RSR-000886-000 (1) Page 2 of 40
Table of Contents
1. Safety ......................................................................................................................................................... 4
1.1. Terminology ........................................................................................................................................... 4
1.2. Laser Safety ........................................................................................................................................... 4
1.3. Laser Treatment Controlled Area (LTCA) .............................................................................................. 4
1.4. Fire and Explosion Hazards .................................................................................................................. 5
1.5. Safety Features ..................................................................................................................................... 5
1.5.1. Emergency Stop Button ...................................................................................................................... 5
1.5.2. Password Entry ................................................................................................................................... 5
1.5.3. Remote Interlock Connector ............................................................................................................... 5
1.5.4. Laser Emission Indicators ................................................................................................................... 5
1.5.5. Unattended Protection 100 Seconds .................................................................................................. 6
1.5.6. Internal Laser Energy Monitor ............................................................................................................ 6
1.6. Laser Eye Protection ............................................................................................................................. 6
2. System Set-Up ........................................................................................................................................... 7
2.1. Location ................................................................................................................................................. 7
2.2. Unpacking and Initial Set-up .................................................................................................................. 7
2.3. Battery Use and Charging ..................................................................................................................... 8
2.4. Replacing the Battery ............................................................................................................................ 9
2.5. Connecting the Beam Delivery Assembly ........................................................................................... 10
3. Device Description ................................................................................................................................... 12
3.1. Indications for Use ............................................................................................................................... 12
3.2. Contraindications ................................................................................................................................. 12
3.3. Maximum Permissible Exposure (MPE) .............................................................................................. 12
3.4. Laser Console Diagrams ..................................................................................................................... 13
3.5. Empower™ Delivery System ............................................................................................................... 14
3.5.1. Quick Disconnect Treatment Heads ................................................................................................. 15
3.5.2. Treatment Head Attachments ........................................................................................................... 16
3.6. Fiber Management ............................................................................................................................... 16
3.7. Laser Safety Eyewear .......................................................................................................................... 17
3.8. Medical Grade Power Cord ................................................................................................................. 17
4. Operation ................................................................................................................................................. 18
4.1. Safety Precautions ............................................................................................................................... 18
4.2. Patient Preparation .............................................................................................................................. 19
4.3. Device Operation ................................................................................................................................. 20
4.3.1. Power On .......................................................................................................................................... 20
4.3.2. Main Menu ........................................................................................................................................ 20
4.3.3. Setup ................................................................................................................................................. 20
4.3.3.1. Standard Settings ......................................................................................................................... 20
4.3.3.2. Language Setting .......................................................................................................................... 21
4.3.4. Protocols ........................................................................................................................................... 21
4.3.5. Operation .......................................................................................................................................... 22
4.3.6. Laser Emission ................................................................................................................................. 22
4.4. Laser Treatment Procedure ................................................................................................................. 24
4.4.1. Pigment Considerations .................................................................................................................... 24
4.4.2. Dose .................................................................................................................................................. 24
4.4.3. Setting Treatment Expectations........................................................................................................ 24
4.4.4. Treatment Technique ........................................................................................................................ 25
5. Maintenance ............................................................................................................................................. 26
5.1. Cleaning ............................................................................................................................................... 26
5.1.1. Cleaning the Console ....................................................................................................................... 26
5.1.2. Cleaning the Large Massage Ball ..................................................................................................... 27
5.2. Before You Call—Troubleshooting ...................................................................................................... 28
5.3. Calibration Check Procedure ............................................................................................................... 28
6. Quality and Regulatory ............................................................................................................................ 30
6.1. Quality Systems ................................................................................................................................... 30