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User Manual
LightForce® FX
Deep Tissue Laser Therapy® System
with Empower™ Delivery System,
Influence® Technology
& Perfect Protocol™
LiteCure® Medical
250 Corporate Blvd, Suite B
Newark, DE 19702
FX
Phone 302.709.0408
Toll Free 877.627.3858
Fax 302.709.0409
LBL000097A
LightForce FX User Manual, DCN: O
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Table of Contents
Summary of Contents for LiteCure Medical LightForce FX
- Page 1 LightForce® FX Deep Tissue Laser Therapy® System with Empower™ Delivery System, Influence® Technology & Perfect Protocol™ LiteCure® Medical 250 Corporate Blvd, Suite B Newark, DE 19702 Phone 302.709.0408 Toll Free 877.627.3858 Fax 302.709.0409 LBL000097A LightForce FX User Manual, DCN: O...
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Page 3: Table Of Contents
Optical Fiber Connections >> Empower™ Delivery System PAGE Preparation of Patient for Laser Therapy Treatment Empower Delivery System Descriptions >> Operation PAGE Fiber Installation Laser Safety Eyewear Power On Main Menu Setup LBL000097A page >> LightForce FX User Manual, DCN: O... - Page 4 Emergency Laser Stop Label 17.8 Finger/ Foot Switch Label 17.9 Remote Interlock Connector Label 17.10 CE Mark Label 17.11 DC Power Input Label 17.12 Protective Earth (Ground) Label (Inside Device) 17.13 Power Switch Label LBL000097A page >> LightForce FX User Manual, DCN: O...
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Page 5: Conventions Used
Describes the conditions or exceptions that may apply to the subject matter presented. NOTE The optical fiber must be properly inserted and secured into the laser emission port before the device’s operational mode can change from standby to ready. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 6: Safety
This switch is located on the front of the LightForce FX. Pushing the switch down terminates laser emission. 2. Power Switch This switch is located on the bottom front of the screen on the LightForce FX. Depress the switch for several seconds to turn on. 3. Remote Interlock The remote interlock is located on the back of the device. -
Page 7: Safety Strategy
Continuous operation 3.2 Regulatory Compliance The LightForce FX laser complies with 21 CFR Chapter 1, Sub chapter J, as administered by the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA). The LightForce FX laser is manufactured in compliance with the provisions of Council Directive 93/42/EEC concerning medical device (MDD, EU) and CMDR SOR/98-282 (CAN). -
Page 8: Indications For Use
3.3 Indication for Use The LightForce FX is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis. - Page 9 980 nm (see specification sheet) laser emission. All personnel present during device operation must wear this eyewear. Contact LiteCure® at 302.709.0408 or 877.627.3858 (for US and Canada) to purchase additional sets of protective eyewear for this device. LBL000097A page >> LightForce FX User Manual, DCN: O...
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Page 10: Fire And Explosion Hazards
A UL-approved or equivalent fire extinguisher should be readily available. This laser unit is not intended for operation in areas subject to explosion hazards such as flammable materials, gases or substances. A fire or explosion could occur. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 11: Glossary And Abbreviations
Unit of measure for laser power Stop End of treatment or treatment break Abbreviation Definition Square Centimeter Hertz Second Watt Joule Nanometer Volt Infrared NOHD Nominal Ocular Hazard Distance According to IEC 60825-1 LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 12: Features
5>> Features >> Front View Touch Screen Interface Emergency Laser Stop Display LED Indicator Power Switch >> Bottom View Fiber Managment System Warranty Seal Label Finger Switch & Optical Port LBL000097A page >> LightForce FX User Manual, DCN: O... - Page 13 >> Back View DC Power Cord Receptacle USB Port Foot Switch Receptacle Remote Interlock Receptacle LBL000097A page >> LightForce FX User Manual, DCN: O...
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Page 14: System Set-Up
Plug the power adapter into the DC input on the rear of the laser device. Plug the AC power cord into the adapter and a grounded electrical outlet. Connect the finger/foot switch to the rear of the LightForce FX laser device. LBL000097A page >>... -
Page 15: Optical Fiber Connections
3. Remove protective cap from the end of the fiber optic cable 4. Carefully insert end of fiber optic cable into optical port 5. Thread connector onto optical port until tight LBL000097A page >> LightForce FX User Manual, DCN: O... - Page 16 Note: Your laser may have come with the optical fiber already connected. 2. Use the device as required. 3. When done using the device, power off in accordance with the User Manual and leave the hand piece connected. LBL000097A page >> LightForce FX User Manual, DCN: O...
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Page 17: Empower™ Delivery System
Warning DO NOT use hand piece without a treatment head or with an improperly attached treatment head. Doing so may cause serious and/or irreversible injury. LBL000097A page >> LightForce FX User Manual, DCN: O... - Page 18 140mm with 10cm from the patient skin Small Ball 6.2 m Full Angle (degrees) 12 Large Ball 24.1 m Full Angle (degrees) 3 Flat Window 1.8 m Full Angle (degrees) 47 Page 5 LBL000097A page >> LightForce FX User Manual, DCN: O...
- Page 19 “painting” or “serpentine” motion. The Flat Window Head can be used at power settings up to 6 W, 10 cm from the skin of the patient. LBL000097A page >> LightForce FX User Manual, DCN: O...
- Page 20 If any part of the hand piece assembly is overheating or producing smoke, then immediately power off device, discontinue operation, and contact LiteCure® at 302.709.0408 or 877.627.3858 (for US and Canada) for immediate assistance. Laser Treatment Head Cleaning: For information on cleaning refer to section 11. LBL000097A page >> LightForce FX User Manual, DCN: O...
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Page 21: Operation
All personnel present during device operation must wear this eyewear. Contact LiteCure® at 302.709.0408 or 877.627.3858 (for US and Canada) to purchase additional sets of protective eyewear for this device. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 22: Power On
8.3 Power On Depress the Power On Switch on the bottom front of the screen on the LightForce FX® to power on. The fan will start and the LCD panel will illuminate displaying a password screen. Enter the password and select “enter” to access the main menu. -
Page 23: Protocol Selection, Influence® Technology
J/cm , and the patient’s skin color to generate custom protocols. Watts may be entered in tenths, while treatment area and target energy density must be entered as whole numbers. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 24: Standby Mode
Time Window. To scroll to the desired time value, maintain pressure on the desired button. • Press the Home Icon in the upper-left corner to return to the Main Menu. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 25: Ready Mode
• Press Energy Reset button to reset the energy monitor value to zero. • The device will return to Standby Mode from Ready Mode if it is inactive for more than 3 minutes. • Press the Ready button to return to Standby Mode. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 26: Emission Mode
Laser emission continues until emission is stopped using the finger/foot switch if timer setting is CW. • If laser emission is interrupted using the finger/foot switch, the laser emission can be resumed by activating the finger/foot switch until the remaining time is over. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 27: Accessories
All personnel who are within the NOHD are considered to be within the controlled area and must wear laser safety eyewear. ALWAYS wear the protective eyewear supplied with this device. All personnel present during device operation must wear this eyewear. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 28: Specifications
Doing so may cause the laser to ignite alcohol solution or vapors. LightForce FX laser device uses solid-state laser technology. It is important to keep the unit and accessories free from dust. To clean the exterior surfaces on the unit or accessories: •... - Page 29 After cleaning the hand piece head, wipe it dry with a soft cloth. Then leave it on a clean surface to dry. To expedite drying time of the hand piece head, you may wipe hand piece head with a solution 70 % (or less) isopropyl alcohol. LBL000097A page >> LightForce FX User Manual, DCN: O...
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Page 30: Maintenance And Calibration
10. If the results are still outside of the 20 % range, discontinue this procedure and contact LiteCure® at 302.709.0408 or 877.627.3858 (for US and Canada) for immediate assistance. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 31: Disposal
American Institute of Medical Laser Applications 18070 Raymond Road Marysville, Ohio 43040 Phone 937.209.0271 Fax 937.642.7880 www.aimla.org Laser Institute of America 12424 Research Parkway, Suite 125 Orlando, FL 32826 Phone 407.380.1553 Fax 407.380.5588 www.laserinstitute.org/ LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 32: Warranty Information
(freight and insurance prepaid) with proper documentation containing the RMA number and the information specified above. LiteCure will advise the purchaser of its determination of warranty at the earliest possible time. Providing complete information as requested will expedite the procedure. LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 33: Electromagnetic Compatibility (Emc) Tables
(All ME Equipment and ME Systems) The LightForce® FX is intended for use in the electromagnetic environment specified below. The customer or user of the LightForce FX should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –... - Page 34 Table 16.2.2 - Guidance and Manufacturer’s Declaration - Immunity (All ME Equipment and ME Systems) The LightForce FX is intended for use in the electromagnetic environment specified below. The customer or user of the LightForce FX should ensure that it is used in such an environment.
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Page 35: Appendix/Labels
NOT Life-supporting) The LightForce® FX is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the LightForce FX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the LightForce FX as recommended below, according to the maximum output power of the communications equipment. -
Page 36: Identification Label
VOID IF SEAL Labels are on the underside of the laser device to indicate IS BROKEN any attempt to open the housing. 17.5 Optical Fiber Applicator Label 17.6 Laser Emission Label LBL000097A page >> LightForce FX User Manual, DCN: O... -
Page 37: Emergency Laser Stop Label
17.7 Emergency Laser Stop Label 17.8 Finger/Foot Switch Label 17.9 Remote Interlock Connector Label 17.10 CE Mark Label 17.11 DC Power Input Label 17.12 Protective Earth (Ground) Label (Inside Device) 17.13 Power Switch Label LBL000097A page >> LightForce FX User Manual, DCN: O... - Page 38 Please have your unit’s serial number ready as Customer Care will need this information to provide you with the highest level of service. Please also be prepared to provide your unit model’s name. Contact LiteCure Medical 250 Corporate Blvd, Suite B Newark, DE 19702 Phone 302.709.0408...
- Page 40 >> Get Back in Action Faster LightForceLasers.com LiteCure® Medical 250 Corporate Blvd, Suite B Newark, DE 19702 Phone 302.709.0408 Toll Free 877.627.3858 Fax 302.709.0409 LBL000097A LightForce FX User Manual, DCN: O...