User Manual - Biolase Romania
Contents
1. WELCOME WELCOME BIOLASE epic Figure 4 1 Figure 4 2 Figure 4 3 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 The system will go to the HOME screen EPIC T Series User Manual pg 15 5400478 Rev A 04 14 Laser Console Battery Strength Indicator Wireless Signal Strength Indicator 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 footswitch are shipped already paired However if pairing is not confirmed an x will appear in the pairing icon located in the upper left hand corner of the touchscreen Figure 4 6 EPIC2. IPX6 EPIC T Series User Manual pg 13 5400478 Rev A 04 14 4 OPERATION INSTRUCTIONS 4 75VSTEM SETUP e Place the unit in a clean dry and well ventilated area e Verify power switch is in the OFF O position e Epic T 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 T 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 The system ships from the factory with the fiber already connected to the laser console NOTE 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 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 no
3. 5 7 in W x 4 4 in H x 6 5 in L Dimensions 14 5 cm x 11 2 cm x 16 5 cm Weight 2 75 Ibs 1 25 kg 5 2 ELECTRICAL Remote Interruption Remote Interlock Disable Control Emergency Stop Button Battery Lithium lon Rechargeable 14 4V 2 9Ah DC Power Supply Module 12V DC 5A 5 7 LASER Power Accuracy 20 Power Modes Continuous Spot size Deep Tissue Handpiece 30 mm diameter 7 1 cm area EPIC T Series User Manual pg 22 5400478 Rev A 04 14 Nominal Ocular Hazard Distance NOHD 4 77 meters Beam Divergence 8 22 per side angle Standard Fiber Cable Length 6 8 feet 2 meters 5 4 OTHER LIGHT SOURCES Aiming Beam Laser diode max 1 mW 625 nm 670 nm Class 1 EPIC T Series User Manual pg 23 5400478 Rev A 04 14 6 CONTRAINDICATIONS WARNINGS c PRECAUTIONS 6 7 LONTRA NDICA TIONS All clinical procedures performed with Epic T 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 cond
4. Safety Precautions for Lithium lon Battery Packs rrrarrrnnrrnnnrrnnrrrnnrnnnnennnnnn 38 PING NMS 41 APPENDIX E Electromagnetic Compatibility rrrorrrrnnrrrrnrrrrnnrrnnnnerranrernnnenrnnernanrnnnnnennnnennnn 42 APPENDIX F Wireless Equipment Compliance Giatement 46 EPIC T Series User Manual pg 3 5400478 Rev A 04 14 INTRODUCTION The Epic T Series diode laser is a therapeutic device at the cutting edge of technology for use in providing temporary relief of minor pain The Epic T 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 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 T Series will prove a valuable addition to your practice Please contact BIOLASE Customer Service at 1 800 321 6717 for any service needs If you are located outside the USA please contact your BIOLASE authorized distributor EPIC T Series User Manual pg 4 5400478 Rev A 04 14 1 PACKAGING 1 1 SYSTEM PARTS
5. User Manual BIOLASE TABLE OF CONTENTS TABLE OF CONTENT Jr 1 g 1 100 7 CTO g EEE EEE EE EEE EE NE 4 I s 6 5 lee EE NR 5 BER ge SE E 5 1 2 Facility Heouremente 5 2 Eg ipment Ree EON DE 6 2 AAC IG ell EE 6 PRE ES COMGOIC EEE ERE EEE EEE EE EE 6 EG SON OL FAC EEE 6 FN SSN 7 2 5 Fiber Optic Connechon 7 Re MIS SUS Ener 8 NNN 9 31 pa 518001 0 EE EEE ERA EEEE PA KAER E 9 EEN EE 9 NN PENN 10 ge 10 0 e 10 Een e 10 POT Mg 11 AcCess Key COQG ne ee en ee ENE EAEE ii ENERE 11 Hoa ONE UIO NE EE S 11 Wireless FOOISWICN TT 11 Binet Io 1119 SE EE EE ET EE 12 ETT 13 Functional DESS ol ER 13 34 Salely ST er de EE 13 A JS AU ON US UC og EE E E 14 4 1 System SN re 14 4 2 Operation Turn on the EPIC T Series Laser 15 e Ee Ee A E E A A E E E E ane tsagend een E 16 4 4 Pairing the Footswitch to the Laser console r rnrrrarrrnrvrnnnrnrernnrrernnernnrennrrnnrennnennsennsennee 16 EPIC T Series User Manual pg 1 5400478 Rev A 04 14 4 5 Control BUTTON EE 18 4 6 Entering READY or STANDBY Modes 18 TREND NOEN 19 4 8 Wireless Footswitch uk 19 4 11 Using the EPIC T Series Touch Screen Display 20 4 14 Tum Ne e CH eek midepannddme 21 JEANNE cance cet RERA EEE IEEE ete getteaettsannas vane caeedeesdenacnes oaateesienaeeenramnoues 22 eM CCG Fall EE 22 EEOC E 22 GJ EEE EEE EEE EE EEE 22 TONEN 23 6 Contraindications Warnings amp Precautions ccccceecccecceceececeeeceecesseeeeseeeeseaeeeseeeeaseeeeaes 2
6. T Series User Manual pg 16 5400478 Rev A 04 14 HOME i 2 Ba PAIN THERAPY ew 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 D a4 to the laser console has been lost Figure 4 7 press the ES green PAIR button PAIR LA 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 Fi gure 4 8 stenge RESET K x Figure 4 8 WIRELESS 4 To complete the pairing process turn the footswitch over en and press the Pairing Button Y for four 4 seconds Figure 4 9 Le EPICTM T Series User Manual pg 17 5400478 Rev A 04 14 WIRELESS deal E ba 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 3 Figure 4 10 WIRELESS amp 5b If pairing has not occurred the Wireless screen will appear again indicating that pairing was not successful Q er ba Figure 4 11 Ss the green button to repeat steps 3 5a Figure 4 11 SETTINGS 6 Press the Settings button to return to the Settings menu d OD press the arrow on the bottom left of the Settings screen to
7. It can be powered by an external mains power supply or an internal replaceable lithium ion battery pack 14 4V 2 9 Ah 2 9 CONTROL PANEL ITEM ITEM DESCRIPTION Activates the controls and display CONTROL Places the unit into STANDBY or READY mode 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 Fiber Storage Channel Control Button e Blinking blue indicates pairing between the footswitch and laser console Is active Figure 2 1 Control Panel Front View EPICTM T Series User Manual pg 6 5400478 Rev A 04 14 2 4 DELIVERY SYSTEM The Epic T Series Delivery System consists of e Re useable Fiber Optic Assembly e Re useable Deep Tissue Handpiece Figure 2 4 The fiber optic cable is detachable from the console The handpiece is a re usable NOTE are accessory and will require disinfection prior to each patient treatment 2 5 FIBER OPTIC CONNECTION 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 The Epic T Series ships with the fiber optic cable already attached 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
8. Series User Manual pg 40 5400478 Rev A 04 14 APPENDIX C ACCESSORIES 6400485 Peel off clear screen covers qty 30 6400457 Lithium ion battery pack for console 6400463 Battery Pack 2 x AAA 6400437 Trunk Fiber Assembly EPICTM T Series User Manual pg 41 5400478 Rev A 04 14 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 3ft 1 meter Biolase p n 2400043 Footswitch Wireless Biolase p n 6400522 The use of accessories other than those specified except those supplied WARNING or sold by Biolase Inc as replacement parts for internal or external componenis 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 emis
9. 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 e Do not place the battery in fire or heat the battery e Do not install the battery backwards so that the polarity is reversed e Do not connect the positive terminal and the negative terminal of the battery to each other with any metal object Such as a wire e Do not carry or store the batteries together with necklaces hairpins or other metal objects e Do not pierce the battery with nails strike the battery with a hammer step on the battery or otherwise subject it to strong impacts or shocks e Do not solder directly onto the battery e Do not expose the battery to water or salt water or allow the battery to get wet 2 Do not disassemble or modify the battery The battery contains safety and protection devices which if damaged may cause the battery to generate heat rupture or ignite 3 Do not place the battery on or near fires stoves or other high temperature locations Do not place the battery in direct sunshine or use or store the battery inside cars 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 conten
10. for 25 cycles lt 5 Ur gt 95 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 lt 5 Ur gt 95 dip in UT for 0 5 cycle 40 Ur 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 50 Main power quality should be that of a typical 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 diode laser requires continued operation during power mains interruptions it is recommended that the model 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 U isthe A C mains voltage prior to applications of the test level EPIC T Series User Manual pg 43 5400478 Rev A 04 14 GUIDANCE AND MANUFACTURER S DECLARAT
11. have to be reduced to avoid overheating e Patients with tender or sensitive skin may be hypersensitive to heat reduce power as necessary to ensure comfort during treatment e Patients with swelling and or inflammation may be sensitive to heat reduce power as necessary to ensure comfort during treatment e Do not treat open wounds EPIC T Series User Manual pg 27 5400478 Rev A 04 14 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 creams 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 o Power output o Distance from the skin surface o Range of movement of the handpiece o Patient skin type Safety and
12. 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 A 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 achi
13. of endogenous gases e All persons present in the operatory must wear protective laser eyewear NOTE For replacement or additional protective laser eyewear please contact BIOLASE CAUTION Periodically inspect laser eyewear for pitting and cracking LASER Use of controls or adjustments or performance of procedures other than WARNING those specified herein may result in hazardous radiation exposure WARNING Do not use this unit if you suspect it of functioning improperly or other than described herein This unit has been designed and tested to meet the requirements of 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 T Series CAUTION ae i laser is used in a clinical setting EPIC T Series User Manual pg 9 5400478 Rev A 04 14 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 e Toggle the ON OFF switch located on the rear of the console to the OFF O position before leav
14. 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 T Series User Manual pg 44 5400478 Rev A 04 14 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 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 frequ
15. 4 SE Re eat ele 1 eg EN 24 6 2 Wamings and Gre 24 Presciption WE cect cccconctcdusscetdansdauscccnsstbdnaeddancdhsenssseemuassidnpucraseastaststedamadeetecue sebdeasdet 24 ST A ee E ET EE 24 DN dall Le EN EE EE REE 24 7 AIMCAL APPICA ONS varde 25 TA Tat dee Lee BEE 25 E ale ETE 25 Fo Ge PINOT OY EEE 25 Pre programmed Pain Therapy Gettmge 26 7 7 Table of Pre Programmed Pain Therapy setimge 27 Pain Therapy Adverse Effects rrnrrrnrrnnrrnnrrnnrrnnnrnnnrvnnrvannvnnnnannnnnnnnnnnnnnnnennnrnnnennnennnennee 27 Pain Therapy Warnings and Hrecautons 27 Recommended EE 28 Using the Deep Tissue Handpiece arrnnnrnnnnrnnnnnvanrnnnnrnnnrnvnnnnanennnnnnnnrnnanennnsnnanennnennnsennnene 28 EE NE NE EE 29 8 1 Daily MAINTENANCE c siceonenaieciaceudausatenrdesseudssisiatesawestavetanesiateuniesvnoumeadudasinnaausateradecasaucsusadeeasinsiivs 29 8 2 Cleaning and disinfection Procedures rrarrnnnnnnnnnnrnnernnnnvnnnvnnrnranennnnnrnnennnnennnnnnnsennsennnne 29 8 3 Installing Replacing the Console Battery Pack 29 8 4 Changing the Wireless Footswitch Batteries rrrrrnrrrnnnennnrrnnrrrnnrnnnnrvnnrnnanennnnennnennnrnnnne 30 SAs MEANS DOM AVON EE 31 EPIC T Series User Manual pg 2 5400478 Rev A 04 14 SO SONA EEE EE EE ER EE 31 JCB oa EEE 32 TSN hhv 32 10 Software Specification rrrrrranrrrnnnerrnnnnrnnrnrnnnennnnrnrannennnnennanennnnrnnnnnennnnennnnsennnsennnssennssnnnnee 32 OE 32 FP SANN 34 APPENDIX B
16. ION 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 E IEC 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 Radiated 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 d 1 2VP 80 MHz to 800 MHz d 2 3VP 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 4 NOTE 2 These guidelines may not apply in 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
17. LIST The Epic T 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 Deep Tissue Handpiece 1 shipped separately Three 3 pairs of protective laser eyewear two 2 pairs of doctor safety glasses one 1 pair of darker patient safety glasses 6 DC power supply and power cord one 1 for North America and one 1 for International 7 Welcome Kit Welcome Letter Limited Warranty Information User Manual 8 Laser Warning Sign 9 Remote Interlock cable 10 Philips head screwdriver for installing Footswitch batteries 11 Footswitch 12 AAA batteries 2 Oh ee w a 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 1 2 FACILITY REQUIREMENTS Electrical Supply 100 240V e 1 5A 50 60Hz Environmental Requirements e Temperature 20 25 C e Humidity 15 95 Non condensing EPIC T Series User Manual pg 5 5400478 Rev A 04 14 2 EOUIPMENT DESCRIPTION 2 7 GENERAL The EPIC T 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
18. 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 EPIC T Series User Manual pg 30 5400478 Rev A 04 14 8 5 TRANSPORTATION The Epic T Series is susceptible to damage if not handled properly The unit should ALWAYS be handled carefully and never banged jarred jolted dropped or knocked Do not transport the unit unless it is completely packaged inside its shipping box If you have any questions regarding transportation please call BIOLASE Service at 1 800 321 6717 8 6 STORAGE The Epic T Series should be stored in a cool dry place when not in use Storage temperature 15 C 35 C 59 F 95 F relative humidity 10 70 non condensing 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 T Series is not likely CAUTION to be used for some time The Epic T Series is shipped inside a custom shipping box Please save and store the box ina cool dry place for use when transporting the laser or for long term storage EPIC T Series User Manual pg 31 5400478 Rev A 04 14 9 CALIBRATION 9 1 CALIBRA TION SCHEDULE Calibration procedure is r
19. SE Part Number 2400129 CAUTION Access Key Code The Access Key Code prevents unauthorized use of the system It is activated every time the 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 T 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 T Series User Manual pg 11 5400478 Rev A 04 14 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 Cover Bea Footswitch Figure 3 3 Footswitch Assembly Remote Interlock This feature allows the laser console to be conne
20. at interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help EPIC T Series User Manual pg 46 5400478 Rev A 04 14 D BIOLASE Inc 4 Cromwell Irvine CA 92618 USA SAS 315 O 888 424 6527 biolase com MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 mt procons com About BIOLASE Founded in 1986 BIOLASE Inc specializes in lasers for medicine and dentistry that feature proprietary and patented technologies for 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 BIOLASE leads the global dental laser market with over 21 000 lasers in use today and the most complete family of dental lasers from diode lasers to the most advanced a
21. cted to the remote sensor preventing its operation when triggered eg by opening door The electric cable from this connector should be wired to the normally closed switch sensing the opening of a door and turning the laser console off when the switch is open To override this feature don t connect the plug Figure 3 4 Remote Interlock Connector EPIC T Series User Manual pg 12 5400478 Rev A 04 14 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 CLASSIFICATION The following safety classifications are applicable to the device Laser Radiation Class 4 Aiming Beam Class 1 Type of protections against electrical shock Class 1 Degree of protection against electrical shock Type B Applied Part Not protected against water ingress Ordinary Equipment Not suitable for use in presence of flammable anesthetic mixture Operation Mode Continuous Wave Wireless Footswitch
22. ecommended 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 BIOLASE Service at 1 800 321 6717 or your Authorized Service Representative to schedule an appointment 10 SOFTWARE SPECIFICATION BIOLASE respects the intellectual property of others and we ask our users to do the same Epic T 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 BIOLASE Service at 1 800 321 6717 or your authorized Service Representative EPIC T Series User Manual pg 32 5400478 Rev A 04 14 I Message Reason Error 1 7 Thermistor Open Thermistor Open Call BIOLASE Service Error 2 Thermistor Shorted Thermistor Shorted Error 3 Shutdown Temperature System too hot Fr 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 Pen pressed or Aa FS or call Biolase Er
23. ed at the factory are based on clinical NOTE recommendations and feedback from experienced laser medical practitioners EPIC T Series User Manual pg 26 5400478 Rev A 04 14 7 7 TABLE OF PRE PROGRAMMED PAIN THERAPY SETTINGS TIME PROCEDURE NAME we SETTING SECONDS ENERGY J SPACER CW JOINT PAIN Continuous 4W 2400 30 mm CW MUSCLE SPASM Continuous 300 1200 30 mm CW CUSTOM Continuous d W 240 Figure 7 10 CW 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 discomfort 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 O Decrease the power setting O Stop treatment 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
24. effectiveness are described by elevating the skin temperature in the treatment area utilizing the setting recommended below Use personal clinical judgment with consideration of the Fitzpatrick Skin Type Scale when selecting procedure parameters monitor the patient and adjust the setting 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 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 needed for patient comfort EPIC T Series User Manual pg 28 5400478 Rev A 04 14 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 T Series system after each procedure Do not use bleach or abrasive cleansers 8 2 CLEANING AND DISINFECTION PROCEDURES The handpiece is sold with clear disposable protective shields It is reusable and must be disinfected between patients to avoid cross conta
25. ency 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 affected by absorption and reflection from structures objects and people EPIC T Series User Manual pg 45 5400478 Rev A 04 14 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 th
26. er 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 T Series User Manual pg 35 5400478 Rev A 04 14 Emergency Laser Stop Switch The switch used in emergencies to stop laser output Location Right side of Laser console 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 Prescription Statement Rx Only Federal Law restricts this device to sale by or on the order of a physician or other 4400417 Rev licensed medical practitioner EPICTM T Series User Manual pg 36 5400478 Rev A 04 14 Atmospheric Pressure Limitations 50 kPa ATMOSPHERIC PRESSURE Fragile Handle with care FRAGILE ES ie Keep Dry KEEP DRY e Humidity Limitations 10 CONDENSING Gar HUMIDITY me Temperature Limitations TEMPERATURE This End UP THIS END UP EPICTM T Series User Manual pg 37 5400478 Rev A 04 14 APPENDIX B SAFETY PRECAUTIONS FOR LITHIUM ION BATTERY PACKS When
27. eves the strongest possible level for optimal operation When the footswitch is not in use it will go into SLEEP mode to conserve battery NOTE power It automatically reactivates when it is pressed EPICTM T Series User Manual pg 19 5400478 Rev A 04 14 4 77 USING THE EPIC T SERIES TOUCH SCREEN DISPLAY BIOLASE epic PAIN THERAPY JOINT PAIN MUSCLE PAIN MUSCLE SPASM CUSTOM JOINT PAIN ENERGY SENEE 2400J 4 O TIME D WW 600s LANGUAGES WIRELESS V 4 ap Q2 PAIR 2 VOLUME EPIC T Series User Manual Figure 4 13 pg 20 WELCOME PAIN THERAPY LA SETTINGS di AIMING RESTORE Restore all Settings This will set the laser to factory settings RESTORE e SERVICE A 5400478 Rev A 04 14 4 74 TURN THE LASER CONSOLE OFF e Wind the fiber cable onto the fiber spool counterclockwise around the base of the console e Place the handpiece onto the handpiece holder SS Verify that the fiber optic tubing assembly is not twisted once the sd 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 EPIC T Series User Manual pg 21 5400478 Rev A 04 14 5 SPECIFICATIONS 5 7 GENERAL
28. hritis 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 7 3 PAIN THERAPY The Epic T 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 Refer to the Fitzpatrick Skin Type Scale Figure 7 1 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 energ
29. ield lt Protective Plug Figure 2 4 Deep Tissue Handpiece e Remove Red Cap Dust Cover and Protective Plug from the Deep Tissue Handpiece P Figure 2 5 e Slide the handpiece over the shaft until it clicks into place Figure 2 5 e Place the protective shield over the adjustable spacer Figure 2 6 Figure 2 6 e Loosen the Lock Ring and set the Spacer at the desired spot size Detent Location Figure 2 7 Tighten the Lock Ring Figure 2 7 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 T Series User Manual pg 8 5400478 Rev A 04 14 3 SAFETY 3 1 PRECAUTIONS Failure to comply with precautions and warnings described in this User Manual may lead to exposure to dangerous optical radiation sources Please comply with all safety instructions and warnings 3 2 SAFETY INSTRUCTIONS Follow these safety instructions before and during treatments e When the laser is in use all operatory entrances must be marked with an appropriate 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
30. ing unit unattended LASER Do not open unit housing at any time Danger from optical radiation may WARNING exist Do not aim the laser at metallic or reflective surfaces such as surgical LASE Instruments or dental mirrors If aimed directly at these surfaces the laser WARNING beam will reflect and create a potential hazard 3 9 SAFETV FEATURES Energy Monitor The energy monitor measures and verifies power output Power deviations of more than 20 from the selected value will cause the display to show the error message LASER CURRENT HIGH LOW The laser console will not operate until the system first clears the error and then goes into READY mode If the error message persists please contact BIOLASE Service at 1 800 321 6717 System Monitor The system monitors the emergency stop switch remote key wireless footswitch connection and output power An error in any one of these will stop the system The text display will indicate the type of error Operation will not resume until the error is cleared EPIC T Series User Manual pg 10 5400478 Rev A 04 14 Power Switch The laser console can be switched ON I or OFF O using the Power Switch on the back of the console it 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 T Series laser system BIOLA
31. 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 pinched between the housing and the fiber optic access plug S Oy Figure 2 2 Fiber Optic Access Plug Figure 2 3 Optical Access Port EPIC T Series User Manual pg 7 5400478 Rev A 04 14 2 6 DEEP TISSUE HANDPIECE The Deep Tissue Handpiece is reusable and equipped with a disposable single use protective shield The handpiece requires disinfection before and after each patient treatment This handpiece cannot be sterilized in the autoclave For instructions NOTE ondisinfecting the handpiece refer to section 8 It is recommended to wipe the disposable shield with alcohol prior to use The disposable shield is for single use only to avoid cross contamination Dispose of when treatment session is completed Spacer Red Cap Dust Handpiece Cover K S Disposable l Sh
32. itions 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 Prescription Statement Federal Law restricts this device to sale by or on the order of a physician or other licensed medical practitioner Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 940 10nm raining Only licensed professionals who have reviewed and understood this User Manual should use this device BIOLASE assumes no responsibility for parameters techniques methods or results Physicians must use their own clinical judgment and professionalism in determining all aspects of treatment technique proper power settings interval duration etc 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 T Series User Manual pg 24 5400478 Rev A 04 14 7 CLINICAL APPLICATIONS 7 1 INTRODUCTION Please review this section carefully before using this device in a clinical situation 7 2 INDICATIONS FOR USE The Epic T Series is intended for topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor art
33. ll tissue laser the WaterLase iPlus Made in the USA 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
34. mination The Deep Tissue Handpiece is not autoclavable The clear protective shields are intended for single use only to avoid cross contamination and should never be re used To disinfect the Deep Tissue Handpiece wipe the entire outer surface of the handpiece with cotton gauze and isopropyl alcohol It is recommended to wipe the disposable shield with alcohol prior to use Dispose of after one time use 8 9 INSTALLING 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 1 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 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 Replace the battery cover on the bottom of the unit using the Phillips screwdriver provided Connect 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 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 Recycle the used Lithium lon battery as regulated Do not thr
35. o direct sunlight When the battery becomes hot the built in safety equipment is activated preventing the battery from charging further and heating the battery can destroy the safety equipment and can cause additional heating breaking or ignition of the battery 2 Do not continue charging the battery if it does not recharge within the specified charging time Doing so may cause the battery to become hot rupture or ignite CAUTION The temperature range over which the battery can be charged is 0 C to 45 C Charging 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 T Series User Manual pg 39 5400478 Rev A 04 14 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 performance of the battery or may reduce its life expectancy EPIC T
36. ow it in a trash bin EPIC T Series User Manual pg 29 5400478 Rev A 04 14 PN MODEL EPIC T SERIES FCC ID G2OEPIC MODEL EPIC T SERIES FCC ID G20EPIC Screws to remove Batterv cover vine CA 92818 USA DS EPIC T SERIES 7400055 Figure 8 1 Battery Cover Bottom of Console Figure 8 2 Battery Pack Connector Wire Only use the battery pack supplied by BIOLASE The battery pack is a separate NOTE 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 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 Replacing the batteries may disrupt the pairing of the laser console and footswitch If you find the wireless communication has been interrupted reestablish pairing by following the instructions provided in Section 4 To ensure the longevity of the battery power only BIOLASE supplied batteries are
37. return to the Home screen Figure 4 12 N Figure 4 12 4 5 CONTROL BUTTON The CONTROL button on the front of the laser console is a multi functional button Figure 2 1 Pressing and holding the Control Button for approximately two 2 seconds will allow the transition from STANDBY or READY mode to SLEEP mode Note that you will not be allowed to go into READY mode unless you have chosen a treatment module on the HOME screen first 4 6 ENTERING READY OR STANDBY MODES Press and release the Control Button to place the laser console into either READY or STANDBY mode The laser console will only emit laser energy when the footswitch is pressed and the laser console is set to READY mode While in READY or STANDBY mode mode setting and or power setting values may be changed only when the laser is not firing If the EPIC T Series User Manual pg 18 5400478 Rev A 04 14 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 delay of two 2 seconds 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
38. ror 6 ON OFF button Stuck Key stuck Press 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 SE RS 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 7 Battery Critically Low Battery Critically Low Plug in DC supply Warning 1 Temp High System is hot Fs 5 10 mins for laser to cool own Warning2 P Battery Low Battery is low Plug in DC supply Warning 3 Battery Not Connected Battery not connected Plug in Battery Warning4 S FS Battery Low Battery on FS low Replace FS battery Alert 1 p Wireless Not Paired No wireless connect Re establish pairing see Sec 4 KS System must be in READY System is not in READY Press the Control Button in any E L N mode to lase mode procedure screen Figure 11 1 EPICTM T Series User Manual pg 33 5400478 Rev A 04 14 APPENDIX A LABELING N BIOLASE MT Promedt Consulting GmbH 4 Cromwell Altenhofstrasse 80 Irvine CA 92618 USA D 66386 St Ingbert GERMANY EPIC T SERIES LASER SYSTEM REF 7400055 REF SN XXXX al YYYY MM 100240 50 60 Hz LSA OUTPUT c US IN oN intertek 0482 Li lon Rechargeable 9800165 Battery 14 4 V 2 9 Ah 5400351 Rev D Made in the USA 5400483 Re
39. sions i SR internal function Therefore its RF emissions are Group 1 very low and are not likely to cause any CISPR 11 l i interference in nearby electronic equipment RF emissions Class A CISPR 11 SCH 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 supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Class A IEC 61000 3 3 EPICTM T Series User Manual pg 42 5400478 Rev A 04 14 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 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 lt 5 Ur gt 95 dip in UT for 0 5 cycle 40 Ur 60 dip in UT for 5 cycles 70 U 30 dip in U
40. t cover or block ventilation channels These channels provide an air flow path to cool the unit Do not bend the fiber optic cable at a sharp angle as it is can break Make CAUTION sure it is not caught or pinched between the housing and the fiber optic access plug e Remove protective cap from the end of the fiber shaft TEE gt i e Carefully connect the handpiece to the fiber optic assembly Figure 2 5 e Wind any excess fiber optic cable onto the fiber spool counterclockwise in the fiber storage channel around the base of the console Figure 2 1 e 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 g N EPIC T Series User Manual pg 14 5400478 Rev A 04 14 LAGER WARNING Never point the laser at a person s eyes LASER WARNING Never operate the laser without a handpiece 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 7 SER ES LASER 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 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 T Series Welcome screen will be displayed Figure 4 2
41. ts 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 appears EPIC T Series User Manual pg 38 5400478 Rev A 04 14 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 a car s cigarette lighter e Do not place the batteries in or near fire or int
42. v A THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCES EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO 50 DATED 24 JUNE 2007 P N 5400341 REV A EPIC T Series User Manual Product ID Label Location Bottom of laser console 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 FDA Compliance Label Indicates the device complies with FDA laser standards 5400478 Rev A 04 14 Warning Label Indicates there is the risk of possible exposure to both infrared and visible laser radiation Location Back of laser console FCC Label MODEL EPIC T SERIES Lists Federal Communication Commission FCC ID G2OEPIC registration number 5400566 Rev A Location Bottom of Console FCC Label MODEL EPIC T SERIES Lists Federal Communication Commission FCC ID G2OEPIC 1 registration number 5400567 Rev A Location Bottom of Footswitch NOTICE FCC Compliance Notice r sitet inal 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 water resistant protected against splashes of wat
43. y or decreasing the power setting EPIC T Series User Manual pg 25 5400478 Rev A 04 14 Fitzpatrick Skin Type Scale Highly sensitive always burns never tans Example Red hair with TYPE I freckles Very sun sensitive burns easily tans minimally Example Fair skinned TYPE Il MM fair haired Caucasians Sun sensitive skin sometimes burns slowly tans to light brown TYPE III 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 never burns deeply pigmented Example Darker Figure 7 1 Pre programmed Pain Therapy Settings To access the pre programmed procedure values 1 Go to the Procedures menu by pressing the Pain Therapy icon KO 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 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 C 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 install
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