1 INTRODUCTION ................................................................................................................. 5
2 INDICATIONS FOR USE .................................................................................................... 6
3 CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS ............................................ 7
3.1 CONTRAINDICATIONS ......................................................................................................... 7
3.2 WARNINGS AND PRECAUTIONS ........................................................................................ 7
PRESCRIPTION STATEMENT .............................................................................................. 7
TRAINING .............................................................................................................................. 7
EYEWEAR ............................................................................................................................. 7
ADJACENT STRUCTURES ................................................................................................... 8
SUCTION ............................................................................................................................... 8
PLUME REMOVAL ................................................................................................................ 8
TREATMENT, TECHNIQUE, AND SETTINGS ...................................................................... 8
CLINICAL ENVIRONMENT .................................................................................................... 8
4 SPECIFICATIONS .............................................................................................................. 9
4.1 GENERAL .............................................................................................................................. 9
4.2 ELECTRICAL ......................................................................................................................... 9
4.3 LASER ................................................................................................................................... 9
4.4 OTHER LIGHT SOURCES .................................................................................................... 9
5 EQUIPMENT DESCRIPTION............................................................................................ 10
5.1 SYSTEM COMPONENTS .....................................................................................................10
5.2 GENERAL .............................................................................................................................11
BASE CONSOLE ..................................................................................................................12
CONTROL BUTTON: ............................................................................................................12
FIBER DELIVERY SYSTEM .................................................................................................12
SURGICAL HANDPIECE ......................................................................................................12
WHITENING HANDPIECE (OPTIONAL) ...............................................................................12
DEEP TISSUE HANDPIECE (OPTIONAL) ...........................................................................13
WIRELESS FOOTSWITCH ...................................................................................................13
6.1 SAFETY INSTRUCTIONS ....................................................................................................14
6.2 SAFETY CLASSIFICATION ..................................................................................................15
6.3 SAFETY FEATURES ............................................................................................................16
ENERGY MONITOR .............................................................................................................16
SYSTEM MONITOR .............................................................................................................16
POWER SWITCH .................................................................................................................16
ACCESS KEY CODE ............................................................................................................16
CONTROL BUTTON .............................................................................................................16
WIRELESS FOOTSWITCH ...................................................................................................17
REMOTE INTERLOCK .........................................................................................................17
EMERGENCY STOP ............................................................................................................17
FUNCTIONAL DISPLAY .......................................................................................................17
7 INSTALLATION AND SET-UP .......................................................................................... 18
7.1 SYSTEM SETUP ..................................................................................................................18
FACILITY REQUIREMENTS: ................................................................................................18
7.2 THE FIBER OPTIC CABLE ...................................................................................................18