Chattanooga LIGHTFORCE XLi 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. Connecting the Beam Delivery Assembly ............. 4
3. Device Description ..................................................... 5
3.1. Indications for Use ................................................ 5
3.2. Contraindications .................................................. 5
3.3. Maximum Permissible Exposure (MPE) ............... 6
3.4. Laser Console Diagrams ...................................... 6
3.5. Empower IQ™ Delivery System ........................... 6
3.5.1. Emission Indicators ........................................... 7
3.5.2. Quick Disconnect Treatment Heads ................. 7
3.5.3. 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 ...................................................... 10
4.3.3. Setup ............................................................... 10
4.3.3.1. Standard Settings ....................................... 10
4.3.3.2. Empower IQ Settings ................................. 10
4.3.3.3. Language Setting ....................................... 10
4.3.4. Protocols ......................................................... 10
4.3.5. Operation ........................................................ 11
4.3.6. Laser Emission ................................................ 11
4.4. Laser Treatment Procedure ................................ 11
4.4.1. Pigment Considerations................................... 12
4.4.2. Dose ................................................................ 12
4.4.3. Setting Treatment Expectations ...................... 12
4.4.4. Treatment Technique....................................... 12
5. Maintenance ............................................................. 12
5.1. Cleaning .............................................................. 12
5.1.1. Cleaning the System........................................ 13
5.1.2. Disassembly and Cleaning of the Massage
Attachments ......................................................................... 13
5.1.2.1. Large Massage Ball (Figure 25) ................. 13
5.1.2.2. Rolling Pin (Figure 26) ................................ 13
5.2. Before You Call—Troubleshooting ...................... 13
5.3. Calibration Check Procedure .............................. 14
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 .......... 15
7.1. System Specifications (LightForce XPi/XLi) ........ 15
7.2. Spare Parts ......................................................... 15
7.3. Electromagnetic Compatibility (EMC) Tables ...... 16
7.3.1. Emissions Test Summary ................................ 16
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 ................. 17
7.4. FCC ..................................................................... 17
7.5. ISED .................................................................... 17
7.6. Radio Equipment Directive (RED) ....................... 17
7.7. Disposal ............................................................... 17
8. Labeling .................................................................... 18
8.1. Explanation of Symbols ....................................... 18
8.2. Laser Product Label ............................................ 19
8.3. Laser Warning ..................................................... 19
8.4. Warranty Seal...................................................... 19
8.5. Unique Device Identification (UDI) Label ............ 19
9. Contact Information .................................................. 20