the non spread part opposes so a few mechanical stresses are thus formed at the limit between the two areas that give birth to elastic waves that propagate into the mass of the material Medium intensity vaporization For bigger energy amounts absorbed the
67. on distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Tab 1 4 Recommended separation distance Examples Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 20 1 4 OCULAR RISKS Eyes can be seriously damaged in case of an unprotected exposure to laser light For this reason it is compulsory to wear protection glasses both for the operator and for the people present in the area of work Protection glasses provided at hand are in accordance with the European norm EN 207 and have a Optical Density gt 5 at the wavelength of emission from the diode Use solely glasses with the same specifications of those provided at hand Our firm can provide protection glasses with these characteristics According to standard EN 60825 CEI 76 2 II ed the following quantities have been estimated Minimum Optical Density 4 37 at 0 01 meters n Nominal Distance of Optical Risk 1 4 meters Using the following data Laser diode Divergence 440 mrad Emission continuous Diameter 0 2 mm Wavelength 808 nm Exposition time 10s Power 6 Watt Observation Direct light Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 21 1 5 LASER BEAM ACTION PRICIPLE Once excited the laser source emits an electromagnetic radiation due to the stimulated emission
68. operate see Tab 4 1 E z key the Ready Indicator yellow colour light turn on and the indicator lamp start blinking see fig 2 3 D If there are no errors the system keeps in Ready state Implant Uncover ra Reaclv Ala PW Av 5 0W FREQ 0Hz FIG 3 9 Laser in Ready state ET mun From the ready state push ready stand I 00 00 by operate see Tab 4 1 key the Operate TE Indicator red colour light turn on and the indicator lamp start blinking see fig 2 3 Implant Uncover D If there are no errors the system gt za keeps in Operate state I dg PW Av 5 0W FREQ 0Hz FIG 3 10 Laser in Operate state At this stage the laser source is active for the laser emission The system automatically deactivates the laser source and goes to the STAND BY mode if the device is not used for several minutes Automatically deactivation is used to safeguard the system components and to guarantee maximum safety Do not leave the machine unsupervised with an active laser source If you need to leave the machine even momentarily switch off the machine Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 39 3 3 1 Laser emission After having carried out the activation of the source the system is ready to emit laser radiation Ensure that all safety measures have been followed and the all personnel present are wearing appropriate protection see Chap 1 a Point the the handpiece to an appro
69. p of the tissue c Formation of vacuoles of vapor inside the tissue with consequent d Mechanical effects caused by the fast expansion of the vapor vacuoles trapped into the tissues The thermal ablate is featured like an explosive event even in case of radiation in continuous mode When the temperature rises over 100 C the max temperature will move from the surface to the inside of the tissue the fluids in the tissue are converted into vapor with pressure over 1 atmosphere and following to overheating they finally explode because of the too high pressure inside of them The removal of the warm tissue will expose a colder layer to the radiation This layer will stay approximately at 100 C for the time taken by the radiation to dishydrate the tissue the water gives a high vaporization heat 2530 J g The loss of water will reduce the local thermal conductibility and will limit the heat conduction in the surrounding areas Thermoablate induced by high temperature between 300 to thousands C When the water in the cells is completely vaporized the temperature in the tissue will increase quickly until 300 C nuclear sites will be generated on the surface and the tissue will be burned and carbonized The vaporization alongwith the carbonization will give way to the decomposition of the components of the tissue The greater optical radiation intensity contributes to the temperature peak on the subsurface compared with that on the surface that
70. potentially flammable materials such as paper wood or plastic Never use flammable gas during laser use Any solvent or inflammable solution must be allowed to completely evaporate before using the laser Avoid using any potentially inflammable anaesthetic or gases such as oxygen or nitrous oxide The saturation of oxygen may ingite many types of materials such as cotton or wadding exposed to laser radiation It is also important that all inflammable solutions normally used to disinfect be allowed to evaporate before using the laser appliance Warning smoke and vapour produced following the exposure to the light radiation may contain vital tissue particles LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 15 1 3 EMC REGULATIONS ELECTROMAGNETIC COMPATIBILITY The existence of regulations for the electromagnetic compatibility is essential to ensure the safety of the appliances and systems in that there are electromagnetic phenomena with various levels of intensity present in the area where these appliances are normally used This means that to ensure the electromagnetic compatibility the device must function correctly within its foreseen working environment The LA3D0001 1 electro medical appliance warrants particular precautions with respect to EMC Electromagnetic Compatibility and must be installed and put into service in conformity with the EMC information contained in this manual WARNING portable and mobile radio
71. priate target n Press finger switch footswitch optional The system starts to emit laser radiation and this is signalled both by sound and visible indicators orange led placed on the keyboard The system also shows on display a picture warning for laser emission Release finger switch footswitch optional to stop the laser emission If the laser reaches a temperature which is too high overheating or temperature will appear in the display The operator should then stop their work for few minutes to allow the cooling system to lower reduce the temperature This automatic signal protects the laser from breakages working wireless the icons will turn red recharge to avoid a sudden O If the energy or the battery charge goes down the security threshold while standby of the device laser 3 4 PROCEDURE FOR DEACTIVATE LASER SOURCE From the Ready or Operate state push Stand By Ready Operate button see Tab 4 1 the system goes in stand by status and disables the source and finger switch footswitch optional button by state by pressing any key and disables COMPLETELY THE LASER D From Ready Operate state is possible to deactivate the laser source Stand SOURCE Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 40 3 5 PROCEDURE FOR SWITCHING OFF THE SYSTEM To switch off the system you will only need to take the following actions ILL ona POWER J 1 TIMER
72. refers to the emission power for the Ton time see picture 2 2A while the one at the bottom refers to the average power during the whole period selected Ton plus Toff It is possible to modify manually the Ton and Toff values and then recall to the default value following the how to recall the default vales procedure 4 3 5 Manual mode functioning This mode allows the operator to select the laser emission type which is the application average power and frequency It may happen that an automatic change is noticed in the variable Toff simultaneously when modifying the Ton value This is a forecasted function provided to keep reasonable values in the parameters In fact it is not possible to set values making either parameter more than a hundred times higher than each other E g if Ton 100ms Toff cannot be higher than 10s nor lower than ims In the following table the Ton and Toff minimum and maximum values are stated Minimum i Minimum Ton Toff Tab 4 3 Ton and Toff selection fields for manual mode Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 50 Values admitted in 20usec 100usec field 20us 30us 40ys 50us 60us 70us 80us 90us Values admitted in 100yusec 1msec field 100us 200us 300us 400us 500us 600us 700us 800us 900 us V Values admitted in 1msec 10msec field ims 2ms 3ms 4ms 5ms 6ms 7ms 8ms 9ms Values admitted in 10msec 100msec field
73. s Stand By Ready Operate to confirm selected default parameters OR Use Right and Left keys to select No to esc recall default parameters procedure with no changes Press long Save Recall key The display shows a message like Loading to confirm the good result of operation Now on display are shown the default values of parameters for the application field in use JOH P Saving modified paramenters is possible only with application fields with an x All the others cannot be saved CAUTION The values recovered won t be saved automatically Should one want to save them it is required to store them with the Save function CAUTION the default values related to the various application fields are purely approximate The manufacturer will not take any responsibility for damage or lesions due to the use of the pre set programs or to their possible therapeutical inadequacy gt pe 1 Endodontics FIG 4 6 Confirmation screen of default parametry recall Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 56 4 6 SYSTEM MENU The system menu see fig 4 5 allows to perform other functions like Language allows to select the language of system Password allows to change the access code Contrast allows to change the brightness while plug connected Stand By allows to change the time of display activity Background turn on off sound advice normally on at start up Password
74. source and battery using at the minimum in wireless mode Use Up and Down keys to select Standby from setting menu the entry turns gree Press Stand By Ready Operate to confirm standby time choice the entry starts to flash Utilizzare i tasti Su e Giu per selezionare la tempistica desiderata in minuti Use Up and Down keys to select desired time minutes OR Press Left key to esc system menu and return to main menu with no changes i Press any key to reactivate display back lighting 4 6 6 Main menu background setting A ODIO K The background setting function permits to match a background to the main menu Use Up and Down keys to select Background from setting menu the entry turns green Press Stand By Ready Operate to confirm backgound choice the entry starts to flash Use Up and Down keys to select tbackground Press Stand By Ready Operate to confirm background choice OR Press Left key to esc system menu and return to main menu with no changes OP EP K Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 61 4 7 SOUND ALARM SETTING The sound alarm informs the user when keys are pressed and the device is firing It can be enabled disabled during laser emission and key pressing Sound setting procedure Press Stand By Ready Operate to enable or disble sound alarm O T Sound ON Sound OFF AN Warning t
75. t to clean e Absolutely don t try to clean the inside of the cavity that houses the tip connector the diode there lodged is particularly delicate and easily subject to break f Take particular care in cleaning the control panel avoiding the use of particularly aggressive detergents Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 65 6 2 GENERAL MAINTENANCE INDICATIONS WARNING all the maintenance operations below mentioned must be carried out by a specialised person and authorised by the manufacturer e Recalibration of measured values by the system power We recommend that the calibration of the system be verified at least once every year and each time the use of the system gives the impression that there is a variation in the emission values of the laser source For the verification use a power meter capable of measuring laser radiation wavelengths of between 800 1100nm and a maximum power of 10W The verification is carried out by checking that the shift between the power indicated on the display and that measured is below 20 in continuous emission mode CW DISPOSAL Do not disperse the laser equipment in the environment at the end of its life cycle It is possible to entrust the laser equipment to LAMBDA SpA that will see to the disposal according to the directives on the subject Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 66 CAP 7 Technical Specifications 7 1 GENERAL SY
76. the error persists 5 2 3 System error Electric failure Signal generated in the event that the system find electric problem Turn off the device wait for few minutes and then turn on Repeat laser source activation procedure Call the help desk service if the error persists Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 64 CAP 6 Cleaning and maintenance 6 1 GENERAL CLEANING INSTRUCTIONS WARNING all cleaning operations must only be conducted with the machine switched off and disconnected from the power point Never let the connector socket of the tips without protection The diode laser lodged inside this port is very fragile and subject to break easily in case of fluid penetration smoke action steam or objects of any kind Absolutely avoid putting fingers into this port and watching directly inside settled down smoke usually may damage the diode laser irreversibly 1 Do not smoke inside the environment where the laser machine has been making it ineffective at all The equipment does not require particular cleaning operation but it is advisable that the following general rules be followed a Keep the working area clean using vacuum cleaners to remove and dirt and dust b Use a soft cloth to clean the metal or plastic surface of the machine Take care not to damage the safety label c Only use detergents with very low levels of alcohol d Do not use sharp instruments for the areas difficul
77. ulating the contract the goods are always shipped without insurance Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 10 INSPECTION OF ELECTRIC CONNECTIONS It is highly important to check the power cable is undamaged before using the laser system In particular the cable plug must be compatible with the powering network socket Do not use adapters or multiple sockets of any type Moreover the electrical network must provide an efficient grounding protection INSTALLATION AND FOLLOWING HANDLINGS At the moment of installation or during necessary movements of the laser system it is recommended to scrupulously follow these indications Model Always use packaging material supplied on delivery for transport Ascertain that the power switch be pressed off Disconnect all cables connected to the laser system main body and in particular the power cable Ascertain the fiber connector be plugged with the special cap supplied Place the laser device at a safety distance in respect to other machinery avoiding possible electromagnetic interference After having chosen the laser place of use set the device in a steady position paying attention to check the support board does not present irregularities Keep the laser in a dry place with a temperature from 15 to 30 C and humidity from 30 to 70 Be sure that the device has been maintained in these environment conditions at least for 2 hours before turning the dev
78. ultimate date of manufacture of the product The present conformity statement The documents relevant to the Complete Quality Guarantee System The comments to the Notified Company relevant to possible equalising or correction in the Complete Quality Guarantee System Details relevant to the design manufacture sterilising and performance of the product Decisions and reporting by the Notified Company relevant to the revision of the Complete Quality Guarantee System Decisions and reporting by the Notified Company relevant to the examination of the design of the product Decisions and reporting by the Notified Company relevant to possible changes in the design Decisions and reporting by the Notified Company relevant to periodic inspections i Decisions and reporting by the Notified Company relevant to unexpected inspections ooo Da Su a Stamp and signature 1 ITALY ey 0476 Model LA3D0001 1 Manual Code LI3D0001 2 Date 25 09 2009 Pag 9 Introduction Particular care has to be taken during the operation of installation and transport due to its rather delicate role It is extremely important to give scrupulous attention to the rules illustrated in the following instructions The first fundamental operation to take into careful consideration is the checking of the shipped parts and their installation in the chosen working area WORKING AREA In the room previously prepared for the laser use it is advis
79. umulated heat and quick vaporization of material and photomechanical mechanisms production of a shock wave are included The prevailing of either of them will depend on the characteristics of the protocol of irradiation 8 4 EXAMPLES OF TREATMENTS TREATMENT POWER FREQ TIME s FIBER MW Hz um eraros SOT Ow m Feres abile f oo CW 60 300_ 8 5 CONTRAINDICATIONS By now no contra indication is known about the use of a diode laser In case of skin treatments on photosensible or coloured people of asiatic or negroid race some unwanted skin reaction may occur The user will be kindly advised to start with low dosage of energy and then increase it evaluating though wether the minor effects noticed are tolerable and less important than the benefits 8 6 COLLATERAL EFFECTS An inappropriate use of the laser device may cause unwanted and sometimes dangerous consequences The laser actually bears some huge and beneficial effects into the human tissue at the right rates of power frequency and treatment time On the other hand especially at high power rates may cause damage vaporising or even necrotizing the tissue that has been lased Therefore as this kind of consequence is unwanted the user must always be aware about the risks for the patient But when one actually plans necrotizing a particular site as in the photodinamic therapy or in the use as scalpel one cannot avoid to necrotizing part of tissue very beside

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