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1. 41 Pain Therapy Adverse Effects nnne nnne nnne nnne nis 41 Pain Therapy Warnings and 42 misiee a cib REPERI 42 Using the Deep Tissue Handpiece nennen 43 NIIS 9 9 OTT 44 Sak aly 44 8 2 Cleaning and Sterilization nennen 44 Cleaning and Disinfecting Instructions Surgical Handpiece Reusable Fiber Optic Cable 44 Manual Cleaning of the Surgical Handpiece 45 Steam Sterilization for Surgical Handpiece and Single Use Tips 45 Disinfecting the Deep Tissue Handpiece 46 8 3 Installing Replacing the Console Battery Pack 47 8 4 Changing the Wireless Footswitch 47 esM Trig grillo RU 48 oe O pas pas sae ree ETT 48 T 49 19 0 49 10 Software Specification eene n 49 11 RR 49 S 52 APPENDIX B
2. 53 APPENDIX C Safety Precautions for Lithium lon Battery 57 APPENDIX D Spare Parts amp 60 APPENDIX E Electromagnetic Compatibility 61 APPENDIX Wireless Equipment Compliance 65 EPIC S Series User Manual pg 3 5400463 EU Rev D 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
3. ape lion Rechargeable 0482 Battery 14 4 V 2 9 5400351 Rev D Made in the USA 5400458 EU Rev 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 THIS PRODUCT COMPLIES WITH FDA 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 EPIC S Series User Manual pg 53 5400463 EU Rev D Warning Label Indicates there is the risk of possible exposure to both infrared and visible laser radiation Location Back of laser console E N FCC Label MODEL EPIC S SERIES Lists Federal Communication Commission FCC ID G20EPIC registration number Location Bottom of Console s FCC Label MODEL EPIC S SERIES Lists Federal Communication Commission FCC ID G20EPIC 1 registration number 5400469 Location Bottom of Footswitch NOTICE FCC Compliance Notice m 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 Ingress Protection Code The footswitch is w
4. cigarette lighter 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 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 S Series User Manual pg 58 5400463 EU Rev D 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 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
5. User Manual 5 TABLE OF CONTENT 1 Ines 4 Tee ACAI Ol T 5 Em 5 1 2 Facility 5 2 Eg ipment DescriptiON TM 6 2 AAC IG NETT EET 6 NENNT 6 Conel 6 24 Surgical 7 2 5 Fiber Optic 7 2 5 8 2 7 Surgical Handpiece 2 Span taken Ex 9E nts puo NM MEDIE 10 2 8 Deep Tissue nennen nennen nnne nnne nnne nnne nnns 11 SE 12 MP UNOS aye cer ce tn eee ed ee E E E 12 12 13 gt gea MONIO RR 13 ROMPE 13 xol m 14 hiwe cHic AG E 14 edic mM E 14 Wireless 14 Remote Interlock 15 EMEEN eio E E 16 m T T c
6. 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 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 596 2959 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 29596 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 2 kV common mode 596 U 2959 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 29596 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 typical commercial or hospital environment N A 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 diode laser requires continued operation during power mains interruptions it is recommended that the model
7. all operatory entrances must be marked with an appropriate warning sign one 1 included Lf e Do not operate in the presence of explosive or flammable materials Flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen should 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 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 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 Always ensure that the proper laser parameters are set before the EPIC S Series CAUTION laser is used in a clinical setting EPIC S Series User Manual pg 12 5400463
8. 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 PULSE DURATION PULSE INTERVAL oft Duty Cycle CPO 10 microseconds 40 microseconds 2096 CP1 100 microseconds 200 microseconds 33 CP2 1 millisecond 1 millisecond 50 20 milliseconds 20 milliseconds 50 CP Comfort Pulse P3 Pulsed Mode which is the standard for most diode lasers currently available to the marketplace Figure 4 13 Operating the laser at a shorter pulse duration typically results in lower tissue NOTE temperature Peak Power INCISION PULSE MODE POWER Biss Glee Hae 1 2 1 10815 1005 Imas Average Power gt X Js Figure 4 14 EPIC S Series User Manual pg 23 5400463 EU Rev D 4 77 USING THE EPIC S SERIES TOUCH SCREEN DISPLAY WELCOME BIOLASE 2 MUSCLE PAIN a 3 MUSCLE SPASM epic 4 CUSTOM m INCISION ENERGY POWER 2 EXCISION 3 VAPORIZATION SURGICAL PAIN 4 COAGULATION PLEASE INITIATE THE TIP USE ONLY NEW AND CLEAN TIPS LI Lye Restore all Settings 10 100 1 to factory settings JUL 20ms RESTORE 26 o SERVICE EPIC S Series User Manual pg 24 5400463 EU Rev D 4 72 SURGICAL PROCEDURES
9. pg 27 5400463 EU Rev D Pulse Interval 0 04 20ms Pulse Repetition Rate Up to 20kHz for reference opot size Surgical Handpiece 400um maximum in contact mode Deep Tissue Handpiece 30mm diameter 7 1cm area 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 1mW 625nm 670nm Class 2 EPIC S Series User Manual pg 28 5400463 EU Rev D 6 CONTRAINDICATIONS WARNINGS PRECAUTIONS 6 7 LONTRA NDICA TIONS All clinical procedures performed with EPIC S 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 2 WARNINGS AND PRECAUTIONS Eyewear Doctor patie
10. Epic diode laser 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 the A C mains voltage prior to applications of the test level EPICTM S Series User Manual 5400463 EU Rev D GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY Continued The model Epic laser is intended for use in the electromagnetic environment specified below The customer or the user of the model Epic laser should assure that it is used in such an environment 60601 Continuous Electromagnetic environment Immunity test 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 diode laser including Badiated RE 3V m cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter IEC61000 4 3 80 MHz to 2 5 GHz Recommended separation distance d 1 2vP 1 2VP 80 MHz 800 MHz 2 3 800MHz to 2 5GHZ Where 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 s
11. READY or STANDBY mode mode setting and or power setting values may be changed only when the laser is not firing If the EPIC S Series User Manual pg 21 5400463 EU Rev D laser is firing 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 console 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
12. and extremities Pilonidal cystectomy 2 254 CW 120 Surgical 0 126 Port wine stains L5 190 5 CW 120 Surgical 0 126 Pulmonary resection 2 254 CW 120 Surgical 0 126 Pyrogenic granuloma lymphangioma and 254 CW 120 Surgical 0 126 lymphangiomatosis disease angiofibromas Release of urethral stricture 2 254 CW 120 Surgical 0 126 Removal of benign lesions from ear nose and 254 CW 120 Surgical 0 126 throat Removal of bladder neck obstruction 2 254 CW 120 Surgical 0 126 Resection of organs 2 254 CW 120 Surgical 0 126 Seborrheic keratosis 2 254 CW 120 Surgical 0 126 Small non malignant skin tumors 2 254 CW 120 Surgical 0 126 Small semi malignant tumors as basalomas 2 254 CW 120 Surgical 0 126 Spider nevi 1 5 190 5 CW 120 Surgical 0 126 Syovectomy 2 254 CW 120 Surgical 0 126 EPIC S Series User Manual 5400463 EU Rev D Total JT Treatment Spot Size Indication for Use Power W eid Mode Time sec Handpiece Telangiectasias 1 5 190 5 CW 120 Surgical 0 126 Thoracotomy 2 254 CW 120 Surgical 0 126 Thyroidectomy 2 254 CW 120 Surgical 0 126 Tracheobronchial malignancy or stricture 2 254 CW 120 Surgical 0 126 Treatment of reticular veins and branch 15 1905 CW 120 Surgical 0 126 varicosities Tumor Excision 2 254 CW 120 Surgical 0 126 Ulcers debridement 2 254 CW 120 Surgical 0 126 Vaporization amp hemostasis of capillary hemangioma 1 5 190 5 CW 120 Surg
13. carcinoma e Excision of polyps e Hemostasis of colonoscopy e Hemostasis of esophageal varices Orthopedics e Dissect and 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 X 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 Debridement of decubitus ulcer Dermabrasion Vaporization amp hemostasis of capillary hemangioma e Excision vaporization amp hemostasis of abdominal tumors e Excision vaporization amp hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs GI GU Excision vaporization and hemostasis of abdominal and rectal tissues such as e Hemorrhoidectomy 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
14. controlled The customer or the user of the Epic diode laser can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Epic diode laser 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 2 d 1 2 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 affected by absorption and reflection from structures objects and people EPIC S Series User Manual pg 64 5400463 EU Rev D APPENDIX WIRELESS 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 digit
15. following safety classifications are applicable to the device e Laser Radiation Class 4 Aiming Beam Class 2 e Type of protections against electrical shock Class 2 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 D 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 position e EPIC S Series will work using either DC power or the rechargeable battery pack o 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 tur
16. 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 Preset Power W Mode 400 1 4 CW 300 1 4 CW 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 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 before the tip is out of the block 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 POWER INITIATE of 10 THE TIP USE ONLY NEW AND CLEAN TIPS EPIC S Series User Manual pg 33 5400463 EU Rev D 7 4 TABLE OF SURGICAL SETTINGS Figure 7 7 represents the recommended initial clinical settings for each indication for u
17. 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 5 SER ES 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 Series 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 seconds to revert back to the Welcome screen re enter the correct code e he 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 D Laser Console Battery Wireless Signal Strength Indicator Strength Indicator Quick Cut Settings Button 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 Selecti
18. 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 TYPE freckles Very sun sensitive burns easily tans minimally Example Fair skinned TYPE Il ae fair haired Caucasians Sun sensitive skin sometimes burns slowly tans to light brown TYPE 111 Example Darker Caucasians Minimally sun sensitive burns minimally always tans to moderate TYPE IV brown Example Mediterranean type Caucasians oun insensitive skin rarely burns tans well Example Some Hispanics TYPE V some Blacks TYPE VI S never burns deeply pigmented Example Darker Figure 7 9 Pre programmed Pain Therapy Settings To access the pre programmed procedure values 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 Always use clinical judgment when selecting power to ensure optimal clinical CAUTION results Observe the clinical effects on the treatment area at all
19. performance of the battery or may reduce its life expectancy EPIC S Series User Manual pg 59 5400463 EU Rev D APPENDIX D SPARE PARTS c ACCESSORIES BIOLASE p n Description 6400479 Surgical Handpiece 2 pack 2400040 Laser Safety Glasses Clinician 2400078 Laser Safety Glasses Patient 6400058 Remote Interlock Plug 2400129 Power Cord with Power Supply 6400516 Wireless Footswitch 6400107 Tip Initiation Kit 6400311 Deep Tissue Handpiece 6400310 Deep Tissue Handpiece protective covers qty 20 6400465 Peel off clear screen covers qty 30 6400457 Lithium ion battery pack for console 6400463 Battery Pack 2 x AAA 6400437 Trunk Fiber Assembly EPIC S Series User Manual pg 60 5400463 EU Rev D APPENDIX E ELECTROMAGNETIC COMPATIBILITY Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the EMC information provided in the following CAUTION tables Portable and mobile Radio Frequency RF communications equipment can affect medical electrical equipment Accessories Medical grade power cord maximum length 1 meter Biolase p n 2400043 Footswitch Wireless Biolase p n 6400516 The use of accessories other than those specified except those supplied WARNING or sold by Biolase Inc as replacement parts for internal or external componen
20. press the Pairing Button Rx for four 4 seconds Figure 4 9 OY S x Lr Se aul Figure 4 9 EPIC S Series User Manual pg 20 5400463 EU Rev D WIRELESS 9 02 The Wireless screen will appear indicating that pairing was successful and that the footswitch and laser console are now paired Figure 4 10 Proceed to step 6 o Figure 4 10 WIRELESS 56 If pairing has not occurred the Wireless screen will appear again indicating that pairing was not successful zi Figure 4 11 the green button to repeat steps 3 5a SETTINGS 6 Press the Settings button to return to the Settings menu 4 COD press the arrow on the bottom left of the Settings screen to return to the Home screen Figure 4 12 EN 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 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
21. the type of error Operation will not resume until the error is cleared EPIC S Series User Manual pg 13 5400463 EU Rev D Power Switch The laser console can be switched ON 1 or OFF 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 S Series laser system CAUTION BIOL ASE 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 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 1 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
22. 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 EPIC S Series User Manual pg 40 5400463 EU Rev D Touch and hold the condition name for more than 2 seconds you will hear 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 SETTINGS PROCEDURE NAME MODE SETTING TIME ENERGY J SPACER CW JOINT PAIN Continuous 4W 600 seconds 2400 30mm CW MUSCLE PAIN Continuous AW 300 seconds 1200 30mm CW MUSCLE SPASM Continuous 4W 300 seconds 1200 30mm CW CUSTOM Continuous 4W 60 seconds 240 30mm Figure 7 10 Pain Therapy Adverse Effects Some 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 temperature at the site of application and increased absorption properties of the skin If discom
23. 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 EPIC S Series User Manual pg 44 5400463 EU Rev D 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 for a minimum of 10 seconds to remove gross 01 5 Wrap the handpiece in a piece of gauze that has been soaked in the cleaning solution leave it wrapped in the gauze for a minimum of 10 minutes
24. transcanalicular 2 254 CW 120 Surgical 0 126 Debridement of decubitus ulcer 2 254 CW 120 Surgical 0 126 Dermabrasion 1 5 190 5 CW 120 Surgical 0 126 Dermatological surgery 2 254 CW 120 Surgical 0 126 EPIC S Series User Manual pg 34 5400463 EU Rev D Indication for Use Ps d Mode Leslie Handpiece ids Dissect and coagulate 2 254 CW 120 Surgical 0 126 Epidermal nevi 1 5 190 5 CW 120 Surgical 0 126 vaporization of colorectal 254 CW 120 Surgical 0 126 Excision and vaporization of condyloma 2 254 CW 120 Surgical 0 126 Sd and vaporization of herpes simplex 254 CW 120 Surgical 0 126 vaporization of vocal cord nodules 254 CW 120 Surgical 0 126 Excision of cutaneous lesions 2 254 120 Surgical 0 126 Excision of Keloids 2 254 CW 120 Surgical 0 126 Excision of neuromas 2 254 CW 120 Surgical 0 126 Excision of periungual and subungual warts 2 254 CW 120 Surgical 0 126 Excision of plantar warts 2 254 CW 120 Surgical 0 126 Excision of polyps 2 254 CW 120 Surgical 0 126 of condylomata 15 190 5 CW 120 Surgical 0 126 15 1905 CW 120 Surgical 0 126 ae amp hemostasis of rectal 15 1905 CW 120 Surgical 0 126 Hemangioma 1 5 190 5 CW 120 Surgical 0 126 Hemorrhoidectomy 2 254 CW 120 Surgical 0 126 Hemostasis 2 254 CW 120 Surgical 0 126 Hemostasis in conjunction with meningiomas 1 5 190 5 CW 120 Surgical 0 12
25. 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 Spacer Dust Cover S J Disposable Shield lt Protective Plug me Figure 2 11 Deep Tissue Handpiece e Remove Red Cap Dust Cover and protective plug from the Deep Tissue Handpiece Figure 2 12 e Slide handpiece over the shaft until it clicks into place Figure 2 12 e Place the protective shield over the adjustable spacer Figure 2 13 Figure 2 13 Loosen the Lock Ring and set the Spacer at the desired spot size Detent Location Figure 2 14 Tighten the Lock Ring Figure 2 14 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 S Series User Manual pg 11 5400463 EU Rev D 3 SAFETY 77 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 SAFETV INSTRUCTIONS Follow these safety instructions before and during treatments When the laser is in use
26. 0463 EU Rev D 9 CALIBRATION 9 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 Bi 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 Figures 11 1 and 11 2 appear follow the troubleshooting instructions for the specific message as noted below For any on screen message not listed in Figures 11 1 and 11 2 re power the laser NOTE console if the message does not clear call your authorized service representative EPIC S Series User Manual pg 49 5400463 EU Rev D SCREEN Error 1 Error 2 Error 3 Error 4 ERROR 5 ERROR 6 ERROR 7 ERROR 9 ERROR 10 ERROR 11 ERROR 12 ERROR 13 ERROR 14 MESSAGE THERMISTOR OPEN THERMISTOR SHORTED SHUTDOWN TEMPERATURE LASER CURRENT HIGH LOW FOOTSWITCH SHORTED ON OFF BUTTON STUCK FLASH CORRUPTED N
27. 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 EPIC S Series User Manual pg 57 5400463 EU Rev D 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 ensure that the battery charging conditions specified are met e Do not attach the batteries to a power supply plug or directly to
28. 3 EU Rev D 8 MAINTENANCE WARNING modification of this equipment is allowed amp 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 Surgical Handpiece Reusable Fiber Optic Cable The cleaning process 15 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 performed prior to sterilization and must be conducted only by qualified office personnel trained
29. 6 Hemostasis of colonoscopy 1 127 CW 120 Surgical 0 126 Hemostasis of esophageal varices 1 127 120 Surgical 0 126 Hemostasis of upper and lower GI bleeding 1 127 CW 120 Surgical 0 126 Herniorraphy 2 254 CW 120 Surgical 0 126 Incision and excision of carcinoma in situ 2 254 CW 120 Surgical 0 126 Kaposi sarcoma 2 254 CW 120 Surgical 0 126 Laparoscopic cholecystecomy 2 254 CW 120 Surgical 0 126 Laryngeal papillomectomy 2 254 CW 120 Surgical 0 126 EPIC S Series User Manual 35 5400463 EU Rev D Total Jo Treatment Spot Size Indication for Use Power W Pus Mode rime sec Handpiece Lesions of external genitalia 2 254 CW 120 Surgical 0 126 Matrixectomy 2 254 CW 120 Surgical 0 126 Menisectomy 2 254 CW 120 Surgical 0 126 Mixoid cyst 2 254 CW 120 Surgical 0 126 Myomectomy 2 254 CW 120 Surgical 0 126 Neck dissection 2 254 CW 120 Surgical 0 126 Open DCR 2 254 CW 120 Surgical 0 126 Ovarian cystectomy 2 254 CW 120 Surgical 0 126 Papillary varix 2 254 CW 120 Surgical 0 126 Parathyroidectomy 2 254 CW 120 Surgical 0 126 Percutaneous Disc Decompression PLDD 2 254 CW 120 Surgical 0 126 Pericardiectomy 2 254 CW 120 Surgical 0 126 Photocoagulation of telangiectasia 15 1905 CW 120 Surgical 0 126 veinulectasia of the legs and face Photocoagulation of vascular amp dermatological 15 1905 CW 120 Surgical 0 126 lesions of the face
30. 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 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 prior to 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 EPIC S Series User Manual pg 45 5400463 EU Rev D a Time Type of Sterilizer Temperature minimum Drying Time 121 C 30 minutes Gravity Displacement 15 30 minutes 132 C 15 minutes 132 C Dynamic Air Removal Pre Vacuum 4 minutes 20 30 minutes 134 C 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
31. 95 Non condensing EPIC S Series User Manual pg 5 5400463 EU Rev D 2 EQUIPMENT DESCRIPTION 2 7 GENERAL The EPIC S Series system consists of three components e aser 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 internal replaceable lithium ion battery pack 14 4V 2 9 Ah 2 3 CONTROL PANEL ITEM ITEM DESCRIPTION Activates the controls and display places the unit into STANDBY LED Indicator LED Indicator e Amber indicates unit is in STANDBY mode e Green indicates unit is in READY mode LED e Blinking green indicates the Indicator emission of laser power Blinking blue indicates pairing Fiber Storage Channel Control Button between the footswitch and laser console is active Figure 2 1 Control Panel Front View EPIC S Series User Manual pg 6 5400463 EU Rev D Z4 SURGICAL DELIVERY SYSTEM NOTE All fiber optic cables handpieces amp tips are shipped non sterile The EPIC S Series Delivery System with Surgical Handpiece consists of Re useable Fiber Optic Assembly e Re useable Surgical Handpiece Figures 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 pat
32. EU Rev D 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 beam at a person s eyes Always place the system into STANDBY mode by pressing the Control Button while in READY mode before exchanging handpieces or disposable tips Toggle the ON OFF switch located on the rear of the console to the OFF 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 reflect and create potential hazard 7 7 SAFETV FEATURES Energy Monitor The energy monitor measures and verifies power output Power deviations of more 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
33. G IN DC SUPPLY PLUG IN THE BATTERY REPLACE FOOTSWITCH BATTERY RELEASE FOOTSWITCH RE ESTABLISH PAIRING SEE SEC 4 PRESS THE CONTROL BUTTON IN ANY PROCEDURE SCREEN EPIC S Series User Manual 5400463 EU Rev D APPENDIX A GUIDE Diameter Length CTL 2 E44 400um 4 30 7400016 44 gt C E4 7 400 7 15 anneal 4 9 400um 9 15 15 4 7 15 4 9 3 4 300um 4 30 7400017 mm 7 3 7 300ym 7 15 Qty Part Number Combo Pack Don E3 9 300um 9 15 15 x E3 7 15 x E3 9 us Ben aun 4 30 7400018 2 14 200um 14 30 7400021 14mm gt Les am dune E2 20 200um 20 20 7400015 20mm NOTE Biolase tips for diode lasers are sold non sterile and are for single use only See Section 8 2 for sterilization instructions EPIC S Series User Manual pg 52 5400463 EU Rev D APPENDIX B LABELING BIOLASE MT Promedt Consulting GmbH 4 Cromwell Altenhofstrasse 80 Irvine CA 92618 USA D 66388 St Ingbert GERMANY EPIC S SERIES 7400054 EU Product ID Label 2 100 240 YYYY MM 50 60 Hz Location Bottom of laser console
34. INGS Pulse Fiber Spot Power Length Pulse Tip Tip Size Setting Procedure Name W Mode Length Size um Initiation mm Neck dissection Dermabrasion Herniorrhaphy Open DCR Blepharoplasty Tracheobronchial malignancy or cw E4 1 INCISION stricture Thoracotomy Release of urethral stricture 1 00 W CW Continuous 400m Yes 0 126 Removal of bladder neck obstruction Lesions of external genitalia Circumcision Removal of benign lesions from 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 warts Excision of keloids Excision of cutaneous lesions Appendectomy Debridement of decubitus ulcer Excision vaporization and hemostasis of abdominal tumors Excision vaporization and hemostasis of rectal CW E4 pathology Pilonidal cystectomy P arathyroidectomy Don Continuous 400 LE Laparoscopic cholecystectomy Thyroidectomy Resection of organs Excision or vaporization of condylomata acuminate Myomectomy Ovarian cystectomy Tumor excision Benign and malignant pulmonary obstruction Pulmonary resection Pericardiectomy Excision and vaporization of condyloma Dermatological surgery Condyloma acuminate Warts Small non malignant sk
35. O FIBER LOST FOOTSWITCH COMMUNICATION EMERGENCY SWITCH REMOTE INTERLOCK BATTERY CRITICALLY LOW INTERNAL ERROR FOOTSWITCH BATTERY REASON THERMISTOR OPEN THERMISTOR SHORTED SYSTEM TOO HOT OUTPUT IS OUT OF SPECS FS IS PARTIALLY PRESSED OR DAMAGED KEY STUCK MEMORY CORRUPTED FIBER NOT INSERTED WIRELESS INTERFERENCE E SWITCH PRESSED REMOTE INTERLOCK OPEN BATTERY IS CRITICALLY LOW INTERNAL ERROR OCCURRED FOOTSWITCH BATTERY CRITICALLY LOW Figure 11 1 CALL BIOLASE SERVICE ALLOW 5 10 MINUTES FOR LASER TO COOL DOWN CALL BIOLASE SERVICE PRESS RELEASE FOOTSWITCH OR CALL BIOLASE SERVICE PRESS FRONT KEY CALL BIOLASE SERVICE PLUG IN TRUNK FIBER REPOSITION CONSOLE OR FOOTSWITCH TO IMPROVE COMMUNICATION PRESS E SWITCH AGAIN CHECK REMOTE INTERLOCK CLOSED PLUG IN DC SUPPLY RESTART UNIT REPLACE FOOTSWITCH BATTERY EPIC S Series User Manual 5400463 EU Rev D SCREEN WARNING 1 WARNING 2 WARNING 3 WARNING 4 WARNING 5 ALERT 1 MESSAGE TEMPERATURE HIGH BATTERY IS LOW BATTERY NOT CONNECTED FOOTSWITCH BATTERY IS LOW FOOTSWITCH WIRELESS NOT PAIRED SYSTEM MUST BE IN READY MODE REASON SYSTEM IS HOT BATTERY IS LOW BATTERY NOT CONNECTED BATTERY ON THE FOOTSWITCH IS LOW FOOTSWITCH HELD NO WIRELESS CONNECTION SYSTEM IS NOT IN READY MODE Figure 11 2 ALLOW 5 10 MINUTES FOR LASER TO COOL DOWN PLU
36. S Series User Manual pg 14 5400463 EU Rev D 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 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 EPIC S Series User Manual pg 15 5400463 EU Rev D 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
37. SE 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 Made the USA Rx Only Copyright 2014 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
38. SEE E E t 27 U 27 27 28 6 Contraindications Warnings amp 29 OEE SAE EEE TAE ETT E 29 6 2 Warnings and lt 29 a 29 29 Adjacent B S RR 29 29 m TT 30 A 30 me 30 zs CnICcatADDIICAHDI IS cierta UM MM 31 MO CCU ON 31 M 31 SOU PERRO M 33 Tip Initiation Parameters and Method Not required if using pre initiated tips 33 LA Tabie or Surgical SENINGS TEE 34 EPIC S Series User Manual pg 2 5400463 EU Rev D Pre programmed Surgical nennen nnns 37 7 5 Table of Pre Programmed SURGICAL 38 750 Fall TROA V TT E A 39 Pre programmed Pain Therapy ener 40 7 7 Table of Pre Programmed Pain Therapy
39. SELECTION SCREEN The EPIC S Series has the ability to store up to 13 pre set procedures For Surgical EPIC S Series 1 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 power pulse duration interval etc fora particular clinical procedure 1 Select SURGICAL on the HOME screen to access the surgical pre set selection screen scroll to the pre set you wish to overwrite Figure 4 16 2 Press and hold the selected procedure for two 2 seconds The parameters for that procedure will be changed and saved the laser console will beep when the adjusted settings are saved OOOO SURGICAL INCISION INCISION 1C POWER EXCISION 1 O VAPORIZATION COAGULATION Figure 4 16 4 77 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 HOME INCISION 3 EXCISION VAPORIZATION SURGICAL PAIN THERAPY COAGULATION EPIC S Series User Manual p
40. a wall outlet Before first use you should fully charge the battery at least three 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 Battery cover Figure 8 2 Battery Cover Bottom of Console Figure 8 3 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 D 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 4 while changing the batteries as this will disrupt the pairing of the laser console and footswitch Pairing Button Internal View Figure 8 4 Replacing the batteries may disrupt the pairing of the laser console and footswitch If you find the wireless communication has been inte
41. al 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 e Heorient 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 5 connected e Consult the dealer an experienced radio TV technician for help EPIC S Series User Manual pg 65 5400463 EU Rev D 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 NTERTE 5 LISTED Conforms to ES60601 1 IEC60601 1 IEC6060 2 22 IEC62366 IEC80601 2 60 IEC60825 1 Certified to CSA C22 2 No 60601 1 0482 About BIOLASE Founded in 1986 BIOLA
42. ase angiofibromas e Superficial benign vascular lesions including Telangiectasias hemangioma Port wine stains angiokeratoma and benign epidermal pigment lesions as lentigines epidermal nevi spider nevi e 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 e Seborrheic keratosis cyst e Papillary varix e Acne treatment Vascular Surgery e Photocoagulation of vascular amp dermatological lesions of the face and extremities e Photocoagulation of telangiectasia veinulectasia of the legs and face e 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 Figure 7 1 EPICTM S Series User Manual 5400463 EU Rev D 7 3 SOFT TISSUE SURGERY Tip Initiation Parameters and Method Not required if using pre initiated tips Most soft tissue surgical procedures require
43. ater 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 EPIC S Series User Manual pg 54 5400463 EU Rev D 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 S Series User Manual pu 55 5400463 EU Rev D Prescription Statement Rx Only Federal Law restricts this device to sale by or on the order of a physician or other licensed medical practitioner gem 106 kPa A Atmospheric Pressure Limitations 50 kPa ATMOSPHERIC PRESSURE 4400417 Rev A Fragile Handle with care Keep Dry Humidity Limitations 10 NON CONDENSING RELATIVE HUMIDITY 607 20 C Temperature Limitations TEMPERATURE This End UP THIS END UP EPIC S Series User Manual pg 56 5400463 EU Re
44. 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 NE 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 4 70 PULSE MODE SELECTION Pulse Mode selection graphically indicates whether the system is in Continuous CW mode or in Pulse mode EPIC S Series User Manual pg 22 5400463 EU Rev D 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
45. fort or redness of the skin occurs at any time during the treatment you have the following options O Move the handpiece relative to the affected anatomy O Defocus the energy by moving the handpiece further away from the skin Decrease the power setting O otop treatment EPIC S Series User Manual pg 41 5400463 EU Rev D Pain Therapy Warnings and Precautions 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 Do not apply ointment creams lotions or heating lotion patches at or in close proximity to the treatment area e Do no
46. g 25 5400463 EU Rev D 4 74 TURN THE LASER CONSOLE OFF e Wind the fiber cable onto the fiber soool counterclockwise around the base of the console Place handpiece the handpiece holder 4i A 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 position if the laser system will not be used for a long period of time EPIC S Series User Manual pg 26 5400463 EU Rev D 5 SPECIFICATIONS 5 7 GENERAL NEM 5 7 in W x 4 4 in H x 6 5 in L 14 5 cm x 11 2 cm x 16 5 Weight 2 75 lbs 1 25 kg 5 2 ELECTRICAL Operating Voltage Frequency External Fuses Main Control Remote Interruption Disable Control 100V 240V at 1 5A 50 60Hz None Power Switch Remote Interlock Emergency Stop Button Battery Lithium lon Rechargeable 14 4V 2 9Ah DC Power Supply Module 12V DC 5A 5 3 LASER Laser Classification IV 4 Medium Wavelength Max Power Output Power Accuracy Power Modes Fiber Tips Diameter Pulse Duration InGaAsP Semiconductor diode 940 10nm 10W 20 Continuous Pulse Modulation 200um 300um 400um 0 01ms 20ms EPIC S Series User Manual
47. hould be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 2 These guidelines may not apply all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies 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 diode laser is used exceeds the applicable RF compliance level above the Epic diode laser should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Epic diode laser 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 63 5400463 EU Rev D RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EPIC DIODE LASER The Epic diode laser is intended for use in an electromagnetic environment in which radiated RF disturbances are
48. ical 0 126 Vaporization of CIN cervical intraepithelial 254 CW 120 Surgical 0 126 neoplasia Vaporization of the prostate to treat benign 254 CW 120 Surgical 0 126 prostate hyperplasia BPH Vaporization of urethral tumors 2 254 CW 120 Surgical 0 126 Warts 2 254 CW 120 Surgical 0 126 Warty leucoplasty 2 254 120 Surgical 0 126 9 30 ON 30 Temporary Increase of clear nail in patients 75 254 CW OFF 30 Deep 30 with onychomycosis ON Tissue Figure 7 7 Pre programmed Surgical Settings The following initial clinical settings are based on clinical case reports combined with NOTE in vitro testing however they are not universal Always use your clinical judgment when selecting power pulse length and pulse interval parameters to ensure optimal clinical results To access the pre programmed procedure values 1 Goto the Procedures menu by pressing the Surgical icon 2 Press the button associated with the desired procedure To store your personal preferred settings for any procedure A Follow steps 1 and 2 above B Enter the new values on the Home screen C Touch and hold the procedure name for more than 2 seconds you will hear a beeping sound confirming the settings are saved EPICTM S Series User Manual 5400463 EU Rev D 300um tips are recommended for removing thin tissue layers 400 tips are NOTE recommended for removing fibrous tissue 7 5 TABLE OF PRE PROGRAMMED SURGICAL SETT
49. ient 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 2 5 FIBER OPTIC CONNECTION The EPIC S Series 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 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 pi
50. in tumors Small semi malignant tumors and basalomas Bowe Kaposi sarcoma Warty leucoplasty Mixoid cyst RO EXCISION 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 Percutaneous disc decompression P LDD CW E4 Dacryocystorhinostomy transcanalicular Adhesiolysis EUM en Continuous 4001 m LEN Vaporization of urethral tumors Vaporization of the prostate to treat benign prostate hyperplasia BP P yrogenic granuloma lymphangioma and lymphangiomatosis disease angiofibromas Seborrheic keratosis Acne treatment VAPORIZATION EPIC S Series User Manual pg 38 5400463 EU Rev D Chondromalacia Hemostasis of upper and lower bleeding Hemostasis of colonoscopy Hemostasis of esophageal varices Dissect and coagulate Matrixectomy Hemostasis in conjunction with meningiomas Coagulation and hemostasis of cardiac tissue Hemostasis Coagulation of blebs and bullae Photocoagulation of vascular amp dermatological lesions of CW E4 4 COAGULATION the face and extremities Photocoagulation of EM Continuous 400u m is ee telangiectasia veinulectasia of the legs and face Treatment of reticular veins and branch varicosities Tela
51. 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 PLDD Ophthalmology Dacryocystorhinostomy transcanalicular e Open DCR 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 Coagulation and hemostasis of cardiac tissue Thoracic Surgery Thoracotomy Pulmonary resection Hemostasis Pericardiectomy Adhesiolysis Coagulation of blebs and bullae Urology Hemostasis vaporization incision coagulation ablation and excision of tissues such as e of urethral tumors e 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 BP H Dermatology Aesthetics e Photocoagulation of vascular amp dermatological lesions of the face and extremities e Photocoagulation of telangiectasia venulectasia of the legs and face e Treatment of reticular veins and branch varicosities e Pyrogenic granuloma lymphangioma and lymphangiomatosis dise
52. ist clockwise until snug Correct Bend Incorrect Bend Figure 2 6 When installing the tip make sure it is Figure 2 7 Bending the tip cannula seated properly thread correctly When the aiming beam 1 not present or has a significantly asymmetrical shape WARNING For tips that require initiation change the tip For tips that do not require initiation change the tip press idi to bypass initiation requirement EPIC S Series User Manual pg 9 5400463 EU Rev D 2 7 SURGICAL HANDPIECE ASSEMBLY 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 Figure 2 9 Surgical handpiece Assembly fully assembled 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 EPIC S Series User Manual pg 10 5400463 EU Rev D 2 8 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 disinfection before and after each patient
53. ly 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 D Ear Nose and Throat and Oral Surgery Hemostasis incision excision ablation and vaporization of tissues from the ear nose throat and adjacent areas including soft tissue in the oral cavity such as e Removal of benign lesions from ear nose and throat Excision and vaporization of vocal cord nodules and polyps e Incision and excision of carcinoma in situ e Ablation and vaporization of hyperkeratosis Laryngeal papillectomy e 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 Hemostasis of upper and lower GI bleeding e Excision and vaporization of colorectal
54. m 16 3 4 Safety Classification cccccccccccseccceeeeceeceeeeeecceeeeseeesseessaeeeseeeeseaeesseeeeseueessaeessueesseeeesens 16 age culo 1 11 ie LEE UT m 17 17 4 2 Operation Turn on the Epic S Series 18 EPIC S Series User Manual pg 1 5400463 EU Rev D lt 19 4 4 Pairing the Footswitch to the Laser console 19 4 5 Ono 1 en ee ee ee eee eee nee 21 4 6 Entering READY or STANDBY emen 21 4 READY TM 22 2 9 Wireless FOOISWItON ED RU RUM e QUA O IUE MK du SR KON UEM RUN EE MUN ERU 22 4 9 Peak Power Display ee nnne nhu nn nu nn nh sake rana ase 22 Z 10 TPulsedMode Sele CHOI E 22 4 11 Using the EPIC S Series Touch Screen 24 4 12 Surgical Procedures Selection 25 ENERO M 25 4 14 Turn the Laser console nennen nennen nennen nnne nnns 26 ODOC e IR 27
55. n 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 Do not cover or block ventilation channels These channels provide an air CAUTION 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 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 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 S Series User Manual pg 17 5400463 EU Rev D LASER WARNING Never point the laser at a person s eyes LASER WARNING Never operate the laser without a handpiece
56. nched between the housing and the fiber optic access plug EPIC M S Series User Manual pg 7 5400463 EU Rev D Figure 2 2 Fiber Optic Access Plug Figure 2 3 Optical Access Port 2 6 SINGLE USE TIPS The tips are single use accessories and are provided in three core diameters 200um 300um and 400 in different lengths see Appendix 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 CAUTION Avoid contact of the with any tissue To connect the tip first connect the handpiece to the fiber then insert the tip firmly into the distal end of the handpiece as far as it will go and 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 To provide proper laser operation do not connect tips when the handpiece is NOTE disconnected from the fiber EPIC S Series User Manual pg 8 5400463 EU Rev D Assembly Figure 2 4 Insert the fiber tip the handpiece only when the handpiece is connected to the fiber and tw
57. ngiectasias Hemagioma P ort wine stains Angiokeratoma Benign epidermal pigment lesions as lentigines E pidermal nevi Spider nevi Ulcers debridement P apillary varix CW E4 5 CUSTOM 1 0 1 W CW Continuous 400um YES 0 120 CW E4 6 CUSTOM2 0 1 W CW Continuous 400u m YES 0 126 CW E4 1 CUSTOM 3 0 1 W CW Continuous 400m NO 0 126 CW E4 8 CUSTOM 4 0 1 W CW Continuous 400m NO 0 126 CW E4 9 QUICK CUT 0 1 W CW Continuous 4001 m NO 0 126 Figure 7 8 7 6 PAIN THERAPY 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 the patient s condition throughout the treatment EPIC S Series User Manual pg 39 5400463 EU Rev D Refer to the Fitzpatrick Skin Type Scale Figure 7 9 when performing
58. nt 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 bone 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 EPIC S Series User Manual pg 29 5400463 EU Rev D Plume Removal opecial 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 o
59. on Aiming Beam 5 levels of brightness adjustment Volume 5 levels of sound adjustment Service Mode accessible only by authorized BIOLASE Service Representatives SETTINGS Restore to Factory Default Settings Q Wireless Menu Access to Pairing Screens Figure 4 5 4 4 PAIRING THE FOOTSWITCH 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 footswitch are shipped already paired However if pairing is not confirmed an 3 will appear 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 D SURGICAL AIN THERAPY O Figure 4 6 To re establish pairing take the following steps 1 Go to the Settings menu on the laser console display by pressing the Settings button and select the Wireless icon WIRELESS 2 A screen will appear indicating that pairing of the footswitch Q eio gt to the laser console has been lost Figure 4 7 press the eZ PAIR green PAIR button m 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 Figure 4 8 EXISTING RESET v Figure 4 8 WIRELESS 4 To complete the pairing process turn the footswitch over ee and
60. rrupted 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 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 EPIC S Series User Manual pg 48 540
61. se 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 Fiber Tip Size um 400 Pulse Interval None CW Continuous Indication for Use des Handpiece priis d Ablation and vaporization of kyperkeratosis 2 254 CW 120 Surgical 0 126 Acne treatment 1 127 120 Surgical 0 126 Adhesiolysis 2 254 CW 120 Surgical 0 126 Angiokeratoma 1 5 190 5 CW 120 Surgical 0 126 Appendectomy 2 254 CW 120 Surgical 0 126 Benign and malignant pulmonary obstruction 2 254 CW 120 Surgical 0 126 Benign epidermal pigment lesions as lentigines 1 5 190 5 CW 120 Surgical 0 126 Blepharoplasty 2 254 CW 120 Surgical 0 126 Bowe 2 254 CW 120 Surgical 0 126 Cervical conization 2 254 CW 120 Surgical 0 126 Chondromalacia 1 127 CW 120 Surgical 0 126 Circumcision 2 254 CW 120 Surgical 0 126 Coagulation and hemostasis of cardiac tissue 1 5 190 5 CW 120 Surgical 0 126 Coagulation of blebs and bullae 0 5 63 5 CW 120 Surgical 0 126 Condyloma acuminate 2 254 CW 120 Surgical 0 126 Dacryocystorhinostomy
62. t apply therapies prior to treatment that could change body temperature such as ultrasound ice heat pack electrical stimulation or heating patches 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 o Power output o Distance from the skin surface o Range of movement of the handpiece o 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 EPIC S Series User Manual pg 42 5400463 EU Rev D Using the Deep Tissue Handpiece If holding the Handpiece in a constant location set the screen to the recommended initial power settings for therapeutic effect 4 0W delivered over 10 minutes 600 seconds of continuous treatment CW with the spacer set at a 30mm spot size Always monitor patient response adjust power and or distance as needed for patient comfort EPIC S Series User Manual pg 43 540046
63. the sterilization pouches until used in order to maintain sterility e For instructions on how to reassemble the handpiece please refer to Section 2 7 Disinfecting 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 disinfect 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 EPIC S Series User Manual pg 46 5400463 EU Rev D 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 Phillips screwdriver included with the laser system Figure 8 2 2 Toremove the battery grip the battery at the top and pull the cable away from the connector Figure 8 3 Do not tug or wrench the cable from the connector 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 3 4 Replace the battery cover on the bottom of the unit using a standard Phillips screwdriver 5 Connect the power cord of the DC power supply to the unit and plug into
64. ther 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 lowest 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 D 7 CLINICAL APPLICATIONS ZTIWIR DUCT ON To efficient
65. training When used and maintained properly the EPIC S Series will prove a valuable addition to your practice Please contact your BIOLASE authorized distributor for any service needs EPIC S Series User Manual pg 4 5400463 EU Rev D 1 7175 75 7 PARTS LIST The EPIC S Series laser system includes the following Laser console lithium ion battery pack already installed Screen Protectors Peel off clear screen cover qty 30 Delivery System installed Assorted Surgical 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 DC power supply and power cord 1 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 des t NOTE 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 1 2 FACILITY REQUIREMENTS Electrical Supply 100 240V 1 5 50 60Hz Environmental Requirements Temperature 20 25 C Humidity 15
66. ts may result in increased EMMISSIONS or decreased IMMUNITY of the EPIC diode laser system GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Epic diode laser is intended for use in the electromagnetic environment specified below The customer or the user of the Epic diode laser should assure it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The Epic diode laser uses RF energy only for its RF emissions internal function Therefore its RF emissions are Group 1 very low and are not likely to cause any CISPR 11 interference in nearby electronic equipment RF emissions Class A CISPR 11 The Epic diode laser is suitable for use in all Harmonic emissions Class A establishments other than domestic and those directly connected to the public low voltage power IEC 61000 3 2 MN supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Class A IEC 61000 3 3 EPIC S Series User Manual pg 61 5400463 EU Rev D GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Epic diode laser is intended for use in the electromagnetic environment specified below The customer or the user of the model Epic diode laser 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
67. v D APPENDIX SAFETY PRECAUTIONS FOR LITHIUM ION BATTERY PACKS When USING the BATTERY WARNING 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 Do not place the battery in fire or heat the battery 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 notcarry or store the batteries together with necklaces hairpins or other metal objects 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 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

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