Implantek Lase Plus
Contents
1. cenit ZBBBEBEENEBBEENENENEBBEN TTTTTTTTTTT TTL LL areata mths BEBEBBEBEBBNENEEEEE COORDS EB ZBBEBBEENEBENENENENEBBEN TET TTT TT ae B BEBBEBNEEBEEENEEBEBE BEERS CUUUUUCUCECUCENN F111 11111111111_ ig E BEBBEBBEBEBNENEEEEE qme k 111111111111111 a t T1111 1111111111_ BEBEBBEBEBENEENEEE T al e DMC EQUIPAMENTOS LTDA a EBBENEBBBEBBBEBBEBN Rua Sebasti o de Moraes 831 Jardim Alvorada BEBBEEBBEBBBEBEBEBB m Sao Carlos SP CEP 13562 030 BRAZIL CNPJ 02 827 605 0001 86 u E BEBBEBENEBEBBBEEEEN E E B H d g E E E B B a E H d Tec Reponsable Renaldo Massini Jr CREA 0601706815 B B n n H g 9 K 5 HU m Technical name Laser system for surgery User Manual B E a a H a s B F i iW E E u Technical Assistence m BERR Moscou alana TUTTI Phone ne 16 2107 2323 Fax 16 2107 2320 me BEBBEBBEBEBENEEEEE 111111111111111 BEBEBBEBEBENEEENEEE 4117111111111111 revisado 02 RA 01 11 42 IMPLANTEK LASE PLUS User Manual thorized people for it e The electric installation of the environment in question will be in according to the appropriate requirements The Equipment will be used according to the instructions SmO The Implantek Lase Plus is an equipment manufactured with the highest technology and all the equipment are tested individually The equipment possesses the INMETRO stamp and the register in the Sanitary Monitoring National2. 2 1 5 3 Xerosthomy 2 1 5 4 Pericoronaritis 2 1 5 5 Anesthesia 2 1 5 6 Geographic Language 2 1 5 7 Simple Herpes 2 1 5 8 Zoster Herpes 2 1 5 9 Post Endodontics 2 2 SURGERY 2 2 1 Biopse 2 2 2 Bridectomy 2 2 3 Fibromectomy 2 2 4 Frenectomy 2 2 5 Gumplastic 2 2 6 Hemangioma Removal 2 2 7 Hiperplasy Removal 2 2 8 Incisions 2 2 9 Periodontic 2 2 9 1 Periodontical cavity decontamination 2 9 2 2 Gumplastic 2 2 10 Endodontic 2 2 10 1 Intra canal Decontamination 2 2 11 Implantodontic High Power 2 2 12 Periimplantitis 2 2 13 Implantations Reopening 3 CLASSIFICATION Principle Directive Classification IEC 60601 1 Class Equipment and Applied Part of Type B MDD 93 42 Europian Union RDC 185 2001 ANVISA M EC 60825 1 Zw Should not be displayed to the solar light g ww Wy Protect against radiation AN E T Keep dry PRN 1 1 Do not tumble B Maximum piling up mU 35 WARRANTY A The equipment manufactured and or commercialized by DMC have a 24 twenty and four months warranty from the purchase date against manufacture problems B The warranty only covers manufacture problems or problems of material used in the manufacture of the products The warranty does NOT cover remittance expenditures C The warranty is automatically cancelled in case of electric physical abuses if the parts are modified or if occurs different applications of those for which the equipment was developed D In
3. Insert the drive key in the equipment front part e Insert the handle A C in the electric net and the potential equalizer to a potential equalization slide bar of electric installation N When the Surgery Optic Fiber Pen handle is not connected to the equipment this must have its extremity protected by the respective lid for optical fiber pen The same alert is to the laser outlet point This must be carried through to prevent damages to the laser and the optic fiber N If the optical fiber pen tip is dirty or damaged this will not be approved during the fiber test N If some of the item mentioned above will not be used these do not need to be connected to the command box N Before using the micron electric motor the drill the contra angle or the saw it must be verified if they are presented barren 20 UTILIZATION When setting in motion the on off key located in the back panel the initial screens will be presented with the equipment name serial number command box use time software version micron electric motor set in motion use time pointer MC therapist laser use time LT and surgical laser use time LC 17 IMPLANTEK LASE PLUS User Manual Serial Number Usage Time 03 52 45h Version 1 0a 1 0 MC Usage Time 00001 12 36h LT Usage Time 00001 12 36h LC Usage Time 00001 12 36h The user will be able to enter in the work screen clicking in any point of the illustrated screens above white part or t
4. W m a 0 0006 m 0 75 rad NOHD 12 8cm Laser pen handle lasertherapy Laser pen handle outlet lasertherapy Handle A C e Handle A C outlet USB Connector e Entrance to pen drive with MP3 or WMA files Potential Equalizer This connector establishes a equi potential linking It s recommended that the link be made by qualified staff Interlock Connector ocal where interlock will be inserted In case that interlock is not connected the laser will be blocked Antenna e This antenna serves to keep the pedal connection with the command box 10 1 Interlock Connection For bigger security the installation of an interlock key to prevent the inadvertent exposition of the laser on someone that may enter in the surgical room without the security equipment is recommended To install the interlock key is necessary a MEDI SNAP connector with two contacts and an IN key opened contact normally MEDI SNAP Connector NA key When the door is opened the IN key will also be opened therefore the laser will not function when closed the laser will operate normally Opened Door Closed Door The Implantek Lase Plus has a connector that allows the laser to function normally when there is no interlock key The interlock key or the connector absence that follows the equipment will make the module does not operate 11 12 IMPLANTEK LASE PLUS User Manual Below there is the connector present in the Impl
5. case of equipment repaired out of the warranty period it will only be extended to the substituted com ponents E The causes of more common defects are proceeding from physical shocks applied to the device cases where the warranty is cancelled F DMC is not responsible for bodily or material injuries caused from improper use of the equipment produced and or commercialized by it being the user charge to provide security measures in order to prevent such oc currences G DMC responsibility regarded to the use of the equipment and its consequences is limited in value of its reposition The equipment will only have the manufacturer warranty if The assembly operations extensions readjustments modifications or repairs will be carried through by au 41 40 IMPLANTEK LASE PLUS User Manual On only for one part of the equipment Promptitude only for one part of the equipment Continuous operation The laser equipment is selected for a mode where the duration of the exposition is limited by the operator action and the pedal release Only exposition The laser equipment is selected for a mode where an only exposition during a certain time is set free when the pedal is set in motion Repetitive exposition The laser equipment is selected for a mode where a series of expositions with a duration and an interval to the pedal be set in motion Pedal Connection Alternating chain Serial number Turn off the laser with emer
6. the SMA lid to con tinue If the laser will be turned off and the message time limit for the continuous application exce eded Verify if the Handle A C is well connected in the electric net Verify with the Handle A C disconnected from the electric net if the fuse is burnt Verity if the plug is functioning correctly Verity if the micron electric motor handle is cor rectly connected to the command panel Send the equipment to the technical assistan ce of the Manufacturer Verity if the hand part selected in the display corresponds to the one that is being used Verify if the micron motor handle is damaged Send the equipment to the technical assistan ce of the Manufacturer Verify if the support with 4 rolls is turning Verity if the silica hose is pierced or obstructed Verity if the bomb cassette is set correctly Substitute the cassette Verity if its cassette is correctly incased Send the command box to the technical assis tance of the Manufacturer Verify the consuming of the drills and saws Substitute the contra angle Substitute the Micron Saw Substitute the micron electric motor Send the equipment to the technical assistan ce of the Manufacturer In this in case the user must verify if the opti cal fiber pen for surgery is incased correctly The pedal must be set free and any part of the display must be pressured 12 1 Peristaltic Bomb Cassette
7. 2 2001 subcl 6 8 3 201 a 3 The Implantek Lase Plus is destined for using in electromagnetic environment specified below The customer or user of the Implantek Lase Plus must guarantee that it is used in such environment Immunity Assay Conformity Electromagnetic environment Direction line RF Group 1 The Implantek Lase Plus uses energy of RF only for its internal functions Thus its emissions of RF are very ABNT NBR IEC CISPR 11 Conform low not being probable that they cause any interferen Emissions It attends ce in close electronic equipment RF B Class ABNT NBR CISPR 11 Emissions mE The Implantek Lase Plus is adjusted for use in all kinds Harmonics Emissions B Class as IEC 61000 3 2 of establishment also residential establishments and those directly connected to the public net of low ten Emissions due the tension sion electric energy distribution that feeds construc fluctuation twinkle Conform tions for domestic use IEC 61000 3 3 Table 1 Information of conformity to electromagnetic emission requirements based in Table 201 60601 1 2 2006 Lines of direction and declaration of the manufacturer Electromagnetic Immunity for all Implantek Lase Plus IEC 60601 1 2 2001 subcl 6 8 3 201 a 6 The Implantek Lase Plus is destined for using in electromagnetic environment specified below The customer or user of the Implantek Lase Plus must guarantee that it is used in such environment Immunity As
8. 3 The Peristaltic Bomb Cassette is constituted by the following items ox 1 Lid m 2 Support with 4 rolls T J 3 Silica Pipe is 12 2 Assembly of the Peristaltic Bomb Cassette Step 01 Insert the support with 4 rolls in the lid axle Step 02 Rabbet the silica pipe between the support with 4 rolls and the lid Step 03 Fix one of the silica pipe tips close to the Optical fiber Pen for Surgery In this way the generated smoke will be removed Step 04 Connect the other hose extremity in the hospital suction system 12 3 Withdrawal of the Peristaltic Bomb Cassette Step 01 Turn the cassette in the counter clockwise direction until it unlocks pulling it after that Step 02 Remove the silica hose pulling it by the extremities Step 03 Remove the support with 4 rolls pulling it Step 04 Send the silica hose for sterilization as item 12 4 12 4 Silica Hose Sterilization The silica hose must be sterilized by rays or ethylene oxide or sterilizer before using it N The silica hose will only have to be sterilized if the same one to present good conditions of use 13 CONTRA ANGLES AND MICRO SAWS The contra angles and the micron saws must be used with the Implantek Lase Plus micron electric moto These must have rabbet e type rabbet with diameter of 9 9mm two rings oring and a lock ring also known as intra rabbet The contra angle 16 1 must support a maximum or equal torque of 45Ncm and the 20 1 a maximum or equ
9. 40 I x 200 mm p Mannufectured and tested according to IEC 60601 1 IEC 60601 2 22 IEC 60601 1 2 IEC 60601 1 4 and IEC 60685 1 Accessories Optic fiber pen for Surgery 400um or 600um of diameter 5 ADVERSE REACTIONS N Swell or bleed can occur as the laser treatment result All the mentioned complications are generally prevented if the professional is duly trained 6 SECURITY IMPORTANT PRECAUTIONS N The laser light is harmful to the eyes therefore they must be protected using the security glasses by all the people in the enclosure where the session is occurring N Never look directly to the emitted laser light and mainly do not direct this on any person unless the person is under treatment N Reflexive surfaces may reflect the laser beam directly to the eyes 34 USED SYMBOLS PE gt gt Ol lt b U lt L U gt lt co E O Remote Interlocking Connector Laser Radiation Potential equalization terminal ptica Optical fiber applicator Applied part of Type B Attention Check Accompanying Documents Not protected Protected against submersion On with feeding electric tension Off without feeding electric tension Manufacture Date Manufactured by 39 38 IMPLANTEK LASE PLUS User Manual NOTE 1 in 80 MHz and 800 MHz it s applied the higher frequency range NOTE 2 These lines of direction can not be applicable in all the situations The electromagneti
10. ANTEK LASE PLUS User Manual In this screen the dosage value can be adjusted by the keys and E In case of returning to the a previous selection the key must be selected To finish the program configuration the key must be pressured If the infra red laser will be selected the screen below will be shown selection the key MEZZAImust be selected To finish the program configuration the key must be pressured To set in motion or do not the laser pen lasertherapy the button located in the pen must be pres sured Opting to the Beaten Mode When opting to the beaten mode the user will be able to adjust the pulses frequency as described below Through the keys and is possible to modify the values of the pulse amount per second In case of returnin must be selected To continue configuring the program g to the previous selection the key the key MEG must be pressured In this mode the power and the dosage can be modified you can select or not the guide light as described in the continuous mode Opting to the Attended Mode The user will be able to select the therapy he wants by the arrows indicated above In case of returning to the 22 previous selection the key must be selected To continue configuring the program the key must be pressured through an icon being able to assume the following forms i Pt Pedal connected with loaded battery E Ln L ji Pedal connected with w
11. Agency thus guaranteeing the national norms fulfillment This equipment also fulfills the requirements established by the European Union MDD 93 42 being able to be commercialized in the European market N The manufacturer recommends the manual complete reading before the use of the product 1 EQUIPMENT FUNCTIONS The Implantek Lase Plus possesses the following functions To emit high power infra red laser light up to 4 5 W used in surgery To emit low power infra red and red light laser 30 mW 100 mW used in lasertherapy To make osseous cuts osseous perforations insertions osseous loopings in general bucco maxilla face sur gical procedures 2 INDICATIONS OF LASERTHERAPY AND LASER SURGERY 2 1 LASERTHERAPY 2 1 1 Soft Tissue repairing 2 1 1 1 Traumatic Aphthas and Ulcers 2 1 1 2 Systemic Illnesses with Buccal Manifestation 2 1 1 2 1 Plan Lichen 2 1 1 2 2 Angular Cheilitis 2 1 1 3 Gum Inflammation 2 1 1 4 Post operative 2 1 1 5 ATM Disturb 2 1 2 Osseous Tissue Repairing 2 1 2 1 Orthodontics 2 1 2 2 Implantodontics 2 1 2 3 Periodontics 2 1 2 4 Exodontics 2 1 2 5 Traumatic Injury 2 1 2 6 Osseous bio stimulation 2 1 3 Dental Tissue repairing 2 1 3 1 Teeth High sensibility 2 1 4 Nervous Repairing 2 1 4 1 Neuralgies 2 1 4 2 Paresthesias 1 4 3 Paralyses 1 2 2 1 4 4 Pain Syndrome IMPLANTEK LASE PLUS User Manual 2 1 5 Other Applications 2 1 5 1 Alveolus inflammation 2 1 5 2 Edema
12. al value of 55Ncm To the other models of contra angles and to all the micron saws the torque will be in percenta ge The minimum and maximum speeds possible for each model are calculated in the following way Minimum 240 x multiplication factor reduction factor Maximum 45000 x multiplication factor reduction factor For example for a contra angle 20 1 20 is the reduction factor and 1 is the multiplication factor Before using a contra angle or a micron saw verify the cleanness and sterilization recommendations from the Manufacturer These can t contain oil residues when plugging in to the micron electric motor therefore this will cause damages to the engine 14 IMPLANTEK LASE PLUS User Manual N verity in the contra angle and the micron saw manuals the maximum speeds and torques that these support 14 MICRON ELETRIC MOTOR The Micron Electric Motor has an e type rabbet also known as intra rabbet The hand part must be incased until the end of the micron electric motor preventing in this way the axle consuming The increase or reduction of the speed depends on the connected hand part The user will have to select correctly in the control panel the hand part connected to the micron electric motor If the user select a hand part in the control panel and incase a different model from the selected the equipment will not have the expected results and could be damaged 14 1 Micron Electric Motor Support This is a res
13. and or solutions chemical Therefore verify the micron electric motor drying process 20 min 130 C There is a protection lid for the micron electric motor This will have to be inserted whenever it is not operating or being sterilized This protection lid prevents the entrance of humidity in the system and will only have to be removed at the moment of the hand part rabbet The micron electric motor micron does not have to be lubricated When the hand part will be lubricated remove the oil excess using the pneumatic micron motor to avoid the oil entrance in the micron electric motor e Silica Hose The silica hose sterilization must be done through the sterilizer ethylene oxide or ray The hose will have to be inserted in the sterilization envelope before being directed to the sterilizer N The silica hose will only have to be sterilized if it presents good conditions for the use 17 COMMAND BOX AND WIRELESS PEDAL The equipment will have to be detached from the electric net before being clean in order to prevent the user exposition to electric shocks Do not wash the command box and the pedal this will imply the warranty loss Their cleanness consists of passing a humidified soft cloth in disinfecting solution letting the liquid remains on the surface during the time recommended by the manufacturer After this time pass another water humidified cloth and after a dry cloth N Don t let liquids drain on the command box ther
14. antek Lase Plus 10 2 Back Panel Warnings The label below indicates the laser radiation exposition Invisible laser radiation Avoid exposition of the eyes or skin to the direct or diffuse radiation Laser Product Classe 4 Maximum power 4 5W Pulse Duration Beaten Option 05 95ms Only Pulse Option 05 5000ms Wave length 808mm 10mm Classification according to IEC 60825 1 2001 11 COMMAND PEDAL The Command Pedal is constituted by three buttons Rev 1 Bomb 2 e Drive 3 To set in motion the micron electric motor or the optical fiber pen for surgery it s necessary to press the set in motion button The Rev button selects the rotation in the counter clockwise direction and the Bomb button the irrigation function both in applications with the micron electric motor When keeping pressured the Rev button approximately 5 seconds the programs election mode will be set in motion for the micron electric motor Through the Bomb and Rev button it is possible to navigate between the equipment available programs The programs alteration could be visualized on its display 12 PERISTALTIC BOMB The Peristaltic Bomb is inserted in the back of the equipment This is constituted by an internal engine and an external cassette Emission of an intermittent sonorous signal en The maximum torque was exceeded and the gine stop and exhibition of the message torque user will have to set free the pedal central but limit exceede
15. arrows will select the laser wave length between red and infra red In case of retur ning to the previous selection the key key PD must be pressured At this moment the user will be able to choose between the continuous or beaten emission through the arrows indicated above In case of returning to the previous selection the key must be selected To continue configu ring the program the key must be pressured must be pressured To continue configuring the program the Opting to the Continuous Mode In this screen it will be possible to be adjust the power that will be emitted by the laser selected through the keys and In case of returning to the previous selection the key gt gt Next must be selected To continue configuring the program the key must be pressured 25 24 IMPLANTEK LASE PLUS User Manual Item Y When selecting this key the user will be selecting the implantation program tem Z When pressuring this key the user will be able to restart the application cycle tem AB The icon AB illustrates the selected power and if this area will be pressured it is possible to do the alteration of this by the k and E To confirm the option press eys previous power select the key ES l and to return to the Item AD When selecting this key the user will be directed to the implantation program Item AE The key AE can be used to restart the
16. c propagation is affected by the absorption and reflection of structures objects and people The field intensities established by the fixed transmitters such as base radio stations telephone cellular wireless and ter restrial mobile radios amateur radio radio AM and FM transmission and TV transmitters cannot theoretically be foreseen with precision To evaluate the electromagnetic environment due the RF fixed transmitters an electromagnetic inspection in the place is recommended If the measure of the field intensity in the place where the Implantek Lase Plus is used exceeds the conformity level used above the Implantek Lase Plus should be observed to verify if the operation is normal If an abnormal performance be observed add procedures can be necessary such as the reorientation or replacement of the Implantek Lase Plus Over the frequency range of 150kHz up to 80MHz the field intensity should be less than 3 V m Table 3 Information of conformity to requirements of electromagnetic immunity for equipment that don t aim the LIFE SUPPORT based in Table 204 60601 1 2 2006 Minimum separation distances recommended between the communication equipment of RF portable and mobile and the Implantek Lase Plus The Implantek Lase Plus is destined for use in electromagnetic environment in which radiated disturbances of RF are con trolled The customer or user of the Implantek Lase Plus can help to prevent electromagnetic interference keepin
17. ctric motor cycle the user will have to set free the command pedal central button In the case of the laser pen lasertherapy the button located in its body must be pressured N It is recommended that the connector of the interlock be connected to the equipment only when this will be used to prevent that the laser goes off in an inadvertently form Whenever the interlock connector will be disconnected from the equipment a message of Open Interlock will be shown N For operational easiness it s recommended that the laser pen lasertherapy is located approximately 2mm from the target tissue Moreover a spacer is sent with the equipment which must be inserted in the tip of the laser pen lasertherapy guaranteeing the right distance of the laser application All the fluency calculations have as base the area covered by the laser light beam considering this distance of application The area of the laser beam transversal section esteemed for this application distance is of 0 02827 cm 2 N The procedures that use high power must be done in contact with the target tissue 21 POST SURGICAL PROCEDURES After using the user must follow these steps Disconnect the security key remove the optical fiber pen for surgery and the interlock e Insert the protection lid of the laser diode in the command box e Disconnect the key on off located in the back panel Remove the Handle A C from the electric net e Disconnect the micron electric mo
18. d ton to liberate the equipment functions If the message motor Error sensors are sho The user must calibrate the engine wn three consecutive times 26 DISCARDING The discarding of the Implantek Lase Plus and its accessories after its useful life is responsibility of the user and must attend the local legislation The Implantek Lase Plus not being used must be protected against inadvertent and not qualified use 27 DOUBLE COMPATIBILITY The applied part that touches the patient is in compliance with the ISO 10993 1 requirements 28 BEAM DIVERGENCE CALCULATION Applied Norm 60825 1 IEC 1993 A1 1997 A2 2001 E Sub clause 3 13 d 0 4mm d 80mm Ec a i p larctan M r 100mm d 0 4 mm d 8mm r 100 mm o 0 75 rad 29 MAXIMUM IRRADIANCE CALCULATION Applied Norm 60825 1 IEC 1993 A1 1997 A2 2001 E Sub clause 3 39 Qui zoll 4 e moe aa Maximum Power 4 5W Area 2 1 2 x 107m E 3 7 x 10 W m 33 32 IMPLANTEK LASE PLUS User Manual 25 PROBLEMS RESOLUTIONS Type of Error Possible Solutions The equipment doesn t turn on The equipment is on but the engine does not turn The indicated speed does not correspond to the real speed The Peristaltic Bomb is not irrigating The Peristaltic Bomb does not turn The set micron electric motor does not present the performance expected The laser does not set in motion and the mes sage Connect the fiber or
19. eak battery substitute Pedal battery 4 IRL F Disconnected pedal 20 2 Micron electric motor connection pointer The icon that indicates the engine connection status with the command box can assume the following forms La Engine 1 connected and active LIZZ Engine 2 connected and active as rw Disconnected engine 20 3 Optical fiber pen for surgery connection pointer The icons below illustrate the forms that the optical fiber pen can be identified AL uo oc Z3 RED d Optical fiber pen for surgery disconnected Optical fiber pen for surgery connected 20 4 Work screens general functions 20 4 1 i yen The key is available in all the work screens and must be used to increase or to diminish the audio volume and to return the information screen about the system When this key will be selected the command bar will be modified to When pressuring the key E the command bar will be modified to To increase the volume the must be pressured to diminish the EE and to remove or to re establish 19 20 IMPLANTEK LASE PLUS User Manual the audio l To return to the main bar command bar the must be pressured 20 5 Using the Implantation Program In this screen the user will be able to adjust or to select some parameters clicking on the keys or illustrated areas above A Amn 20 1 program ERG D a HS yA E c LESME _ Item A Clicking on this area the user w
20. east be calibrated each two years by the manufacturer If this maintenance will not be done the manufacturer does not assume any responsibility for the security in the equipment functioning All the assistance services such as alterations repairings calibratings etc only can be done by the manufac turer If the maintenance or another type of assistance service will be carried through by technician staff not authori zed the manufacturer does not assume any responsibility for the security in the functioning of the equipment N Never open the command box Any problem contact the technical assistance from DMC Equipment 24 STORAGE AND TRANSPORT e Storage the equipment protected from dust direct exposition to the solar light distant from chemical products and cleanness agents The equipment must be stored be carried and used in the following ambient conditions Temperature 10 C to 40 C Humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa N Prevent the equipment fall N Keep the equipment in safe places preventing to submit it to blows and vibrations 31 30 IMPLANTEK LASE PLUS User Manual key MESZMN must be pressured To set in motion the optical fiber pen for surgery the security key must be set in motion interlock must be con nected in the back of the equipment and the command pedal central button must be set in motion N To interrupt optical fiber pen for surgery and the micron ele
21. efore it will be damaged SmO In case of returning to the previous selection the key must be selected To finish the program PP configuration the key must be pressured To set in motion the optical fiber pen for surgery the security key must be set in motion interlock must be connected in the back of the equipment and the command pedal central button must be set in motion Opting to the Only Pulse Mode The pulse width can be adjusted by using the keys or E illustrated above In case of returning to the previous selection the key must be selected To continue configuring the program the key must be pressured In this screen it s possible to adjust the power that will be emitted by the laser selected through the keys and In case of returning to the previous selection the key 2 IU must be pressured configuring the program the key Opting to the Attended Mode must be selected and to continue previous selection the key must be pressured In this screen the user will be able to adjust the power through the keys and The user will only be able to modify the power in the interval defined by the Manufacturer which can be visualized in the command Next bar To finish the configuration the key must be pressured and to return to the previous screen the 29 28 IMPLANTEK LASE PLUS User Manual Opting to the Continuous Mode E In case of returning to the previous se
22. etic inspection in local be shorter than the level of conformity in each frequency range Interference around the equipment ma rked with the following symbol can occur D 37 36 IMPLANTEK LASE PLUS User Manual lt 5 Ut gt 95 of tension decrease in Ut per 0 5 cycles 40 Ut Energy supply quality must be that of a Tension decreases short 60 of tension decrease in typical hospital or commercial environ interruptions and tension Ut per 5 cycles ment If the user of the Implantek Lase variation in the input lines Conform Plus demands continuous operation of feeding 70 Ut during energy interruption it is recom IEC 61000 4 11 mended that the Implantek Lase Plus be 30 of tension decrease in fed by an uninterrupted feeding source Ut per 25 cycles or a battery lt 5 Ut gt 95 of tension decrease in Ut per 5 seconds Magnetic field in the fee Conform Magnetic fields in the feeding frequency ding frequency 50 60 Hz 3 Alm should be in characteristic levels of a IEC 61000 4 8 typical hospital or commercial environ ment NOTE Ut is the feeding tension c a before the assay level application Table 2 Information of conformity to requirements of electromagnetic immunity based in Table 202 60601 1 2 2006 9 PANEL FRONTAL PARAMETERS Implantek Lase Plus Fiber Connector 1 e Connection local of the Optical fiber Pen for Surgery Fiber Check Point 2 Test
23. g minimum distance between the communication equipment portable or mobile of RF transmitting and the Implantek Lase Plus as recommended below according to the maximum power outlet of the communication equipment of the transmitter outlet W For transmitters with a nominal maximum power outlet not listed above the separation distance recommended in meters m can be determined through the applicable equation to the transmitter frequency Note 1 in 80 MHz up to 800 MHz it is applied the separation distance for the higher frequency range Note 2 these lines of direction can be not applied in all the situations The electromagnetic propagation is affected by the absorption and reflection of structures objects and people Table 4 Recommendations of separation distances between the equipment and RF emission sources based on Table 206 60601 1 2 2006 N Never radiate tumor processes directly the laser can stimulate them N Never radiate infectious processes directly the laser can exacerbate them N Never radiate an injury without diagnosis N Do not make extra oral applications in patients who use photo sensible drugs any light of high intensity can interact with the drug and to provoke spots in the irradiation place N Do not radiate the beam on the women womb with less than three months of gestation N The use of anesthetics inflammable gases or oxided such as nitrous oxide N20 and oxygen must be avoided Some mate
24. gency Temperature limits Fragile Indicates the transport position 4 SPECIFICATIONS 4 1 Surgery Function Continuous operation Continuous The exposition duration is limited by the pedal release An only exposition is liberated when the pedal is Only exposition Only Pulse pressured This time of exposition can be adjus ted between 05 5000ms In this in case an expositions series with the duration varying between 05 95ms and inter val between 05 95ms liberated The laser fre quency laser in this application may be between 10 100PPS Infra red Laser Mira Laser Characteristics Wave length 650nm 10nm Sender useful power 0 5mW 2 5mW 4 2 Lasertherapy Function Infra red Laser Characteristics Wave length 808nm 10nm Sender useful power 100mW 20 Characteristics Wave length 650nm 10nm Sender useful power 0 5mW 2 5mW 4 3 General Characteristics Characteristics Specifications Feed Tension 90 240V Repetitive exposition Beaten 200 VA Feed Frequency 50 60Hz IMPLANTEK LASE PLUS User Manual Prote o a penetra o de gua IPXO cabinet and IPX8 pedal Operation Mode Speed 240 rom 45 000rpm Micron Eletric Motor Sterilization Sterilizer ethilene oxid or gamma ray Connection type e type Peristaltic Bomb Flood Maximum 50 mL min and Minimum 8 mL min Nominal Chain 2 A Type T Tension 250 V Rupture Capacity 35 A or L Dimension 290 x 2
25. ill activate the command bar for the selection of a program pre viously determined VY The illustrated arrows above will modify the program After its selection the ke we must be pressured If the user doesn t want to select another program he must pressure the key It is possible to modify pre adjusted configurations from P1 to P12 programs The user will be able to define all the parameters of each program mounting a sequence of programs for the surgical process All the programs defined for the micron electric motor use will be recorded always after the micron electric motor drive through the command pedal central button Item B When pressuring the area B the user will activate the command bar for the torque selection Through the keys and the user will be able to adjust the torque he wants After its selection the key must be pressured If the user doesn t want to modify the torque value he will have to pressure the key SmO user to the selected function configurations If the user wants to leave this screen the key must be selected 20 8 1 Using the Lasertherapy mode The arrows indicated above must be used to carry through the mode choice that is normal or attended In case of d to the previous selection the key the key must be pressured Opting to the Normal Mode must be selected To continue configuring the program S5ELECT THERAPEUTIC LASERS In this screen the illustrated
26. lection the key MASSA must be selected To finish the program configuration the key ce must be pressured To set in motion the optical fiber pen for surgery the security key must be set in motion interlock must be connected in the back of the equipment and the command pedal central button must be set in motion Opting to the Beaten Mode The pulse width can be adjusted by using the keys and illustrated above In case of returning to the T selection the key must be pressured must be selected To continue configuring the program the key In this screen the user will be able to adjust the power that will be emitted by the laser using the keys or SmO 18 INSPECTION BEFORE USING Before each use the optical fiber pen for surgery will have to be inspected by the user This will not be able to present cracks grooves or any mechanical damage Moreover the fiber surface must be clean as described in item 15 19 INSTALLATION e Remove the laser outlet lid that covers the laser opening in the command box e Remove optical fiber pen lid e Connect the Optical fiber Pen for Surgery in the equipment front part turning it in clockwise direction until stopping e Connect the micron electric motor in the command box front part e Connect the contra angle or saw in the micron electric motor e Insert the bomb cassette hoses and the serum e Connect the handle A C and the interlock connector in the equipment back part e
27. local of the Optical fiber Pen for Surgery Security Key 3 Drive key local of connection Engine Connector 4 e Electric micron motor local of connection Loudspeaker 5 Audio outlet place Emergency Key 6 n emergency case the laser emission can be interrupted immediately by this key Touch Screen Display 7 The equipment possess a touch screen display that is sensible to the touch which must be used for adjust ments and elections during the equipment use Laser Pen Lasertherapy 8 e This pen must be used when lasertherapy sessions are carried through 10 IMPLANTEK LASE PLUS User Manual 10 BACK PANEL COMPONENTS On Off Button 1 e Turns on and off the command box Micro fan 2 Air outlet it must not be obstructed Fuse porters 3 e Fuses plug in Peristaltic bomb 4 e Plug in of the peristaltic bomb cassette optional Serum connecting rod support 5 e Plug in of the serum connecting rod optional Connection Niple 6 e Silica hose of 3m plug in optional Linking Niple 7 Serum plug in optional Serum connecting rod 8 Serum support place optional 33 EQUIPMENT ELECTROMAGNETIC SECURITY STANDARDS Below tables that represent the adequacy to the emission and electromagnetic immunity norms are described Lines of direction and declaration of the manufacturer Electromagnetic Emissions for all Equipment and System IEC 60601 1
28. o wait the equipment time to enter automatically There are four possibilities of work screens depending on the function that the user wants to execute These screens will be illustrated throughout the manual However when turning the equipment on this will always enter with the implantation screen which follows below 20 1 Pedal connection pointer To connect the command pedal it s necessary to press its right or left button The connection can be observed In this screen the user will be able to adjust the dosage value through the keys and In case of returning to the previous selection the key key dw must be pressured must be selected To finish the program configuration the In the case of choosing a therapy that uses the infra red laser the screen below will be shown selection the key must be selected To finish the program configuration the key must be pressured To set in motion or do not the laser pen lasertherapy the button located in the pen must be pres sured 20 8 2 Using the Surgery Mode the key MASS must be selected To continue configuring the program the key Opting to the Normal Mode At this moment the user will be able to choose between the continuous emission beaten or only pulse through the arrows indicated above In case of N to the previous selection the key must be selected To continue configuring the program the key must be pressured 27 26 IMPL
29. od Serum optional User manual and Warranty Term Micron electric motor support Micron Electric motor Protection lid of the micron electric motor 04 Fuses 02 reserve fuses Lines of direction and declaration of the manufacturer Electromagnetic Immunity Equipment that is not of SUPPORT TO LIFE IEC 60601 1 2 2001 subcl 6 8 The Implantek Lase Plus is destined for using in electromagnetic environment specified below The customer or user of the Implantek Lase Plus must guarantee that it is used in such environment Immunity Assay Assay level of ABNT NBR Level of Electromagnetic environment Line IEC 60601 conformity of direction Portable and mobile communication equi pment of RF should not be used next to any part to the Implantek Lase Plus in cluding handles with separation distance of less than the recommended calculated from the applicable equation to the trans mitter frequency Separation distance of recommended D 10 10 m D 10 10 m RF Lead 3 Vrms 80 MHz up to 800 MHZ IEC 61000 4 6 150 kHz up to 80 MHz D 20 20 m RF Radiated 3V m 800 MHz up to 2 5 GHz IEC 61000 4 3 80 MHz up to 2 5 GHz Where P is the transmitter nominal maxi mum power of exit in watts w according to the transmitter manufacturer and D is the separation distance recommended in meters m It is recommended that the intensity of field established by the RF transmitter as determined through an electromag n
30. rials for example cotton when saturated with oxygen can be inflamed for the high tem peratures produced The adhesive solvents and inflammable solutions used for cleanness and disinfection must evaporate before the equipment be used N Certify that the equipment is linked correctly to the land this way prevents energy peaks and the functio ning will be successful N Only trained people can operate the equipment The inadequate use can cause irreversible damages N Only the components mentioned in this manual can be used with the equipment N In case that it is necessary to cease the laser emission quickly the red key located in the equipment top part must be used N Avoid oil entrance in the engine interior N Avoid working with the engine overheated In case that this occurs interrupt the use alternating the use N Never use consumed drills or saws N Never lubricate the micron electric motor N Never connect or remove a contra angle or micron saw with the micron electric motor IMPLANTEK LASE PLUS User Manual 7 EQUIPMENT SECURITY ITEMS The equipment makes use of some security item that include e Sonorous signal emission while the laser is active e Emergency key destined to interrupt the laser outlet immediately A connector for remote inter locking which prevents the laser inadvertent exposition on any person who has opened the surgical room door Security key which will only make possible the eq
31. say Assay Level of ABNT Level of Electromagnetic environment NBR IEC60601 conformity Line of direction 6 kV eac h contact Conform Floor must be wooden concrete or cera Electrostatic discharge ESD 8 kV through air mic If the floor is covered with synthetic IEC 61000 4 2 material the relative humidity must be at least 30 Fast electric transitories pul 2 kV in the feeding line Conform Energy supply quality must be that of a se train Burst 1 kV in the lines of input typical hospital or commercial environ IEC 610004 4 output ment Outbreaks 2 kV line s the ground Conform Energy supply quality must be that of a IEC 61000 4 5 1 kV line s the line typical hospital or commercial environ ment 35 IMPLANTEK LASE PLUS User Manual 30 MPE CALCULATION TO THE CORNEA Applied Norm 60825 1 IEC 1993 A1 1997 A2 2001 E Appendix A1 According to Table06 E 18C C CT W m2 t gt T2 and a gt 1 5 mrad 4767 2 C 66 7 C 1 64 C 1 T 1005 E 610 Wm 31 MPE CALCULATION TO THE SKIN Applied Norm 60825 1 IEC 1993 A1 1997 A2 2001 E Appendix A1 E pe 2000C Wm C 1 64 4 E p 3280 W m 32 NOHD CALCULATION Applied Norm 60825 1 IEC 1993 A1 1997 A2 2001 E Appendix A5 32 1 Surgery Function 400pm Fiber NOHD P 4 5W Epp 610 W m a 0 0004 m Q 0 75 rad NOHD 12 4 cm 32 2 Surgery Function 600pm Fiber NOHD P 4 5W E oe 010
32. selection the ke ME must be pressured If the user doesn t want to modify the flow he will have to pressure the key Item F When selecting this key the user will have access the lasertherapy or laser surgery screens e Item G When clicking on the key G the user will activate the command bar for the engines selection and adjustments To select the engine 1 the ke must be pressured and the engine 2 the key To adjust the engine brake the key must be pressured being able to choose a softer stop 10 or more brusque 100 21 22 IMPLANTEK LASE PLUS User Manual To calibrate the engine the key calibrate engine must be pressured After that it s necessary to follow the instructions presented in the display and press the key confirm to effect the calibration or the key cancel to return to the main menu tem H Clicking on the key H the user will have access to the micron electric motor micron saw screen e Item I When clicking on the key I the user will activate the command bar for the bomb selection When e Item J When clicking on the key J the user will activate the command bar for the selection of the micron electric motor rotation direction that is direct hourly or reverse counter clockwise Items N and Q When clicking on the key N or Q the user will activate the command bar for the micron saw selection Through the arrows illustrated above i
33. t is possible to select a micron saw model that is oscillatory micron saw v sagittal reciproking and recipro sagittal After the selection the user will have to pressure the key to validate the option selected In case that the user does not want to modify the current configuration the key will have to be pressured e Items O P U T W and R The user will be able to program the item mentioned above according to what is described in item 15 5 Item V When selecting this key the user will have access to the implantation programming 20 7 Micron electric motor drive To set in motion the micron electric motor in the implant programming or micron saw the command pedal central button must be pressured 20 8 Entering in the Laser Programming 23
34. t support to the micron electric motor 15 OPTICAL FIBER PENS FOR SURGERY This pen must be used whenever surgical applications will be carried through When this is not being used it is important to keep the handle extremity with the respective lid There are two options for the optical fiber pen for surgery diameter 400um or 600um N At the moment of the equipment purchase the user will have to choose between the Optical fiber Pen for Surgery of 400um or 600um In case of both fibers the last will be commercialized separately N At the moment of the Optical fiber Pen for Surgery use the user must leave a minimum length of 15mm from the fiber out of the pen 15 1 Clivage process The optic fiber in its extremities must have a total plain surface so that there is no loss of optic power for refraction In such a way it must be clivaded according to the pen use All the clivage process follows below 22 FUSE CHANGING AND CHECKING PROCEDURE e Disconnect handle A C from the electric net Using a crack key dislocate the two extremities of the fuse porter lid see picture below until it is possible to remove it with the hand Remove each fuse and verify if they are burnt observe if the fuse is darkened or with broken filament e f necessary substitute the fuse using reserves supplied or another one of equal value e Push the fuse porter with the hand until stopping 23 PREVENTING MAINTENANCE The laser outlet must at l
35. time accountant of application of the surgical laser Item AF The keyboard key AF must be selected whenever a optical fiber pen for surgery is connected to the equipment therefore this verifies the conditions of the connected pen that is if it is adjusted to the use Item AA and AG When selecting the function available The user will be able to select surgical or therapeutical mode pressuring the key Later the command bar will be modified to Pe The user will have to select the laser he wants using the arrows indicated above The key SEG the SmO Item C When pressuring the area C the user will activate the command bar for the rotation selection VA E Through the keys and E the user will be able to adjust the rotation he wants After the its selection the key must be pressured If the user doesn t want to modify the rotation value he will have to pres sure the key e Item D When pressuring the area D the user will activate the command bar for the contra angle model selection 4 gt VY The illustrated arrows above will modify the contra angle model After its selection the key N be pressured If the user doesn t want to select another contra angle he will have to pressure the key tem E When pressuring the area E the user will activate the command bar for the flow level selection v 4 VY The illustrated arrows above will modify the flow level After its
36. tor from the equipment front part removing the connector never pull by the handle When the equipment possess the peristaltic bomb its cassette must be removed 1 To pull the fiber to the front and cut the protective layer with the Stripper aid C1 MM Protective Layer Optic Fiber i 2 To scratch out transversally the fiber through the clivage pen after being softly bended so the cut is carried through by the surface with no damage Clivage Pen E E f i Mark made with the pen y eooo o de _ 15 16 IMPLANTEK LASE PLUS User Manual 3 To insert the optical fiber handle in the pen until the clivaded tip is apparent in the extremity N When the optical fiber handle becomes very short hindering its use another optical fiber pen must be acquired N THE OPTICAL FIBER PEN FOR SURGERY MUST BE ACQUIRED AT DMC EQUIPMENT 15 2 Sterilization The Optical fiber Pen for Surgery must be sterilized by 5 rays or ethylene oxide 16 MICRON ELETRIC MOTOR AND SILICA HOSES STERILIZATION e Micron electric motor This part can be sterilized in sterilizer ethylene oxide or ray ray If the sterilization will be by sterilizer the equipment useful life will be lesser The micron electric motor is constituted by metallic material therefore it is subjected to the rust and oxidation process caused by the metal contact with the water
37. uipment use for the responsible person only e Aiming beam emission i l M aS e Indication on the display of the laser on by the symbol 7 1 Aiming Beam The Implantek Lase Plus uses an aiming beam of low intensity This laser is visible and destined to indicate the infra red laser impact anticipated point When turning on the equipment the aiming beam remains 500 ms on before the infra red laser This action is used so that the operator possesses a time to locate the work beam correctly As the aiming beam passes on the same supply system as the infra red laser it provides a good supply system integrity verification method If the aiming focus is not present in the supply system distal extremity its intensity will be reduced or seems to be diffuse it is a possible indication of a damage or inadequate operation of the conduction system 8 COMPONENTS LIST The Implantek Lase Plus is constituted by the following items e Command Box Cabinet e Laser Pen lasertherapy e Optical fiber Pen for Surgery Optic Fiber of 400um or 600um of diameter e Lid for the Optical fiber Pen for Surgery e Lid for the Laser Slot e 02 drive keys e Interlock Connector 02 pairs of protection glasses user 01 pair of protection glasses patient e 01 lasertherapy CD A C Handle Wireless Pedal Clivage Pen e Stripper Peristaltic Bomb optional e Serum connecting rod support optional e Serum Connecting r
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