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SIROLaser

1. SIROLaser Operating Instructions SIROLaser a CE 0123 No part of this publication may be reproduced transmitted stored or translated into any language in any form or through any electronic magnetic optical chemical manual physical device or other means without the prior written consent from Sirona Dental Systems GmbH Fabrikstrasse 31 64625 Bensheim Germany Sirona Dental Systems GmbH reserves the right to correct or modify the present document without prior notice SIROLaser is manufactured in compliance with the provisions of Council Directive 93 42 EEC concerning medical devices MDD Its compliance is based on the following standards IEC 60601 1 1998 IEC 60601 1 A2 1998 and IEC 60601 2 22 1997 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 Index 1 Warning and safety information 1 6 1 1 Highlighting of warning and safety information sscc 6 1 2 intended use 222225 EDER EKK AEAEE AAEE 6 1 3 Instructions on use of the laser protective goggles 7 1 4 Wireless phone interference 00 0 eceneeeeeeeeeeeeeeeetneeeeeeenaneees 7 125 Dispelled ane 8 2 Glossary symbols and abbreviations 9 2 1 Symbols on the SIROLASEL cceecceeeeeeeeeeeeeeeneeeseteeeseneeeeseaes 9 2 2 GOSS ANY ese eeeeeececeeeeeeeeeeeneeeeeeaeeeeeeeeseaeeeesaeeseaaeeeseaeeesieeeeseaeeeseaees 10 23 Abbreviations iis cccecnstcecedesetcaedied ieee iveeeienceeetint eveeitt riean 11
2. gt Remove the black protective cap A from the optical fiber Figure 12 Take up device Tapered part with slot Screw on optical fiber connector with magnet Cylindrical part The connector comprises 2 parts Tapered part with slot Cylindrical part O notice The S ROLaser detects that the optical fiber is also properly connected only if itis connected to the connector If the connector or the optical fiber is missing an error message is output KLA GG Bannere gt Attach the slotted optical fiber connector with magnet see Fig 13 to the optical fiber gt The optical fiber must be laid in the slot of the tapered part see Fig 14 gt Screw on the tapered part from the rear up to the stop of the optical fiber see Fig 15 You do not have to roll up the optical fiber The optical fiber is thus protected against contamination The optical fiber can now be connected to the SIROLaser see Fig 16 Figure 14 Optical fiber with protection caps Figure 15 Optical fiber with magnet 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 23 Figure 16 Connecting the optical fiber Figure 17 Protection cap on the laser unit 4 7 3 24 4 Installation gt Screw the optical fiber onto the laser See Fig 16 gt Put the laser into operation A corresponding description is provided in Chapter 5 A WARNING The aiming beam must not be aimed at anyone s retina It comprises a
3. 3 Introduction cece secrete ie eee 12 3T Classificato isisisi nananana etait ih ieee 12 3 2 Safety precautions cccceccceceeeeeeeeeeeeeeeeeeaeeeeeaeeeteaeeeseaeeesenees 12 3 amp 3 Transport and Storage sesiis dise D RDEKER 14 3 3 1 Transport and storage 2222222 EEG SEEREN ENN RBR na 14 3 3 2 Operating conditions u u u ssssseeereerererssenrr ener nnnn nn n nen krnnnnee 14 BA Precautions E AR RIE nen tig 15 4 Installation 1 222 ragastrederceeavets oinaunesisrchveaibelvients 17 4 1 Packaging CONtent HEE Elo lee 17 42 Spare pantsa ioniske A erence ets eg es E era are 18 4 2 1 ACCOSSOSIOS o eeeeeesceceeeeeseceeeeeeeneeeeeeeeeeceeeeenaaeaeeeeeeeenseeeeneneneeeeees 18 AS Labels iisssnectsiccnad chive avidin deeds eesti atest 18 AA Vite rlOCk E RES veetdes usage cesevaeedetenet 19 4 4 1 gt Fel ge UHL meer ee nee reer ere erence ere eer genrer 19 4 4 2 Installation of an interlock with door switch eec 19 4 4 3 Installation of an interlock jumper without door switch 20 4 5 Connection of the foot SWitCh cee ceee cette eeeeeeeeeeeeeeeeeetenees 20 4 6 Connection of the finger SWitCN cceeeeeeeeeeteeeeeeeeeteneeetenees 21 4 7 Connecting the optical fiber ccececeeeeeeeeeeeeeeeeeeeeeeeeeeeeteaees 22 4 7 1 Feld OF APPIICALION eng E 22 4 7 2 Initial use of an optical fiber oo eee eeneeeeeeetneeeeeeeetaeeeeeeenaes 22 4 7 3 Preparation for Clinical USC ie ERR Ed 24 4 7 4 Adju
4. A CAUTION Never allow dust or dirt to enter the optical fiber socket and the optical system Otherwise the unit may be permanently damaged A CAUTION Always protect the optical fiber socket as well as the optical fiber itself with the special protection caps Do not allow dust dirt or other foreign bodies to enter the optical fiber socket Always make sure that the optical system is clean be fore connecting the optical fiber A WARNING Prior to each treatment the handpieces must be sterilized and the optical fi bers must be wipe disinfected A CAUTION Switch the laser off immediately if the optical fiber is broken Otherwise the tips may become hot O notice The tips must be checked for sure seating prior to each use 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 4 Installation 4 Installation 4 1 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 If national or local legal regulations require that the installation of the SIROLaser be performed by specialized personnel these regulations must be complied with A WARNING The handpieces and the tips are supplied non sterile you must clean disin fect and sterilize these products prior to first use and prior to each subsequent use Packaging contents The following components are included in the scope of supply of the SIROLaser fel ay Designation 1 SIROLaser unit 1 Transport case Power cord Switching power supply Int
5. The power meter is on and set to correct measuring range of up to 10 W at 970 nm 15nm NO Set power meter to measuring range of up to 10 W upper end of scale and wavelength of 970 nm 15 nm YES Does the error persist when repeating the measurement Sirona Dental Systems LLC Dental distributor or authorized customer service 45 8 Maintenance and service Action 8 2 8 3 Check of the optical fiber see chapter 4 7 Connecting the optical fiber on page 22 Calibration of the laser see chapter 8 1 Calibration Check on page 43 Safety checks required by law in some European countries 46 8 4 Safety checks The following safety checks must be performed every 24 months by a quali fied service engineer Visual inspection of the unit and its accessories for mechanical damage that might impair operation General function check Check of the audible and visual indicators Earth leakage current NC and SFC accd to IEC 601 Housing leakage current NC and SFC accd to IEC 601 Patient leakage current NC and SFC accd to IEC 601 Laser power measurement with calibrated measuring equipment in the range between 0 5 W and 7 W Maintenance The SIlROLaser does not require special maintenance In case of malfunc tioning see chapter Technical support repair and testing However Sirona Dental Systems GmbH recommends the following action
6. A WARNING As soon as you have selected the program the SIROLaser is in standby mode As soon as you press the foot switch or finger switch the laser unit is activated When you actuate the foot switch or finger switch the message LASER ON appears At the same time 4 yellow LEDs light up the audible alarm sounds and the laser starts emitting When you release the foot switch or finger switch to interrupt treatment the laser is deactivated but remains ready for opera tion To change the output parameters press the ENTER key As soon as the area has been selected you can change the parameters by pressing the RIGHT ARROW or LEFT ARROW key When you press the red LASER STOP emergency button laser radiation and thus also treatment is terminated immediately To quit the selected menu or save your changes press the ENTER key for more than 1 second A message confirming the end of the therapy appears on the display THERAPY COMPLETED gt The LEFT ARROW key returns you to the main menu 5 9 SETUP AREA submenu After accessing the SETUP AREA you can scroll through the available functions with the ENTER key The following functions are available FUNCTION 1 Adjustment of the display contrast SETUP FUNCTION 2 Activation or deactivation of the key tones AREA FUNCTION 3 Activation or deactivation of the audible alarm during laser radiation Sirona Den
7. Dental Systems GmbH your local dental distributor or your authorized service center A WARNING Using the laser unit without a properly working aiming beam may cause inju ries to operators assistants and patients A CAUTION The optical fiber must be cleaned and disinfected prior to the first treatment A CAUTION Remove the protection caps only for operation A CAUTION Do not touch the end surfaces of connectors and protect against damage A CAUTION Do not kink or pinch the optical fiber as this would cause breaking the optical fi ber A CAUTION Do not pull on the optical fiber A CAUTION Note the maximum permissible bending radius of the optical fiber Short term during use 100 x radius of optical fiber e Long term during storage 600 x radius of optical fiber O notice Magnet is for recognizing the presence and absence of the fiber Inserting the optical fiber into a sterilized handpiece gt Loosen the proximal part of the handpiece 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 25 7 Figure 18 Inserting the optical fiber into the handpiece Figure 19 Fitting the tip Figure 20 Adjusting the length of the optical fiber 4 Installation gt Insert the optical fiber in to the handpiece gt Insert the desired curved tip by applying pressure and twisting it A CAUTION Do not use the 320 um fiber or one larger in combination with t
8. off and switch it on again If the error message is displayed again contact your local dealer or your authorized service center This error message indicates that the foot switch or finger switch was pressed during menu selection or that you foot switch or finger switch is defective short circuited Please make sure that neither the finger switch nor the foot switch is pressed during menu selection If the error message is still displayed please contact your local dealer or your authorized service center This error message indicates that the fiber connection sensor is defective or the fiber is not properly connected to your laser Try to disconnect and err 7 connect the fiber again if the error message is still displayed please contact your local dealer or your authorized service center 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 29 5 Operating Instructions 5 2 PRESS ENTER TO SWITCH THE LASER OFF 5 3 Switching the laser unit on and off Once you have completed the installation procedure press the ENTER key to switch on the laser unit After 2 minutes of inactivity the SIROLaser enters the standby mode You can leave the unit in standby mode with the power cord connected gt To switch off the laser unit select OFF AREA press the ENTER key and unplug the power cord Key panel Figure 23 Key panel LEFT ARROW key Navigate to the left Decrease parameter values Qu
9. the depth and stop 1mm above the apex Never direct the optical fiber to one single spot in the root apex for too long The op tical fiber must be moved constantly during treatment Start in the apical re gion and work upward toward the crown e Gangrenous canals A WARNING Risk Contraction fusion and bone necrosis Countermeasure Measure the depth and stop 1 mm above the apex Never direct the optical fiber to one single spot in the root apex for too long The op tical fiber must be moved constantly during treatment Start in the apical re gion and work upwards toward the crown Contraindications At present no contraindications are known for the use of therapeutic lasers in dentistry with devices of the same power and wavelength as the SIROLaser Precautions A WARNING Never direct the laser beam or the aiming beam toward the eyes or the thyroid gland of a person A WARNING The eyes of patients assistants and dentists must always be protected with the laser protective goggles provided with the unit even when only the aiming beam is active Wearer of glasses should use the special offered protective goggles 39 7 Cleaning and sterilization 40 7 1 Cleaning and sterilization After finishing treatment switch off the laser and disconnect the power cord from the power supply A WARNING The handpieces and the tips are supplied non sterile you must sterilize these products prior to f
10. when the laser is in standby mode 4 Selected laser power in our example 0 8 W peak power Using the LEFT ARROW and RIGHT ARROW key you can adjust the emitted power between 0 5 W and 7 W in 0 1 W increments A WARNING The preset power levels are safe for the patient Increasing the power levels entails the risk of overheating the patient s soft or hard tissue Lowering the power levels may result in reduced treatment efficacy 5 Frequency Modulation frequency of the laser unit The frequency range is from 1 to 10 000 Hz If set to zero CW for continuous wave mode is displayed O notice In the preset menus the frequency cannot be modified by the user 6 Treatment energy The system automatically calculates the energy in mJ applied during treatment from the power value and the selected laser activation time If no activation time has been preset the energy will not be calculated When you actuate the foot switch or finger switch the message LASER ON appears At the same time 4 yellow LEDs light up the audible alarm sounds and the laser starts emitting When you release the foot switch or finger switch to interrupt treatment the laser is deactivated but remains ready for opera tion When you press the red LASER STOP emergency button laser radiation and thus also treatment is terminated immediately gt To quit the selected preset menu press the ENTER key A message co
11. CAUTION Never insert your fingers or any objects into the exit ports This is important in order to avoid damage to the optical system A CAUTION In case of an emergency switch the laser unit OFF immediately To do this press the LASER STOP button on the control panel 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 3 Introduction 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 Figure 1 LASER STOP button Observe all labels on the laser unit A WARNING Operation of this laser unit by unauthorized persons must be prohibited in or der to prevent incorrect or improper use A WARNING Never direct the laser beam or the aiming beam toward the eyes or the thyroid gland of a person All persons present in the room patient dentist and assis tant must always wear the laser protective goggles delivered along with the laser unit A WARNING Never use optical instruments such as microscopes eye loupes or magnifiers together with the original protective goggles Adequate eye protection is no longer ensured in this case A CAUTION Always cover the optical fiber connection with the special protection caps pro vided A WARNING The unit is not suitable for use in the presence of anesthetics that are flamma ble when in contact with air oxygen or protoxide A WARNING Oxygen saturated materials such as cotton wool can catch fire due to the high temperature that the unit reaches dur
12. ING You must wear the laser protective goggles supplied with the laser unit during the entire calibration procedure gt Connect an optical fiber to the SIROLaser gt Make the optical fiber point in a controlled direction in the air gt Wear the laser protective goggles and verify that the entrance to the room where the calibration is being performed is controlled by an INTERLOCK device or is locked gt Switch on the SIROLaser and go to the SETUP AREA gt Select SERVICE The first test 1W is highlighted gt Use the RIGHT ARROW key to select the test you want to perform 1 W 3 W 5 W To quit the test area press the LEFT ARROW key Test for 1 W gt Release laser radiation with the foot switch or finger switch until the message OK appears Test for 3 W gt Release laser radiation again until the message OK appears Test for 5 W gt Release laser radiation again until the message OK appears gt Quit the calibration menu by pressing the LEFT ARROW key 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 43 8 Maintenance and service 44 8 1 2 Ifyou did the test correctly and got an OK message on all three tests the laser unit has been successfully calibrated Calibration Check with use of an external power meter Equipment Needed Certified traceable power meter that can measure a min imum of 10 Watt A WARNING You must wear the laser protective goggles supplied w
13. Label 3 Label 8 Label 7 Figure 28 Label positions bottom view 60 90 570 D 3485 54 D 3485 201 04 09 02 09 2007 11 Appendix B2 Label list The following labels are attached to the SIROLaser Sirona Label 1a Label 1 Label 2 Label 3 Label 4 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 55 11 Appendix an Label 5 Label 6 NU Label 7 SA 1 Software extention CU NU SA 1 CU NU SA Gus ROLaser REF 6046960 SN 90001 REF 0048994 SH 0204F Sirona Dental Systems GmbH Fabrikstr 31 64625 Benchoun Sirana Dental Systema GmbH Sssmany Fabrikatr 34 64625 Bensheim cE Germany 0123 ROLase REF 6046978 SN 00001 Sirona Dental Systems GmbH Fabrikstr 31 64625 Benchoun Germany ROLases REF 6046986 SN 00001 11 13V DC 4A max 48VA Sirona Dental Systems GmbH Fabrikstr 31 64625 Benchoun Germany 1 Software extention CU NU SA Label 8 56 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 We reserve the right to make any alterations which may be required due to technical improvements Sirona Dental Systems GmbH 2005 2007 Sprache englisch Printed in Germany D 3485 201 04 09 02 09 2007 A Nr 107 804 Imprim en Allemagne SSS SEE a EET Sirona Dental Systems GmbH FabrikstraBe 31 Order No 60 90 570 D 3485 64625 Bensheim Germany www sirona com
14. NTER key to access the MANUAL SETTING AREA In this area you can manually configure up to 10 different sets of treatment parameters The sets are stored and will be available for use in future treatment sessions gt Press the ENTER key to access the setup area In this submenu you can make basic settings such as interface language sound brightness The service menu is also located in this area gt Press the ENTER key to switch off the laser SURGERY PERIODONTICS and ENDODONTICS submenus The submenus of the surgery periodontology and endodoncy area are arranged in the same way After opening one of the submenus you can choose among various indications with preset treatment parameters gt Use the RIGHT ARROW key to scroll through the different indications gt The LEFT ARROW key returns you to the main menu The following submenus are available SURGERY AREA S1 Gingivectomy S2 Exposing implantations 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 5 Operating Instructions 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 3 Operculectomy S4 Frenulectomy S5 Hemostasis S6 Gingival incisions S7 Aphthae S8 Herpes PERIODONTICS AREAPERIODONTICS P1 Periodont lesions P2 Periodont pockets P3 Peri implantitis ENDODONTICS AREA E1 Endodont germ reduction E2 Gangrene germ reduction After you have selected the desired indication with the ENTER key the fol
15. approx 1 5 m for 10 s radiation exposure of the unprotected eye numerical aperture of the optical fiber NA 0 22 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 10 Manufacturer s declaration regarding electromagnetic compatibility Manufacturer s declaration regarding electromagnetic compatibility O notice The SIROLaser complies with all requirements for electromagnetic compati bility according to IEC 60601 1 2 2005 10 1 Definitions 10 1 1 Emission electromagnetic When electromagnetic energy is emitted by a source 10 1 2 Interference immunity The ability of a device or system to work without errors even if there is elec tromagnetic interference 10 1 3 Immunity level The maximum level of a certain electromagnetic interference that affects a particular device or system where the device or system remains operative with a certain level of performance ELECTROMAGNETIC EMISSION Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The SIROLaser UNIT uses HF energy only for its internal CISPR 11 function The HF emission is therefore very low and it is improbable that nearby electronic devices might be dis turbed RF emissions Class B The SIROLaser UNIT is intended for use in all facilities CISPR 11 including residential areas and in any facilities connected directly to a public power supply providing electricity to Harmonic emissions Class A buildings used
16. att Milliwatt one thousandth of a Watt Joule Nanometer Volt Infrared diode Nominal Ocular Hazard Distance according to IEC 60825 1 1993 A1 1997 A2 2001 3 Introduction 12 3 1 3 2 Introduction Classification According to the applicable standards the SIROLaser is classified as follows Class Type B according to EN IEC 60601 1 1990 A1 1993 A2 1 1995 Class IIb according to Council Directive 93 42 EEC Class IV laser product according to IEC 60825 1 1993 A1 1997 A2 2001 Degree of protection according to EN IEC 60601 1 1990 A1 1993 A2 1 1995 medical unit IP 20 enclosure not water proof foot switch IPX5 A CAUTION The laser unit itself cannot be sterilized However some accessories must be sterilized when used for contact applications A WARNING The laser unit is not suitable for use in the presence of anesthetics that are flammable when in contact with air oxygen or nitrogen monoxide Safety precautions SIROLaser is manufactured in compliance with the provisions of Council Directive 93 42 EEC concerning medical devices MDD Always observe the following precautions A WARNING Always cover the optical fiber connection with the special protection caps pro vided if the fiber is disconnected from the laser A CAUTION Use of the operating controls or adjustment options in a way other than de scribed herein can lead to dangerous radiation A
17. d 60 s 60000 ms in 50 ms intervals When you press the key for more than 3 s the value increases at a faster rate 3 Laser radiation ON when the foot switch or finger switch is actuated OFF when the laser is in standby mode 4 Selected laser power in our example 0 8 W peak power Using the LEFT ARROW and RIGHT ARROW key you can adjust the emitted power between 0 5 W and 7 W in 0 1 W increments A WARNING Setting the power to excessively high levels increases the risk of overheating the patient s soft or hard tissue Setting the power to excessively low levels may result in reduced treatment efficacy 5 Frequency Modulation frequency of the laser The frequency range is from 1 to 10 000 Hz If set to zero CW for continuous wave mode is displayed Up to 100 Hz the parameter value can be increased in 1 Hz increments Between 100 Hz and 1 000 Hz the parameter value can be increased in 100 Hz increments Between 1 000 Hz and 10 000 Hz the 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 35 5 Operating Instructions parameter value can be increased in 1 000 Hz increments When you press the RIGHT ARROW key for more than 3s the value increases at a faster rate 6 Treatment energy The laser unit automatically calculates the energy in mJ applied during treatment from the power value and the selected laser activation time If no activation time has been preset the energy will not be calculated
18. dpiece and tips gt The disassembled handpiece and the tips may be sterilized only in autoclaves with saturated water vapor at 135 C 275 F 3 min holding time and 2 13 bar 33 88 psi overpressure A CAUTION The optical fiber may be damaged if it is seriously bent or improperly routed in side the handpiece This may constitute a health hazard for patients dentists and dental assistants The minimum bending radius of the light guide is 4 5 cm diameter 9 cm Be careful not to pinch or tear the optical fiber when inserting or cleaning it 41 7 Cleaning and sterilization 42 7 4 Approved for sterilization are steam sterilizers that fulfill the requirements of EN 13060 or at least use fractionated vacuum and are suitable for the steril ization of dental handpieces such as e g SIRONA DAC PROFESSIONAL Cleaning of the laser unit and finger switch gt Use adry soft cloth to remove dust from the SIROLaser More stubborn spots can be removed with a damp cloth For disinfection you can treat the SIROLaser with all products commonly used for medical electrical equipment such as MinutenSpray classic CAVICIDE or Caviwipe Observe the instructions provided by the manufacturers of these disinfec tants gt Disinfect the finger switch by spray or wipe disinfection You can use for instance MinutenSpray classic from Alpro MinutenWipes from Alpro In the USA cavicide and caviwipes Observe the i
19. e gt Disassemble the handpiece by unscrewing the two threaded joints gt Clean the handpiece and tip by scrubbing them with a suitable brush under running water Clean the distal end of the optical fiber using a soft damp cloth gt Ifa finger switch is installed remove it as described in Chapter 4 6 Installation page 21 Disinfection gt Disinfect the optical fiber and the take up reel by spray or wipe disinfection gt Disinfect the finger switch by spray or wipe disinfection O notice Use only disinfectants that comply with the requirements of your national authorities and whose bactericidal fungicidal and virucidal properties have been tested and properly certified You can use for instance MinutenSpray classic from Alpro MinutenWipes from Alpro In the USA Cavicide and Caviwipes Observe the instructions provided by the manufacturers of these disinfec tants A CAUTION The optical fiber may be damaged if it is seriously bent or improperly routed in side the handpiece This may constitute a health hazard for patients dentists and dental assistants The minimum bending radius of the light guide is 4 5 cm diameter 9 cm Be careful not to pinch or tear the optical fiber when inserting or cleaning it Sterilization A WARNING The handpiece and tips must be sterilized prior to initial use and before each subsequent use O notice Remove any possible water residues from the han
20. e desired language appears The following abbreviations are used CU NU SA EN English EN English EN English FR French DK Danish NL Dutch IT Italian SE Swedish FR French ESP Spanish FIN Finnish PT Portuguese DE German NO Norwegian ESP Spanish gt Press the ENTER key gt Press the LEFT ARROW key You are now in the main menu 5 6 Main menu The following section describes the main menu You will find an explanation of the different menu items and the steps that are required for accessing the submenus 1 Software extention CU NU SA 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 31 5 Operating Instructions 32 Push to select the working area SURGICAL AREA PERIODONTICS AREA ENDODONTICS AREA MANUAL SETTING AREA SETUP AREA PRESS ENTER TO SWITCH THE LASER OFF 5 7 gt Press the RIGHT ARROW key to select the treatment area gt Press the ENTER key to access the surgery area SURGERY AREA In this area you will find a number of surgical submenus with preset treatment parameters gt Press the ENTER key to access the periodontics area PERIODONTICS AREA In this area you will find a number of periodontic submenus with preset treatment parameters gt Press the ENTER key to access the endodontics area In this area you will find a number of endodontic submenus with preset treatment parameters gt Press the E
21. e technical data sheet with wiring diagram for installation of the interlock device O notice If national or local legal regulations require additional or different measures to be taken for the safety of dentist assistant or patient these regulations must be complied with Installation of an interlock with door switch gt Plug the Y connector into the INTERLOCK SWITCH socket gt As soon as a cable is connected to the interlock connector connect the interlock connector to the Y connector 19 4 Installation 4 4 3 Installation of an interlock jumper without door switch If you have protected the treatment room via suitable measures however have not installed the interlock with the door switch you can replace the Y connector with the space saving interlock jumper gt Plug the interlock jumper into the interlock socket d Figure 4 Connection of the interlock jumper to the interlock socket 4 5 Connection of the foot switch Figure 5 Foot switch gt Plug the foot switch cable into the socket of the Y connector or into the interlock jumper O notice The degree of protection of the foot switch is IPX5 Therefore this foot switch may not be used in hospital operating rooms Please contact Sirona Dental Systems LLC or your local dental distributor if you want to use the laser unit to gether with the foot switch in a hospital OR operation theatre 5 Figure 6 Connection of the fo
22. eading is within the permissible range of 5 W 20 gt Quit the calibration menu by pressing the LEFT ARROW key If the test procedure runs without errors the message OK will appear for each test and the values measured on the power meter will be within the permis sible range In this case the unit has been successfully calibrated 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 8 Maintenance and service 8 1 3 Error message and incorrect parameter values Calibration error 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 If the following screen appears during one of the three calibration tests Repeat the test from the beginning If the error persists please contact your local dental distributor or your authorized service center Do not under any circumstances continue to use the laser unit If the values measured by the power meter are outside the permissible range in each of the three calibration tests please proceed according to the follow ing flow chart One of the three power values is outside the permissible range Has the optical fiber been properly prepared Trim the end of the fiber so that it projects a well defined circle Does the optical fiber point exactly to the sensor area Make the optical fiber point to the measuring head from a min distance of 2 cm and ensure that the red circle is within the sensor area
23. eeeeseaeeeeeneeeee 13 Figure 2 Plugging the Y connector into the laser Unit 0 00 0 eee 19 Figure 3 Plugging the interlock connector into the Y connector 19 Figure 4 Connection of the interlock jumper to the interlock socket 20 Figure 5 FOOt SWItCH oo eeceeeeeeeeene eee eeeeeeeeeeeeaeeeeeseaaeeeeeteaaeeeeeseeaeeeees 20 Figure 6 Connection of the foot switch ccceeeeeeeeeeeeneeeeeeeeeeeeeeeeeneeeeee 20 Figure 7 Distal part of the handpiece eee eee eeeee eee eeeeteeeeeeeeeneeeees 21 Figure 8 Distal part with finger switch W W u u u ddssnseeeeeeeee reen erne eres renee 21 Figure 9 Finger switch mounted on handpiece ssassn 21 Figure 10 Optical fiber and guiding rings c cccseeeeeeeeeeeeneeeseneeeteneeeteaes 21 Figure 11 Connection of the finger switch ccccceeeeeeeeeeeeeseteeeteneeeteaes 22 Figure 12 Take Up device ses ririri iiai 23 Figure 13 Connector ceeeeecceeeeeeeeceeeeeeneeeeeeaeeeeeaeeeeaeeseeaeeeseaeeeseeeeseaeeeseaes 23 Figure 14 Optical fiber with protection Caps ccceeeeeeeeeeeteeeeseteeeeeteeeteaes 23 Figure 15 Optical fiber with Magnet cceeeeeeeeeeeeeeeeeeeeneeeeeeeeeteaeeeteaes 23 Figure 16 Connecting the optical fiber c ecceeeeeeeeeeeeeeeeeeeeeeeeeseaeeeteaes 24 Figure 17 Protection cap on the laser unit ce eeeeeeeeeetneeeeeeeeneeeeeeeeee 24 Figure 18 Inserting the optical fiber into the hand
24. ental conditions Temperatures from 40 C 40 F to 70 C 158 F Relative humidity from 10 to 90 Atmospheric pressure from 800 hPa to 1060 hPa When stored in its original transport packing the SIROLaser withstands the following environmental conditions Temperatures from 40 C 40 F to 70 C 158 F Relative humidity from 10 to 95 Atmospheric pressure from 800 hPa to 1060 hPa Operating conditions The SIROLaser may be operated in the following environmental conditions Temperatures from 10 C 50 F to 33 C 92 F Relative humidity from 10 to 95 Atmospheric pressure from 800 hPa to 1060 hPa 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 3 Introduction 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 3 4 A CAUTION Following transport and storage allow the laser unit to acclimate for about 1 hour in order to reduce the risk of malfunction due to condensation Precautions Using controls or settings or performing functional tests other than those specified in this manual may result in hazardous radiation exposure Sirona Dental Systems GmbH cannot be held liable for any damage caused by improper use or non compliance with the instructions and information pro vided in this manual Please remember the following A CAUTION S ROLaser may only be operated by trained and qualified personnel A CAUTION Laser equipment not in use must be protected again
25. erlock connector Y connector Interlock jumper Laser protective goggles for operator and assistant Laser protective goggles for patients Take up reel incl 200um optic fiber L 3 m long 9 10 Take up reel incl 320m optic fiber L 3 m long 9 10 Handpieces Finger switch Foot switch Ceramic coated scissors for optical fiber trimming Set of tips 30 45 60 sterilizable User Manual Set of warning labels country specific Optical fiber connectors with magnet po mM a ho Nn Dependent on the SIROLaser version 17 4 Installation 4 2 Spare parts Qty Designation Order Number 1 Laser protective goggles for operator and 60 47 737 assistant 1 Laser protective goggles for patient 60 47 745 1 Switching power supply 60 47 778 1 Power cord EU 60 56 613 1 Power cord AUS 61 29 741 1 Power cord DK 61 30 012 1 Interlock connector 60 56 472 1 Y connector 60 56 506 1 Interlock jumper 61 47 024 1 Take up reel incl 200um optic fiber 3m long 60 47 786 9 10 1 Take up reel incl 320um optic fiber 3mlong 60 53 578 9 10 1 Handpiece 60 47 695 1 Finger switch 60 47 760 1 foot switch 60 47 752 1 Ceramic coated scissors for optical fiber 60 56 480 trimming 1 Set of tips 30 45 60 sterilizable 60 47 794 1 User Manual 60 50 092 1 Set of warning labels country specific 60 56 498 1 Optical fiber connector with magnet 60 56 647 50 SIROLaser patient information brochu
26. for 5 cycles 70 Ur 30 dip in Uz for 25 cycles lt 5 Uy gt 95 dip of Uz for 5 seconds lt 5 Uy gt 95 dip of U7 for 0 5 cycles 40 Ur 60 dip in Ux for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Uy gt 95 dip of Uz for 5 seconds The quality of the line power supply should be that of a typical commercial or hospital environment If the user of the SIROLaser UNIT requires continued operation during power mains interruptions it is recommended that the SIROLaser UNIT be powered by an uninter ruptible power supply or a battery Power frequency magnetic field EN 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environ ment 50 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 10 Manufacturer s declaration regarding electromagnetic compatibility RF immunity The SIROLaser is intended for use in the electromagnetic environment specified below The end user should ensure that it is used in such an environment Immunity test EN 60601 1 2 test level Compliance level Electromagnetic environment guidance Conducted RF EN 61000 4 6 3 Vrms from 150 kHz to 80 MHz 3 Vrms from 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the unit includin
27. for residential purposes IEC 61000 3 2 Voltage fluctuations flicker emis Complies sions IEC 61000 3 3 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 49 10 Manufacturer s declaration regarding electromagnetic compatibility Interference immunity The SIROLaser is intended for use in the electromagnetic environment specified below The end user should ensure that it is used in such an environment Immunity test EN 60601 1 2 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD EN 61000 4 2 6 kV contact dis charge 8 kV air discharge 6 kV contact dis charge 8 kV air discharge Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power sup ply lines 2 kV for power sup ply lines The quality of the line power supply should be that of a typical commercial or hospital environment EN 61000 4 4 Surge 1 kV differential 1 kV differential The quality of the line power supply should that of a typical ial or hospital EN 61000 4 5 mode mode be that of a typical commercial or hospita environment Voltage dips short inter ruptions and voltage vari ations on power supply input lines EN 61000 4 11 lt 5 UT gt 95 dip of Uz for 0 5 cycles 40 Ur 60 dip in Uz
28. g cables than the recommended separation distance calcu lated from the equation applicable to the fre quency of the transmitter d 1 2 VP from 150 kHz to 80 MHz d 1 2 VP from 80 MHz to 800 MHz d 2 3 VP from 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watt according to the trans mitter manufacturer and d is the recom mended separation distance in meters Radiated RF EN 61000 4 3 3 Vrms from 80 MHz to 2 5 GHz 3 Vrms from 80 MHz to 2 5 GHz GD 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 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 51 10 Manufacturer s declaration regarding electromagnetic compatibility Recommended separation distances between portable and mobile RF communications equipment and the SIROLaser The SIROLaser model is intended for use in an electromagnetic environment in which radiated RF disturbances are con trolled The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SIROLaser as recommended below according to the maximum output power of the communications equipment Rated maximum
29. gival incisions 320 um cw AW Aphthae 320 um cw 2 W without contact Herpes 320 um cw 2 4 W without contact PERIODONTICS AREA Periodont lesions see periodont pockets see periodont pockets see periodont pockets Periodont pockets 320 um cw 1W Periodont pockets 320 um chopped mode 2 5 W 75 100 Hz Peri implantitis 320 um cw 1 1 5W Peri implantitis 320 um chopped mode 2 5 3W ENDODONTICS AREA Endodont germ reduction 200 um cw 1 5 W Gangrene germ reduction 200 um cw 1 5 W 6 2 1 Examples of treatment risks SURGERY AREA A WARNING Risk Soft and hard tissue necrosis or overheating of the tooth Countermeasure Use the laser beam like a scalpel perpendicular to the treated area and never direct it to one single spot for too long Do not set the la ser power to excessively high levels 60 90 570 D 3485 38 D 3485 201 04 09 02 09 2007 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 6 Indications contraindications and medical precautions 6 3 6 4 PERIODONTICS AREA A WARNING Risk Minor necrosis or scarring of the radicular area Countermeasure When working in periodontal pockets always align the la ser exactly parallel to the roots never perpendicular Brush over the entire in terior of the pocket with the the distal end of the optical fiber ENDODONTICS AREA Root canal germ reduction A WARNING Risk Contraction at the apical level small fusions and microfractures Countermeasure Measure
30. he 60 tip A CAUTION Check the tip for damage before inserting it Replace it if necessary A CAUTION Check the tip to make sure it is firmly seated gt Using the scissors trim the end of the optical fiber millimeter by millimeter until it projects a well defined circle Always cut perpendicular to the fiber Check whether the aiming beam is evenly illuminated ring shaped pattern To do this please aim the tip of the probe vertically at a white background located approx 20 cm away If there is no beam pattern at all or the beam pattern of the laser probe is unevenly illuminated pls cut off 1 2mm again gt Loosen the proximal part of the handpiece that blocks the protective sheath gt Adjust the length of the optical fiber so that the optical fiber projects out of the tip at least 1 cm A CAUTION If the optical fiber does not project out of the tip at least 1 centimeter there is danger of the tip heating up 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 4 Installation 4 7 4 Figure 21 Sheath of the optical fiber is too long 4 8 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 Adjusting the sheath The silicone sheath should be 5 10 cm shorter than the optical fiber itself If the sheath is too short the optical fiber may not be fastened properly in the handpiece If the sheath is too long the optical fiber cannot be inserted into the handpiece To shorten the sheath to an appro
31. ing operation Label removers and flam mable solutions used for cleaning and disinfecting the laser unit should be al lowed to evaporate before using the device Be aware of the fire risk caused by flamable gases 13 3 Introduction 14 3 3 3 3 1 3 3 2 A WARNING Never direct the laser beam toward paper plastics or dark surfaces They may catch fire or be damaged due to the high temperatures produced by the laser beam A WARNING Laser plume must contain tissue particles There is a risk of contamination Al ways wear a face mask Observe the following in addition NOTICE The unit must only be operated in rooms that comply with the requirements of Council Directive 89 336 EEC The applicable national or local legal regula tions must be complied with A CAUTION Avoid interference of the laser emission with optical sensors of devices oper ated in the vicinity of the SIROLaser Transport and storage Transport and storage The SIROLaser is supplied in a case that ensures proper and easy transport However please observe the following A CAUTION Do not leave the laser unit in a car parked in the sun The temperature inside the car can reach levels that may damage its components To ensure appropriate storage the laser unit must always be kept in the case supplied When stored in the case provided by Sirona Dental Systems the SIROLaser withstands the following environm
32. irst use and prior to each subsequent use A WARNING Disinfect the finger switch and the fiber prior to the first use and prior to each subsequent use Laser protective goggles Before cleaning the laser protective goggles please read and observe the instructions for use provided by the manufacturer and attached to the goggles in the case Cleaning O notice Manual cleaning must always be combined with disinfection Notice All tissue residues must be removed from the optical fiber before it is detached from the handpiece This prevents internal contamination of the tip Following treatment Optical fiber A CAUTION Reattach the black protective cap to the laser end of the connector before taking any hygienic measures gt Remove the optical fiber from the handpiece gt Cut off approx 4 cm from the distal end of the optical fiber The cut must be made perpendicular to the axis of the optical fiber gt Remove approx 4 cm of the sheath if necessary see Chapter 4 7 4 page 27 gt The take up reel and optical fiber must be disinfected first gt After it is removed from the reel the optical fiber can be cleaned with a suitable brush under running water of at least drinking water quality 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 7 Cleaning and sterilization 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 7 2 7 3 Handpiece gt Remove the tip from the handpiec
33. it certain menus ENTER key Confirms starts or stops a selected action following setup RIGHT ARROW key Navigate to the right in all menus Increase parameter values LASER STOP button The LASER STOP button acts as emergency stop for the laser 30 5 4 Electronic access key Only authorized personnel is allowed to operate the SIROLaser Therefore once the unit has completed its power up and self test routines you will be prompted to enter an access code which works as an electronic key The access code consists of a sequence of four keys The code is 6251 To enter the access code press the following keys consecutively gt Scroll to the given number by pressing the RIGHT ARROW key gt Change from one number to the next by pressing the ENTER key A WARNING Do not give the access code to non authorized users Risk of misuse of the la ser by unqualified persons 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 5 Operating Instructions 5 5 Setting up the software interface language gt Press the RIGHT ARROW key to select the treatment area gt Press the LEFT ARROW key twice The following screen appears on the display U SETUP AREA gt Press the ENTER key Anew screen appears on the display Press the ENTER key until the menu item LANGUAGE EN is highlighted gt Press the RIGHT ARROW key until th
34. ith the laser unit during the entire calibration procedure gt Connect an optical fiber to the SIROLaser gt Make the optical fiber point to the measuring head of the power meter Keep a minimum distance of 20 mm between the optical fiber and the surface of the measuring head This will prevent damage to the measuring instrument due to the high energy density resulting from the small fiber diameter gt Wear the laser protective goggles and verify that the entrance to the room where the calibration is being performed is controlled by an interlock device or is locked Switch on the SIROLaser and go to the SETUP AREA Select SERVICE gt Check to see that the fiber is neatly cut and that the laser beam projects a red circle The circle must be as well defined as possible The first test 1 W is highlighted gt Use the RIGHT ARROW key to select the test you want to perform 1 W 3 W 5 W To quit the test area press the LEFT ARROW key Test for 1 W v Y gt Release radiation with the foot switch or finger switch until the message OK appears Check whether the power meter reading is within the permissible range of 1 W 20 Test for 3 W gt Release radiation again until the message OK appears Check whether the power meter reading is within the permissible range of 3 W 20 Test for 5 W gt Release radiation again until the message OK appears Check whether the power meter r
35. les supplied from an outside source that are not included in the scope of delivery of the SIROLaser Wireless phone interference A CAUTION To ensure the operational safety of medical electrical equipment the use of mobile wireless phones in practice or hospital environments must be prohibit ed 1 Warning and safety information 1 5 Disposal If you plan to discontinue the use of your SIROLaser and intend to dispose of the unit make sure to observe the applicable legal provisions Please contact your local dental distributor or authorized service center for the disposal of the SIROLaser 60 90 570 D 3485 8 D 3485 201 04 09 02 09 2007 2 Glossary symbols and abbreviations Glossary symbols and abbreviations 2 1 Symbols on the SIROLaser CE mark in accordance with Council Directive 93 42 EEC stating the 0123 Manufacturer s Notified Body Date of manufacture January 2005 01 2005 Best before date Do not use after January 2007 01 2007 0123 12 05 Batch number consecutive number month year Type B applied part according to IEC 60601 1 i Please refer to manual first jj Refers to directive 2002 96 EC and EN 50419 Do not dispose with domestic waste DC IN Optical fiber INTERLOCK Socket for DC input from Sinpro MPU50 105 switching power supply SWITCH Socket for optical fiber Socket for Y connector Laser radiation warning Specification of laser output power and wavelength of IR and ai
36. lowing happens You are prompted to connect the specified fiber 200 um 320 um gt Confirm with ENTER once you have connected the right fiber The green LEDs start flashing indicating that the laser is in standby mode now After a delay of 2 seconds the aiming beam is switched on The laser is now ready for operation If aiming beam is on please wear protective goggles A WARNING The operator assistant and patient all must wear the special protective laser goggles supplied when the green LEDs are active A WARNING Any actuation of the foot switch or finger switch activates the laser unit Below you will find an example of a typical treatment submenu Figure 24 Example of a treatment submenu 1 Selected program in our example P3 33 5 Operating Instructions 34 5 8 2 Pulse duration in milliseconds in single pulse or auto repeat mode If set to any time laser radiation will stop after this time even if you continue to press the foot switch or finger switch If set to zero appears on the display and the laser remains activated as long you press the foot switch or finger switch In the autorepeat mode the laser unit switches back on after two sec if the finger foot switch is actuated O notice In the preset menus the laser unit activation time cannot be modified by the user 3 Laser radiation ON when the foot switch or finger switch is actuated OFF
37. maged When necessary hold the optic fiber approx 10 cm below the distal end Press the sheath and the optical fiber together Pull off approximately 10cm of the sheath with your thumbnail Mount the dust cap to the fiber plug VV VV WV Clean and disinfect the optical fiber Descriped in chapter Cleaning and sterilization on page 40 Preparation for clinical use gt Select the optical fiber you need either 200um or 320um gt Make sure that the optical fiber is clean and disinfected All handpieces are autoclavable see chapter Cleaning and sterilization on page 40 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 4 Installation A CAUTION Strong bending or improper routing of the optical fiber inside the handpiece may damage the optical fiber creating a health hazard for patients dentists and assistants A CAUTION If you switch on the laser unit and the signal of the red aiming laser is not visi ble or if you cannot see the aiming beam during treatment proceed as follows gt Check the optical fiber as well as the fiber connection for mechanical damage If the optical fiber is damaged replace it with a new one Connect the fiber to the laser Check the optical fiber whether the signal of the aimingbeam is visible If you cannot detect any damage on the optical fiber and the signal of the aiming laser is not visible with the new optical fiber either turn off the laser and contact Sirona
38. ming beam see also chapter Technical data States the compliance of the SIROLaser with IEC 60825 1 edition 1 2 Warns of potential laser radiation hazards when opening the laser unit DUER 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 9 2 Glossary symbols and abbreviations Warns of class 4 laser radiation hazards when using the laser unit LASER STOP button Press this button in case of an emergency Laser STOP CU Operate the laser unit exclusively with the Sinpro MPU50 105 power sup ply NU SA The disassembled handpiece and the tips must be sterilized only in auto 5 claves with saturated water vapor at 135 C 275 F 3 min holding time f 2 13 bar 30 89 psi overpressure 1 Software extention CU NU SA 2 2 Glossary CONTINUOUS EMISSION Continuous laser emission PULSED EMISSION Pulsed laser emission chopped mode FREQUENCY Number of laser pulses per second HERTZ Measuring unit for frequency INTERLOCK Safety device that stops laser radiation when the door of the treatment room is opened JOULE Unit of measure for emitted energy WATT Unit of measure for laser power STOP End of treatment or treatment break TIME Treatment time setting mode 60 90 570 D 3485 10 D 3485 201 04 09 02 09 2007 2 Glossary symbols and abbreviations 2 3 cm Hz 2 s WwW mW J nm V IR NOHD 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 Abbreviations Square centimeter Hertz Seconds W
39. n inten sive light source even when set to a low power level Always wear protective goggles gt Check to make sure that the aiming beam illuminates evenly i e projects a circular light pattern To do this aim the probe tip vertically at a white background located approx 20 cm away If the beam shows no pattern or the beam pattern is not illuminated evenly the optical fiber may be damaged or defective In this case return the laser to your dental depot so that it can be replaced under warranty Do not use any defective optical fibers Preparation gt If the aiming beam signal produces an evenly illuminated circular beam pattern remove the attached distal seal by cutting it off with a pair of scissors This results in the expiration of Sirona Dental Systems GmbH s liability for any mechanical damage to the optical fiber gt Protect the optical fiber socket see Fig 17 page 24 as well as the optical fiber see Fig 14 page 23 itself with the special protection caps A CAUTION Always protect the optical fiber socket as well as the optical fiber itself with the special protection caps at the end of treatment Do not allow dust dirt or other foreign bodies to enter the optical fiber socket Always make sure that the op tical system is clean before connecting the optical fiber A CAUTION Never allow dust or dirt to enter the optical fiber socket and the optical system Otherwise the unit may be permanently da
40. nfirming the end of the therapy appears on the display THERAPY COMPLETED gt The LEFT ARROW key returns you to the main menu MANUAL SETTING AREA submenu After accessing the MANUAL SETTING AREA the illustrated screen appears on the display see Fig 25 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 5 Operating Instructions Here you can select from 10 programs with the arrow keys gt Pressing the ENTER key takes you to the selected program PP1 for program 1 PP2 for program 2 gt Confirm the fiber you would like to have for your personal setting 200um or 320 um with ENTER or change it with the RIGHT ARROW key After selected the submenu The green LEDs start flashing indicating that the laser is in standby mode now The laser is now ready for operation If aiming beam is on please wear protective goggles Figure 25 MANUAL SETTING AREA submenu 1 Selected program in our example PP3 2 Laser activation time in milliseconds in single pulse or auto repeat mode In the autorepeat mode the laser unit switches back on after two seconds if the foot switch is actuated If set to any time laser radiation will stop after this time even if you continue to press the foot switch or finger switch If set to zero appears on the display and the laser remains activated as long you press the foot switch or finger switch You can set a time between 100 ms an
41. ng and error messages After selecting the indication press the ENTER key The laser unit is now ready for operation The message Wear protective goggles appears on the display and four green LEDs start flashing If this message is displayed check whether the optical fiber is properly con nected Once the optical fiber is properly connected the message will dis appear automatically If this message is displayed you must select an optical fiber diameter with the RIGHT ARROW key and then confirm your selection with the ENTER key If this message is displayed you must insert the specified optical fiber and then confirm your action with the ENTER key This message signals that the INTERLOCK safety device has responded Either the door of the treatment room is open or the INTERLOCK connector is not properly seated in its socket If this message is displayed allow the laser unit to cool down for a few min utes The temperature of the laser diode is lt 5 C or gt 90 C or the temperature sensor is defective Adapt the SIROLaser to room temperature over a period of 2 hours If this message nevertheless still appears contact your dealer or an authorized Customer Service Department 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 5 Operating Instructions This message indicates an error of the laser current output power The SIROLaser output is out of the 20 tolerance Switch the laser unit
42. nstructions provided by the manufacturers of these disinfec tants A CAUTION Take care that the fiber will not be damaged in case of disconnecting the finger switch A WARNING For further precautions see chapter 1 3 A CAUTION The SIROLaser unit cannot be sterilized A CAUTION The handpieces and tips must be sterilized after each treatment 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 8 Maintenance and service Maintenance and service 8 1 Calibration Check A WARNING You must wear the laser protective goggles supplied with the laser unit during the entire calibration procedure The following section explains how to calibrate the SIROLaser We recommend performing this check at least once a week To ensure precise control of the efficiency and perfect functioning of your SIROLaser unit we recommend you to perform a calibration at three different power levels iW e 3W e SW The SIROLaser performs a self calibration during which the system will check whether the parameters responsible for laser emission are correct In addition we recommend that you check these values at least once every six months with the help of a suitable external power meter for power mea surements at a wavelength of 970 nm 15 nm a power between 0 5 W and 7 W and a resolution better than 5 that has been properly calibrated 8 1 1 Calibration Check without use of an external power meter A WARN
43. ol indicates that you have to take action This symbol indicates that a certain result will occur Intended use Q notice The user should read and be thoroughly familiar with this manual before oper ating the laser The equipment should be routinely inspected and maintained in accordance with the instructions given in the maintenance section of this manual Accidental irradiation to other than the target tissue may result in laser burn Surrounding the target area with moist drapes or saline soaked gauze pads and keeping them moist will greatly reduce this hazards Be sure the draping is appropriate for laser surgery It is recommended that a smoke evac uator or in line filter be used to capture the plume whenever possible The plum should be regarded as a source of active biological material by the oper ating room personnel it may contain viable tissue particulates 0 notice Nominal Ocular Hazards Distance NOHD is 1 5 m from the distal end of the fibre Q notice For the installation and use of the S ROLaser Sirona Dental Systems GmbH requires e compliance with IEC 60825 1 and its amendments e compliance with any additional national laws and ordinances 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 1 Warning and safety information 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 1 3 1 4 notice SIROLaser is intended for surgery and coagulation of oral soft tissue as well This laser unit mus
44. ot switch 60 90 570 D 3485 20 D 3485 201 04 09 02 09 2007 4 Installation 4 6 Connection of the finger switch gt Unscrew the distal part of the handpiece Figure 7 Distal part of the handpiece gt Mount the finger switch Figure 8 Distal part with finger switch gt Screw the distal part of the handpiece back onto the rest of the handpiece Figure 9 Finger switch mounted on handpiece gt Run the optical fiber through the guiding rings on the finger switch supply cable Figure 10 Optical fiber and guiding rings 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 21 4 Installation Figure 11 Connection of the finger 22 switch 4 7 4 7 1 4 7 2 gt Plug the connector of the finger switch cable into the socket of the Y connector or into the interlock jumper Connecting the optical fiber Field of application For different dental procedures and indications two SIROLaser optical fibers with different diameters are supplied with your SIROLaser the 200um fiber bend protection colored black and the 320 um fiber bend protection colored yellow The user will be prompted by the laser software to select the appro priate fiber for each indication The SIROLaser optical fibers have a standard SMA 905 connection and can be used only with the SIROLaser in the spectral range of 970nm 15 nm If optical fibers from other manufacturers are used physical properties such as tensile streng
45. output power of transmitter in watt Separation distance according to frequency of transmitter in meters From 150 kHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2 GHz d 1 2 VP d 1 2 VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watt according to the transmitter manufacturer Remarks At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people 60 90 570 D 3485 52 D 3485 201 04 09 02 09 2007 11 Appendix 1 1 Appendix 11 1 Appendix A Approvals The unit is manufactured in compliance with the provisions of Council Directive 93 42 EEC concerning medical devices 11 2 Appendix B Label positions The following figures show the positions of the labels on the SIROLaser Label 1 Figure 26 Label positions top view Label 5 Figure 27 Label position rear view 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 53 11 Appendix wm Label 2 Label 6
46. piece eee 26 Figure 19 Fitting the IP ssscci iecdsiaddaievtesave sehee uttered nieve enced ogee 26 Figure 20 Adjusting the length of the optical fiber eeen 26 Figure 21 Sheath of the optical fiber is too long cceeeeeeeeeeeeeeeteeeteees 27 Figure 22 Power supply CONNECTION 0 0 2 ee eeeeeeeeeeteeeeeteeteeeeeetenneeeeeetenaeeeeenenae 27 Figure23 Key Panel tistics celina tenet nani aie 30 Figure 24 Example of a treatment submenu ceeeeeeeeetteeeeetenteeeeeeeeee 33 Figure 25 MANUAL SETTING AREA submenu ccecceeeeeeeeeteeeeeeeee 35 Figure 26 Label positions top VIEW 0 eeceeeceeeeeeeeeeeeenneeeeeeeenaeeeeeteneeeeeneaa 53 Figure 27 Label position rear view eeceecceeeeeteeeeeeeenneeeeeeeeneeeeeeteneeeeeeeaa 53 Figure 28 Label positions bottom view eee eetteeeeetetneeeeeeeetaeeeeeeeeee 54 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 5 1 Warning and safety information 1 1 1 2 Warning and safety information Highlighting of warning and safety information To prevent any personal injury or material damage please observe the warn ing and safety information provided in the present operating instructions All such information is highlighted as follows 0 notice For additional information A CAUTION If there is any risk of damage to the laser unit A WARNING If there is any hazard to the life or health of persons gt This symb
47. priate length in relation to the optical fiber proceed as follows gt Hold the optic fiber approx 10 cm below the distal end gt Press the sheath and the optical fiber together gt Pull off approximately 10cm of the sheath with your thumbnail O notice After stripping the optical fiber bend it back and forth to make sure it has not been damaged Power supply connection gt Connect the power cord to the DC IN socket at the back of the SlIROLaser see figure 22 Figure 22 Power supply connection A CAUTION The SIROLaser may only be operated with the Sinpro MPU50 105 power sup ply Operation with other power supplies may result in failure or destruction of the laser unit Using power supplies other than the recommended one results in invalidation of the approval of the entire unit and loss of the warranty granted by Sirona Dental Systems GmbH A WARNING Using power supplies other than the recommended one may cause the risk of overheating and malfunction of the laser unit 27 5 Operating Instructions Aiming beam ON Wear protection goggles Have you inserted the optical fibre Select the optic fibre with o a T 28 Insertthe indicated optic fibre Wait for laser source cooling 5 1 Operating Instructions A CAUTION Always protect the optical fiber as well as its connector with the special protec tion caps at the end of treatment see Fig 17 page 24 Warni
48. res German 60 85 695 English 60 85 711 French 60 85 737 Spanish 60 85 703 Italian 60 85 729 4 2 1 Accessories Upon request the SIROLaser can be delivered with the following accesso ries Laser protective goggles for wearers of 60 56 514 glasses nontransparent Take up reel incl 400 um optic fiber 60 53 586 3 m long 4 3 Labels Attach the appropriate country specific labels to your laser unit For more information regarding the labels and label positions see Appendix B Label positions gt Attach country specific label 1 on the opposite side of English label 1 gt Attach country specific label 2 below English label 2 60 90 570 D 3485 18 D 3485 201 04 09 02 09 2007 4 Installation 4 4 4 4 1 4 4 2 Figure 2 Plugging the Y connector into the laser unit Figure 3 Plugging the interlock connector into the Y connector 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 Interlock Explanation The interlock is a safety device that stops laser radiation whenever the door of the treatment room is opened It is essential to connect the interlock device to a switch that is located near the door of the treatment room in order to ensure automatic interruption of the laser radiation O notice The installation must be performed by a qualified electrician who is also re sponsible for the installation and maintenance of the electrical system to which the SIROLaser is connected Please request th
49. s and after providing a training course to the technical personnel Please contact your local dental distributor or authorized service center for technical support The laser unit may be sent in for repair or for safety inspection only in its orig inal packaging including all accessories Disinfect and sterilize the laser unit according to the relevant instructions for use before shipping it 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 47 9 Technical data Laser system Equipment classification IP degree of protection Wavelength Power max Aiming beam Emission mode Pulse chopped mode Pulse duration Optical fiber thicknesses Start Adapter Rating Isolation class Operation parameters Dimensions Weight Power supply NOHD Nominal Ocular Hazard Distance 48 Technical data Class IV according to IEC 60825 1 2003 Class llb according to Council Directive 93 42 EEC Laser unit IP20 foot switch IPX5 970 nm 15 nm approx 7 W CW optical 635 or 650 nm 1 mW max CW continuous wave or modulated 1 Hz to 10 kHz Single or repeated pulse 100 ms 60 s in 50 ms intervals 200 320 and 400 um NA gt 0 22 Electrical foot switch finger switch plus electronic access key External 100 240 VAC 50 60 Hz 48 VA Class 1 type B on graphical display 87 x 54 x 190 mm 3 43 x 2 1 x 7 48 0 45 kg 1 Ib The SIROLaser may only be operated with the Sinpro MPU50 105 power supply provided
50. s to be taken at reg ular intervals Interval Person in charge before each treatment Operator session weekly Operator every 2 years Sirona Dental Systems GmbH local dental distributor or authorized service center O notice If national or local legal regulations require additional safety checks for your la ser unit these regulations must be complied with and the corresponding checks must be performed The manufacturer accepts responsibility for the safety of the laser unit only if the following prerequisites are fulfilled Modifications of the laser unit or repair work must be performed by autho rized personnel The electrical system at the premises where the SIROLaser is installed must comply with the applicable legal requirements for electrical installa tions The laser unit must be used in compliance with the instructions provided in this manual Basic troubleshooting In case of malfunctions check the following first gt Check the connection of the power cord gt Check the connection of the INTERLOCK device gt Check the connection of the optical fiber gt Be sure that all operational steps have been executed correctly 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 8 Maintenance and service gt Check the connection of the foot switch 8 5 Technical support repair and testing Technical information concerning parts to be repaired may be supplied by Sirona only to authorized agent
51. st unauthorized access This can be achieved for example by switching off the laser unit after use so that the electronic access key must be entered prior to further operation Set up the SIROLaser laser unit properly and completely before putting it into operation see chapter 4 Make sure that the electrical system is equipped with the required devices for protection against direct and indirect contact thermomagnetic switches residual current circuit breaker and has been set up by a qualified electrician in compliance with the applicable standards National regulations concerning electrical installations shall be obeyed Verify that the line voltage corresponds to the voltage indicated on the rating plate of the switching power supply or in the technical specifications A WARNING Do not use the laser unit if a visual inspection reveals damage A WARNING Do not use the laser unit in the presence of flammable materials If you accidentally spill liquid on the unit immediately stop treatment discon nect the power supply cable and contact your local dental distributor or autho rized service center for assistance A CAUTION Do not attempt to disassemble the laser unit in any case This is limited exclu sively to trained and authorized personnel Do not place the laser unit near heat sources Do not cover the convection openings for air cooling on the sides of the unit 15 3 Introduction 16
52. sting the Sheath ee eeeceesesneeeeeeeeneeeeeeeneeeeeeeeeaeeeeeeeeaaes 27 4 8 Power Supply CONNECTION 4222222 on ELLE sirinin 27 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 3 5 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 6 6 1 6 2 6 2 1 6 3 6 4 7 7 1 7 2 7 3 7 4 8 8 1 8 1 1 8 1 2 8 1 3 8 2 8 3 8 4 8 5 10 10 1 10 1 1 10 1 2 10 1 3 11 11 1 11 2 Operating Instructions esserne arne 28 Warning and error messages M M sseeesersereeerne renerne erne rnrnnne 28 Switching the laser unit on and Off u u sseneeerrererrrrrrr ennen ennen 30 OY e rr dre en E E 30 Electronic access Key 5240 srini naai 30 Setting up the software interface language W u sssseeeerererrere 31 Main MENU il renee 31 SURGERY PERIODONTICS and ENDODONTICS submenus 2 32 MANUAL SETTING AREA submenu seeren 34 SETUP AREA SUDMENU ccecceeeeteeeeeeeeeeeeeeteeeeeeaeeeteeaeeees 36 Indications contraindications and medical precautions38 IACI Senan sc ec tue ve detectass cc vated A 38 LIST OF INGIGATIONS veo ns ED eva cce e e i 38 Examples of treatment riSkS ooo ee eececeeeeeneeeeeeeeneeeeeeeeeneeeeeeneaes 38 Contraindications cistern ee cee 39 PreCaUtions ccccceseececeeeeseeeeeeeeeeeneeeeessaeeeeseensaeeeesesseaeeeseeseaees 39 Cleaning and sterilization seeren 40 CIS Ta IT gfo os iois ea a iaaygndsdeencdaneesicex saute NE A cars 40 DISIMT CHON ed scene
53. t only be used by trained personnel in compliance with the applicable occupational safety regulations and accident prevention measures as well as the present operating instructions O NOTICE The user is obliged to use only faultless materials to observe the correct ap plication as well as to protect himself or herself the patient and other persons against hazards A WARNING This laser unit is not intended for operation in areas subject to explosion haz ards or in the vicinity of flammable materials or substances A WARNING Public legal provisions may include special safety regulations for the protec tion of persons against laser radiation These regulations must be complied with A WARNING Using controls or settings or performing procedures other than those specified in this manual may result in hazardous radiation exposure Instructions on use of the laser protective goggles Before using the laser protective goggles please read and observe the instructions for use provided by the manufacturer and attached to the goggles in the case Before using the laser protective goggles please make sure thatthe laser protective goggles are not damaged thatthe laser protective goggles conform to standard EN 207 with pro tection level L5 e and that the laser protective goggles are suitable for the correct wave length labeled on the goggles These instructions apply particularly when using gogg
54. tal Systems GmbH recommends acti vating this function FUNCTION 4 Activation or deactivation of the auto repeat function for the laser activation time in single pulse mode FUNCTION 5 Selection of the interface language FUNCTION 6 Service program for laser calibration 36 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 5 Operating Instructions A function is activated when it is highlighted To save the changes made press the ENTER key Pressing the ENTER key again highlights the next function To quit the SETUP AREA press the LEFT ARROW key while no functions are highlighted 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 37 6 Indications contraindications and medical precautions Indications contraindications and medical precautions 6 1 Indications Compared to conventional dental surgery treatment with the SIROLaser offers the following advantages less invasive minimum cell destruction less bleeding better coagulation negligible post operative edema The SIROLa ser may only be operated by trained and qualified personnel At the end of this section you will find an overview where some possible treat ments with the SIROLaser as well as the power values to be used are listed 6 2 List of indications Indications Optical fiber thickness Mode Power SURGERY AREA Gingivectomy 320 um cw 4 6W Operculectomy 320 um cw 4W Frenectomy 320 um CW 3 4W Hemostasis 320 um cw 6 W Gin
55. th and transmission behavior may vary For this reason Sirona Dental Systems GmbH assumes no liability in such cases Use Sirona optical fibers only Initial use of an optical fiber Initial check gt Before using an optical fiber for the first time check its best before date Anonsterile optical fiber can be used maximally 4 years after its month of manufacture This information is printed on the product label of the packaging A WARNING If the optical fiber is used after the best before date some of its physical properties e g its load carrying strength and transmission behavior will change thus posing a hazard to the health of the patient the dentist and the dental assistant gt Do not use the laser probe if its packaging is damaged or the best before month has been exceeded gt After removing the optical fibers from their original packaging perform a visual check to make sure that they were not damaged during shipment Initial startup A CAUTION The optical fiber and the take up reel must be disinfected prior to initial use 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 4 Installation The optical fibers are supplied in nonsterile condition and wound up on the take up reel see illustration below The optical fiber can be wound onto the take up reel either clockwise or counterclockwise gt Remove the end of the optical fiber with the black protective cap from the fastening of the take up reel
56. vewaet eae sen Maks a 41 Sterili atiO Mis Seascape sce cp ene ae aa Ea o re edt 41 Cleaning of the laser unit and finger switch u u sseeseererere 42 Maintenance and service serne REE REE 43 Calibration Check u W G M sssseeeeeeerer ennen ere r renerne nr renerne nr n rener 43 Calibration Check without use of an external power meter 43 Calibration Check with use of an external power meter 44 Error message and incorrect parameter values cee 45 Safety checks sii c scene iia Hi eee 46 Maintenance cc ecceeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeenaeeeeeestaeeeeeeesieeeeeeneaaes 46 Basic troubleshooting e ccccceeeececeeeeseeeeeeeeeseeeeeseeseaneeteeseaees 46 Technical support repair and testing ceeeeeeeeeeeeeeeeeeeeneeees 47 T chni cal CALA se Erde 48 Manufacturer s declaration regarding electromagnetic compatibility Er 49 Demons E E E TT 49 Emission electromagnetic cccceeccceeeseeeeeneeeeeseeeeeneeeeseeeeeeees 49 Interference IMMUNItY sisisi ED EU ar nd 49 pl ng ITST 8 YA TOVEL E E st BRET ES ESRB E beneeees 49 ADDED 53 Appendix A Approvals 11c0cusessne starter ask rr ELLER ELENA EDEL EEK KEE SEE 53 Appendix B Label positions 0 0 0 0 eccccceetceeeeeeeeetteeeeetenneeeeetees 53 60 90 570 D 3485 D 3485 201 04 09 02 09 2007 List of Figures List of Figures Figure 1 LASER STOP button 000 2 eeeceececeeeeeceeeeeneeeeeeeeee

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