SIROLaser - Sirona Support
Contents
1. 5 1 3 Intended use 5 1 4 Wireless phone interference 6 1 5 Disposal 6 2 Glossary symbols and abbreviations 7 2 1 Symbols on the SIROLaser 7 2 2 Glossary 9 2 3 Abbreviations 9 3 Maintenance and service 10 3 1 Checking the calibration 10 3 1 1 Calibration check without an external power meter 10 3 1 2 Error message and incorrect parameter values 11 3 2 Function check 12 3 2 1 Visual inspection 12 3 2 2 General function check 12 3 3 Electrical safety test 13 3 3 1 Tester setup based on2. 1990 Limit value1 Earth leakage current NC Patient leakage current NC Housing leakage current NC Earth leakage current SFC Patient leakage current SFC Housing leakage current SFC _____________ mA _____________ mA _____________ mA _____________ mA _____________ mA _____________ mA 0 5 0 01 0 1 1 0 05 0 5 5 Laser power measurement2 with calibrated measuring instrument in the range of 0 5 to 7 W 0 5W 1W 2W 3W 4W 5W 6W 7W 1 If the limit values are exceeded the laser must be repaired by Sirona or by an authroized dealer 2 If one of the tests is not passed the laser must be repaired by Sirona or by an authroized dealer 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 17 3 Maintenance and service 3 5 Final work Switch unit off and pull power plug Enter readings in test certificate If a medical product log is present it must be filled out Complete as required by the customer if necessary 3 6 Technical support Technical information concerning parts requiring repair will be supplied by Sirona only to authorized agents w
3. Dimensions Approx 87 x 54 x 190 mm 3 43 x 2 1 x 7 48 in Weight Approx 0 45 kg 1 lb Power supply The SIROLaser may only be operated with the Sinpro MPU50 105 power supply NOHD Nominal Ocular Hazard Distance Approx 1 5 m for 10 s radiation exposure of the unprotected eye numerical aperture of the optical fiber NA 0 22 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 19 5 Appendix 5 Appendix 5 1 Appendix A Certification The unit is manufactured in compliance with the provisions of Council Directive 93 42 EEC concerning medical devices 5 2 Appendix B Label positions The following figures show the positions of the labels on the SIROLaser Fig 2 Label positions top view Fig 3 Label positions bottom view Label 1a Label 1 Label 4 Label 2 Label 6 Label 3 Label 8 Label 7 61 96 542 D 3485 20 D 3485 076 02 01 02 11 2007 5 Appendix B2 Label list The following labels are attached to the SIROLaser Label 1a Label 1 CU1 1 Software extension CU NU SA US CN1 SA1 US1 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 21 5 Appendix Label 2 Label 3 Label 4 CU1 CN1 SA1 US1 1 Software extension CU NU SA US 61 96 542 D 3485 22 D 3485 076 02 01 02 11 2007 5 Appendix Label 5 Label 6 Label 71 Label 8 Label 9 CU US1 NU1 SA1 1 Software extension CU NU SA 1 Dependent on the SIROLaser version
4. erate the unit Please read the operating instructions prior to startup to famil iarize yourself with the operation of the SIROLaser CAUTION Perform maintenance only on a cleaned and disinfected unit 1 1 1 Preparation for testing Testing may be performed only by authorized personnel If deviations from the specified values are detected during the tests their cause must be deter mined immediately 1 1 2 Laser protection NOTE i Laser protection Observe the relevant national regulations and ordinances when repairing and or servicing the SIROLaser Regarding the installation and startup of the SIROLaser Sirona Dental Systems GmbH requires in particular Compliance with IEC 60825 1 including all annexes If you have any further questions please contact your laser protection officer Testing of the SiroLaser may be performed only in a room that complies with the relevant laser protection requirements The testing personnel must be properly instructed by the laser protection officer During testing suitable safety goggles must be worn as soon as the laser is switched on Noone except for persons directly involved with the testing may be located in the laser testing room 1 1 3 Measuring equipment The following measuring equipment is required for the test run Tester for leakage current tests acc to IEC 60601 1 Optical power meter 0 1 10 W for 970 nm with accuracy of 5 Good as new optical fiber
5. 96 542 D 3485 D 3485 076 02 01 02 11 2007 13 3 Maintenance and service 4 yellow diodes flash when the laser is ON Activate the buzzer in the Settings menu Check the the buzzer for proper functioning Check the the finger switch for proper functioning Perform a complete test treatment in any case and check the power pa rameters The power must not fluctuate by more than 20 throughout the entire treatment However Sirona Dental Systems GmbH recom mends recalibration if the deviation exceeds 5 Enter the items in the attached certificate see page 15 3 3 Electrical safety test Before you run the test familiarize yourself with the tester using its operating instructions 3 3 1 Tester setup based on the Bender tester 1 Power outlet for test object 4 Sockets for patient electrodes 11 Selection keys 15 Alphanumeric keyboard 16 Program control keys 18 Function key 20 Test prod 21 Test terminal 61 96 542 D 3485 14 D 3485 076 02 01 02 11 2007 3 Maintenance and service 3 3 2 Test setup and performance Perform this test with the leakage current tester Fig 1 Cable connections of the SIROLaser to the leakage current tester 1 Plug the connector of the SIROLaser power supply into the socket of the tester 1 provided for that purpose 2 Connect the finger switch to the patient elektrode 4 3 Connect the metallic SMA socket of the laser to the test terminal 2
6. CU NU SA1 USA1 GUS1 1 Software extension CU NU SA USA GUS USA SA up to SN 4225 US SA from SN 4226 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 23 5 Appendix 5 3 Safety circuit interlock CAUTION It is recommended to keep the distance between connection JP1 and relay K1 as short as possible Units designed for this purpose are already available from various compa nies however are also unreasonably expensive in some cases We recom mend having the installation performed by a qualified electrician who is also responsible for the electrical system JP1 Interlock connection supplied with the SIROLaser Insulate the jumper between pins 1 and 2 connect both of these pins to relay K1 with a two core cable K1 Low level relay AC Door switch S1 must close the interlock circuit when the treatment room door is closed Lp1 Optional low level lamp used as an optical warning while the laser is in operation T1 Power transformer S2 Main switch for power supply J1 Possible power supply for the SIROLaser 61 96 542 D 3485 24 D 3485 076 02 01 02 11 2007 5 Appendix t K p a p d e OMMS p W m d a PQURKMTSKMOKMNKMO NNKOMMT KJk KW MMM
7. the Sirolaser SW Date of manufacture January 2005 Best before date Do not use after January 2007 Batch number consecutive number month year Type B applied part according to IEC 60601 1 Please refer to manual first Refers to directive 2002 96 EC and EN 50419 Do not dispose with domestic waste Socket for DC input from Sinpro MPU50 105 switching power supply Socket for optical fiber Socket for interlock connector Laser radiation warning 01 2005 01 2007 0123 12 05 LOT DC IN INTERLOCK SWITCH Optical fiber 61 96 542 D 3485 8 D 3485 076 02 01 02 11 2007 2 Glossary symbols and abbreviations Specification of laser output power and wavelength of IR and aiming 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 unit Warns of class 4 laser radiation hazards when using the laser unit LASER STOP button Press this button in case of an emergency Operate the laser unit exclusively with the Sinpro MPU50 105 power supply Can be sterilized in an autoclave with saturated water vapor at 135 C 275 F 3 min holding time and 2 13 bar 30 89 PSI Can be sterilized in an autoclave with saturated water vapor at 132 C 270 F 3 min holding time and 1 87 bar overpressure 27 12 PSI Laser STOP 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 9 2 Glossary symbols
8. 1 4 Switch the laser on 5 Perform the measurement of the patient leakage current acc to IEC 6060 1 1 NC SFC of the housing leakage current acc to IEC 60601 1 NC SFC and of the earth leakage current acc to IEC 60601 1 NC SFC as specified by the Tester Operating Instructions 6 During an STK enter the values in the medical product log of the laser if it is available Enter the values in the attached certificate see page 15 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 15 3 Maintenance and service 3 4 Repair test certificate SIROLaser DE EN FR ES IT 60 46 960 SIROLaser EN DK SV FI NO 60 46 978 SIROLaser EN FR ES NL PT 60 46 986 SIROLaser EN RUS PL TR GR 60 46 994 SIROLaser USA 60 88 749 Serial number Software version 61 96 542 D 3485 16 D 3485 076 02 01 02 11 2007 3 Maintenance and service Safety tests Performed by Date ___________________________________ Signature Test Passed Y N Remarks 1 Visual inspection of unit and accessories for mechanical damage 2 General function check 3 Check of the audible and visual indicators 4 Measured values according to EN 60601 1
9. MMM f p a p d e f rp W f W c PN SQSOR _ d K K p a p ii QUPR p a I p NMM I k OUOTP rp p PORM o a J r R j I l iRi RvS l k K SN VS RQO a PQUR
10. and abbreviations 2 2 Glossary 2 3 Abbreviations CONTINUOUS EMISSION Continuous laser emission PULSED EMISSION Pulsed laser emission chopped mode FREQUENCY Number of laser pulses per second HERTZ Unit of measure 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 cm2 Square centimeter Hz Hertz s Seconds W Watt mW Milliwatt one thousandth of a Watt Y Joule nm Nanometer V Volt IR Infrared diode NOHD Nominal Ocular Hazard Distance according to EN 60825 1 2003 61 96 542 D 3485 10 D 3485 076 02 01 02 11 2007 3 Maintenance and service 3 Maintenance and service 3 1 Checking the calibration 3 1 1 Calibration check with an external power meter Connect an optical fiber to the SIROLaser Aim the optical fiber at 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 diameter of the optical fiber 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 th
11. e SIROLaser and go to the MANUAL SETTING area Select MANUAL SETTINGS NO 1 Check to see that the optical 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 is performed at 0 5 W Press the ENTER key until the W are is highlighted Select the required power level with the RIGHT ARROW key or the LEFT ARROW key You can quit the MANUAL SETTINGS area once again by pressing the ENTER key The test is performed in the following steps 0 5 W 1 W 2 W 3 W 4 W 5 W 6 W 7 W see Calibration Optical power measurement table Test at 0 5 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Test at 1 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Test at 2 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power mete
12. ermissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Test at 7 W NOTE i The maximum value for a setting of 7 W is 6 5 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Quit the calibration menu by pressing the ENTER key If the process is completed without errors and the values measured with the power meter are within the permissible range the calibration of the SIROLaser has been tested successfully Enter the values in the attached certificate see page 15 Enter the measured values in the medical product log 3 1 2 Error message and incorrect parameter values If the following screen appears during one of the three calibration tests 61 96 542 D 3485 12 D 3485 076 02 01 02 11 2007 3 Maintenance and service Repeat the test from the beginning If the error persists do not continue work ing with the unit in any case Please contact our Service in Bensheim 3 2 Function check 3 2 1 Visual inspection Damage and completeness check Perform a completeness check according to the current SiroLaser Operating Instructi
13. hose technical personnel have completed a corresponding product training course Please contact your local dental depot or authorized service center for technical support Please always use the original packaging when shipping the laser unit Please disinfect and sterilize the laser unit according to the relevant Operating Instructions before shipping it Accessories completed at the customer s request Yes No STK performed and parameters entered in medical product log or supplementary attached sheet repeated measurement Yes No Test certificate completed and attached to laser Yes No 61 96 542 D 3485 18 D 3485 076 02 01 02 11 2007 4 Technical data 4 Technical data Laser system Class IV according to DIN EN IEC 60825 1 2003 Equipment classification Class IIb according to Council Directive 93 42 EEC IP degree of protection Laser unit IP20 foot control IPX5 Wavelength 970 nm 15 nm Power max Approx 7 W CW Aiming beam 635 or 650 nm 1 mW max Emission mode CW continuous wave or modulated 1 to 10 kHz Pulse chopped mode Single or repeated pulse Pulse duration 100 ms to 60 sec in steps of 50 ms Optical fiber thickness 200 m 320 m and 400 m NA gt 0 22 Start Electrical foot control finger switch plus electronic access key Adapter External 90 264 VAC 47 63 Hz Insulation class Class 1 type B Performance data displays On graphic display
14. k W NNKOMMT b pfoli p q p j 61 96 542 D 3485 2 D 3485 076 02 01 02 11 2007 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 of 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 Compliance is determined based on the following standards IEC 60601 1 1998 IEC 60601 1 A2 1998 and IEC 60601 2 22 1997 0123 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 3 Contents b Contents 1 Warning and safety information 4 1 1 Before you begin 4 1 1 1 Preparation for testing 4 1 1 2 Laser protection 4 1 1 3 Measuring equipment 4 1 2 Highlighting of warning and safety information
15. n and to protect themselves the patient and other persons against hazards 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 WARNING Public legal provisions may include special safety regulations for the protec tion of persons against laser radiation These regulations must be complied with NOTE i CAUTION WARNING 61 96 542 D 3485 6 D 3485 076 02 01 02 11 2007 1 Warning and safety information WARNING WARNING Using controls or settings or performing procedures other than those specified in this manual may result in hazardous radiation exposure 1 4 Wireless phone interference CAUTION To ensure safe operation of medical electrical equipment the use of mobile wireless phones in practice or hospital environments must be prohibited 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 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 7 2 Glossary symbols and abbreviations 2 Glossary symbols and abbreviations 2 1 Symbols on the SIROLaser CE mark in accordance with Council Directive 93 42 EEC stating the manufacturer s recognized certifying body depending on the Sirolaser SW GOST Certificate for Russia depending on the Sirolaser SW UL CSA Certificate for the USA Canada depending on
16. ons NOTE i If the laser including all accessories is not complete the visual check must be regarded as passed only to a limited degree Missing parts must be entered in the test certificate and in the medical product log If the customer demands a test of an incomplete unit this also must be docu mented If any parts are damaged or missing the resulting safety impairment must be calculated and entered in the test certificate Example A deep scratch in the paint job of the foot switch is not safety impair ing A deep scratch in the glass of the safety goggles is safety impairing Enter the defects in the attached certificate see page 15 3 2 2 General function check Switch the unit on and check each key for proper functioning Select an indication and check the corresponding functions one after the other 4 green diodes are flashing Red pilot beam is ON Check readiness for exposure Pull off the interlock connector The laser emission is terminated immediately and the message appears on the display Reconnect the interlock connector The display indicates the start param eter and the laser is ready for operation again Check of fiber optic cable connection Pull off the fiber optic cable connection The laser emission is terminated immediately and the message appears on the display Reconnect the fiber optic cable the display indicates the start parameter and the laser is ready for operation again 61
17. r is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 11 3 Maintenance and service Test at 3 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Test at 4 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Test at 5 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the permissible range Acc to the standard the maximum deviation is 20 However Sirona Dental Systems GmbH recommends performing recalibration if the deviation is 5 Test at 6 W Trigger the foot or finger switch until the power meter displays a stable value Check whether the reading displayed on the power meter is within the p
18. reserved for calibration dia 320 m Mat No 60 53 578 61 96 542 D 3485 D 3485 076 02 01 02 11 2007 5 1 Warning and safety information 1 2 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 The information is highlighted as follows for additional information if there is any risk of damage to the laser unit if there is any hazard to the life or health of persons This symbol indicates that you have to take action This symbol indicates that a certain result will occur 1 3 Intended use NOTE i SIROLaser is intended for surgery and coagulation of oral soft tissue in peri odontal pockets and root canals This laser unit may only be used by trained and qualified personnel in compliance with the applicable occupational safety regulations and accident prevention measures as well as the operating in structions and the present service manual NOTE i The SIROLaser is also suitable for surgical interventions and for stopping bleeding in soft tissue This laser device may be operated only in a dental prac tice by trained persons who are familiar with the labor protection laws and ac cident prevention regulations and have read the present maintenance and op erating instructions NOTE i Users are obliged to use only faultless materials to ensure correct applicatio
19. the Bender tester 13 3 3 2 Test setup and performance 14 3 4 Repair test certificate 15 3 5 Final work 17 3 6 Technical support 17 4 Technical data 18 5 Appendix 19 5 1 Appendix A Certification 19 5 2 Appendix B Label positions 19 5 3 Safety circuit interlock 23 61 96 542 D 3485 4 D 3485 076 02 01 02 11 2007 1 Warning and safety information 1 Warning and safety information 1 1 Before you begin NOTE i Technical information concerning parts requiring repair will be supplied by Sirona only to authorized agents whose technical personnel have completed a corresponding product training course No maintenance or repairs may be performed on the SIROLaser without the corresponding product training NOTE i Knowledge and understanding of the operating instructions is required to op
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