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User Manual - Biolase Romania

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1. Tips are single use only to avoid cross contamination and are designed to withstand only a single sterilization cycle they must be disposed of after use in a CAUTION biohazard medical waste Sharps container Always visually inspect the tip prior to use to make sure it is free of debris or damage Be aware that the metal plastic cannula on the tips may become hot during use Avoid contact of the cannula with any tissue CAUTION 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 4 Bend the metal cannula according to the specific procedure requirements Figure 2 7 Remove the fiber tip by twisting the tip counterclockwise Figure 2 5 EPICTM S Series User Manual pg 8 5400463 EU Rev A 12 13 Tip Assembly Figure 2 4 Insert the fiber tip into the handpiece and twist clockwise until snug Figure 2 5 Remove the fiber Tip by twisting the tip counterclockwise W af aL Correct Bend T emm JV i zal Incorrect Bend Figure 2 6 When installing the tip make sure it is Figure 2 7 Bending the tip cannula seated properly thread correctly To provide proper laser operation do not connect tips when the handpiece is NOTE disconnected When the aiming beam is not present or has a significantly asymmetrical shape VOR change the tip EPICTM S Series User Manual pg 9 5400463 EU Rev A 12 13 2 8 SURCIC
2. User Manual TABLE OF CONTENTS TABLE OF CONTENT os ta 1 nn RR O 4 LE es e ELO lee EE 5 A e o O PR E E 5 1 2 Facility ReQUIFEMERIS coi TT 5 2 EQUIPA DESCI o o AP 6 E A rol TT Tm 6 2 2 oo AA o POE ROMEO O ROSE ES CO OOO E A 6 gg Conto PANO masai ERO e nMEIVREDII UN 6 2 4 Surgical Delivery SIC iio Ia Do as dio sia 7 2 6 Fiber Optic Connection nennen enne nene nnn nnn nnns nnne ns 7 Ze laa 0 ME o seer eee eee eee eee ee ee DR SOR SR E DR ee 8 2 8 Surgical E Lull EE 10 2 9 Deep Tissue Handpiece nennen nennen nenne ne nnne nnne snas nans 11 ST oe A Y 12 Sl Le el sr reyes techn O M OVEM E UE ER PII EU MEL ER ER E ceda 12 Du grelv Insti Egger 12 SEENEN 13 sins qe INI OUILOF sr saio ea Sonate conten 13 E eege 13 PONOT NC EE 14 ACCESS Key COJO EN 14 CONTO DUO WEE 14 WISIESS TOOLS WI No animes aie Ei 14 Remote Interlock AA 15 o ME 16 FPUNICHONIAL DISDIAY mr a iveyne eviverseyineyne aA UReUn UinaeenaRNnAUinaeLnoN 16 3 4 Safety Caseticaton nennen nennen nnns nans rsen nnn 16 CFA Oy EE eio ETT TT 17 a VV cub E 17 4 2 Operation Turn on the EPIC G Geneslaser erraram 18 EPIC S Series User Manual pg 1 5400463 EU Rev A 12 13 BO RES EEE E K E A A T PO AO EE A AA A E E E 19 4 4 Pairing the Footswitch to the Laser console ooocconcccocccconccnoccconcconcnconcnnnncconcncnncnnnnnonnnnnns 19 A e o 21
3. IEC61000 4 3 80 MHz to 2 5 GHz Recommended separation distance d 1 2vP d 1 2VP 80 MHz to 800 MHz d 2 3VP 800MHz to 2 5GHZ Wher P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d 8s the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A Field strengths from fixed transmitters such as base stations for radio cellular cordless telephone and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Epic 10 is used exceeds the applicable RF compliance level above the Epic 10 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the
4. 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 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 S 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 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 your authorized service representative EPICTM S Series User Manual pg 49 5400463 EU Rev A 12 13 Message a Reason Error 1 Thermistor Open Thermistor Open Call BIOLASE Service Error 2 Thermistor Shorted Thermistor Shorted Error 3 Shutdown Temperature System too hot n 9 10 mins for laser to cool Error 4 Laser Current High Low Output is out of specs Call BIOLASE Service Error 5 FS shorted in Standby Pete pressed or lee FS or call Biolase Error 6 ON OFF button Stuck Key stuck Pr
5. Wm tone Les 0m sugar m tus 0 126 0 126 0 126 Vaporization ofthe prostate to treat benign prostate DEZ None Continuous 20 MT MIXTA MIT Suse 4m 016 20 o oo EPIC S Series User Manual pg 36 5400463 EU Rev A 12 13 STEET Total Energy Pulse EH Treatment Handoi Fiber Size Spot Size MES kJ Interval pica Time sec PRAN um mm Photocoagulation of vascular amp dermatological lesions 15 190 5 ora Conii 120 Surgical 0 126 ofthe face and extremities Photocoagulation of telangiectasia veinulectasia of the 15 190 5 W s to 120 Surgical 0 126 legs and face i Treatment of reticular veins and branch varicosities 190 5 0 126 Temporary increase of clear nail in patients with 254 TN Comm 30 ON 30 OFF Deep Tissue 30 onychomycosis 30 ON Figure 7 7 Pre programmed Surgical Settings The following initial clinical settings are based on clinical case reports combined with in vitro testing however they are not universal Observe the tissue under treatment closely during the procedure and adjust the average power as needed to achieve optimum clinical outcomes with minimal collateral tissue damage NOTE To access the pre programmed procedure values 1 Goto the Procedures menu by pressing the Surgical icon N on the Home screen 2 Press the button associated with the desired procedure To store your personal preferred settings for any procedure A Follow steps 1 and 2
6. Pain Therapy Warnings and Hrecautons eene 42 MNECOMMENDCA USO icaden 42 Using the Deep Tissue Handpiece ccoccccoccccccncccnccocncnnnonncnnnnnonnnnconrnnnnnnnnrnnnnnnnnrnnnnnnnnnnnnnrs 43 E Te 44 Ss Daly ET e 44 8 2 Cleaning and Sterilization Procecdures nennen 44 Cleaning and Disinfecting Instructions for the Surgical Handpiece and the Reusable Fiber Soid6 o P 44 Manual Cleaning of the Surgical Handpiece occccoccnccccncccccnccncncnncnononnnonncnnnonnnnnnnncnncnnnos 45 Steam Sterilization for Surgical Handpiece and Single Use Tips 45 Cleaning the Deep Tissue Handoece enne 46 8 3 Installing Replacing the Console Battery Pack 47 8 4 Changing the Wireless Footswitch Batteries oocccoccccocnccccncoononanocnnnconcononnnnncnonanonons 47 lla ooo AAA E sm mye aeds 48 o o ge ONO OPA Pe E PRA PR PRN E E 48 ele A 49 OC loci El TE 49 10 Software Specification seeessesssssssseseseeee nennen nnne nnne nennen nnne nnne nnns nans nasse nns 49 K Lolo S OO MING MANET mm 49 APRENDIZ Tip BE caia 51 APPENDIX B Definition of Symbols on Labeling eee 52 APPENDIX C Safety Precautions for Lithium lon Battery Dacks 56 APPENDIX D Spare Parts 8 ACceseories nennen nennen 59 APPENDIX E Electromagnetic Compatibility ooocccooccccocnnocccncononnnnanononcnonnnnnnoncnnnos
7. 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 S 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 your BIOLASE authorized service representative 8 6 STORAGE The EPIC S Series should be stored in a cool dry place when not in use Storage temperature 15 C 35 C relative humidity 10 70 non condensing 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 with the protective tip plug and handpiece CAUTION Remove the batteries from the footswitch if the EPIC S Series is not likely to be used for some time The EPIC S Series is shipped inside a custom shipping box Please save and store the box in a cool dry place for use when transporting the laser or for long term storage EPICTM S Series User Manual pg 48 5400463 EU Rev A 12 13 9 CALIBRATION 9 1 CALIBRA TION SCHEDULE
8. 12 13 4 OPERATION INSTRUCTIONS 4 75Y57 M 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 S 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 S 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 NOTE The system ships from the factory with the fiber already connected to the laser console 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 CAUTION Do not connect or disconnect the fiber while the laser console is turned on Only connect or disconnect the fiber when the laser console is turned off CAUTION Do not cover or block ventilation channels The
9. 4 6 Entering READY or STANDBY Modes oocccoccccccncoccccncnccocconcnconcnnnnncnnconnnnonnnnnnnnnnncnonanonos 21 a READY lee MER T Um 22 2 0 WIrelessFOOLSWILOLI EE 22 4 9 Peak Power RE UE 22 4 10 Pulse ee EE 23 4 11 Using the EPIC S Series Touch Screen Display 24 4 12 Surgical Procedures Selection Screen eene 25 SN uek CURBE dT TERR UU m 25 4 14 Turn the Laser console Om 26 wD OO CIC MNT 27 NEP o E o ES E E E 27 Dee Ee Le EE 21 E EE 21 SE PO plo le wie 28 Contraindications Warnings amp Precautions ee eeererereeeerree renan nnns 29 651 GOntamalca e q EE 29 6 2 Warnings and Precautions esses nennen nennen nnne nnns nennen 29 c 29 Aen E E 29 Adjacent SUC RTE 29 wee eT 29 POME ue mmm 29 SRU nico 30 Ici E M 30 gO ING AN PO ON te EE 31 Pel INF O GUC OM am 31 Fae glo e PA 31 Lo DOI TISSHO IO astron 33 Tip Initiation Parameters and Method 33 LA Table elle Uer Kul EE 34 EPIC S Series User Manual pg 2 5400463 EU Rev A 12 13 Pre programmed Surgical Settings nennen nennen 97 7 5 Table of Pre Programmed SURGICAL Settings ri 38 A e Rate La o A P Po E bere metNCONnENDS 39 Pre programmed Pain Therapy Gettmge nn 40 7 7 Table of Pre Programmed Pain Therapy setimgs erraram 41 Pain Therapy Adverse Effects eege id EN 41
10. 5 120 CAE 0 126 pathology TM N NM NH IM Excision E E acuminata SES 190 5 Continuous Eos ia 0 126 Le pm EPICTM S Series User Manual pg 35 5400463 EU Rev A 12 13 EE CN Jl wen Pm Leer EE kJ Interval Time sec um mm Wemsmsmcwwenwhnenwoms 15 1005 none Comme 100 Leila om gt Perwareos Ds Decompression pup 2 2 wore Contnmus 2 Leila om o Deywosbsom mscr 12 e Ww como mm m m um pence E 2 Ww Gs mm Suir ao om o Wmrb m 2 2 Ww Leer m5 sui ao om o Berion and genial 2 a wore coros swa o om Coagulation and hemostasis of cardiac tissue 190 5 Surgical 40 0126 EE None Continuous MP mM NM MN F N swe m ore seu a am 254 254 254 254 254 254 254 254 254 254 1 5 P ericardiectomy Coagulation of blebs and bullae 0 5 2 5 seu wm sea wm seu om sea m EECHER m Circumcision hyperplasia BP H Treatment of reticular veins and branch varicosities Surgical eee o om me eme m pm m pm Teogecisias 13 395 195 twee 3 Ses 49 Lu been s me 195 mes mm Siew 49 Lu Pormes f 15 1 15 tms 1m sms m tm Laien s os 195 Les mm Sw a Lu benigneitemalpiomentstns as moms 15 195 105 www 5 swa 46 tms gt temer fas m 195 common mm m m tm Smer as amos Coro 3 wks 4 am Ww Como 0 Sumit am
11. Always use clinical judgment when selecting power to ensure optimal clinical CAUTION results Observe the clinical effects on the treatment area at all times and adjust settings parameters accordingly To store your personal preferred settings for any procedure A Follow steps 1 and 2 above B Enter the new values EPICTM S Series User Manual pg 40 5400463 EU Rev A 12 13 Touch and hold the condition name for more than 2 seconds you will hear a beeping sound confirming the settings are saved The pain therapy pre sets installed at the factory are based on clinical NOTE T recommendations and feedback from experienced laser medical practitioners 7 7 TABLE OF PRE PROGRAMMED PAIN THERAPY SETTINCS TIME PROCEDURE NAME ES SETTING SECONDS ENERGY J SPACER CW JOINT PAIN Continuous 4 W 2400 30 mm CW MUSCLE PAIN Continuous 4 W 300 1200 30 mm CW MUSCLE SPASM Continuous 300 1200 30 mm CW CUSTOM Continuous 4 W 240 Figure 7 10 Pain Therapy Adverse Effects oome reddening of the skin at the treatment site is normal due to increased circulation however in very rare cases burning or blistering of the skin may occur Immediately stop treatment rinse the area with cool water or place a cold pack to the affected area for at least 5 minutes then apply a burn ointment or spray DO NOT USE ICE Patients should be monitored for discomfort and visual skin changes Redness has been associated with increased tem
12. Epic 10 B Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m EPIC S Series User Manual pg 62 5400463 EU Rev A 12 13 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EPIC 10 The Epic 10 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Epic 10can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Epic 10 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter M output power of 150kHz to 80Mhz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d 1 2vP d 1 2vP d 2 3vP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHZ the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affe
13. including soft tissue in the oral cavity such as e Removal of benign lesions from ear nose and throat e Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in situ Ablation and vaporization of hyperkeratosis Laryngeal papillectomy Excision and vaporization of herpes simplex and Il e Neck dissection Arthroscopy Hemostasis incision excision vaporization and ablation of joint tissues during arthroscopic surgery such as e Meniscectomy e Syovectomy e Chondromalacia Gastroenterology Hemostasis incision excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy such as e Hemostasis of upper and lower GI bleeding e Excision and vaporization of colorectal carcinoma e Excision of polyps e Hemostasis of colonoscopy e Hemostasis of esophageal varices Orthopedics e Dissectand coagulate General Surgery Dematology amp Plastic Surgery and Podiatry Excision ablation vaporization and photocoagulation of skin lesions hemostasis incision excision vaporization ablation and debulking of soft tissue abdominal rectal skin fat or muscle tissue and dermabrasion such as e Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Hemorrhoidectomy Hepatobiliary Mastectomy Appendectomy Deb
14. used in order to maintain sterility 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 Always wipe the disposable shield with alcohol prior to use Dispose of after one time use EPICTM S Series User Manual pg 46 5400463 EU Rev A 12 13 8 3 INSTALLINC REPLALINC THE CONSOLE BATTERY PACK 1 To install or replace the battery pack remove the battery cover on the underside of the console using the Phillips 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 three 3 hours Once the battery i
15. 2 4 2004 m E2 20 1400018 1400021 20 1400015 200um Ie CO Oo 200um c rri GO KA KA CO I I CO un un c ul UI c i All Biolase tips for diode lasers are sold non sterile and are for single use NOTE only See Section 8 2 for sterilization instructions EPICTM S Series User Manual pg 51 5400463 EU Rev A 12 13 APPENDIX B DEFINITION OF SYMBOLS ON LABELING sil BIOLASE MT Promedt Consulting GmbH 4 Cromwell Altenhofstrasse 80 Irvine C 92618 USA D 66386 St Ingbert GERMANY EPIC S SERIES 7400054 EU Product ID Label XAXXXXX YYYY MM ur Location Bottom of laser console 12V 5A Li lon Rech eable Battery 14 4 V 2 9 Ah BASS EV Rey A 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 EPICTM S Series User Manual pg 52 5400463 EU Rev A 12 13 THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER FRODUC LS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO 50 DATED 24 JUNE 2007 P N 5400341 REV A 3 mal BIOLASE MT Promedt Consulting GmbH 4 Cromwell Altenhofstrasse 80 Irvine CA 92618 USA D 66386 St Ingbert GERMANY EPIC S SERIES FOOTSWITCH 6400516 PPXXXXX 2013 08 IPX6 Made in e USA NOTIC This device complies with Part 15 of FCC Rules Operation is subject to the following two conditions 1 t
16. 61 APPENDIX F Wireless Equipment Compliance Giatement eee 64 EPICTM S Series User Manual pg 3 5400463 EU Rev A 12 13 INTRODUCTION The EPIC S Series diode laser is a surgical and therapeutic device at the cutting edge of technology designed for a wide variety of surgical soft tissue procedures as well as for use in providing temporary relief of minor pain The EPIC S 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 surgical applications The device is activated by means of a wireless footswitch This is a prescription device that is indicated for professional use only by licensed medical practitioners The use of this device requires proper clinical and technical training This manual provides instructions for those professionals that have completed the appropriate training When used and maintained properly the EPIC M S Series will prove a valuable addition to your practice Please contact your BIOLASE authorized distributor for any service needs EPICTM S Series User Manual pg 4 5400463 EU Rev A 12 13 1 PACKAGING 1 7 SYSTEM PARTS LIST The EPIC S Series laser system includes the following Laser console lithium ion battery pack alr
17. AL HANDPIECE ASSEMBLY gt Connect the handpiece to the fiber optic assembly by pushing the handpiece on the fiber shaft until it clicks on and is secured at connected position Figures 2 8 2 9 Fiber Shaft Protective Cap Handpiece e Figure 2 9 Surgical handpiece Assembly fully assembled gt Disconnect the handpiece from the fiber optic assembly Figure 2 10 by 1 Taking the handpiece body in one hand and the shaft in the other 2 Pushing the two buttons on the Fiber Shaft 3 Pulling the handpiece with the ring to separate Figure 2 10 Disconnect the handpiece from the fiber optic assembly by pressing both buttons at the base of the Fiber Shaft EPICTM S Series User Manual pg 10 5400463 EU Rev A 12 13 2 9 DEEP TISSUE HANDPIECE 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 cleaning 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 Red Cap Dust Cover Handpiece Disposable Shield Figure 2 15 Deep Tissue Handpiece e Remove Red Cap Dust Cover from the Deep Tissue Handpie
18. ND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The model Epic 10 is intended for use in the electromagnetic environment specified below The customer or the user of the model Epic 10 should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact t 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2kV common mode 596 U 59596 dip in UT for 0 5 cycle 4096 U 6096 dip in UT for 5 cycles 7096 U 3096 dip in U for 25 cycles 596 Ur 59596 dip in U for 5 seconds 3 A m Continuous level 6 kV contact 8kV air 2 kV for power supply lines N A 1 kV differential mode 2kV common mode 596 U gt 95 dip in UT for 0 5 cycle 40 U 60 dip in UT for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in U for 5 seconds 3 A m Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material relative humidity should be at least 5096 Main power quality should be that of a t
19. User Manual pg 26 5400463 EU Rev A 12 13 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 S 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 75 lbs 1 25 kg 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 Semiconductor diode 940 10nm 10W 20 Continuous Pulse Modulation 200um 300 um 400um 0 01 ms 20 ms pg 27 5400463 EU Rev A 12 13 Pulse Interval 0 01 ms 20 ms Pulse Repetition Rate Up to 20kHz for reference opot size Surgical Handpiece 400 um maximum in contact mode Deep Tissue Handpiece 30mm diameter 7 1 cm area NOHD 4 77 meters Beam Divergence 8 22 per side angle otandard Fiber Cable Length 6 8 feet 2 meters 5 4 OTHER LIGHT SOURCES Aiming Beam Laser diode max 1 mW 625 nm 670 nm EPICTM S Series User Manual pg 28 5400463 EU Rev A 12 13 6 CONTRAINDICATIONS WARNINGS e PRECAUTIONS 6 1LONTRAINDICA TIONS All clinical procedures performed with EPIC M S Series must be subjected to the same clinical j
20. 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 300um tips are recommended for removing thin tissue layers 400um tips are recommended for removing fibrous tissue NOTE Always use your clinical judgment when selecting power pulse length and pulse interval parameters to ensure optimal clinical results Observe the clinical effects on the treatment area at all times and adjust settings parameters accordingly EPICTM S Series User Manual pg 97 5400463 EU Rev A 12 13 CW Continu ous Appendectomy Debridement of decubitus ulcer Excision vaporization and hemostasis of abdominal EXCISION cystectomy Tumor excision Benign and malignant pulmonary obstruction P ulmonary resection 7 5 TABLE OF PRE PROGRAMMED SURCICAL SETTINGS ay Procedure Name Neck dissection Dermabrasion Herniorrhaphy Open DCR Blepharoplasty Tracheobronchial malignancy or INCISION stricture Thoracotomy Release of urethral stricture Continu Removal of bladder neck obstruction Lesions of external genitalia Circumcision tumors Excision vaporization and hemostasis of rectal pathology Pilonidal cystectomy P arathyroidectomy Laparoscopic cholecystectomy Thyroidectomy P ericardiectomy Excision and vaporization of condyloma Dermatological surgery Condyloma acuminate Warts Small non malignant skin tumors Removal of benign lesions from
21. acic Surgery Thoracotomy Pulmonary resection Hemostasis P ericardiectomy Adhesiolysis Coagulation of blebs and bullae Figure 7 1 pg 32 Urology Hemostasis vaporization incision coagulation ablation and excision of tissues such as Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Circumcision Vaporization of the prostate to treat benign prostate hyperplasia BPH Dermatology Aesthetics Photocoagulation of vascular amp dermatological lesions of the face and extremities Photocoagulation of telangiectasia venulectasia of the legs and face Treatment of reticular veins and branch varicosities P yrogenic granuloma lymphangioma and lymphangiomatosis disease angiofibromas Superficial benign vascular lesions including Telangiectasias hemangioma Port wine stains angiokeratoma and benign epidermal pigment lesions as lentigines epidermal nevi spider nevi Dermatological surgery Condyloma acuminate warts small non malignant skin tumors small semi malignant tumors as basaliomas Bowe and Kaposi sarcoma warty leucoplasty and ulcers debridement Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment Vascular Surgery Photocoagulation of vascular amp dermatological lesions of the face and extremities Photocoagulation of telangiectasia veinulectasia of the l
22. ammer 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 rupture 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 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 EPICTM S Series User Manual pg 56 5400463 EU Rev A 12 13 appears abnormal in any other way Contact your sales location or BIOLASE if any of these prob
23. been soaked in the cleaning solution leave it wrapped in the gauze for a minimum of 10 minutes 6 Unwrap the handpiece from the gauze and use a soft bristled brush dipped in the cleaning solution to gently scrub it for at least 15 seconds 7 Rinse the handpiece under running lukewarm tap water 22 43 C for a minimum of 10 seconds and then dry with a lint free cloth 8 Visually inspect the handpiece for any residual soil If necessary repeat steps 5 7 until all residual soil is removed Steam Sterilization for Surgical Handpiece and Single Use Tips The steam sterilization process is intended to destroy infectious microorganisms and pathogens Always perform the procedure immediately after cleaning and priorto use and only NOTE use CE marked sterilization accessories i e sterilization pouch and autoclave tray e Place the handpiece and fiber tips in separate single wrap self seal autoclave pouches e Place on an autoclave tray do not stack other instruments on top of the pouches e Place the tray inside the autoclave chamber and set the appropriate cycle as recommended in Figure 8 1 EPICTM S Series User Manual pg 45 5400463 EU Rev A 12 13 Gravity Displacement 15 30 minutes 132 C Dynamic Air Removal Pre Vacuum 20 30 minutes NS NS Figure 8 1 e Once the cycle is completed remove the tray and let each sterilized item cool and dry The handpiece and tips must remain in the sterilization pouches until
24. ce e Slide the handpiece over the shaft until it clicks into place Figure 2 16 e Place the protective shield over the adjustable spacer Figure 2 17 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 EPICTM S Series User Manual pg 11 5400463 EU Rev A 12 13 3 SAFETY 3 7 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 e When the laser is in use all operatory entrances must be marked with an appropriate warning sign one 1 included EE e Do not operate in the presence of explosive or flammable materials Flammable anesthetics or oxidizing 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 re
25. cted by absorption and reflection from structures objects and people EPICTM S Series User Manual pg 63 5400463 EU Rev A 12 13 APPENDIX F 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 energy 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 Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help EPICTM S Series User Manual pg 64 5400463 EU Rev A 12 13 BIOLASE Inc 4 Cromwell Irvine CA 92618 USA 9493611200 888 424 6527 bi
26. d for patient comfort EPICTM S Series User Manual pg 43 5400463 EU Rev A 12 13 8 MAINTENANCE WARNING No modification of this equipment is allowed 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 S 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 S Series Surgical Handpiece and tips is the steam sterilization method However before sterilization the EPIC S Series reusable handpiece should be carefully cleaned per the following procedure Handpiece and tips must be sterilized prior to initial use Tips are single use only to avoid cross contamination and are designed to CAUTION withstand a single sterilization cycle they must be disposed of after use ina 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 surfaces and crevices of reusable accessories This process may also reduce the quantity of particles microorganisms and pathogens present Cleaning should be perfor
27. eady installed Screen Protectors Peel off clear screen cover qty 30 Delivery System installed Tips Surgical Handpieces 2 Deep Tissue Handpiece 1 shipped separately 6 Three 3 pairs of protective laser eyewear two 2 pairs of doctor safety glasses one 1 pair of darker patient safety glasses 7 One 1 DC power supply and power cord 8 Welcome Kit Welcome Letter Product Registration Card Limited Warranty Information User Manual 9 Laser Warning Sign 10 Tip Initiation Kit 11 Remote Interlock cable 12 Philips head screwdriver for installing Footswitch batteries 13 Footswitch 14 AAA batteries 2 A dee uo qu t 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 NOTE Manual for instructions WARNING No modification of this equipment is allowed Z2 FACILITY REQUIREMENTS Electrical Supply 100 240V 1 5A 50 60Hz Environmental Requirements Temperature 20 25 C Humidity 15 9596 Non condensing EPIC S Series User Manual pg 5 5400463 EU Rev A 12 13 2 EQUIPMENT DESCRIPTION 2 7 GENERAL The EPIC S Series system consists of three components e Laser console e Delivery System e Wireless Footswitch 2 2 LASER 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 inte
28. ear nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in situ Laryngeal papillomectomy Meniscectomy S yovectomy Excision and vaporization of colorectal carcinoma Excision of polyps Excision of neuromas Excision of periungual and subungual warts Excision of plantar 2 Resection of organs Excision or vaporization of S mall semi malignant tumors and basalomas Bowe Warts Excision of keloids Excision of cutaneous lesions condylomata acuminate Myomectomy Ovarian Kaposi sarcoma Warty leucoplasty Mixoid cyst Ablation and vaporization of hyperkeratosis Excision and vaporization of herpes simplex and Il Hemorrhoidectomy Vaporization and hemostasis of capillary hemangioma Vaporization of CIN cervical intraepithelial neoplasia Cervical conization VAPORIZATION Percutaneous disc decompression PLDD o Continu Dacryocystorhinostomy transcanalicular Adhesiolysis Vaporization of urethral tumors Vaporization of the prostate to treat benign prostate hyperplasia BP H P yrogenic granuloma lymphangioma and lymphangiomatosis disease angiofibromas S eborrheic keratosis Acne treatment EPICTM S Series User Manual pg 38 5400463 EU Rev A 12 13 Chondromalacia Hemostasis of upper and lower GI bleeding Hemostasis of colonoscopy Hemostasis of esophageal varices Dissect and coagulate Matrixectomy Hemostasis in conjunction with meningiomas Coagulation and
29. eat steps 3 da 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 EPIC S Series User Manual pg 21 5400463 EU Rev A 12 13 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 the footswitch will activate laser radiation There is a two 2 sec delay between switching to READY mode and the ability of the laser con
30. ectric 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 EPICTM S Series User Manual pg 15 5400463 EU Rev A 12 13 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 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 1 e Type of protections against electrical shock Class 1 e Degree of protection against electrical shock Type B 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 Wave and Pulse Mode e Wireless Footswitch IPX6 EPIC S Series User Manual pg 16 5400463 EU Rev A
31. efore 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 Figure 7 6 TIP INITIATION INCISION 1 0 PLEASE F BEER INITIATE THE TIP 10 USE ONLY NEW AND CLEAN TIPS EPICTM S Series User Manual pg 33 5400463 EU Rev A 12 13 7 4 TABLE OF SURCICAL SETTINGS Figure 7 7 represents the recommended initial clinical settings for each indication for use based on clinical case reports combined with in vitro testing During any of the following procedures you must observe the tissue under treatment closely and adjust the average power as needed to achieve optimum clinical outcomes with minimal collateral tissue damage Always use clinical judgment when selecting power pulse length and pulse CAUTION interval parameters to ensure optimal clinical results These recommended settings apply only to the 400um tips EPICTM S Series User Manual pg 34 5400463 EU Rev A 12 13 E E E TF Indication for Use Ge Pulse Interval Pulse Length uid ba et SO EE E OlyDps sedens 7 a Wwe Coniuow um ws am lm horon and vaporaion oriee 1 2 24 we commos xm Lal am am Lage aptomectny 2 a Wwe cana
32. egs and face Treatment of reticular veins and branch varicosities Pain Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis pain or muscle spasm minor sprains and strains and minor muscular back pain the temporary increase in local blood circulation the temporary relaxation of muscle Podiatry Temporary increase of clear nail in patients with onychomycosis e g Dermatophytes Trichophyton rubrum and T mentagrophytes and or yeast Candida Albicans etc 5400463 EU Rev A 12 13 7 3 SOFT TISSUE SURGERY 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 and the system will automatically go to the settings shown in Figure 7 2 based on the tip used while in the TIP INITIATION screen initiate the tip by following the steps outlined below Tip Diameter um Preset Power W 400 1 4 Tip initiation not required when used for recommended procedures Figure 7 2 e Touch 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 footswitch to activate the laser allowing the tip to sink into the block Pull the tip out when the metal cannula touches the block still firing until just b
33. ess Front key Error 7 Flash Corrupted Memory Corrupted Call BIOLASE Service Error 8 Fiber not inserted Plug in Trunk Fiber Reposition console or FS to Error L F witch mmunication Wireless Interference et d EE EH Improve communication Error 10 Emergency Switch E Switch Pressed Press E Switch Again Error 11 Remote Interlock Remote interlock open Check Remote Interlock closed Error 12 T Battery Critically Low Battery Critically Low Plug in DC supply Warning 1 Temp High System is hot GC 5 10 mins for laser to cool own Warning2 E Battery Low Battery is low Plug in DC supply Warning 3 Battery Not Connected Battery not connected Plug in Battery Warning 4 5 FS Battery Low Battery on FS low Replace FS battery Alert 1 lee Wireless Not Paired No wireless conneci Re establish pairing see Sec 4 Alert 2 System must be in READY System is notin READY Press the Control Button in any S mode to lase mode procedure screen Figure 11 1 EPICTM S Series User Manual pg 50 5400463 EU Rev A 12 13 APPENDIX A TIP GUIDE Diameter Length Part Number um mm i Tip Name 2 lt E4 4 400um 7400016 E4 7 4004 m 1400019 Combo Pack 15 x E4 7 15 x E4 9 1400017 1400020 Combo Pack E4 9 400u m E3 4 300um 3004 m 15 x E3 7 15 x E3 9 E3 9 300um LA O E
34. est power setting for that specific indication and increase as required BIOLASE assumes no responsibility for parameters techniques methods or results Training 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 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 S Series User Manual pg 30 5400463 EU Rev A 12 13 7 CLINICAL APPLICATIONS ZTIWIR DUCT ON To efficiently remove tissues it is imperative to understand the nature of the EPIC S 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 situation 7 2 INDICATIONS FOR USE The EPIC S Series is intended for use as a laser surgical instrument for use in general surgery plastic surgery and dermatology procedures as noted in Figure 7 1 EPIC S Series User Manual pg 31 5400463 EU Rev A 12 13 Ear Nose and Throat and Oral Surgery Hemostasis incision excision ablation and vaporization of tissues from the ear nose throat and adjacent areas
35. he patient s condition throughout the treatment EPIC S Series User Manual pg 39 5400463 EU Rev A 12 13 Refer to the Fitzpatrick Skin Type Scale Figure 7 9 when performing pain therapy procedures 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 Patients with higher melanin content in their skin may feel more discomfort during treatment which may be alleviated by moving the handpiece defocusing the energy or decreasing the power setting Fitzpatrick Skin Type Scale Highly sensitive always burns never tans Example Red hair with TYPEI freckles Very sun sensitive burns easily tans minimally Example Fair skinned TYPE Il gef fair haired Caucasians Sun sensitive skin sometimes burns slowly tans to light brown TYPE lll i Example Darker Caucasians Minimally sun sensitive burns minimally always tans to moderate TYPE IV l brown Example Mediterranean type Caucasians Sun insensitive skin rarely burns tans well Example Some Hispanics TYPE V some Blacks TYPE VI osi never burns deeply pigmented Example Darker Figure 7 9 Pre programmed Pain Therapy Settings To access the pre programmed procedure values y 1 Goto the Procedures menu by pressing the Pain Therapy icon on the Home screen 2 Press the button associated with the type of condition requiring treatment
36. hemostasis of cardiac tissue Hemostasis Coagulation of blebs and bullae 4 COAGULATION Photocoagulation of vascular amp dermatological lesions of Contr the face and extremities Photocoagulation of telangiectasia veinulectasia of the legs and face reatment of reticular veins and branch varicosities elangiectasias Hemagioma P ort wine stains Angiokeratoma Benign epidermal pigment lesions as lentigines E pidermal nevi Spider nevi Ulcers debridement P apillary varix CUSTOM 1 CUSTOM 2 Continu ous CW Continu ous CW Continu ous CUSTOM 4 QUICK CUT 7 6 PAIN THERAPY CW Continu ous CN H CUSTOM 3 Continu OUS Figure 7 8 The EPIC S Series diode laser is designed to provide near infrared laser energy to a tissue surface for the purpose of temporary pain relief when applied with the 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 t
37. his device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operalion MODEL EPIC S SERIES FCC ID G2OEPIC 5400469 Rev A EPICTM S Series User Manual pg 53 FDA Compliance Label Indicates the device complies with FDA laser standards Location Bottom of laser console Warning Label Indicates there is the risk of possible exposure to both infrared and visible laser radiation Location Back of laser console Product ID Label Location Bottom of footswitch Ingress Protection Code The footswitch is water resistant protected against splashes of water FCC Compliance Notice The footswitch and laser console comply with Part 15 of FCC Rules regarding unlicensed transmissions Location Bottom of footswitch FCC and IC Label Lists Federal Communication Commission and Industry Canada registration numbers Location Bottom of footswitch Laser Warning Indicates the system contains a laser Location Back of Laser console 5400463 EU Rev A 12 13 Fiber Warning Indicates the laser aperture is at the end of the fiber Location Back of Laser console 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 thro
38. ies Welcome screen will be displayed Figure 4 2 WELCOME WELCOME BIOLASE epic Q 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 press the X or wait 3 seconds to revert back to the Welcome screen re enter the correct code e The system will go to the HOME screen which identifies two procedure categories to choose from Surgical or Pain Therapy EPIC S Series User Manual pg 18 5400463 EU Rev A 12 13 Laser Console Battery Wireless Signal Strength Indicator Strength Indicator SURGICAL AIN THERAPY Quick Cut Button Settings Button Figure 4 4 Home Screen 4 9 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 footswitch and laser console are paired a blue LED indicator light on the laser console will blink when pairing is established The laser and footsw
39. ies ships with the fiber optic cable already attached CAUTION Do not connect or disconnect the fiber while the laser console is turned on Only connect or disconnect the fiber when the laser console is turned off To disconnect the fiber optic cable from the laser console make sure the laser console is turned off and 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 Figure 2 3 To re install the fiber optic cable make sure 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 You should hear the fiber optic click into place if you do not hear it click remove NOTE j E the fiber optic and reinstall it For storage wind the cable in the fiber storage channel around the base of the console in a counterclockwise direction Figure 2 1 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 EPIC M S Series User Manual pg 7 5400463 EU Rev A 12 13 lt S O 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 A
40. itch are shipped already paired However if pairing is not confirmed an B5 will appear in the pairing icon located in the upper left hand corner of the touchscreen Figure 4 6 EPIC S Series User Manual pg 19 5400463 EU Rev A 12 13 SURGICAL o Figure 4 6 To re establish pairing take the following steps AIN THERAPY 1 Go to the Settings menu on the laser console display by pressing the Settings button and select the Wireless icon 2 screen will appear indicating that pairing of the footswitch to the laser console has been lost Figure 4 7 press the green PAIR button ZU 3 The message that PAIRING WILL NOW BEGIN will appear press the green check mark to continue Figure 4 8 4 To complete the pairing process turn the footswitch over and press the Pairing Button Figure 4 9 for four 4 seconds EPIC M S Series User Manual pg 20 WIRELESS Figure 4 7 WIRELESS PAIRING WILL NOW BEGIN EXISTING CONNECTION WILL BE RESET CONTINUE Y x Figure 4 8 WIRELESS PRESS FOR 4 SECONDS 5400463 EU Rev A 12 13 WIRELESS 5a The Wireless screen will appear indicating that pairing was successful and that the footswitch and laser Q f EZ console are now paired Figure 4 10 mr Proceed to step 6 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 rep
41. lems 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 WARNING When charging the battery 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 ensure 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 O C to 45 C Changing the battery at temperatures outside of this range may cause the battery to become hot or
42. med prior to sterilization and must be conducted only by qualified office personnel trained to perform the procedure and handle the EPIC S 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 2096 alcohol or less and follow the manufacturer s instructions Avoid getting any liquid or debris near the distal end of the fiber cable EPICTM S Series User Manual pg 44 5400463 EU Rev A 12 13 Manual Cleaning of the Surgical Handpiece Cleaning must be performed within a maximum of 1 hour after the procedure and always prior to sterilization 1 After use carefully remove the tip from the handpiece and dispose of in a biohazard medical waste Sharps container Carefully remove the handpiece from the fiber optic cable see Section 2 3 Prepare any commercially available surgical instrument detergent enzymatic cleaning solution with a pH of 7 0 such as Enzol or similar enzymatic presoak and cleaner per the manufacturer s instructions Follow the manufacturer s instructions for disposal of used solution 4 Rinse the Handpiece under running lukewarm tap water 22 43 C for a minimum of 10 seconds to remove gross soil 5 Wrap the handpiece in a piece of gauze that has
43. ms lotions or heating lotion patches at or in close proximity to the treatment area e Do not apply therapies prior to treatment that could change body temperature such as ultrasound ice heat pack electrical stimulation or heating patches e Do not apply treatment over articles of clothing 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 Hange of movement of the handpiece e Patient skin type oafety and effectiveness are described by elevating the skin temperature in the treatment area utilizing the settings recommended below Use personal clinical judgment with consideration of the Fitzpatrick Skin Type Scale when selecting procedure parameters monitor the patient and adjust the settings as necessary for effectiveness and patient comfort To avoid potential patient discomfort and or skin damage it is advisable to use a test NOTE spot prior to the initial treatment to assess the suitability of the selected settings for the individual patient EPICTM S Series User Manual pg 42 5400463 EU Rev A 12 13 Using the Deep Tissue Handpiece If holding the handpiece in a constant location the 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 neede
44. olase com MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 mt procons com NTERTE US LISTED Conforms to AAMI ES60601 1 IEC60601 1 IEC6060 2 22 IEC62366 IEC80601 2 60 IEC60825 1 Certified to CSA C22 2 No 60601 1 0482 SERIES 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 continuously improved through ongoing clinical R amp D and engineering with unmatched training practice integration support and service Manufactured in the United States of America Rx Only O 2013 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
45. oll to the pre set you wish to overwrite 2 Press and hold the name of the selected procedure Figure 4 16 for approximately two 2 seconds The parameters for that procedure will be changed and saved the laser console will beep when the adjusted settings are saved p o c INCISION 1 0 POWER TON E Figure 4 16 4 737 OUILK LUT BUTTON The Quick Cut button located on the bottom left of the HOME screen Figure 4 17 allows the user to bypass the Surgical Procedures Selection and Tip Initiation screens When pressed it goes directly to the Quick Cut screen The user may use the preset settings displayed or customize them before proceeding with the procedure SURGICAL INCISION EXCISION VAPORIZATION SURGICAL PAIN THERAPY COAGULATION Figure 4 17 EPICTM S Series User Manual pg 25 5400463 EU Rev A 12 13 4 74 TURN THE LASER CONSOLE OFF e Wind the fiber cable onto the fiber spool counterclockwise around the base of the console geg es e Place the handpiece onto the handpiece holder MA CAUTION Verify that the fiber optic tubing assembly is not twisted once the handpiece is returned 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 EPICTM S Series
46. one Do not direct energy towards any metallic surfaces or non soft tissue surfaces Exercise extreme caution when using this where critical structures I e nerves vessels could be damaged Do not proceed with using the laser if visibility is limited in these areas Suction Use high speed suction as required to maintain a clear field of vision during treatment Do not use the EPIC S 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 EPIC S Series User Manual pg 29 5400463 EU Rev A 12 13 high speed suction to remove the plume appropriately filtered masks and other protective equipment is used at all times during the laser procedure 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 e g 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 low
47. perature 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 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 otop treatment EPICTM S Series User Manual pg 41 5400463 EU Rev A 12 13 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 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 Avoid treatment of sites that have tattoos e Do not apply ointment crea
48. place Figure 4 13 Operating the laser at a shorter pulse duration typically results in lower tissue MOS temperature Peak Power INCISION PULSE MODE POWER zip el SAs CPO CP CP2 1 O Ww TG Imas o JUL x CW Average Power wg P w Or Figure 4 14 EPIC S Series User Manual pg 23 5400463 EU Rev A 12 13 4 77 USING THE EP C S SERIES TOUCH SCREEN DISPLAY WELCOME 2 MUSCLE PAIN 3 MUSCLE SPASM 4 CUSTOM ENERGY 2 EXCISION 3 VAPORIZATION SURGICAL PAIN THERAPY 4 COAGULATION r ce PLEASE INITIATE y THE TIP USE ONLY NEW AND CLEAN TIPS SKIS GER Els Restore all Settings The wall Se he Gener CPO CP1 CP2 ky bti 10us 100us ims TE Al x RESTORE Y gt CW 20ms y e SERVICE Figure 4 15 EPICTM S Series User Manual 5400463 EU Rev A 12 13 4 72 SURGICAL PROCEDURES SELECTION SCREEN The EPIC S Series has the ability to store up to 13 pre set procedures For Surgical EPIC M S Series is factory installed with 4 pre programmed procedural presets and 4 slots for custom pre sets plus the Quick Cut option for Pain there are 3 pre programmed presets with 1 slot for custom pre sets However all of the pre sets can be customized to your preference In order to customize the operating parameters e g power pulse duration interval etc for a particular clinical procedure 1 Select SURGICAL on the HOME screen to access the surgical pre set selection screen scr
49. placement 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 CAUTION 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 i EPIC S Series laser is used in a clinical setting EPIC S Series User Manual pg 12 5400463 EU Rev A 12 13 LAGER 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 beam 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 radia
50. revents 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 S 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 S Series User Manual pg 14 5400463 EU Rev A 12 13 Two 2 AAA batteries are required to power the footswitch included For instructions on how to replace the footswitch batteries see Section 8 The footswitch is protected by a metal cover To access first press down on the cover to unlatch it Now the footswitch can be pressed to fire the laser Footswitch Figure 3 3 Footswitch Assembly 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 el
51. ridement of decubitus ulcer Dermabrasion Vaporization amp hemostasis of capillary hemangioma e Excision vaporization amp hemostasis of abdominal tumors EPIC S Series User Manual e Excision vaporization hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis P arathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs GI GU Excision vaporization and hemostasis of abdominal and rectal tissues such as e Hemorroidectomy e Excision vaporization and hemostasis of rectal pathology e Excision vaporization and hemostasis of abdominal tumors Gynecology Ablation excision hemostasis and vaporization of tissue Such as e Excision or vaporization of condylomata acuminata e Vaporization of CIN cervical intraepithelial neoplasia e Cervical conization e Menorrhagia e Ovarian cystectomy Neurosurgery Vaporization coagulation excision incision ablation and hemostasis of tissue such as e Hemostasis in conjunction with meningiomas e Percutaneous Disc Decompression P LDD Ophthalmology e Dacryocystorhinostomy transcanalicular e OpenDCR e Tumor Excision e Blepharoplasty Pulmonary Surgery Hemostasis vaporization and excision of tissue such as e Tracheobronchial malignancy or stricture e Benign and malignant pulmonary obstruction Cardiac Surgery e Coagulation and hemostasis of cardiac tissue Thor
52. rnal replaceable lithium ion battery pack 14 4V 2 9 Ah 2 3 CONTROL PANEL ITEM DESCRIPTION Turns the controls and display on and sah oad off places the unit into STANDBY or LED Indicator LED Indicator READY or SLEEP mode PET E Y Blinking blue indicates pairing Fiber Storage Channel Control Button between the footswitch and laser console is active Amber indicates unit is in STANDBY mode Green indicates unit is in READY mode LED Blinking green indicates the Indicator emission of laser power Figure 2 1 Control Panel Front View EPICTM S Series User Manual pg 6 5400463 EU Rev A 12 13 2 4 SURGICAL DELIVERY SYSTEM NOTE All fiber optic cables handpieces amp tips are shipped non sterile The EPIC S Series Re Useable Delivery System with Surgical Handpiece consists of e Re useable Fiber Optic Assembly e Re useable Surgical Handpiece Figure 2 9 e Disposable Tips Appendix A 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 NOTE 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 Z6 FIBER OPTIC CONNECTION The EPIC S Ser
53. s m sees am wm Excon ara vaporeaton ortens smeca n 2 we Xmas 2 Las am wm esee fa m we ums m sss 3m wm Mem 2 a we cars xm sem um lm Bom 2 Ia we cams 3m se um om Gene 3 3m Wwe canas 3m sms sm eege ergzere 1 3m wore Comme im Lal sm Losst vroreatonororcalcacrana 2 a Wwe commos m La am am Ema 2 m we Ges xm Lal m wm besate 17 3m Wwe comme xm ses sl estate 1 1 3m Wwe Gm xm ses sl pesecandcooute a Wwe Gs xm ses sl preco 7 m Wwe cars xm ss am wm Beson o La Wwe canas 3m mem am wm Eresonofpengulandabagalrs 2 24 Wwe commos m sugea sl Geng 2 La Wwe canas m sume sl Eme 2 m Wwe canas m swa um wm promessas fa m we mes mm ma m mw e cones mm seem m uus seem 1 3 owe omes 3m sea 3m ux pebtenewotaecmascer 2 2 more tons a suga m lm Dmm 15 105 wwe Gs xm ses sl Vaporeon remos sagten 15 1905 Wwe commos xm sues am um son vprzaton temas gege 15 wos tone Camus 29 seen m oms Fudge 3 Yor mos 3m see 3m ux mmy E 2 we cams 3m aal sl ege 2 2 we cams 3m Lal um om ege 2 m me mes m ma m om a me cos a sued m ome omes suma m ems SECHER Excision vaporization and hemostasis of rectal 190
54. s 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 trash bin Screws to remove ge E Batterv cover 4 ed ESSA E 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 EPIC S Series User Manual pg 47 5400463 EU Rev A 12 13 footswitch 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 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
55. se 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 Hemove protective cap from the end of the fiber shaft see Figure 2 8 e Carefully connect the handpiece to the fiber optic assembly see Figure 2 9 e Insert the selected tip and tighten it clockwise until snug see Figure 2 4 e Wind any excess fiber optic cable onto the fiber spool counterclockwise in the fiber storage channel around the base of the console see Figure 2 1 Am he 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 S Series User Manual pg 17 5400463 EU Rev A 12 13 LAGER WARNING Never point the laser at a person s eyes LASER WARNING Never operate the laser without a handpiece or 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 S SERIES LASER 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 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 S Ser
56. sole to emit a laser beam The aiming beam is on only when the laser is in READY mode or when adjusting the brightness of the beam while in Settings mode If the aiming beam is not visible in either instance remove the handpiece and confirm the beam is actually on by NOTE shining the end of the trunk fiber on a plain non reflective surface DO NOT look directly at the output end of the trunk fiber If the aiming beam is not on turn off the laser console then remove and re install the trunk fiber see Section 2 6 If the aiming beam is still not on turn off the laser console and call Biolase Service 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
57. 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 NOTE A power It automatically reactivates when it is pressed 4 9 PEAK POWER DISPLAY This number is shown only when the system is in pulse mode and presents the value of the peak power based on the Power Setting and Pulse Mode EPICTM S Series User Manual pg 22 5400463 EU Rev A 12 13 4 70 PULSE MODE SELECTION Pulse Mode selection graphically indicates whether the system is in Continuous CW 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 14 MODE PULSE DURATION on PULSE INTERVAL off Duty Cycle CPO 10 microseconds 40microseconds 20 OPT 100 microseconds _ 200microseconds 3370 CP2 1 millisecond 1 millisecond 50 UN P3 20miliseconds 20 milliseconds 50 E CP Comfort Pulse P3 Pulsed Mode which is the standard for most diode lasers currently available to the market
58. tion 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 33 SAFETY 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 your BIOLASE authorized service representative 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 S Series User Manual pg 13 5400463 EU Rev A 12 13 Power Switch The laser console can be switched ON I or OFF O using the Power Switch on the back of the console Power Switch DC Power Remote Interlock Figure 3 1 Power Switch DC Power Input Figure 3 2 Power Supply Module with cord Remote Interlock Use only the Power Supply Module supplied with the EPIC M S Series laser CAUTION gy stem BIOLASE Part Number 2400129 Access Key Code The Access Key Code p
59. 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 EPICTM S Series User Manual pg 57 5400463 EU Rev A 12 13 WARNING When discharging the battery 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 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 EPICTM S Series User Manual pg 58 5400463 EU Rev A 12 13 APPENDIX D SPARE PARTS c ACCESSORIES 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 EPICTM S Series User Manual pg 59 5400463 EU Rev A 12 13 Perio 7400020 300 um core diameters qty 30 7400019 400 um core diameters qty 30 Endo 400015 EZTIP Endo Kit E2 20mm 7400021 200 um core diameters qty 30 EPICTM S Series User Manual pg 60 5400463 EU Rev A 12 13 APPENDIX E ELECTROMAGNETIC COMPATIBILITY GUIDANCE A
60. udgment 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 2 WARNINGS AND PRECAUTIONS Eyewear Doctor patient assistant and all others 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 closely monitored for signs of pain or discomfort at all times If such signs are present adjust settings apply anesthesia or cease treatment if required Adjacent Structures EPIC S 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 b
61. w 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 EPICTM S Series User Manual pg 54 5400463 EU Rev A 12 13 106 kPa 2 Atmospheric Pressure Limitations 50 kPa ATMOSPHERIC PRESSURE Fragile Handle with care FRAGILE gia D dt fie e Keep Dry KEEP DRY ei Humidity Limitations 10 NON CONDENSING RELATIVE HUMIDITY nai Temperature Limitations TEMPERATURE This End UP THIS END UP EPICTM S Series User Manual Dg 55 5400463 EU Rev A 12 13 APPENDIX C SAFETY PRECAUTIONS FOR LITHIUM ION BATTERY PACKS WARNING 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 h
62. ypical commercial or hospital environment Input output that does not apply because the footswitch cable length is less than 3 meters Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the model Epic 10 requires continued operation during power mains interruptions it is recommended that the model Epic 10 be powered from an uninterrupted power supply Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the A C mains voltage prior to applications of the test level EPICTM S Series User Manual pg 61 5400463 EU Rev A 12 13 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY Continued The model Epic 10 is intended for use in the electromagnetic environment specified below The customer or the user of the model Epic 10 should assure that it is used in such an environment Immunity test IEC 60601 Continuous Electromagnetic environment test level level guidance Conducted RF 3 Vrms 3V Portable and mobile RF IEC 61000 4 6 150 kHz to 80 GHz communications equipment should be 3Vm used no closer to any part of the model Epic 10 including cables than Radiated RF 3V m the recommended separation distance calculated from the equation applicable to the frequency of the transmitter

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