Chattanooga LIGHTFORCE FXi LTC-1510-L-B6 Gebrauchsanleitung Seite 23

Table of Contents
1. Safety ............................................................................ 3
1.1. Terminology ............................................................. 3
1.2. Laser Safety ............................................................. 3
1.3. Laser Treatment Controlled Area (LTCA) ................ 3
1.4. Fire and Explosion Hazards ..................................... 3
1.5. Safety Features ........................................................ 3
1.5.1. Emergency Stop Button ....................................... 3
1.5.2. Password Entry .................................................... 3
1.5.3. Remote Interlock Connector ................................. 3
1.5.4. Laser Emission Indicators .................................... 3
1.5.5. Unattended Protection 100 Seconds .................... 4
1.5.6. Internal Laser Energy Monitor .............................. 4
1.6. Laser Eye Protection ................................................ 4
2. System Set-Up .............................................................. 4
2.1. Location ................................................................... 4
2.2. Unpacking and Initial Set-up .................................... 4
2.3. Battery Use and Charging ........................................ 5
2.4. Replacing the Battery ............................................... 5
2.5. Connecting the Beam Delivery Assembly ................ 5
3. Device Description ........................................................ 6
3.1. Indications for Use ................................................... 6
3.2. Contraindications ..................................................... 6
3.3. Maximum Permissible Exposure (MPE) .................. 6
3.4. Laser Console Diagrams ......................................... 6
3.5. Empower™ Delivery System ................................... 7
3.5.1. Quick Disconnect Treatment Heads ..................... 7
3.5.2. Treatment Head Attachments .............................. 7
3.6. Fiber Management ................................................... 8
3.7. Laser Safety Eyewear .............................................. 8
3.8. Medical Grade Power Cord ...................................... 8
4. Operation ....................................................................... 8
4.1. Safety Precautions ................................................... 8
4.2. Patient Preparation .................................................. 9
4.3. Device Operation ..................................................... 9
4.3.1. Power On ............................................................. 9
4.3.2. Main Menu ............................................................ 9
4.3.3. Setup .................................................................... 9
4.3.3.1. Standard Settings .......................................... 10
4.3.3.2. Language Setting .......................................... 10
4.3.4. Protocols ............................................................ 10
4.3.5. Operation ............................................................ 10
4.3.6. Laser Emission ................................................... 11
4.4. Laser Treatment Procedure ................................... 11
4.4.1. Pigment Considerations...................................... 11
4.4.2. Dose ................................................................... 11
4.4.3. Setting Treatment Expectations ......................... 11
4.4.4. Treatment Technique.......................................... 12
5. Maintenance ................................................................ 12
5.1. Cleaning ................................................................. 12
5.1.1. Cleaning the Console ......................................... 12
5.1.2. Cleaning the Large Massage Ball ....................... 12
5.2. Before You Call-Troubleshooting ......................... 13
5.3. Calibration Check Procedure ................................. 13
6. Quality and Regulatory ................................................ 14
6.1. Quality Systems ..................................................... 14
6.2. Device Classification .............................................. 14
6.3. Declaration of Conformity (EU) .............................. 14
7. Specifications and Environmental Conditions ............. 14
7.1. System Specifications (LightForce FXi) ................. 14
7.2. Spare Parts ............................................................ 15
7.3. Electromagnetic Compatibility (EMC) Tables ......... 15
7.3.1. Emissions Test Summary ................................... 15
7.3.2. Immunity Test Summary ..................................... 16
7.3.3. Recommended Separation Distances ................ 16
7.3.4. Guidance and Manufacturer's Declaration -
Immunity - For Non-Life-Supporting Equipment .................... 16
7.4. FCC ........................................................................ 17
7.5. ISED ....................................................................... 17
7.6. Radio Equipment Directive (RED) .......................... 17
7.7. Disposal .................................................................. 17
8. Labeling ....................................................................... 17
8.1. Explanation of Symbols .......................................... 17
8.2. Laser Product Label ............................................... 18
8.3. Laser Warnings ...................................................... 19
8.4. Warranty Seal......................................................... 19
8.5. Unique Device Identification (UDI) Label ............... 19
9. Contact Information ..................................................... 20