background image

4

Remote Interlock ......................................................................................................................... 1

6

Emergency Stop ......................................................................................................................... 1

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Functional Display ...................................................................................................................... 1

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7  INSTALLATION AND SETUP ........................................................................................ 1

7

7.1  System Setup ............................................................................................................................. 1

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7.2  Connecting the Fiber Optic..........................................................................................................1

7

7.3 
7.4 
7.5 
7.6 

Connecting/Disconnecting the Deep

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Tissue Handpiece ............................................................ 1

8

7.7 

Operation

 

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Turn on the Epic T ...................................................................................................  2

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7.8 

Home Screen ..............................................................................................................................  2

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7.9 

Settings Screen ..........................................................................................................................  2

1

7.10  Ready Mode................................................................................................................................. 2

3

7.11  Wireless  Footswitch......................................................................................................... ............ 2

3

7.12   Using  the  Epic T  Touch  Screen  Display......................................................................................... 2

4

7.13  Turn the Laser Console Off .......................................................................................................

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 .2

5

8  CLINICAL APPLICATION ............................................

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 2

6

Contents

Pairing the Footswitch to the Laser Console.................................................................................. 2

1

Control Button ............................................................................................................................. 2

2

Entering Ready or Standby Modes ............................................................................................. 2

3

Pain Therapy 

Preset Values .......................................................................................................  2

6

Pain Therapy

 

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Adverse Effects ................................................................................................

 

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7

Pain Therapy

 

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Warnings and Precautions ............................................................................

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2

8

Epic 

T

   User Manual

9  MAINTENANCE .............................................................................................................

 

 

29

9.1  Daily Maintenance ......................................................................................................................  

29

9.4  Fiber Cable Lens Inspection and Cleaning ..................................................................................3

0

Lens Inspection Procedure ..........................................................................................................3

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Cleaning the Lens  ....................................................................................................................... 3

0

9.5  Installing/Replacing the Console Battery Pack ...........................................................................  3

0

Changing the Wireless Footswitch Batteries ..............................................................................  3

1

9.7  Transportation .............................................................................................................................  3

2

9.8  Storage .......................................................................................................................................  3

2

9.2  Disinfecting the Fiber Optic Cable ..............................................................................................  29
9.3  Disinfecting the Deep Tissue Handpiece..................................................................................... 

29

9.6 

Recommended Use ..................................................................................................................

 

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6

Facility Requirements

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7

8

.1 

Overview ................

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 .2

6

Summary of Contents for Epic T Series

Page 1: ...ut BIOLASE 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 2014...

Page 2: ...Page Left Blank...

Page 3: ...ch 12 6 SAFETY WITH THE EPIC T 13 6 1 Safety Instructions 13 6 3 Safety Features 15 Energy Monitor 15 3 6 2 Safety Classification 14 System Monitor 15 Power Switch 15 Access Key Code 15 Control Button...

Page 4: ...ents PairingtheFootswitchtotheLaserConsole 21 Control Button 22 Entering Ready or Standby Modes 23 Pain Therapy Preset Values 26 Pain Therapy Adverse Effects 27 Pain Therapy Warnings and Precautions 2...

Page 5: ...RE SPECIFICATION 33 12 TROUBLESHOOTING 33 APPENDIX A ACCESSORIES 36 APPENDIX B LABELING 37 APPENDIX C SAFETY LITHIUM ION BATTERY PACKS 41 APPENDIX D ELECTROMAGNETIC COMPATIBILITY 43 APPENDIX E WIRELES...

Page 6: ...via a 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 indica...

Page 7: ...s with neurodegeneration associated with Type II diabetes Medical clearance from the patient s physician is advisable when doubt exists regarding treatment 3 2 WARNINGS AND PRECAUTIONS PRESCRIPTION ST...

Page 8: ...ication and increase as required BIOLASE assumes no responsibility for parameters techniques methods or results CLINICAL ENVIRONMENT Only use this device in clinical environments that observe proper s...

Page 9: ...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 1 kg 100V 240...

Page 10: ...shipped separately 6 Deep Tissue Handpiece Disposable Shields qty 20 packaged shipped separately 7 DC Power Supply Module 8 Power Cord U S qty 1 9 Power Cord International qty 1 10 Welcome Kit Includ...

Page 11: ...11 Epic T User Manual 5 2 GENERAL The Epic T system consists of three components Figure 4 1 Wireless Footswitch 5Equipment Description Handpiece Fiber Optic Assembly Spacer...

Page 12: ...aser console through the Handpiece to the target tissue The laser ships from the factory with the Fiber Optic Cable already attached to the base console Figure 4 2 DEEP TISSUE HANDPIECE The Deep Tissu...

Page 13: ...before laser is used Attention should also be drawn to the danger of ignition of endogenous gases All persons present in the operatory must wear laser protective eyewear Always ensure that the laser p...

Page 14: ...some materials e g cotton wool when saturated with oxygen solvents or adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is...

Page 15: ...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 ba...

Page 16: ...remote interlock Figure 6 4 insert the plug at the end of the connector into the rear of the laser console and attach the two wires at the other end to a door switch the laser will stop immediately w...

Page 17: ...C power supply module and plug the other end of the power cord into a wall outlet Rechargeable Battery The Epic T is shipped with the battery pack already installed to charge the battery pack connect...

Page 18: ...ure the laser is turned OFF Make sure the Fiber Optic Cable is connected to the laser console Section 7 2 Remove yellow cap dust cover from the distal end of the Deep Tissue Handpiece Figure 7 4 Figur...

Page 19: ...tive shield over the spacer Figure 7 7 NOTE Refer to the individual Instructions for Use included with the Deep Tissue Handpiece packaging for additional details 19 7Installation and Set Up NOTE When...

Page 20: ...de is entered an X appears briefly in the window 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 Settings icon bottom...

Page 21: ...en 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 to...

Page 22: ...ow paired Figure 7 15 Proceed to step 6 6 If pairing has not occurred the wireless screen will appear again indicating that pairing was not successful Figure 7 16 press the green button to repeat step...

Page 23: ...embly If the aiming beam is still not on turn off the laser console and call a Biolase authorized service representative 7 11 WIRELESS FOOTSWITCH The wireless Footswitch is powered by two 2 AAA batter...

Page 24: ...Epic T User Manual Figure 7 18 24 7Installation and Set Up 7 12 USING THE EPIC T TOUCH SCREEN DISPLAY...

Page 25: ...r console to the OFF O position if the laser system will not be used for a long period of time 7Installation and Set Up CAUTION Verify that the Fiber Optic Cable is not twisted once the Handpiece is r...

Page 26: ...ive effects Some patients may require more than one laser application or a series of treatments before significant improvement is reported Repeat the therapy as necessary and monitor the progress of t...

Page 27: ...ue 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 f...

Page 28: ...Do not treat open wounds Muscle tissue closer to the skin surface may experience a higher absorption of heat carefully monitor skin temperature and reduce power as necessary Excessive fatty tissue is...

Page 29: ...9 2 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 c...

Page 30: ...as needed using a new Microbrush each time until no residue appears on the swab Figure 9 3 Figure 9 4 Figure 9 1 Figure 9 2 9 5 INSTALLING REPLACING THE CONSOLE BATTERY PACK 1 To install or replace t...

Page 31: ...the console the unit will run on battery power alone 6 Recycle the used Lithium Ion battery as regulated Do not discard in a trash bin The wireless Footswitch is powered by two AAA batteries When the...

Page 32: ...hould 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...

Page 33: ...ted software developed by BIOLASE Inc All rights reserved in the USA and other countries 11 Software Specification Calibration is recommended every twenty four 24 months in order to maintain the requi...

Page 34: ...Warning 3 Battery is not connected 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 Foo...

Page 35: ...ton stuck 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 in...

Page 36: ...Module 6400522 Wireless Footswitch 6400311 Deep Tissue Handpiece 6400310 Deep Tissue Handpiece Disposable Shields qty 20 6400465 Peel off Clear Screen Covers qty 20 6400457 Lithium ion Battery Pack fo...

Page 37: ...laser beam hazard Always wear appropriate eye protection LOCATION Back of Laser Console TYPE BF APPLIED PART The applied part is not conductive to the patient LASER APERTURE WARNING Indicates visible...

Page 38: ...ication Commission and Industry Canada registration numbers LOCATION Bottom of laser console REFER TO USER MANUAL FCC COMPLIANCE NOTICE The Footswitch and laser console comply with Part 15 of FCC Rule...

Page 39: ...ITH CARE LOCATION Outer carton shipping box KEEP DRY LOCATION Outer carton shipping box TRANSPORTATION TEMPERATURE LIMITATIONS LOCATION Outer carton shipping box HUMIDITY LIMITATIONS LOCATION Outer ca...

Page 40: ...nal programming REMOTE INTERLOCK Input for Remote Interlock Connector SIGN DANGER LASER WARNING 10W 940nm ENGLISH 5400386 B 105798 09 11 15 1 of 1 FULL 4 Cromwell Irvine CA 92618 Approved ____________...

Page 41: ...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 m...

Page 42: ...42 Epic T User Manual Appendix C Safety Lithium Ion Battery Packs WHEN CHARGING THE BATTERY WARNING CAUTION WHEN DISCHARGING THE BATTERY WARNING CAUTION WARNING...

Page 43: ...tions equipment can affect medical electrical equipment Accessories Medical grade power cord maximum length 3ft 1 meter BIOLASE p n 2400043 DC Power Supply Module BIOLASE p n 2400075 Wireless Footswit...

Page 44: ...44 Epic T User Manual Appendix D Electromagnetic Compatibility...

Page 45: ...Epic T User Manual 45 Appendix D Electromagnetic Compatibility...

Page 46: ...46 Epic T User Manual Appendix D Electromagnetic Compatibility...

Page 47: ...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 i...

Page 48: ...Page Left Blank...

Page 49: ...WaterLase iPlus About BIOLASE 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 m...

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