Chattanooga LIGHTFORCE FXi Instrucciones De Uso página 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