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Appendix A

Tip Guide

PRE-INITIATED

E4-4

400µm

7400016

E4-7

400µm

7410003/

7400019

E4-9

400µm

0019

NON

-INITIATED

Tip

Name

Diameter

Length (mm)

Part Number

NOTE:

All BIOLASE tips for diode lasers are sold non-sterile and are for single-use

only. See Section 9 in this User Manual for cleaning and ste

ilization instructions.

4-4

400µm

74000

4-7

400µm

74000

4-9

400µm

Tip

Name

Diameter

Length (mm)

Part Number

Epic Hygiene

User Manual

Summary of Contents for Epic

Page 1: ...rated in the United States and or other countries All other trademarks are property of their registered owners Subject to change without notice MADE IN THE USA biolase com BIOLASE INC 4 Cromwell Irvine CA 92618 USA Telephone 888 424 6527 Telephone 949 361 1200 Fax 949 273 6687 Service 800 321 6717 EU REPRESENTATIVE MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 58...

Page 2: ...PAGE LEFT BLANK ...

Page 3: ... Wireless Footswitch 14 6 SAFETY WITH THE EPIC HYGIENE 15 6 1 Safety Instructions 15 6 3 Safety Features 17 3 Contents 6 2 Safety Classification 16 Control Button 13 3 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 7 3 1 Contraindications 7 3 2 Warnings and Precautions 7 Prescription Statement 7 Training 7 Eyewear 8 Anesthesia 8 Adjacent Structures 8 Suction 8 Plume Removal 8 Treatment Technique and S...

Page 4: ...ation Turn on the Epic Hygiene 23 7 6 Settings Screen 24 7 7 Pairing the Footswitch to the Laser Console 24 7 8 Control Button 25 7 9 Entering Ready or Standby Modes 26 7 10 Ready Mode 26 7 11 Wireless Footswitch 26 7 12 Peak Power Display 27 7 13 Pulse Mode Selection 27 7 14 Using the Epic Hygiene Touch Screen Display 28 7 15 Procedures Button 29 7 16 Turn the Laser Console Off 29 8 CLINICAL APPL...

Page 5: ...ng Replacing theConsoleBatteryPack 35 9 5 Changing the WirelessFootswitchBatteries 36 9 7 Storage 37 10CALIBRATION 38 11 SOFTWARE SPECIFICATION 38 12TROUBLESHOOTING 39 APPENDIX A TIP GUIDE 41 APPENDIX C ACCESSORIES 43 APPENDIX D LABELING 44 APPENDIX E SAFETY LITHIUM ION BATTERY PACKS 48 APPENDIX F ELECTROMAGNETIC COMPATIBILITY 50 APPENDIX G WIRELESS EQUIPMENT COMPLIANCE STATEMENT 54 5 Contents 9 6...

Page 6: ...e Handpiece Various types of single use disposable tips are designed and optimized for different applications The device is activated by means of a wireless footswitch This is a prescription device that is indicated for professional use only by dentists and other licensed dental professionals such as dental hygienists where permitted by state or local practice regulations The use of this device re...

Page 7: ... medical conditions that might contraindicate a local procedure such conditions may include but are not limited to allergy to local or topical anesthetics heart disease including pacemakers and implantable defibrillators lung disease bleeding disorders sleep apnea an immune system deficiency or any medical conditions or medications that may contraindicate the use of certain light laser type source...

Page 8: ...UCTURES Always be aware of adjacent structures and substructures during use Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues Do not direct energy toward hard tissue such as tooth or bone Do not direct energy towards amalgam gold or other metallic surfaces Do not direct energy towards cements or other filling materials Exercise extreme caution when using ...

Page 9: ...ts Closely observe and monitor clinical effects and use your judgment to determine the 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 the specific indication and increase as required BIOLASE assumes no responsibi...

Page 10: ... Maximum Permissible Exposure Beam Divergence Standard Fiber Cable Length 4 4 OTHER LIGHT SOURCES Aiming Beam 4 Specifications 5 7 in x 6 5 in x 4 4 in 14 5 cm x 11 2 cm x 16 5 cm 2 5 lbs 1kg 100V 240V at 1 5A 50 60 Hz None Main Power Switch ON OFF Control Button Remote interlock Emergency Stop Button Lithium Ion Rechargeable 14 4V 2 9Ah 12V DC 5A IV 4 InGaAs Semi conductor diode 980 10nm 1 5W Max...

Page 11: ...Tips 5 Handpiece qty 2 6 Laser Protective Eyewear qty 3 7 DC Power Supply Module 8 Power Cord qty 1 9 Welcome Kit Includes User Manual 10 Laser Warning Sign 11 Tip Initiation Kit 12 Remote Interlock Cable 13 Wireless Footswitch 14 Philips Head Screwdriver for installing Footswitch batteries 15 AAA Batteries qty 2 WARNING No modification of this equipment is allowed 11 5 Equipment Description ...

Page 12: ... The Epic Hygiene system consists of three components Figure 5 1 Wireless Footswitch Fiber Optic Cable Handpiece Tip 5Equipment Description Base Console Fiber Delivery System LED Indicators LED Indicators Control Button Fiber Storage Channel ...

Page 13: ...g active FIBER DELIVERY SYSTEM The fiber delivery system Figure 5 2 consists of the Fiber Optic Cable the reusable Handpiece and the fiber Tips and transmits laser radiation from the laser console through the Handpiece and fiber Tips to the target tissue The laser ships from the factory with the Fiber Optic Cable already attached to the base console HANDPIECE The Handpiece Figure 5 3 is re usable ...

Page 14: ...s designed to work using wireless technology and is powered by two AAA batteries which are installed prior to shipment from thefactory it ships already paired to the base console The Footswitch is protected by a metal cover To access first press down on the cover to unlatch it then press the Footswitch to fire the laser Figure 5 4 Figure 5 4 Footswitch Cover 5Equipment Description ...

Page 15: ...cifications of the protection provided Prior to use inspect the eyewear for pitting and or cracking do not use if damaged for replacement or additional laser protective eyewear please contact BIOLASE Do not look directly into the beam or at specular reflections Never direct or point the beam at a person s eyes Do not aim the laser at metallic or reflective surfaces such as surgical instruments or ...

Page 16: ...ed The following safety classifications are applicable to the device Laser radiation Class 4 Aiming Beam Class 2 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 and pulse modulat...

Page 17: ...he system The text display will indicate the type of error Operation cannot resume until the error is cleared POWER SWITCH The laser console can be switched ON I or OFF O using the power switch on the back of the console Turn the power switch OFF O only when the system will not be in use for a long period of time ACCESS KEY CODE The Access Key Code 888 prevents unauthorized use of the system It is...

Page 18: ... will stop immediately when the connection to the door switch is deactivated i e when the door is opened EMERGENCY STOP Press the red emergency laser stop button to instantly turn off the laser console Figure 6 5 The message Emergency Switch Error will appear on the console display and the amber LED will begin flashing To clear the error press the emergency laser stop button again in 2 to 5 second...

Page 19: ...ill work using either DC power or its rechargeable battery pack o DC Power Supply Module Connect the DC power supply module to the laser console attach one end of the power cord to the DC power supply module and plug the other end of the power cord into a wall outlet o Rechargeable Battery The Epic Hygiene is shipped with the battery pack already installed to charge the battery pack connect the po...

Page 20: ...ct the Handpiece and then re install it Figure 7 3 Connecting the Handpiece to the Fiber Optic Cable Figure 7 4 Handpiece Assembly fully assembled CAUTION The Handpiece is not sterile when shipped and MUST be sterilized prior to initial use and cleaned and sterilized between patients Protective Cap Fiber Shaft Collar 7Installation and Set Up Handpiece CAUTION Do not bend the Fiber Optic Cable at a...

Page 21: ... 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 biohazard medical waste sharps container Always visually inspect the Tip prior to use to make sure it is free of debris or damage 21 7Installation and Set Up To connect the Tip remove the protective cap from the end of the fiber shaft connect the Handpiece ...

Page 22: ...not be visible or may be fuzzy this is normal The tip does not need to be replaced LASER WARNING Never operate the laser without a fiber Tip attached to the Handpiece Never point the laser at a person s eyes All persons present in the operatory must wear protective eyewear when the laser is in use Incorrect Correct Correct Incorrect 7Installation and Set Up CAUTION Should the Tip become excessivel...

Page 23: ...nd whether the wireless connection between the Footswitch and console is at full strength upper left corner Figure 7 18 Figure 7 17 7Installation and Set Up 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 press the X or wait 3 seconds to revert back to the Welcome screen then re enter the correc...

Page 24: ... pairing is established The laser and Footswitch are shipped already paired However if pairing is not confirmed an x will appear over the pairing icon located in the upper left hand corner of the touchscreen 7Installation and Set Up 24 Pressing the Settings button on the HOME PROCEDURES screen Figure 7 20 accesses the Settings screen here the user may make changes to any or all of the following 7 ...

Page 25: ...tch and laser console are now paired Figure 7 24 Proceed to step 7 6 If pairing has not occurred the wireless screen will appear again indicating that pairing was not successful Figure 7 25 press the green button to repeat steps 3 and 4 7 Press the settings button to return to the settings menu press the arrow on the bottom left of the settings screen to return to the home screen Figure 7 26 Figur...

Page 26: ...f the aiming beam is not visible in either instance remove the Handpiece and confirm the beam is actually on by shining the end of the Fiber Optic Cable on a plain non reflective surface DO NOT look directly at the output end of the Fiber Optic Cable If the aiming beam is not on turn off the laser console then remove and re install the Fiber Optic Cable assembly If the aiming beam is still not on ...

Page 27: ... the laser console is in Ready mode and the wireless Footswitch is activated i e there is no duty cycle In Pulse mode CP or Comfortpulse 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 7 28 By pressing the X on the bottom left of the screen the use...

Page 28: ...Epic Hygiene User Manual Figure 7 29 7 14 USING THE Epic Hygiene TOUCH SCREEN DISPLAY 7Installation and Set Up 28 ...

Page 29: ...nd select the pre set for overwrite Figure 7 30 2 Make the desired changes then press and hold the banner on the selected procedure for two seconds Figure 7 31 The parameters for that one procedure will be changed and saved the laser console will beep when the adjusted settings are saved 7 16 TURNING THE LASER CONSOLE OFF Wind the Fiber Optic Cable onto the fiber storage channel counterclockwise a...

Page 30: ...a and adjust parameters accordingly 8 1 OVERVIEW To efficiently treat tissues it is imperative to understand the nature of the Epic Hygiene 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 within the applicable scope of practice 8 2 TABLE OF PRE PROGRAMMED HYGIENE SETTINGS 1 This setting...

Page 31: ...viceable parts and therefore no servicing instructions are available other than the regular maintenance procedures described in this manual Any attempt to modify or repair the laser by anyone other than an authorized BIOLASE technician may lead to exposure to laser radiation and collateral radiation CAUTION Handpieces and laser Tips are not sterile when sold and must be sterilized prior to initial...

Page 32: ...22 43 C for a minimum of 10 seconds to remove gross soil 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 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 ...

Page 33: ...he Fiber Optic Cable push the Handpiece onto the fiber shaft without twisting until it clicks into place and is secured as described in Section 7 3 STEP 3 DISINFECTING THE FIBER OPTIC CABLE Always disinfect the fiber between patients by wiping it completely with an appropriate disinfecting solution such as Cavicide or a similar quaternary ammonium compound product containing 20 alcohol or less and...

Page 34: ...ned below 1 Always use a new unused Microbrush provided to clean the lens Figure 9 4 2 Dip the Microbrush in isopropyl alcohol 3 Gently rub the lens surface to remove debris or dark spots Figure 9 5 4 Repeat as needed using a new Mirocbrush each time until no residue appears on the swab CAUTION DO NOT inspect the lens while the laser system is powered on the aiming beam or laser beam can permanent...

Page 35: ...nd gently place the battery into the compartment 4 Replace the battery cover on the bottom of the unit using the Phillips screwdriver provided 5 Connect the power cord of the DC power supply module to the unit and plug into a wall outlet Before first use it is recommended to fully charge the battery for at least three 3 hours Once the battery is charged unplug the power cord from the wall outlet a...

Page 36: ...icating that the batteries need to be replaced To replace the batteries remove the 3 screws on the underside of the Footswitch to remove the battery cover Figure 9 7 take out the old batteries and install the new ones replacing the cover when done Discard the used batteries as regulated do not throw them in a trash bin Do not press push touch the pairing button Figure 9 8 while changing the batter...

Page 37: ...questions regarding transportation please call BIOLASE Service at 1 800 321 6717 9 7 STORAGE The Epic Hygiene should be stored in a cool dry place when not in use under the following environmental conditions Storage temperature 15 C 35 C 59 F 95 F Relative humidity 10 90 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 acci...

Page 38: ...eral radiation Call BIOLASE Service at 1 800 321 6717 or your Authorized Service Representative to schedule an appointment BIOLASE respects the intellectual property of others and we ask our users to do the same Epic Hygiene software is protected by copyright and other intellectual property laws This product contains proprietary copyrighted software developed by BIOLASE Inc All rights reserved in ...

Page 39: ...Battery is not connected Plug in the battery Warning 4 Footswitch battery is low Battery on the Footswitch is low Replace Footswitch battery Warning 5 Footswitch Footswitch held Release Footswitch Alert 1 Wireless not paired No wireless connection Re establish pairing see sec 4 Alert 2 System must be in Ready mode to lase System is not in Ready mode Press the control button in any procedure screen...

Page 40: ...tuck Key stuck Press front key Error 7 Flash corrupted Memory corrupted Call BIOLASE Service Error 8 Fiber not inserted Plug in Fiber Optic Cable Error 9 Lost Footswitch communication Wireless interference Reposition console Footswitch to improve communication Error 10 Emergency switch E switch pressed Press E switch again Error 11 Remote interlock Remote interlock open Check remote interlock clos...

Page 41: ...Diameter Length mm Part Number NOTE All BIOLASE tips for diode lasers are sold non sterile and are for single use only See Section 9 in this User Manual for cleaning and sterilization instructions Pi4 4 400µm 4 7400067 Pi4 7 400µm 7 7400068 Pi4 9 400µm 9 7400069 Tip Name Diameter Length mm Part Number Epic Hygiene User Manual 41 ...

Page 42: ...igure 1 2 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 2 3 Press the Footswitch to activate the laser into the air once a white flash will be visible or the Tip will glow Figure 3 4 Repeat initiation process as needed to ensure the Tip is...

Page 43: ... 2400075 DC Power Supply Module 6400541 Wireless Footswitch 6400107 Tip Initiation Kit 6400465 Peel off Clear Screen Protectors qty 30 6400457 Lithium Ion Battery Pack for Console 2400203 Battery Pack 2 x AAA 6400437 Fiber Optic Cable 2400043 Power Cord U S 5400110 Laser Warning Sign 7420004 43 Epic Hygiene User Manual ...

Page 44: ...MBER PRODUCT SERIAL NUMBER DATE OF MANUFACTURE LASER WARNING Indicates the system contains a laser LOCATION Back of Laser Console TYPE BF APPLIED PART The applied part is not conductive to the patient FIBER WARNING Indicates the system contains a laser LOCATION Back of laser console Epic Hygiene User Manual 44 ...

Page 45: ...rs LOCATION Bottom of laser console REFER TO USER MANUAL FCC COMPLIANCE NOTICE The Footswitch and laser console comply with Part 15 of FCC Rules regarding unlicensed transmissions LOCATION Bottom of Footswitch INGRESS PROTECTION CODE The Footswitch is water resistant protected from splashes of water IPX6 SINGLE USE ONLY DO NOT REUSE Appendix D Labeling 45 Epic Hygiene User Manual ...

Page 46: ...ION Outer carton shipping box FRAGILE HANDLE WITH CARE LOCATION Outer carton shipping box KEEP DRY LOCATION Outer carton shipping box HUMIDITY LIMITATIONS LOCATION Outer carton shipping box ATMOSPHERIC PRESSURE LIMITATIONS LOCATION Outer carton shipping box SYSTEM SHIPPING LABEL LOCATION Outer carton shipping box Epic Hygiene User Manual 46 ...

Page 47: ... whenever the laser system is in use POWER INPUT RATING 12 Volts Direct Current 5 amps MINI USB INPUT For external programming REMOTE INTERLOCK Input for Remote Interlock Connector DC POWER USB REMOTE INTERLOCK LABEL Identifies input ports Appendix D Labeling 47 Epic Hygiene User Manual ...

Page 48: ...mperature 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 1 If the device is to be used by small children the caregiver should explain the contents of the user s manu...

Page 49: ...wise ensure that the battery charging conditions specified are met Do not attach the batteries to a power supply plug or directly to a car s 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 ...

Page 50: ...c compatibility EMC and needs to be installed and put into service according to the EMC information provided in the following tables Portable and mobile radio frequency RF communications equipment can affect medical electrical equipment WARNING The use of accessories other than those supplied or sold by BIOLASE Inc as replacement parts for internal or external components may result in increased EM...

Page 51: ...Appendix F Electromagnetic Compatibility 51 Epic Hygiene User Manual ...

Page 52: ...Appendix F Electromagnetic Compatibility Epic Hygiene User Manual 52 ...

Page 53: ...Appendix F Electromagnetic Compatibility Epic Hygiene User Manual 53 ...

Page 54: ...ul interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the r...

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Page 56: ... 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 MADE IN THE USA biolase com BIOLASE INC 4 Cromwell Irvine CA 92618 USA Telephone 888 424 6527 Telephone 949 361 1200 Fax 949 273 6687 Service 800 321 6717 19 1703 Epic H UserManual_Cover r1 indd...

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