BWF5810 Dental Laser User Manual
Contents
1. Emergency Stop switch BY MEDIVANCE page 7 CE mark in accordance with Council Directive 93 42 EEC stating the manufacturer s Notified body A Type BF device REP EU representative Manufacture Uii Read instruction Please refer to the user manual The symbol indicating separate collection for electrical and electronic equipment SN Product Series Number Foot Switch M gt Interlock 2 2 23 BY MEDIVANCE Glossary CONTINUOUS EMISSION PULSED EMISSION FREQUENCY HERTZ INTERLOCK JOULE WATT STOP TIME Abbreviations nm IR NOHD page 8 Continuous laser emission Pulsed laser emission chopped mode Number of laser pulses per second Measuring unit for frequency safety device that stops laser radiation when the door of the treatment room 1s opened Unit of measure for emitted energy Unit of measure for laser power End of treatment or treatment break Treatment time setting mode Square centimeter Hertz Second Watt Milliwatt one thousandth of a Watt Joule Nanometer Volt Infrared diode Nominal Ocular Hazard Distance according to EN 60825 1 2003 e page 9 3 3 1 9 2 BY MEDIVANCE Introduction Classification According to the applicable standards the BWF 5 810 5 laser is classified as follows e Class I Type B device according to EN IEC 60601 1 1990 A1 1993 A2 1 1995 plus amendments e Class II2. N 12 4 Dh S OU Nr 15 PARTS uL 15 4 1 MS Uy MM M LAU M EM M E M MEE 15 4 2 TAA TO a ct nsec se eee LM M M EM E I M ERES 18 4 3 CONNECTION OF THE FOOT CON UROL tat ot drea cunt at 18 4 4 SWITCHING THE LASER UNIT ON AND OFF cccccecececscecececccececscscceccscecscecscecsuenscsessesscssecesscessuscseeasnsscssecssesstsnsusesescecececs 18 4 5 OPLEHCATPIBERODEED ARN rs dee seen te scans Sie naturae edd eos de oc Rd a MT RII S EMI LUDERE IDEAE 19 5 GI RR ra wc aca aa ows cc cscs crc sa Des edebat ccs eu a a arse see Let eo vce ces 21 5 1 POV NP gan retest che DER AMI ae acim M D i MM ace MN M I 21 3 2 STANDBY AND READY DISPLAY ccccccccecececececececececececececeucucececececececeueceueeeeecesesesecetsceueceaeesneesesececsessenseeaeeueececesececenes 22 5 3 LASER POWER SETTING sissscscisisadacccisscscsstvadancaidcascenssedenesadacacavabadanestdacadasdvadancabdenstessveteneesdacatacabasaesndacndaeivavancabdensdeesnenace 23 5 4 23 5 5 23 5 6 LUE 23 5 7 LASER EMISSION ENERGY RESET scccscierscessadcscasaccevevensdeseneondeSedavadabenacece edavedebeenscddsecunedeeewenede ededadabeeavedadennvedebecaieeebenusededes 24 5 8 PTOP NOD 24 5 9 PRESET PROGRAM
3. The BWF 5 810 5 laser unit cannot be sterilized N CAUTION The hand pieces and tips must be sterilized after each treatment up 7 1 7 2 BY MEDIVANCE page 31 Maintenance and Service Safety checks The following safety checks must be performed every 24 months by a qualified 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 1 0 W and 5 0 W Maintenance The BWF 5 810 5 laser does not require special maintenance In case of malfunctioning see chapter Technical support e NOTICE If national or local legal regulations require additional safety checks for your laser 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 authorized personnel The electrical system at the premises where the BWF 5 810 5 laser is installed must comply with the applicable legal requirements for electrical installations The lase
4. Medium High Low Medium High etc Valid downward selection sequence High Medium Low High Medium Low etc Aiming Beam Flash Frequency Valid upward selection sequence CW Slow Fast CW Slow Fast etc Valid downward selection sequence Fast Slow CW Fast Slow CW etc e page 25 The system shall remember and restore the settings ofthe Audible Tone Aiming Beam Flash Frequency and Aiming Beam Intensity last used across a POWER OFF POWER ON cycle 5 9 Preset Programming The Preset buttons on the Setup screen shall enable programming of three treatment preset configurations The programming sequence shall be as follows l On the Main Menu screen press Run button 2 While in Standby mode set the power and On Off durations as desired 3 Press Exit button to return to the Main Menu screen 4 Press Setup button 5 Set the parameters of Audible Tone Volume Aiming Beam Flash Frequency and Aiming Beam Intensity as desired 6 Press one of Preset 1 Preset 2 and Preset 3 buttons where you wish to assign above set parameters 7 Press Exit button 8 Preset programming is complete To confirm a successful Preset programming the operator shall press one of Preset buttons on Main Menu screen to enter Standby mode and observe to confirm the previously programmed parameters of power and On Off durations are presented in Standby mode If desired the operator shall press Exit button to go back to Main Menu
5. Press the Exit button to return to Standby mode If the error message still comes up after the corrective action contact Velopex for assistance e page 28 BY MEDIVANCE 6 Cleaning and Sterilization After finishing treatment switch off the laser and disconnect the power cord from the power supply The fibers hand pieces are both provided sterile please check that pack seals are Not broken The tips are supplied non sterile you must sterilise cold sterilant these products prior to use Please note these should be disposed of as Clinical waste after each use 6 1 Cleaning O NOTICE Manual cleaning must always be combined with disinfection 9 NOTICE Before you remove the optical fiber from the hand piece please be sure to clean any tissue residue from the optical fiber This prevents contamination of the inside of the tip After treatment end Remove the optical fiber from the hand piece Cut off approx 4 cm from the distal end of the optical fiber Make sure to cut perpendicular to the fiber axis Remove approx 4 cm of the sheath if necessary Remove the tip from the hand piece Disassemble the hand piece by unscrewing the two threaded joints Clean the hand piece and the tip by brushing them off under running water Clean the distal end of the optical fiber using a soft damp cloth Disinfect the distal end of the optical fiber by spray or wipe disinfection Disinfect
6. screen Power on off LED indicator Emission port Safety interlock L dd Optional I O terminal Manufacture use only DO NOT connect anything to this terminal Footswitch connector Power connector F315AL250V 07 e page 18 BY MEDIVANCE WARNING The optional I O terminal is only for manufacture use only DON T connect anything to this terminal 4 2 Fiber Installation N aiv Please follow the recommend sterilization condition to sterilize the optical fiber before laser surgery Use of a non sterilized optical fiber to perform surgery may cause serious infection Only standard SMA 905 connector can be used with the BWF 5 810 5 laser in the spectral range of 810nm 10nm If the optical fibers from other manufacturers are used physical properties such as tensile and transmission behavior may vary For this reason Velopex assumes no liability in such cases N WARNING 400um or larger core size with 0 37NA silicon core silicon cladding optical fiber with Use Velopex or CE marked Medical Grade optical fiber only 4 3 Connection of the foot control Uncoil the footswitch Connect the footswitch to the laser unit on the rear 4 4 Switching the laser unit on and off Locate and uncoil the AC power cord Plug the power cord into the AC input on the rear of the laser system Plug the male end of the AC power cord into an available electrical outlet Insert t
7. screen then press Setup button enter Setup screen to observe and confirm the previously programmed parameters of Audible Tone Volume Aiming Beam Flash Frequency and Aiming Beam Intensity are presented 5 10 Emission Mode In Ready Mode the device shall produce laser energy when the foot switch is depressed The device shall present a flashing EMISSION message on the screen during emission No button is selectable or changeable during laser emission 5 11 Stop Emission gt When the laser is in EMISSION mode release footswitch to stop the emission and get the laser back to Ready mode 5 12 Preset Mode Press Preset 1 2 or 3 on Main Menu S Enter Preset Mode e page 26 BY MEDIVANCE Preset 1 Perio Power Variable or set at 1 6W in repeat mode On time 50m sec amp Off time 120m sec Preset 2 Endo Power variable or set at 1 8W in repeat mode On time 60m sec amp Off time 130m sec Preset 3 Toughing Power variable or set at 1 0W in repeat mode On time 100m sec amp Off time 100m sec 5 13 Error Message 0 NOTICE In the event there is an error or a non standard operating condition exists the screen will clear and an explanation of the error condition will appear The error messages are listed as follows standby Standby a BY MEDIVANCE standby ae reset Please follow the message to correct the non standard operating condition
8. specifications N WARNING Do not use the laser unit 1f a visual inspection reveals damage N WARNING Do not use the laser unit in the presence of flammable materials If you accidentally spill liquid on the unit immediately stop treatment disconnect the power supply cable and contact your local distributor or authorized service center for assistance N CAUTION Never attempt to disassemble the laser unit This 1s limited exclusively to the manufacturer Do not place the laser unit near heat sources Do not cover the convection openings for air cooling on the back of the unit 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 before connecting the optical fiber e page 14 BY MEDIVANCE N WARNING Prior to each treatment the hand pieces must be sterilized and the optical fibers must be steam sterilized e page 15 BY MEDIVANCE 4 System Set up If national or local legal regulations require that the installation of the BWF 5 810 5 laser be performed by specialized personnel these regulations must be complied with N WARNING The optical fibers and hand piece are supplied non sterile you must clean disinfect and sterilize these products prior to first use and prior to each subsequent use Spare part
9. the finger switch by spray or wipe disinfection UU 415 UU Disinfect the LCD touch screen by spray or wipe disinfection e page 29 BY MEDIVANCE 6 2 Disinfection Disinfect the distal end of the optical fiber by spray or wipe disinfection a gt NOTICE Use only disinfectants that have been tested and approved by the competent national bodies or have been proven to have bactericidal fungicidal and virucidal properties You can use MinutenSpray classic from Alpro MinutenWipes from Alpro In USA cavicide and caviwipes Observe the instructions provided by the manufacturers of these disinfectants caution Strong bending or improper routing of the optical fiber inside the hand piece may damage the optical fiber thus creating a health hazard for patients doctors and assistants The minimum bending radius for the fiber 1s 9 cm diameter 10 cm Take care that the fiber will not be squeezed or cracked during the handling procedure 6 3 Sterilization ab NOTICE Manual cleaning and disinfection must always be combined with sterilization 48 NOTICE Remove any residual water from the hand piece and the tips C The disassembled hand piece the tips and the fiber must be sterilized only in autoclaves with saturated water vapor at 121 1 122 3 C 250 252 1 F 30 min A 10 SAL would be obtained N WARNING You must sterilize the hand piece the tips and the fiber prior to first use and prior t
10. 5 N CAUTION Following transport and storage allow the laser unit to acclimate for about hour in order to reduce the risk of malfunction due to condensation 3 4 Precautions Using controls or settings or performing functional tests other than those specified in this manual may result in hazardous radiation exposure Velopex can not be held liable for any damage caused by improper use or non compliance with the instructions and information provided in this manual Please remember the following N CAUTION BWF 5 810 5 laser may only be operated by trained and qualified personnel A e page 13 BY MEDIVANCE CAUTION Laser equipment not in use must be protected against unauthorized access This can be achieved by switching off the laser unit after use so that the electronic access key must be entered prior to further operation Set up the BWF 5 810 5 laser unit properly and completely before putting it into operation See Chapter 4 Make sure that the electrical system 1s equipped with the required devices for protection against direct and indirect contact thermo magnetic switches residual current circuit breaker and has been set up by a qualified electrician in compliance with the applicable IEC 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
11. ING Operation of this laser unit by unauthorized persons must be prohibited in order to prevent incorrect or improper use N WARNING Never direct the laser beam or the aiming beam towards the eyes or the thyroid gland of a person All persons present in the room patient doctor and assistant must always wear the laser protective goggles delivered along with the laser unit N 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 up page 11 BY MEDIVANCE CAUTION Always cover the optical fiber connection with the special protection caps provided N WARNING The unit is not suitable for use in the presence of anesthetics that are flammable when in contact with air oxygen or nitrous oxide N WARNING Oxygen saturated materials such as cotton wool can catch fire due to the high temperature that the unit reaches during operation Label removers and flammable solutions used for cleaning and disinfecting the laser unit should be allowed to evaporate before using the device Be aware of the fire risk caused by flammable gases N 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 N WARNING Laser plume must contain tissue particles There is a risk of contaminat
12. M IN M MEM eee wees ett eet 25 5 10 I Dio 25 5 11 NS SOI cis M ME M M LL E 25 5 12 PRESETIVIODE orsi rc ocu M LM ME M HL M M M 25 5 13 TI Md Ee T RP M V 26 6 CLEANING AND SEERIDEIZATICON I Iisivinisisizistetoisistedt zistszxieiaieddisiatsicksdcieidivisteizieizizidieiste siaiaieldssdeiokoisesse dde tias 28 6 1 CERAMIC acs ests casts M E 28 6 2 IS GROUND 29 6 3 LOT E 29 6 4 CLEANING OF THE LASER UNIT ccccecececececececccececcccccccccccececscecessueueneeeeuescececeseceseueteneueeuseeesscesecssetsnsasasusesecececseeeeueususuees 30 7 MEAINTENANCE ANDISERVIC erritarrai 62520 da Bilal adrian 31 Tal AP VC 31 Fe MAITEA E 31 7 3 BASIC TROUBLESHOOTING 32 8 BY MEDIVANCE 7 4 TECHNICAL SUPPORT TECHNICAL DATA WARRANTY INFORMATION TERMS AND CONDITIONS 1 1 BY up page 4 MEDIVANCE Warning and Safety Information Highlighting of warning and safety in
13. all change to Ready button The laser will be enabled upon the completion of the laser emission alert sequence and occur when the footswitch is pressed A AA Ready screen presentation 2 PE ME page 23 BY MEDIVANCE 5 2 2 5 3 5 4 5 5 5 6 WARNING The device shall not leave Standby mode if any of the following conditions occur If the device is already in Ready mode the device shall go back to Standby mode if any of the following conditions happen e Optical fiber is not properly inserted e Safety interlock is not properly installed e Footswitch is depressed Ready to Standby Mode gt Press Ready button to return to Standby mode S The Ready button shall change to Standby button Laser Power Setting E Pressing the Up arrow shall increase the power setting until the maximum power 1s reached Pressing the Down arrow shall decrease the power setting until the minimum power is reached S Set laser power will be displayed as mean power for CW mode and peak power for Pulse mode and Repeat Pulse mode CW Mode Set Off duration to CW by pressing Down arrow under the Off icon The word CW will appear on the mid top of the screen S In CW mode the On duration is not allowed to be set Single Pulse Mode Set Off duration by pressing Up arrow or Down arrow under the Off icon The word PULSE will appear on the mid top of the screen S In Single Pulse mode the On duration can b
14. b according to Council Directive 93 42 EEC e Class IV laser product according to IEC 60825 1 plus amendments Degree of protection according to EN IEC 60601 1 1990 A1 1993 A2 1 1995 plus amendments medical unit IP 20 enclosure not waterproof foot control IPX7 N CAUTION The laser unit itself cannot be sterilized However some accessories must be sterilized when used for contact applications N 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 BWF 5 810 5 laser 15 manufactured in compliance with the provisions of Council Directive 93 42 EEC concerning medical devices MDD Always observe the following precautions N WARNING Always cover the optical fiber connection with the special protection caps provided if the fiber is disconnected from the laser N CAUTION Use of the operating controls or adjustment options in a way other than described herein can lead to dangerous radiation N CAUTION e page 10 BY MEDIVANCE Never insert your fingers or any objects into the exit ports This 1s important in order to avoid damage to the optical system N CAUTION In case of an emergency switch the laser unit OFF immediately To do this press the LASER STOP button on the top of the unit Figure 1 LASER EMERGENCY STOP button Observe all labels on the laser unit N WARN
15. d to BWTEK with transportation and insurance if necessary prepaid by purchaser BWTEK will return repaired or replaced products to purchaser with FOB city destination within the Continental United States Transportation fees insurance if necessary beyond this limit will be charged to purchaser
16. e set within 0 1S 120 08 Repeat Pulse Mode gt Set Off duration between 0 1S and 120 0S by pressing Up arrow or Down arrow under the Off icon The word REPEAT will appear on the mid top of the screen S In Repeat Pulse mode the On duration can be set within 0 1S 120 0S e page 24 BY MEDIVANCE 5 7 Laser Emission Energy Reset The laser emission energy could be automatically accumulated and monitored during laser emission Press Energy Reset button under the Energy icon to reset accumulated energy to 0 0J The laser emission energy can be reset only in Standby mode or Ready mode 5 8 SETUP Mode Aiming beam status audible warning tone and preset could be set in Setup mode gt Turn on the main power the Main Menu screen will display Or press Exit button at Standby mode or Ready mode to enter Main Menu screen S The SETUP screen shall display by pressing Setup button in Main Menu screen The SETUP screen presents four columns buttons and an Exit button on the right top of the screen Press the Exit button to enter the Main Menu screen The sequential sequencing ofthe Audible Tone Aiming Beam Frequency and Aiming Beam Intensity settings shall occur as follows Audible Tone Volume Level Valid upward selection sequence Low Medium High Low Medium High etc Valid downward selection sequence High Medium Low High Medium Low etc Aiming Beam Intensity Valid upward selection sequence Low
17. e with IEC 60825 1 and its amendments e Compliance with any additional national laws and ordinances e page 5 BY MEDIVANCE 48 NOTICE BWF 5 810 5 laser is intended for surgery and coagulation of soft tissues This laser unit must 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 qd NOTICE The user is obliged to use only faultless materials to observe the correct application as well as to protect himself or herself the patient and other persons against hazards N WARNING This laser unit is not intended for operation in areas subject to explosion hazards or in the vicinity of flammable materials or substances N WARNING Public legal provisions may include special safety regulations for the protection of persons against laser radiation These regulations must be complied with N WARNING Using controls or settings or performing procedures other than those specified in this manual may result in hazardous radiation exposure 1 3 Wireless phone interference N CAUTION To ensure the operational safety of electro medical equipment the use of mobile wireless phones in practice or hospital environments must be prohibited I 4 Disposal fa wax you plan to discontinue the use of your BWF 5 810 5 and intend to dispose of the unit observe all applicable legal provisions Pl
18. ease contact Velopex for the disposal of the BWF 5 810 5 1 5 Sale N CAUTION Federal Law US A restricts sales of this device to or on the order of a physician dentist or licensed practitioner e page 6 BY MEDIVANCE 2 Glossary Symbols and Abbreviations 2 1 Symbols and labels the BWF 5 810 5 ud BWIEC bises Manufacturer s General Identification Label See eee eee Figure Located on the side of the device The label EC REP eiesasse 80 20537 Hamburg Germany displays the manufacturer model number serial number Se eee date of manufacture of the unit This label also presents BWF 5 SN various regulatory compliance declarations T E Con hal Min 0123 General Safety Declaration Label See Figure Located on the side of the device this label indicates the laser classification It warns of the radiation exposure hazard potential to eyes and skin Laser Radiation warning Label See Figure Located at the top center of the front faceplate Laser Emission Aperture Located on the front of the device the laser emission Aperture label indicates that the laser energy emission occurs at the distal end of a properly connected optical fiber menue Warranty Seal Label See Figure These labels are VOID positioned on the underside of the laser device in such a way that any attempt to open the panels of this device will break this seal
19. ee the aiming beam during the treatment proceed as follows Turn off the laser and 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 Check the setting to make sure the aiming is not set at OFF selection e page 20 BY MEDIVANCE If you cannot detect any damage on the optical fiber and the aiming setting 1s not at OFF but the signal of the aiming laser is not visible with the new optical fiber either turn off the laser and contact BWTEK your local distributor or your authorized service center N CAUTION The optical fiber must be sterilized prior to the first treatment e page 21 BY MEDIVANCE 5 Operating Instructions 5 1 Power ON Display The presentation of the revision display screen signals the initiation of the power ON sequence and shall be accompanied by an audible alert i i INTERNATIONAL S The initialization process shall not exceed 5 seconds and then change to main menu as following Eun Setup Calibrate Preset Preset Preset 1 2 3 e page 22 BY MEDIVANCE 5 2 Standby and Ready Display Press Run button to enter Standby mode S Standby screen presentation Standby 52 5 2 1 Standby to Ready Mode Press Standby button to enter Ready mode A six second laser emission enabling audible alert notification sequence occurs The Standby button sh
20. formation To prevent any personal injury or material damage please observe the warning and safety information provided in the present operating instructions All such information 1s highlighted as follows NOTICE For additional information cavrion If there is any risk of damage to the laser unit If there 1s any hazard to the life or health of persons This symbol indicates that you have to take action S This symbol indicates that a certain result will occur Intended use 45 NOTICE The user should read and be thoroughly familiar with this manual before operating the instrument 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 these hazards Be sure the draping is appropriate for laser surgery It is recommended that a smoke evacuator or in line filter be used to capture the plume whenever possible The plume should be regarded as source of active biological material by the operating room personnel it may contain viable tissue particulates NOTICE Nominal Ocular Hazards Distance NOHD is 1 5 m from the distal end of the fiber 0 NOTICE For the installation and use of the BWF 5 810 5 Velopex requires e Complianc
21. he safety interlock into position OU UU Insert one of the keys into the key lock switch located the front of the system e page 19 BY MEDIVANCE Turn the key clockwise to the right one quarter turn sme The key can only be inserted into and removed from the key switch when it 1s in the vertical standby position S The fan will start There will be an audible beep and the LCD panel will illuminate displaying the initial start up splash screen E Refer to the Operation Section to configure and operate the system 4 5 Optical fiber preparing Always avoid pointing the aiming beam at of anyone s eyes It is an intense light source even at lower power levels Wear laser protective goggles Check whether the aiming beam signal is an evenly illuminated round shaped pattern To do this aim the tip of the probe vertically at a white background located approx 15cm away If there is no beam pattern at all or the beam pattern of the laser probe is unevenly illuminated the fiber may be damaged or broken In this case send the laser fiber in to your distributor for exchange under warranty Do not use damaged optical fibers If the aiming beam signal produces a non evenly illuminated beam pattern cut the fiber off with the fiber cleaver until an evenly illuminated round pattern has been obtained If you switch on the laser unit and the signal of the red aiming laser is not visible or you cannot s
22. ion Always wear a face mask Observe the following in addition e NOTICE The unit must only be operated in rooms that comply with requirements of Council Directive 89 336 EEC The applicable national or local legal regulations must be complied with N CAUTION Avoid interference of the laser emission with optical sensors of devices operated in the vicinity of the BWF 5 810 5 laser e page 12 BY MEDIVANCE 3 3 Transport and storage 3 3 1 Transport and storage The BWF 5 810 5 laser is supplied in a case that ensures proper and easy transport However please observe the following 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 Velopex the BWF 5 810 5 laser withstands the following environmental conditions Temperatures from 20 C 4 F to 70 C 158 F e Relative humidity from 10 to 90 When stored in its original transport packing the BWF 5 810 5 laser withstands the following environmental conditions Temperatures from 20 C 4 F to 70 C 158 F e Relative humidity from 10 to 95 3 3 2 Operating conditions The BWF 5 810 5 laser may be operated in the following environmental conditions e Temperatures from 10 C 50 F to 35 C 95 F e Relative humidity from 10 to 9
23. o each subsequent use N CAUTION Strong bending or improper routing of the optical fiber inside the hand piece may damage the optical fiber thus creating a health hazard for patients dentists and assistants The minimum e page 30 bending radius for the fiber 15 9 cm diameter 10 cm Take care that the fiber will not be squeezed or cracked during the handling procedure A CAUTION Please always cover the proximal end of the fiber with the special protection cap for sterilization Use only this special protection cap for sterilization Approved for sterilization are steam sterilizers that fulfill the requirements of prEN 13060 or at least use fractionated vacuum and are suitable for the sterilization of hand pieces 6 4 Cleaning of the laser unit Use a dry soft cloth to remove dust from the BWF 5 810 5 laser More stubborn spots can be removed with a damp cloth For disinfection you can treat the BWF 5 810 5 laser with all products commonly used for medical electrical equipment such as MinutenSpray classic cavicide and caviwipes Observe the instructions provided by the manufactures of these disinfectants You can use MinutenSpray classic from Alpro MinutenWipes from Alpro In the USA cavicide and caviwipes Observe the instructions provided by the manufacturers of these disinfectants Take care that the fiber will not be damaged in case of disconnecting the finger switch N ranne
24. page BWE 5 810 Dental Laser User Manual Se eR ERT x IA Main Menu iE fum Semp hot e page 2 BY MEDIVANCE TABLE OF CONTENT 1 WARNING AND SAFETY INFORMATION ee eee eee ee eee ee e e esee ee eeseo esee eese esses esee 4 1 1 HIGHLIGHTING OF WARNING AND SAFETY INFORMATION cccececcccececccccecececcecececcnceeeacccececencecececeesetsucececsucucesseeceseeeeeeeens 4 1 2 NR esc sca cesta esc R 4 1 3 WIRELESS PHONE INTERFERENCE dea 5 4 D S 5 1 5 a A 5 2 GLOSSARY SYMBOLS AND ABBREVIATIONS 55 e eee e reno eu en e pea apa o neo Peas uua n DEP aee Inte Pega ea one eoe s pue nee pe ase a o pee esa eese oe Vae a oS T ups 6 2 1 SYMBOLS AND LABELS ON THE BWF 5 810 5 c ccccececccccccccccccccccccecscecscscecenseeecesesecscecesssstsuseeaeesesecesssesecessususasasuseeececs 6 2 2 GEO eee eee 8 2 3 POUT TNS 8 3 INTRODU TIIN sancti E 9 3 1 E Si We 9 3 2 RM id Oe Os ce 9 3 3 TRAN TORTA E E ER 12 3 4 I ds e
25. r unit must be used in compliance with the instructions provided in this manual e page 32 BY MEDIVANCE Le Basic troubleshooting In case of malfunctions check the following first e Check the connection of the power cord e Check the connection of the Safety Interlock connector e Check the connection of the optical fiber Be sure that all operational steps have been executed correctly e Check the connection of the foot control 7 4 Technical support Technical information concerning parts to be repaired may be supplied by Velopex only to authorized agents and after providing a training course to the technical personnel Please contact your local distributor 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 Velopex can be contacted via Tel 44 20 8965 2913 Fax 44 20 8963 1270 E mail mark velopex com BY MEDIVANCE Technical Data Model Laser Type Wavelength Output power Output Port Fiber Operating modes Duty ratio Cooling Weight Dimensions Power requirement Operation Temperature storage Temperature page 33 BWF 5 810 5 Solid State laser Class IV 810nm Max 5 0W output port SMA 905 400um 0 37NA Continuous Wave CW Pulsed On Off duration adjustable Thermal Electrically Cooled wi
26. s A single intensity footswitch comes with this laser device The laser device treats the footswitch as a simple on off device Pressing down on the footswitch produces 100 of the laser energy set by the operator Fully releasing the pressed footswitch stops laser energy generation NOTICE When closed the cover of the foot switch 1s designed to prevent inadvertent foot pedal control When the laser 1s properly configured and all safety features have been complied with open the footswitch cover by pressing it fully down then releasing Disable laser emission and or turn power off to further prevent inadvertent laser activation due to unattended foot switch depression 4 1 Laser unit Set up Setup Location aD NOTICE Ensure that the surface will properly support the entire system BY MEDIVANCE page 16 4 NOTICE Place within 6 feet of an available 110 240V electrical outlet NOTICE Ensure adequate airflow around the system Open the box Remove the protective packaging cover Locate and keep this manual in a secure location Remove any intermediate protective packaging material Remove the power supply and power cord Remove the laser system Select a flat surface not a surface that will inhibit airflow through the base of the system There must be a minimum 4 10 cm clearance around the rear of the system BY MEDIVANCE Laser emission LED indicator Display and control touch
27. th Forced Air 4 5 kg 170mm x 235mm x 320mm WxHxL 100 220V AC 50 60Hz 250V A 10 Cto35 C 20 C to 70 C e page 34 BY MEDIVANCE 9 Warranty Information Terms and Conditions BWTEK lasers and power supplies are warranted to be free from defects in materials and workmanship for a period of 12 months starting from the date of initial shipment This warranty does not extend to incidental or consequential damages and to damage caused by negligent or improper handling in use storage nor to products from which the original identification markings or labels have been defaced altered or removed Special contracts or contracts for non standard products may have modified terms of warranty and in such cases the terms as stated in the individual contract must be signed by the duty officer of BWTEK and will supersede the standard terms BWTEK reserve the rights of determining cause or existence of defect and the options to repair the products which prove to be defective during the warranty period Products replaced under warranty will be warranted only for the balance of the warranty period starting from the date of the first shipment This warranty extends only to the original purchaser of the equipment from BWTEK The purchaser must notify BWTEK within 15 days of first detecting the defect and promptly return the defective product before expiration of the warranty period Products claimed by purchaser to be defective shall be returne
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