User Manual - Biolase Romania
Contents
1. 2 4 SURGICAL DELIVERY SYSTEM NOTE All fiber optic cables Handpieces amp tips are shipped non sterile The EPIC V Series Re Useable Delivery System with surgical Handpiece consists of e Re useable Fiber Optic Assembly e Re useable Surgical Handpiece Figures 2 4 2 5 e Disposable Tips See Figures 2 7 2 8 2 9 2 10 The fiber optic cable is detachable from the console The Handpiece is a Re usable accessory and will require cleaning and sterilization prior to each patient treatment Tips are intended for single use only and must be disposed of after each patient use Proper tip disposal in a biohazard medical waste Sharps container is required Tips must be steam sterilized prior to use For instructions on cleaning and sterilization of the Handpiece and tips Refer to Section 8 NOTE 2 6 FIBER OPTIC CONNECTION Only install the fiber optic cable while the laser console is turned off The fiber optic cable is attached to the console by inserting the optical access plug Figure 2 2 into the optical access port Figure 2 3 _ Make sure you hear the fiber optic click into place if you do not hear it click NOTE remove the fiber optic and reinstall it Do not connect or disconnect the fiber while the laser console is turned CAUTION on Only connect or disconnect the fiber when the laser console is turned off For storage wind the cable in the fiber storage channel around the base of the console in a cou2. User Manual TABLE OF CONTENTS TABLE OF CONTENTO nessas A e AN E 0 Idee Tel De ION te fo ee erste see ARIDI DER DE NR RE RED NE A RE RP 3 Tel ACI CACO in aieeniare sind ncradineaieclarantn A opresaie mina inmninemaictiiae iad A A E 4 Tell OV SUS e gs 1S E PERDESSE RD ERR RR RE 4 1 2 Facility Ee Ten CN 4 2 E guipment Descriptio raso do ance Ea E 5 PEE o EEN 5 Bee BTE OON OIG EE 5 2 3 SOMO UI AO E siri 5 24 Surgical Delivery EE 6 2 6 Fiber Optic CGonnechon erre eeeree renan ee aa era a acre na nene ra een ere aa renanana 6 Cap OWIGICS TT 6 o RD RE teenage dete ceece free ace DORIR NNE RT E DE DRE 7 2 8 Surgical Handpiece Assembly cccccccseeccceececseeeeceececseeeseaeceseucessueeeseueessueeeseueesseeesaases 7 2 9 Deep Tissue Handpiece Optional ACGceseonm 10 EE 11 APEC el E 11 EEGENEN 11 DO EE 12 ECE i e TE 12 TEE UU RE RR RR te RR ANG SR GR 12 PONOR WIC ME 13 Access Key COCO E 13 COn oE UO E 13 Wireless ROO SANTO EE 13 Remote Interlochk eee erre rere era eea area ncea area nen arena nen arena na nen arena renaado 14 EMETON lO E 14 Wiedere VE 15 3 4 Safety Classification eee eeere rrenan era n aerea cre a arena renan anne re nara renan 15 i OSTA OMS MEIC o flo OM RARE E O I nase E E 16 E ET e sais sds eee eee SE SEDE eee ee Ea eee cando dE Cu ee 16 4 2 Operation Turn on the EPIC V Gertes errar serena rra nana 17 Ao DOM S SCCO empresarios nasal sia E A E I E E A A T A A A 18 4 4 Pairi
3. Applied Part e Not protected against water ingress Ordinary Equipment e Not suitable for use in presence of flammable anesthetic mixture e Operation Mode Continuous Operation e Wireless Footswitch IPX6 EPIC V Series User Manual pg 15 5400430 RevA 4 OPERATION INSTRUCTIONS 4 75VSTEM SETUP e Place the unit in a clean dry and well ventilated area e Verify power switch is in the OFF O position e EPIC V Series will work using either DC power or the rechargeable battery pack o DC Power Connect the power cord of the power supply to the laser console and plug into a wall outlet o Rechargeable Battery The EPIC V Series is shipped with the battery pack already installed to charge the battery pack connect the power cord of the DC power supply to the laser console and plug into a wall outlet Before first use fully charge the battery at least 3 hours Once the battery is charged unplug the power cord from the wall outlet and the laser console The laser console will run on battery power alone To fully charge the battery plug the power supply in and then turn the laser console ON I at the Power Switch The laser console will start to charge and the unit will go NOTE into sleep mode with the screen off after 5 minutes if the power supply is plugged in but turned OFF O at the Power Switch the battery will still charge but at a slower rate e Connect the fiber to the laser console see Section 2 Do
4. a tissue surface for the purpose of temporary pain relief when applied with the Whitening Contour or Deep Tissue Handpiece The pain therapy procedure is the process by which tissue temperature is elevated for the temporary relief of minor pain the temporary increase in local blood circulation and the temporary relaxation of muscle as stated in the Indications for Use Affected muscles and or joints have to be exposed to an adequate level of therapeutic energy over a short period of time to provide effective therapeutic effects Some patients may require more than one laser application or a series of treatments before significant improvement is reported Repeat the therapy as necessary and monitor the progress of the patient s condition throughout the treatment The diode wavelength has increased absorption in melanin in the skin causing greater heating of the skin surface of patients with a higher melanin concentration darker skin types Although patients with darker fur or coat colors may feel more discomfort during treatment this may be alleviated by moving the Handpiece defocusing the energy or decreasing the power seiting Recommended Use There are four main variables that impact the safety and effectiveness of pain therapy procedures e Power output e Distance from the skin surface e Range of movement of the Handpiece e Patient fur coat color Safety and effectiveness are described by elevating the skin temperature in the t
5. instructions for the specific message as noted below For any on screen message not listed in Figure 11 1 re power the laser console if NOTE the message does not clear call BIOLASE Service at 1 800 321 6717 or your authorized Service Representative EPIC V Series User Manual pg 40 5400430 Rev A Title Message Reason Error 1 Thermistor Open Thermistor Open Call BIOLASE Service Error 2 Thermistor Shorted System too hot GC 5 10 mins for laser to cool own Call BIOLASE Service Thermistor Shorted Error 3 Shutdown Temperature Error 4 Laser Current High Low Output is out of specs Press Release FS or call Biolase Service Key stuck Press Front key Call BIOLASE Service FS is partially pressed or FS shorted in Standby is damaged Error 6 ON OFF button Stuck Error 7 Flash Corrupted Memory Corrupted Error 8 No Fiber Fiber not inserted Plug in Trunk Fiber Reposition console or FS to Error l mee org Improve communication Lost Footswitch Communication Wireless Interference Error 10 Emergency Switch E Switch Pressed Press E Switch Again Error 11 Remote Interlock Remote interlock open Check Remote Interlock closed Error 12 Battery Critically Low Battery Critically Low Plug in DC supply Allow 5 10 mins for laser to cool Warning 1 down Temp High System is hot Battery Low Battery is low iil o Warning 2 Plug in DC supply Warning 3 Warning 4 Alert 1 Alert 2 EPICTM V Series User Ma
6. over which the battery can be discharged is 20 C to 60 C Use of the battery outside of this temperature range may damage the performance of the battery or may reduce its life expectancy EPIC V Series User Manual pg 48 5400430 RevA APPENDIX C SPARE PARTS e ACCESSORIES SVSTEM ACCESSORIES 2400040 Laser Safety Glasses Clinician 6400310 Deen Tissue Handpiece protective covers qty 20 6400485 Peel off clear screen covers qty 30 6400457 Lithium ion battery pack for console 6400463 Battery Pack 2 x AAA 6400437 Trunk Fiber Assembly SINGLE USE TIPS Surgical 7400018 200 um core diameters qty 30 7400017 300 um core diameters qty 30 7400016 400 um core diameters qty 30 Perio 7400020 300 um core diameters qty 30 7400019 400 um core diameters qty 30 EPIC V Series User Manual pg 49 5400430 Rev A Endo 7400015 EZTIP Endo Kit E2 20mm 7400021 200 um core diameters qty 30 EPIC V Series User Manual pg 50 5400430 Rev A APPENDIX D WIRELESS EQUIPMENT COMPLIANCE STATEMENT This statement applies only to the wireless portion of the device This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency ener
7. 0 RevA 5b If pairing has not occurred the Wireless screen will appear again indicating that pairing was not successful Figure 4 11 press the green button to repeat steps 3 da Q WIRELESS amp 0 x 6 Press the Settings button to return to the Settings menu press the arrow on the bottom left of the Settings screen to return to the Home screen Figure 4 12 Figure 4 12 4 5 CONTROL BUTTON The CONTROL button on the front of the laser console is a multi functional button Figure 2 1 Pressing and holding the Control Button for approximately two 2 seconds will allow the transition from STANDBY or READY mode to SLEEP mode Note that you will not be allowed to go into READY mode unless you have chosen a treatment module on the HOME screen first 4 6 ENTERING READY OR STANDBY MODES Press and release the Control Button to place the laser console into either READY or STANDBY mode The laser console will only emit laser energy when the footswitch is pressed and the laser console is set to READY mode While in READY or STANDBY mode mode setting and or power setting values may be changed only when the laser is not firing If the laser is firing Le the footswitch is engaged the ability to change the settings is blocked READY or STANDBY is displayed in the lower right hand corner of the display screen 4 7 READY MODE When entering READY mode the laser console fan will turn on and pressing th
8. 1 cm area 4 meters 8 22 per side angle 5 feet 1 524 meters Laser diode max 1 mW 625 nm 670 nm pg 26 5400430 Rev A 6 CONTRAINDICATIONS WARNINGS e PRECAUTIONS 6 7 LONTRA INDICA TIONS All clinical procedures performed with EPIC V Series must be subjected to the same clinical judgment and care used with traditional techniques Patient risk must always be considered and fully understood before clinical treatment The clinician must completely understand the patient s medical history prior to treatment Exercise caution for general medical conditions that might contraindicate a local procedure Such conditions may include allergy to local or topical anesthetics heart disease including pacemakers lung disease bleeding disorders sleep apnea or an immune system deficiency or any medical conditions or medications that may contraindicate use of certain light laser type sources associated with this device Medical clearance from patient s physician is advisable when doubt exists regarding treatment 6 WARNINGS AND PRECAUTIONS Prescription Statement Federal Law restricts this device to sale by or on the order of a licensed veterinarian for Canine Feline Equine and Avian use Eyewear All personnel inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 940 10nm Anesthesia In soft tissue cases anesthesia may not be required but patients should be clo
9. Cover the unit when not in use for extended periods of time Store the system in a place where it will not be accidentally bumped or banged Make sure the distal end of the Handpiece shaft is protected from dirt AUTION au with the protective tip plug and Handpiece CAUTION Remove the batteries from the footswitch if the EPIC V Series is not likely to be used for some time The EPIC V Series is shipped inside a custom shipping box Please save and store the box ina cool dry place for use when transporting the laser or for long term storage EPIC V Series User Manual pg 39 5400430 RevA 9 CALIBRATION 9 1 CALIBRA TION SCHEDULE Calibration procedure is recommended to be performed every twenty four 24 months in order to maintain the required accuracy of output power versus displayed power Annual calibrations can be performed at a certified depot repair facility Call BIOLASE Service at 1 800 321 6717 or your Authorized Service Representative to schedule an appointment 10 SOFTWARE SPECIFICATION BIOLASE respects the intellectual property of others and we ask our users to do the same EPIC V Series software is protected by copyright and other intellectual property laws This product contains proprietary copyrighted software developed by BIOLASE Inc All rights reserved in the USA and other countries 11 TROUBLESHOOTING Should any of the on screen messages listed in Figure 11 1 appear follow the troubleshooting
10. Power Switch at the rear of the console to the ON I position The BIOLASE logo screen will appear Figure 4 1 After three 3 seconds the EPIC V Series Welcome screen will be displayed Figure 4 2 WELCOME WELCOME BIOLASE Figure 4 1 Figure 4 2 Figure 4 3 e Enter the three digit access code using the touch screen The Access Key Code is 888 If the incorrect code is entered an X appears briefly in the window Figure 4 3 and then the screen reverts back to the Welcome screen re enter the correct code e The system will go to the HOME screen which identifies three procedure categories to choose from Soft Tissue Whitening Pain Therapy Laser Console Battery Wireless Signal Strength Indicator Strength Indicator DENTAL PAIN soFT TISSUE SURGICAL THERAPY Settings Button e Figure 4 4 Home Screen EPICTM V Series User Manual pg 17 5400430 Rev A 4 3 SETTINGS SCREEN Pressing the Settings button on the HOME screen accesses the Settings screen this screen allows the user to make changes to several system settings Language Selection Aiming Beam 5 levels of brightness adjustment SETTINGS Volume 5 levels of sound adjustment Service Mode accessible only by authorized BIOLASE Service Representatives Restore to Factory Default Settings Wireless Menu Access to Pairing Screens Figure 4 5 4 4 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE Verify that the foots
11. User Manual pg 12 5400430 Rev A Power Switch The laser console can be switched ON or OFF O using the Power Switch on the back of the console Power Switch DC Powe Remote Interlock Figure 3 1 Power Switch DC Power Input Figure 3 2 Power Supply Module with cord Remote Interlock CAUTION Use only the Power Supply Module supplied with the EPIC V Series laser system BIOLASE Part Number 2400129 Access Key Code The Access Key Code prevents unauthorized use of the system It is activated every time system is turned on with the Power Switch refer to Section 4 for code Placing the laser in sleep mode by pressing and holding the Control button on the NOTE front panel does not re set the Access Key Code Turn the Power Switch OFF O only when the system will not be in use for a long period of time Control Button Once the power switch is set to the ON I position enter the access key code After setting the desired parameters for a procedure press the CONTROL button on the control panel to enter into READY mode The aiming beam will illuminate to indicate that the system is ready for use Wireless Footswitch The EPIC V Series will not emit laser energy until the user presses down on the Footswitch while the laser is in READY mode The footswitch is designed to work using wireless technology EPIC V Series User Manual pg 13 5400430 Rev A Two 2 AAA batteries are required to power the footsw
12. WER MOI AVIAN EQUINE 2 TROUGHING 2 0 e 3 CURETTAGE 4 EXCISION PLEASE INITIATE w THE TIP USE ONLY NEW AND CLEAN TIPS SERVICE 5 0 MODE POWER TOR Ki gt LSE MODE Restore all Settings SISIA alelo eile This will set the laser CPO CP1 CP2 to factory settings 10us 100ys Ims RESTORE a Mr x P3 CW Q ams Figure 4 15 EPIC V Series User Manual pg 23 5400430 Rev A 4 1 PROCEDURES BUTTON The EPIC V Series comes with 12 Soft Tissue procedural presets already installed and 4 empty Slots for custom pre sets as well as one factory installed preset for Surgical All presets can be customized to your preference In order to customize the parameters for a particular clinical procedure 1 Adjust the operating parameters of the laser ed power pulse duration interval etc select PROCEDURES Mode and scroll to the pre set you wish to overwrite 2 Press and hold the selected Procedure for two 2 seconds Parameters for that procedure will be changed and saved the laser console will beep when the adjusted settings are saved DENTAL ait GINGIVECTOMY TROUGHING PAS Ke KI CURETTAGE EXCISION vw Figure 4 16 4 77 TURN THE LASER CONSOLE OFF e Wind the fiber cable onto the fiber spool counterclockwise around the base of the console e Place the Handpiece onto the Handpiece holder CAUTION Verify that the fiber optic tubing assembly is not twisted once the Handpiece is retu
13. acks 46 When USING He os ate os Sie Da Scere nde nse ntact an soa a pisa e Dies Sit 46 WEEN CHARGING Whe EE 47 When DISCHARGING the Battery cccccccccccsecccceeeeeeeeeseeeesseeeeseeeessaeecseeeeseeeeseeeesseeesanees 48 Appendix C Spare Parts amp Accessories cccccceececececeeeeseeeeeseeeeseeeeeseeeeseuseseusessaeeeseeesseeeas 49 System ACCESSOS ccccceececeeececeeceseeeeceeceesueeeseecesseeeeseeessaeeeseusessaeesseueessneesseeeeseeeeseeeensaees 49 WAE U E TIDS PREDADOR E DE RR ene ee ee ee ee 49 Appendix D Wireless Equipment Compliance Statement erra 51 EPIC V Series User Manual pg 2 5400430 RevA INTRODUCTION The EPIC V Series diode laser is a surgical and therapeutic device at the cutting edge of technology designed for a wide variety of dental and surgical soft tissue procedures as well as for use in providing temporary relief of minor pain in domestic animals e dogs cats birds and horses The EPIC V Series utilizes a solid state diode as a semiconductor source for invisible infrared radiation The energy is delivered to the treatment site via flexible fiber connected at one end to the laser source and the other end to the Handpiece Various types of single use disposable tips are designed and optimized for different applications The device is activated by means of a wireless footswitch The EPIC V Series is restricted to sale by or on the order of a licensed veterinarian and its
14. dpiece Single Use Tips Tip Initiation Block Before sterilization the Surgical Handpiece must be cleaned and disassembled To sterilize the Handpiece tips and tip initiation block follow these step by step instructions e Place the Handpiece fiber tips and tip initiation block in separate single wrap self seal autoclave pouches e Remove autoclave tray and the place pouch s on the tray e Place tray inside the autoclave chamber and sterilize per the following gravity displacement sterilization cycle Temperature 250 F 121 C Pressure 15 PSI 1 bar Time cycle 30 minutes Drying time 15 30 minutes e Once the cycle is completed remove the tray and let each sterilized item cool and dry Cleaning the Deep Tissue Handpiece The Deep Tissue Handpiece is sold with non sterile disposable protective shields The Handpiece and clear protective shield are not autoclavable The clear protective shields are intended for single time use only and should never be reused To clean the Deep Tissue Handpiece wipe the entire outer surface of the Handpiece with cotton gauze and isopropyl alcohol or a mild chemical disinfectant Always wipe the disposable shield with alcohol prior to use Dispose of after one time use EPIC V Series User Manual pg 37 5400430 Rev A 8 3 INSTALLINC REPLACING THE CONSOLE BATTERY PACK 1 To install or replace the battery pack remove the battery cover on the underside of the console using the Phill
15. e footswitch will activate laser radiation There is a two 2 sec delay between switching to READY mode and the ability of the laser console to emit a laser beam EPIC V Series User Manual pg 20 5400430 RevA 4 8 WIRELESS FOOTSWITCH The wireless footswitch is powered by two 2 AAA batteries When the wireless footswitch is pressed in READY mode and the laser fires a beeping sound indicates that laser energy is present A green LED will begin flashing and a blue LED will light at the top corners of the laser console confirming the footswitch and laser are paired In the top left corner of most screens is a Signal Strength Indicator E which displays the signal strength between the laser console and the footswitch strongest is five 5 bars Pressing and releasing the footswitch while in Standby mode will update this indicator Although the unit will work with a signal level as low as one 1 bar a weaker signal level will make the connection between the footswitch and laser console more vulnerable to wireless RF interference from other sources such as cell phones or microwaves To improve the signal strength reposition either the footswitch or the laser console until the signal indicator achieves the strongest possible level for optimal operation When the footswitch is not in use it will go into SLEEP mode to conserve battery MOE power It automatically reactivates when it is pressed 4 9 PEAK POWER DISPLAY This number is s
16. e recommended initial power setting for therapeutic effect is 4 0W CW delivered over 10 minutes of continuous treatment with the spacer set at a 30mm spot size Always monitor patient response adjust power and or distance as needed for patient comfort EPIC V Series User Manual pg 35 5400430 Rev A 8 MAINTENANCE 8 7 DAILY MAINTENANCE Use the peel off clear covers for the laser console supplied with the system Use disinfectant to wipe down the front panel and Handpiece holder of the EPIC V Series system after each procedure Do not use bleach or abrasive cleansers 8 2 CLEANING AND STERILIZATION PROCEDURES The contamination control suggested for the EPIC V Series Surgical Handpiece and tips is the steam sterilization method However before sterilization the EPIC V Series reusable Handpiece should be carefully cleaned per the following procedure Handpiece and tips must be cleaned and sterilized prior to initial use Tips are single use only to avoid cross contamination and are designed to withstand a single sterilization cycle they must be disposed of after use ina et biohazard medical waste Sharps container Handpieces are reusable and must be cleaned and sterilized between patients to avoid cross contamination Cleaning and Disintecting Instructions for the Surgical Handpiece and the Reusable Fiber Optic Cable The cleaning process is intended to remove blood protein and other potential contaminants from the surfac
17. ect the Handpiece from fiber optic assembly e Take the Handpiece body in one hand and the shaft in another e Push the two buttons on the Fiber Shaft e Pull the Handpiece with the ring to separate Remove the fiber tip by twisting the tip counterclockwise EPIC V Series User Manual pg 7 5400430 RevA Fiber Shaft Protective Cap Figure 2 5 Surgical Handpiece Assembly fully assembled Figure 2 6 Disconnect the Handpiece from the fiber optic assembly by pressing both buttons at the base of the Fiber Shaft Tip Assembly gt d eg Figure 2 7 Insert the fiber tip into the Handpiece and twist clockwise until snug _ GH Sa Figure 2 8 Remove the fiber Tip by twisting the tip counterclockwise EPICTM V Series User Manual pg 8 5400430 RevA Correct Bend iT sm Incorrect Bend Figure 2 9 When installing the tip make sure it is Figure 2 10 Bending the tip cannula seated properly thread correctly WARNING When the aiming beam is not present or has a significantly different shape change the tip EPICTM V Series User Manual pg 9 5400430 Rev A 2 9 DEEP TISSUE HANDPIECE OPTIONAL ACCESSORY The Deep Tissue Handpiece is reusable and equipped with a disposable non sterile protective shield for single patient use The Handpiece is non sterile and requires cleaning before and after each patient treatment This Handpiece cannot be sterilized in the autoclave For instructions on cleanin
18. eric Pressure Limitations Fragile Handle with care Keep Dry Humidity Limitations Temperature Limitations This End UP pg 45 5400430 Rev A APPENDIX B SAFETY PRECAUTIONS FOR LITHIUM ION BATTERY PACKS WHEN USING THE BATTERY 1 Misusing the battery may cause the battery to get hot rupture or ignite and cause serious injury Be sure to follow the safety rules listed below e Do not place the battery in fire or heat the battery e Do not install the battery backwards so that the polarity is reversed e Do not connect the positive terminal and the negative terminal of the battery to each other with any metal object Such as a wire e Do not carry or store the batteries together with necklaces hairpins or other metal objects e Do not pierce the battery with nails strike the battery with a hammer step on the battery or otherwise subject it to strong impacts or shocks e Do not solder directly onto the battery e Do not expose the battery to water or salt water or allow the battery to get wet 2 Do not disassemble or modify the battery The battery contains safety and protection devices which if damaged may cause the battery to generate heat rupture or ignite 3 Do not place the battery on or near fires stoves or other high temperature locations Do not place the battery in direct sunshine or use or store the battery inside cards in hot weather Doing so may cause the battery to generate heat ruptu
19. es and crevices of reusable accessories This process may also reduce the quantity of particles microorganisms and pathogens present Cleaning should be performed prior to sterilization and must be conducted only by qualified office personnel trained to perform the procedure and handle the EPIC V Series fiber optic delivery system Wear protective latex gloves when handling the contaminated delivery system To disinfect the fiber cable wipe the entire cable including the shaft with an appropriate disinfecting solution such as Cavicide or a similar quaternary ammonium compound product containing 20 alcohol or less and follow the manufacturer s instructions Avoid getting any liquid or debris near the distal end of the fiber cable EPIC V Series User Manual pg 36 5400430 RevA To Clean the Surgical Handpiece e Carefully remove the tip from the Handpiece and dispose of it in a biohazard medical waste Sharps container e Carefully remove the Handpiece from the fiber optic cable see Section 3 e Wipe the entire Handpiece outer surface with cotton gauze and a detergent enzymatic cleaning solution such as Klenzyme or similar enzymatic presoak and cleaner e Soak gauze in the detergent enzymatic cleaning solution and then wrap the Handpiece in the gauze e Leave the Handpiece wrapped in the soaked gauze for 30 minutes e Remove the Handpiece from the soaked gauze and wipe it with dry gauze Steam Sterilization tor Surgical Han
20. g the Handpiece refer to NOTE section 8 Always wipe the disposable shield with alcohol prior to use The disposable shield is for single use only to avoid cross contamination Dispose of when treatment session is completed Spacer Red Cap Dust Cover Handpiece Veto Disposable Shield Ka Figure 2 15 Deep Tissue Handpiece e Remove Red Cap Dust Cover from the Deep Tissue Handpiece e Slide Handpiece over shaft until it clicks into place Figure 2 16 e Place protective shield over the adjustable spacer Figure 2 17 e Loosen the Lock Ring and set the Spacer at the desired spot size Detent Location Figure 2 18 Tighten the Lock Ring Figure 2 18 The Handpiece is now ready to use To remove the Handpiece press and hold the buttons on the side of the Fiber Shaft and pull the Handpiece away from the shaft EPIC V Series User Manual pg 10 5400430 RevA 3 SAFETY 3 1 PRECAUTIONS Failure to comply with precautions and warnings described in this User Manual may lead to exposure to dangerous optical radiation sources Please comply with all safety instructions and warnings 3 2 SAFETY INSTRUCTIONS Follow these safety instructions before and during treatments When the laser is in use all operatory entrances must be marked with an appropriate warning sign one 1 included e Do not operate in the presence of explosive or flammable materials Flammable anesthetics or o
21. gy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help Intertek BBDO TES Conforms to AAMI ES60601 1 IEC60601 1 IEC60601 2 22 IEC62366 IEC80601 2 60 IEC60825 1 Certified to CSA C22 2 No 60601 1 EPIC V Series User Manual pg 51 5400430 Rev A E BIOLASE Inc 4 Cromwell Irvine CA 92618 USA 949 361 1200 888 424 6527 biolase com MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 mt procons com About BIOLASE Founded in 1986 BIOLASE Inc specializes in lasers for medicine and dentistry that feature proprietary and patented technologies for performing minimally invasive surgeries reducing pain and improving clinical results Only BIOLASE combines the leading laser technology contin
22. h Section 3 remove the old batteries and install the new ones replacing the cover when done Dispose of the used batteries as regulated do not throw them in a trash bin EPIC V Series User Manual pg 38 5400430 RevA Do not press push touch the Pairing Button Figure 8 3 while changing the batteries as this will disrupt the pairing of the laser console and footswitch Pairing Button Internal View Figure 8 3 Although replacing the batteries will not disrupt the pairing of the laser console and footswitch if you find the wireless communication has been interrupted reestablish pairing by following the instructions provided in Section 4 To ensure the longevity of the battery power only BIOLASE supplied batteries are NOTE recommended as replacements BIOLASE p n 6400463 these are industrial grade batteries which under normal use have a longer life than conventional AAA batteries 8 5 TRANSPORTATION The EPIC V Series is susceptible to damage if not handled properly The unit should ALWAYS be handled carefully and never banged jarred jolted dropped or knocked Do not transport the unit unless it is completely packaged inside its shipping box If you have any questions regarding transportation please call BIOLASE Service at 1 800 321 6717 8 6 STORAGE The EPIC V Series should be stored in a cool dry place when not in use Storage temperature 15 C 35 C 59 F 95 F relative humidity 10 70 non condensing
23. hown only when the system is in pulse mode and presents the value of the peak power based on the Power Setting and Pulse Mode 4 70 PULSE MODE SELECTION Pulse Mode selection graphically indicates whether the system is in Continuous Mode or in Pulse Mode In Continuous Mode laser power is constantly delivered when the laser console is in Ready Mode and the wireless footswitch is activated In Pulse Mode laser power is delivered in repetitive pulses controlled by the Pulse Length and Pulse Interval settings Pressing the Pulse Mode button will allow switching between Pulsed and Continuous Modes Figure 4 12 EPIC V Series User Manual pg 21 5400430 RevA GINGIVECTOMY Peak Power MODE POWER TOM Ki Average Power ys o PULSE MODE oo CB AOL CPO CPI CP2 10us 1004us Ims m A V eo o X 20ms Figure 4 13 MODE PULSE DURATION on PULSE INTERVAL off Duty Cycle Time On Time off CPO 10 microseconds 40 microseconds 20 CP Comfort Pulse P3 Pulsed Mode which is the standard for most diode lasers currently available to the dental market Figure 4 14 Operating the laser at a shorter pulse duration typically results in lower tissue NOTE temperature EPIC V Series User Manual pg 22 5400430 Rev A 4 77 USING THE EPIC V SERIES TOUCH SCREEN DISPLAY WELCOME JOME BIOLASE o ls E SOFT TISSUE 9 SURGICAL THERAPY CANINE va K GINGIVECTOMY MP a PO
24. ication Commission FCC ID G20EPIC and Industry Canada registration numbers 540045 Rev A Ingress Protection Code The footswitch is water resistant protected against splashes of water Laser Warning Indicates the system contains a laser Location Back of Laser Console Fiber Warning Indicates the laser aperture is at the end of the fiber Location Back of Laser Console EPICTM V Series User Manual pg 43 5400430 Rev A Emergency Laser Stop Switch The switch used in emergencies to stop laser output Location Right side of Laser Console DO NOT REUSE For single use only WEEE Waste Electrical and Electronic Recycle Lithium lon battery as regulated Do not throw in trash bin DC Power USB Remote Interlock Label Identifies input ports Power Input Rating 12 Volts Direct Current 5 amps Mini USB Input For external programming Remote Interlock Input for Remote Interlock Connector which when applied to the access door of the operatory and activated will shut off the laser EPIC V Series User Manual pg 44 5400430 RevA Rx Only 4400417 Rev A a 50 kPa ATMOSPHERIC PRESSURE FRAGILE KEEP DRY NON CONDENSING RELATIVE HUMIDITY 20 o C TEMPERATURE THIS END UP EPICTM V Series User Manual Prescription Statement Federal Law restricts this device to sale by or on the order of a licensed veterinarian for Canine Feline Equine and Avian use Atmosph
25. ips screwdriver included with the laser system Figure 8 1 2 Toremove the battery grip the battery at the top and pull the cable away from the connector Figure 8 2 Do not tug or wrench the cable from the connector 3 To install the battery insert the connector wire from the battery to the unit making sure the red wire is on the left and gently place the battery into the compartment Figure 8 2 4 Replace the battery cover on the bottom of the unit using a standard Phillips screwdriver 5 Conneci the power cord of the DC power supply to the unit and plug into a wall outlet Before first use you should fully charge the battery at least 3 hours Once the battery is charged unplug the power cord from the wall outlet and the console The unit will run on battery power alone See Section 4 1 6 Recycle the used Lithium lon battery as regulated Do not throw it in a trashbin Screws to remove Batterv cover Figure 8 1 Battery Cover Bottom of Console Figure 8 2 Battery Pack Connector Wire NOTE Only use the battery pack supplied by BIOLASE The battery pack is a separate accessory BIOLASE p n 6400457 8 4 CHANCING THE WIRELESS FOOTSWITCH BATTERIES The wireless footswitch is powered by two AAA batteries When the batteries are low a warning message will appear on the touchscreen indicating that the batteries need to be replaced To replace the batteries unscrew the battery cover on the underside of the footswitc
26. itch included For instructions on how to replace the footswitch batteries see Section 4 Figure 3 3 Footswitch Remote Interlock This feature allows the laser console to be connected to the remote sensor preventing its operation when triggered eg by opening door The electric cable from this connector should be wired to the normally closed switch sensing the opening of a door and turning the laser console off when the switch is open To override this feature don t connect the plug Figure 3 4 Remote Interlock Connector Emergency Stop Press the red Emergency Laser Stop button to instantly turn off the laser console The error screen will display an Emergency Switch Error message and the amber LED will begin flashing To clear the error press the Emergency Laser Stop button again in 2 to 5 seconds the amber LED will stop flashing and the system will automatically go into STANDBY mode EPICTM V Series User Manual pg 14 5400430 Rev A Figure 3 5 Emergency Laser Stop Left Profile View Functional Display The System Color Display with Touch Screen and LED indicators on the control panel show the functional conditions of the system 3 4 SAFETY CLASSIFICA TION The following safety classifications are applicable to the device e Laser Radiation Class 4 e Aiming Beam Class 2 e Type of protections against electrical shock Class 1 e Degree of protection against electrical shock Type B
27. l the tip out when the metal cannula touches the block still firing until just before the tip is out of the block Figure 7 4 Figure 7 4 e Press the footswitch to activate the laser into the air once you will see a white flash or the tip will glow Figure 7 5 Figure 7 5 e Repeat initiation process as needed to ensure the tip is initiated After tip initiation is completed press the check mark to access the screen for the selected procedure TIP INITIATION GINGIVECTOMY 5 0 MODE PLEASE POWER INITIATE w AHi THE TIP 1 0 cro DS USE ONLY NEW AND CLEAN TIPS L Figure 7 6 CAUTION If the laser console is in READY mode the laser will fire if the footswitch is activated LASER Never point the laser at a person s eyes All persons present in the WARNING operatory must wear protective eyewear when the laser is in operation EPIC V Series User Manual pg 30 5400430 RevA Pre programmed Settings for Dental Soft Tissue and Surgical Procedures To access the pre programmed procedure values 1 Goto the Procedures menu by pressing the Soft Tissue icon or the Surgical icon on the Home screen 2 Press the button associated with the desired procedure 3 Press the up and down arrows IM to scroll for additional procedures Always use clinical judgment when selecting power pulse length and pulse CAUTION interval parameters to ensure optimal clinical results The recommended settings apply only to
28. m at a person s eyes e Always place the system into STANDBY mode by pressing the Control Button while in READY mode before exchanging Handpieces or disposable tips e Toggle the ON OFF switch located on the rear of the console to the OFF O position before leaving unit unattended LASER Do not open unit housing at any time Danger from optical radiation may WARNING exist Do not aim the laser at metallic or reflective surfaces such as surgical LASE _ Instruments or dental mirrors If aimed directly at these surfaces the laser WARNING beam will reflect and create a potential hazard Be aware that the metal plastic cannula on the tips may become hot during use Avoid contact of the cannula with any tissue CAUTION AI SAFETV FEATURES Energy Monitor The energy monitor measures and verifies power output Power deviations of more than 20 from the selected value will cause the display to show the error message LASER CURRENT HIGH LOW The laser console will not operate until the system first clears the error and then goes into READY mode If the error message persists please contact BIOLASE Service at 1 800 321 6717 System Monitor The system monitors the emergency stop switch remote key wireless footswitch connection and output power An error in any one of these will stop the system The text display will indicate the type of error Operation will not resume until the error is cleared EPIC V Series
29. ng the Footswitch to the Laser console eee rere rena 18 SR GONT OLD MON fo cone RR on nee RP OR ee ee eee 20 4 6 Entering READY or STANDBY Modes cece eeseeeeeeeeseeeseueeseeseueesaeeeaes 20 CC READY MOC sa SS 20 AO Wireless ROO LS WINCH EEN 21 4 9 Peak Power Display eee eee re e ree rea re career rea re area ra nc nana ra nana 21 410 RulSe Mode EH See Eege 21 4 11 Using the EPIC V Series Touch Screen Display 23 4 12 Procedures e E 24 ao Tum ne Laser CONSOIC Oilicccasanssacsncasseasassssecasento E E E 24 Ds OCC INC den E cisse sae N A T P M A E A ene tems sauebeare sue dos A A E AE 25 EE EE E 25 E ee E 25 EEGEN 25 GRE TINS LIE deier 26 6 Contraindications Warnings amp Precautions cccceccccecceseeeeseeeceeeeeseeeeseeesseseseeeesseeeesaaess 27 6 1 GON AINGICAN ONG EE 27 6 2 Warnings and Precautions jair a N nE A Ei ia EE 27 Prescription Be MEET E 27 EVOCAR 21 PUSHING E 21 Adjacent SIN CHUN E 27 Ee 28 Ile E ne all saa ute cine srta EU E sata rena dute sian sein sinenetaeatonnsautsausessaumauteaans 28 UMC AHI SS ci ceedsnndsutasnacatedeaae gemesesanewnsepe nest aroennertneusacsadanadasbasaneataceaas AE A 28 WN o ME 28 FER el Te 1726 ONC AMON pera RI E NS NR RR URIA E E ED 29 TaN air dee UCU ON pe DR RR DRE E SD RCE DE RS A 29 FLMC An tee 29 7 3 Soft Tissue Surgery and Dental Uee e eeereeeereeerea eee rere na neennd 29 Tip Initiation Parameters and Method 29 Pre programmed Settings for Dental Soft Tis
30. not connect or disconnect the fiber while the laser console is turned on RANMA Only connect or disconnect the fiber when the laser console is turned off CAUTION Do not cover or block ventilation channels These channels provide an air flow path to cool the unit CAUTION Do not bend the fiber optic at a sharp angle as it is can break Make sure it is not caught or pinched between the housing and the fiber optic access plug e Remove protective cap from the end of the fiber shaft See Figure 2 4 e Carefully connect the Handpiece to the fiber optic assembly see Figure 2 5 e Insert the selected tip and tighten it clockwise until snug See Figure 2 7 e Wind any excess fiber optic cable onto the fiber spool counterclockwise around the base of the console fa 3 sm Sa The Handpiece is now ready to use To store the Handpiece place it in the Handpiece holder located at the top of the laser console EPIC V Series User Manual pg 16 5400430 Rev A LASER WARNING Never point the laser at a person s eyes LASER WARNING Never operate the laser without a fiber tip attached LASER All persons present in the operatory must wear protective eyewear when WARNING the laser is in use 4 2 OPERATION TURN ON THE EPIC V SERIES e Ensure that the battery has enough charge for operation or connect the power supply cord to the power connector on the laser console and plug the cord into a wall outlet e Turn the
31. nterclockwise direction Figure 2 7 Do not bend the fiber optic at a sharp angle as it is can break Make CAUTION sure it is not caught or pinched between the housing and the fiber optic access plug To disconnect the fiber optic cable from the laser console make sure the cable is completely unwound from the console base grab the fiber optic access plug and slowly pull it straight back from the optical access port EPIC V Series User Manual pg 6 5400430 RevA Figure 2 2 Fiber Optic Access Plug Figure 2 3 Optical Access Port 2 7 SINGLE USE TIPS The tips are single use accessories and are provided in three core diameters 200um 300um and 400um in different lengths see Appendix C Tips are single use only to avoid cross contamination and are designed CAUTION to withstand a single sterilization cycle they must be disposed of after use in a biohazard medical waste Sharps container To connect the tip insert it firmly into the distal end of the Handpiece as far as it will go then tighten by turning clockwise Figure 2 7 Bend the metal cannula according to the specific procedure requirements Figure 2 10 _ To provide proper laser operation do not connect tips when the Handpiece is NOTE disconnected 2 8 SURGICAL HANDPIECE ASSEMBLY gt To connect the Handpiece to the fiber optic assembly push the Handpiece on the fiber shaft until it clicks on and is secured at connected position gt To disconn
32. nual Battery Not Connected Battery not connected FS Battery Low Battery on FS low Wireless Not Paired No wireless connect System must be in READY mode to lase Figure 11 1 pg 41 Plug in Battery Replace FS battery Re establish pairing see Sec 4 System is notin READY Press the Control Button in any mode procedure screen 5400430 Rev A APPENDIX A DEFINITION OF SYMBOLS ON LABELING Date of Manufacture Catalog Part Number Product Serial Number Refer to User Manual Type B Applied Part The applied part is not conductive to the patient EPIC V Series User Manual pg 42 5400430 Rev A THIS PRODUCT COMPLIES WITH FDA l PERFORMANCE STANDARDS FOR FDA Compliance Label LASER PRODUCTS EXCEPT FOR Indicates the device complies with FDA laser DEVIATIONS PURSUANT TO LASER standards NOTICE NO 50 DATED 24 JUNE 2007 P N 5400341 REV A Warning Label Indicates there is the risk of possible exposure to both infrared and visible laser radiation Location Back of laser console NOTICE FCC Compliance Notice aspen ei dt The footswitch and laser console comply with two conditions 1 this device may not Part 15 of FCC Rules regarding unlicensed cause harmful interference and 2 this transmissions device must accept any interference received including interference that may Cause undesired operation Location Bottom of Footswitch MODEL EPIC V SERIES FCC Label 7 Lists Federal Commun
33. or patient comfort ee em eame wa owe mmm canine Mesum ook mmm Figure 7 8 Pain Therapy Warnings and Precautions e Scar tissue has been associated with poor circulation and reduced cooling through heat transport by blood power settings may have to be reduced to avoid overheating e Patients with tender or sensitive skin may be hypersensitive to heat reduce power as necessary to ensure comfort during treatment e Patients with swelling and or inflammation may be sensitive to heat reduce power as necessary to ensure comfort during treatment e Do not treat open wounds EPIC V Series User Manual pg 34 5400430 RevA e Muscle tissue closer to the skin surface may experience a higher absorption of heat carefully monitor skin temperature and reduce power as necessary e Excessive fatty tissue is known to transmit heat without much attenuation reduce power e Different implant materials will respond differently to laser energy and heat be aware of any implants and their location avoid direct exposure to laser energy or heat at the site of the implant e Do not apply ointments creams lotions or heating lotion patches at or in close proximity to the site of treatment e Do not apply therapies prior to treatment that could change body temperature such as ultrasound ice heat pack electrical stimulation or heating patches Using the Deep Tissue Handpiece If holding the Handpiece in a constant location th
34. re or ignite Using the battery in this manner may also result in a loss of performance and a shortened life expectancy CAUTION 1 If the device is to be used by small children the caregiver should explain the contents of the user s manual to the children The caregiver should provide adequate supervision to ensure that the device is being used as explained in the user s manual 2 When the battery is worn out insulate the terminals with adhesive tape or similar materials before disposal EPIC V Series User Manual pg 46 5400430 Rev A 3 Immediately discontinue use of the battery if while using charging or storing the battery the battery emits an unusual smell feels hot changes color changes shape or appears abnormal in any other way Contact your sales location or BIOLASE if any of these problems are observed 4 Do not place the batteries in microwave ovens high pressure containers or on induction cookware 5 Inthe event that the battery leaks and the fluid gets into one s eye s do not rub the eye s Rinse well with water and immediately seek medical care If left untreated the battery fluid could cause damage to the eye WHEN CHARGING THE BATTERY WARNING 1 Be sure to follow the rules listed below while charging the battery Failure to do so may cause the battery to become hot rupture or ignite and cause serious injury e When charging the battery either use a specified battery charger or otherwise en
35. reatment area between 40 C 45 C Use personal clinical judgment with consideration of the fur or coat color when selecting procedure parameters monitor the patient and adjust the settings as necessary for effectiveness and patient comfort CAUTION Do not exceed a skin surface temperature of 47 C A skin surface temperature rise above 47 C for a duration of approximately 16 minutes will cause irreversible skin damage Patients should be monitored for discomfort and visual skin changes Redness has been associated with increased temperature at the site of application and increased absorption properties of the skin If discomfort or redness of the skin occurs at any time during the treatment you have the following options EPIC V Series User Manual pg 33 5400430 RevA e Move the Handpiece relative to the affected anatomy e Defocus the energy by moving the Handpiece further away from the skin e Decrease the power setting e Stop treatment Pre Progammed Settings for Pain Therapy The Epic V comes from the factory already programmed with 12 settings specific to the type of animal being treated Treatment will vary depending on the type of animal the color of its coat light vs dark and in some cases its size You can override and store these pre sets based on your results see Section 7 To store your personal preferred settings for any procedure Always monitor patient response adjust power and or distance as needed f
36. rned to the holder The fiber may break if it is twisted e Press the CONTROL button on the front of the console for more than 2 seconds to turn the display off e Press the Power Switch at the rear of the laser console to the OFF O position if the laser system will not be used for a long period of time EPIC V Series User Manual pg 24 5400430 RevA 5 SPECIFICATIONS 5 7 GENERAL Dimension Weight 5 2 ELECTRICAL Operating Voltage Frequency External Fuses Main Control Remote Interruption Disable Control Battery DC Power Supply Module 5 7 LASER Laser Classification Medium Wavelength Max Power Output Power Accuracy Power Modes Fiber Tips Diameter Pulse Duration EPIC V Series User Manual 5 7 in W x 4 4 in H x 6 5 in L 14 5 cm x 11 2 cm x 16 5 cm 2 5 lbs 1kg 100V 240V at 1 5A 50 60Hz None Power Switch Remote Interlock Emergency Stop Button Lithium lon Rechargeable 14 4V 2 9Ah 12V DC 5A IV 4 InGaAsP Semi conductor diode 940 10nm 10W 20 Continuous Pulse Modulation 200um 300 um 400um 0 01 ms 20 ms pg 25 5400430 Rev A Pulse Interval Pulse Repetition Rate Spot size Surgical Handpiece Deep Tissue Handpiece NOHD Beam Divergence Standard Fiber Cable Length 5 4 OTHER LIGHT SOURCES Aiming Beam EPIC V Series User Manual 0 04 ms 20 ms Up to 20kHz for reference 400 um maximum in contact mode 30 mm diameter 7
37. rocedure Clinical Use Use your clinical judgment to determine all aspects of treatment including but not limited to the laser treatment protocol technique power settings pulse duration and interval settings mode of operation as well as the accessories ed tip type and other procedural requirements Closely observe and monitor clinical effects and use your judgment to determine clinical parameters and approach for the treatment Make appropriate power pulse length and interval adjustments to compensate for varying tissue compositions density and thickness Always start treatment at the lowest power setting for that specific indication and increase as required BIOLASE assumes no responsibility for parameters techniques methods or results raining Only licensed professionals who have reviewed and understood this User Manual should use this device BIOLASE assumes no responsibility for parameters techniques methods or results Physicians must use their own clinical judgment and professionalism in determining all aspects of treatment technique proper power settings interval duration etc EPIC V Series User Manual pg 28 5400430 RevA 7 CLINICAL APPLICATIONS 7 1 INTRODUCTION To efficiently remove tissues it is imperative to understand the nature of the EPIC V Series device Please review this section carefully practice on model tissues and attend a diode laser training session before using this device in a clinical si
38. sely monitored for signs of pain or discomfort at all times by touching the treatment area If such signs are present adjust settings apply anesthesia or cease treatment if required Adjacent Structures EPIC V Series is designed to remove soft tissues Therefore always be aware of adjacent structures and substructures during use Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues Do not direct energy toward hard tissue such as tooth or bone Do not direct energy towards amalgam gold or other metallic surfaces Do not direct energy towards cements or other filling materials Exercise extreme caution when using this device in areas such as pockets cavities or channels such as third molar sockets where critical structures i e nerves vessels could be damaged Do not proceed with using the laser if visibility is limited in these areas EPIC V Series User Manual pg 27 5400430 RevA Suction Use high speed suction as required to maintain a clear field of vision during treatment Do not use the EPIC V Series if you cannot clearly see the treatment site Plume Removal Special care must be taken to prevent infection from the laser plume generated by vaporization of virally or bacterially infected tissue Ensure that appropriate protective equipment including high speed suction to remove the plume appropriately filtered masks and other protective equipment is used at all times during the laser p
39. sue and Surgical Procedures 31 EPICTM V Series User Manual pg 1 5400430 RevA 7 4 Table of EPIC V Series Pre Programmed Geitmgs 32 TO TPO Eeer 33 VS COMMING CO USO aspas Dan E TESE DSO DUE EDS 33 Pre Progammed Settings for Pain Therapy 34 Pain Therapy Warnings and Precautions eee erre ere cre cra nana 34 Using the Deep Tissue Handpiece erre erre era er en erer acre ereaaeen o 35 RE Le 36 S Daily MACACO E 36 8 2 Cleaning and Sterilization Procedures snnnnnnnnennnennennnsnnnsnrnsnrrnnrnnrrrnrrrnnrrerersnrrsnenne 36 Cleaning and Disinfecting Instructions for the Surgical Handpiece and the Reusable Fiber OC CADIO EE 36 To Clean the Surgical And DiC EE 37 Steam Sterilization for Surgical Handpiece Single Use Tips Tip Initiation Block 37 Cleaning the Deep Tissue Handpiece nnnnnnnnnnnannnennnnnnennnrnenrnnnsrrrnnrrnrrrnrrrsnrrenersnrrnnrnne SR 8 3 Installing Replacing the Console Battery Pack 38 8 4 Changing the Wireless Footswitch Batteries cccccsecccceeeeeeeeeeeeeeeseeeeseeeesseeeeseeeesanees 38 Bo PRAMS OOM aU O i E 39 Ree MAR PEN RAD ees RO RD OD DE ED PAES OND RR 39 SAR G2 jo 211 6 q PAON PE Rea IR EE E PRADA NA E ee O UERR E ee DR eee 40 Ol Calbradon SCMCO EE 40 10 Software SPCCINCAL OM E 40 11 Kreien een EE 40 APPENDIX A Definition of Symbols on Labeling A 42 APPENDIX B Safety Precautions for Lithium lon Battery D
40. sure that the battery charging conditions specified are met e Do not attach the batteries to a power supply plug or directly to a car s cigarette lighter e Do not place the batteries in or near fire or into direct sunlight When the battery becomes hot the built in safety equipment is activated preventing the battery from charging further and heating the battery can destroy the safety equipment and can cause additional heating breaking or ignition of the battery 2 Do not continue charging the battery if it does not recharge within the specified charging time Doing so may cause the battery to become hot rupture or ignite CAUTION The temperature range over which the battery can be charged is 0 C to 45 C Changing the battery at temperatures outside of this range may cause the battery to become hot or to break Charging the battery outside of this temperature range may also harm the performance of the battery or reduce the battery s life expectancy EPIC V Series User Manual pg 47 5400430 RevA WHEN DISCHARGING THE BATTERY WARNING Do not discharge the battery using any device except for the specified device When the battery is used in devices aside from the specified device it may damage the performance of the battery or reduce its life expectancy and if the device causes an abnormal current to flow it may cause the battery to become hot rupture or ignite and cause serious injury CAUTION The temperature range
41. the 300um and 400um tips To store your personal preferred settings for any procedure A Follow steps 1 and 2 above B Enter the new values C Touch and hold the Procedure name for more than 2 seconds you will hear a beeping sound confirming the settings are saved The Procedure Pre Sets installed at the factory are based on clinical recommendations and feedback from experienced laser dentists 300um tips are recommended for removing thin tissue layers 400um tips are NOTE recommended for removing fibrous tissue Always use your clinical judgment when selecting power pulse length and pulse interval parameters to ensure optimal clinical results At all times observe the clinical effects on the treatment area and adjust parameters accordingly EPIC V Series User Manual pg 31 5400430 RevA 7 4 TABLE OF EPIC V SERIES PRE PROGRAMMED SETTINGS a fff se i PROCDURE NAME POWER POWER INTERVAL LENGTH CYCLE TYPE INITIATION OC e e e 7 0 80W 1 0ms 1 0ms 50 NN e CROWN 2 W 0 90W 0 20ms 0 10ms 33 0 10W LENGTHENING 2 Im Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and Pulpotomy as an adjunct to root canal therapy LOW 0 10W OW 0 50W LOW 0 10W JON JON 0 10W o JON 0 10W Figure 7 7 EPIC V Series User Manual pg 32 5400430 Rev A 7 5 PAIN THERAPY The EPIC V Series diode laser is designed to provide near infrared laser energy to
42. tuation 7 2 INDICATIONS FOR USE Use of the EPIC V Series device may be appropriate for incision excision vaporization ablation and coagulation of oral soft tissues including marginal and inter dental gingival and epithelial lining of free gingiva and the following specific indications e Gingivectomy e Pulpotomy e Troughing e Crown Lengthening e Currettage o Infected Pockets e Excision e Endo e Frenectomy e Hemostasis e Implant Recovery e Surgical e Perio Pockets e Pain Relief 7 3 SOFT TISSUE SURCER V AND DENTAL USE Tip Initiation Parameters and Method Most soft tissue surgical procedures require initiation of the fiber tip The TIP INITIATION screen will appear in READY mode if tip initiation is recommended while in the TIP INITIATION screen initiate the tip by following the steps outlined below TIP INITIATION PLEASE INITIATE y THE TIP USE ONLY NEW AND CLEAN TIPS Figure 7 1 NOTE Sterilize the tip initiation block as described in Section 8 3 prior to tip initiation EPIC V Series User Manual pg 29 5400430 RevA Tip Diameter um Preset Power W Mode 400 300 200 Tip initiation not required when used for recommended procedures Figure 7 2 e ouch the tip to the surface of the initiation block without activating the laser don t press down on the footswitch Figure 7 3 Figure 7 3 e Press the fooiswitch to activate the laser allowing the tip to sink into the block Pul
43. uously improved through ongoing clinical R amp D and engineering with unmatched training practice integration support and service Made in the USA Copyright O BIOLASE Inc All rights reserved EPIC iLase ezLase ezTip LaserWhite Deep Tissue Handpiece ComfortPulse WaterLase and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE Incorporated in the United States and or other countries All other trademarks are property of their registered owners Subject to change without notice
44. use requires proper clinical and technical training This manual provides instructions for those professionals who have completed the appropriate training When used and maintained properly the EPIC V Series will prove a valuable addition to your practice Please contact BIOLASE Customer Service at 1 800 321 6717 in the USA and Canada for any service needs If you are located outside the U S please contact your BIOLASE authorized distributor for any service needs CANADA This device must be installed and operated according the guidelines of CAN CSA 2386 92 Laser safety in a health care facility BIOLASE EPIC V Series User Manual pg 3 5400430 RevA 1 PACKAGING L7SVSTEM PARTS LIST The EPIC V Series laser system includes the following Laser Console lithium ion battery pack already installed Screen Protectors box Peel off clear screen cover qty 30 Delivery System box Tips box Surgical Handpiece box contains two 2 Surgical Handpieces Three 3 pairs of protective laser eyewear DC power supply and power cord one 1 US and one 1 International User Manual Hard Copy only Welcome Kit Welcome Letter BIOLASE store information Quick Setup Guide Guide to Online Training amp Product Registration Card Tip User Guide Limited Warranty Information 10 Laser Warning Sign 11 Tip Initiation Kit 12 Remote Interlock cable 13 Philips head screwdriver for installing Footswitch batteries 14 Foots
45. witch 15 AAA batteries 2 ee a ee ee eS IND NOTE The laser ships with the lithium ion battery pack already installed Use proper care when transporting the unit Refer to Section 8 in this User Manual for instructions WARNING No modification of this equipment is allowed 1 2 FACILITY REQUIREMENTS Electrical Supply 100 240V 1 5A 50 60Hz Environmental Requirements Temperature 20 25 C Humidity 15 95 Non condensing NOTE EPIC V Series User Manual pg 4 5400430 RevA 2 EQUIPMENT DESCRIPTION 2 7 GENERAL The EPIC V Series system consists of three components e Base Console e Delivery System e Wireless Footswitch 2 2 BASE CONSOLE The Console has a Display Panel Touch Screen and Control Button in front It can be powered by an external mains power supply or an internal replaceable lithium ion battery pack 14 4V 2 9 Ah 2 3 CONTROL PANEL ITEM ITEM DESCRIPTION Turns the controls and display on and GA off places the unit into STANDBY or Button READY or SLEEP mode LED Indicator LED Indicator Po fe Amberindicates unitisin STANDBY mode e Green indicates unit is in READY mode LED e Blinking green indicates the Indicator emission of laser power e Blinking blue indicates pairing between the footswitch and laser Control Button console is active Fiqure 2 1 Control Panel Front View UE ee EPIC V Series User Manual pg 5 5400430 RevA
46. witch and laser console are paired a blue LED indicator light on the laser console will blink when pairing is established The laser and footswitch are shipped already paired However if pairing is not confirmed an ES will appear in the pairing icon located in the upper left hand corner of the touchscreen Figure 4 6 i DENTAL PAIN soFTTISSUE SURGICAL THERAPY o Figure 4 6 EPICTM V Series User Manual pg 18 5400430 Rev A To re establish pairing take the following steps O 1 Go to the Settings menu on the laser console display by pressing the Settings button and select the Wireless icon WIRELESS Wer 2 screen will appear indicating that pairing of the E 26 footswitch to the laser console has been lost Figure 4 7 ts ES PAIR press the green PAIR button Figure 4 7 WIRELESS 3 The message that PAIRING WILL NOW BEGIN will appear press the green check mark to continue PAIRING WILL NOW BEGIN E EXISTING CONNECTION WILL BE RESET CONTINUE Figure 4 8 x Figure 4 8 WIRELESS 4 To complete the pairing process turn the footswitch over PRESS FOR 4 SECONDS and press the Pairing Button Figure 4 9 WIRELESS 5a The Wireless screen will appear indicating that pairing Y Ki was successful and that the footswitch and laser console Gomm are now paired Figure 4 10 Proceed to step 6 0 Figure 4 10 EPIC V Series User Manual pg 19 540043
47. xidizing gases such as nitrous oxide N O and oxygen should be avoided solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before laser is used Attention should also be drawn to the danger of ignition of endogenous gases e All persons present in the operatory must wear protective laser eyewear NOTE For replacement or additional protective laser eyewear please contact BIOLASE CAUTION Periodically inspect laser eyewear for pitting and cracking LASER Use of controls or adjustments or performance of procedures other than WARNING those specified herein may result in hazardous radiation exposure WARNING Do not use this unit if you suspect it of functioning improperly or other than described herein This unit has been designed and tested to meet the requirements of electromagnetic electrostatic and radio frequency interference standards However the possibility of electromagnetic or other interference may still exist Relocating the device may help to eliminate the interference CAUTION Always ensure that the proper laser parameters are set before the EPIC V Series laser is used in a clinical setting CAUTION EPIC V Series User Manual pg 11 5400430 Rev A LASER Always ensure that the protective laser eyewear is appropriate for the WARNING laser wavelength e Do not look directly into the beam or at specular reflections e Never direct or point the bea
Download Pdf Manuals
Related Search