LiteCure Medical LightForce FX User manual

>> User Manual
LiteCure® Medical
250 Corporate Blvd, Suite B
Newark, DE 19702
Phone [phone]
Toll Free 877.627.3858
Fax [phone]
FX
LightForce® FX
with Empower™ Delivery System,
Influence® Technology
& Perfect Protocol™
Deep Tissue Laser Therapy® System
LBL000097A LightForce FX User Manual, DCN: O

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LBL000097A LightForce FX User Manual, DCN: O
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1>> Conventions Used PAGE 3
1.1 Warning 3
1.2 Caution 3
1.3 Recommendation 3
1.4 Note 3
2>> Safety PAGE 4
2.1 Laser Safety Supervision 4
2.2 Safety Devices 4
2.3 Safety Strategy 5
3>> Device Description PAGE 5
3.1 Classification 5
3.2 Regulatory Compliance 5
3.3 Indications for Use 6
3.4 Contraindications 6
3.5 Warnings and Cautions 6
3.6 Fire and Explosion Hazards 8
4>> Glossary and Abbreviations PAGE 9
5>> Features PAGE 10
6>> System Set-Up PAGE 12
6.1 Receipt and Unpacking 12
6.2 Usage Prerequisites 12
6.3 Set-Up/ Location 12
6.4 Optical Fiber Connections 13
7>> Empower™ Delivery System PAGE 15
7.1 Preparation of Patient for Laser Therapy Treatment 15
7.2 Empower Delivery System Descriptions 15
8>> Operation PAGE 19
8.1 Fiber Installation 19
8.2 Laser Safety Eyewear 19
8.3 Power On 20
8.4 Main Menu 20
8.5 Setup 20
>> Table of Contents

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8.6 Protocol Selection, Influence® Technology 21
8.7 Perfect Protocol™ 21
8.8 Standby Mode 22
8.9 Ready Mode 23
8.10 Emission Mode 24
9>> Accessories PAGE 25
9.1 Finger Switch 25
9.2 Foot Switch 25
9.3 AC Power Cord 25
9.4 Power Adapter 25
9.5 Laser Safety Eyewear 25
10 >> Specifications PAGE 26
11 >> Cleaning PAGE 26
12 >> Maintenance and Calibration PAGE 28
13 >> Disposal PAGE 29
14 >> Sources for Additional Information PAGE 29
and Assistance on Laser Safety
15 >> Warranty Information PAGE 30
15.1 Terms and Conditions 30
15.2 Return Procedure 30
16 >> Electromagnetic Compatibility (EMC) Tables PAGE 31
17 >> Appendix/Labels PAGE 33
17.1 Warning Label 33
17.2 Identification Label 34
17.3 Non Interlocked Protective Housing Label 34
17.4 Warranty Seal 34
17.5 Optical Fiber Applicator Label 34
17.6 Laser Emission Label 34
17.7 Emergency Laser Stop Label 35
17.8 Finger/ Foot Switch Label 35
17.9 Remote Interlock Connector Label 35
17.10 CE Mark Label 35
17.11 DC Power Input Label 35
17.12 Protective Earth (Ground) Label (Inside Device) 35
17.13 Power Switch Label 35

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LBL000097A LightForce FX User Manual, DCN: O
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1.1 Warning
Calls the reader’s attention to a specific or potential danger in advance. If ignored or compromised,
the situation could result in the possibility of injury, death or other serious adverse reaction
associated with the use or misuse of the device.
WARNING!
DO NOT direct the laser beam at anything other than the area to be treated.
1.2 Caution
Alerts the user to the possibility of a problem with the device associated with its use or misuse.
Such problems include device malfunction, device failure, damage to the device or damage to
other property.
CAUTION
DO NOT allow untrained personnel to operate this device unless directly supervised by a
properly trained and experienced individual.
1.3 Recommendation
Offers guidance that may be worthy of acceptance or trial within a specific area of LightForce® FX
application and may serve to optimize overall utilization.
RECOMMENDATION
Designate at least one person at each facility that utilizes this device as laser safety
supervisor, responsible for providing training on all operating and safety procedures.
1.4 Note
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.
1>> Conventions Used
Various Warnings, Cautions, Recommendations and Notes are presented throughout
this document. Explanations and examples of each follow.

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2.1 Laser Safety Supervision
RECOMMENDATION
Designate at least one person (e.g. Laser Safety Supervisor) as responsible for providing
training on all operating and safety procedures at each facility that utilizes this device.
Individuals planning to use the laser system should attend laser orientation and
education sessions to achieve operational proficiency.
2.2 Safety Devices
The following components have specific safety-related features. All individuals who use this laser device
should be familiar with the purpose and the operation of these components.
1. Emergency Laser Stop
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. If the interlock is not
inserted into the connector jack, all electrical power to the controls and laser
components is terminated. The remote interlock MUST be inserted for laser
emission.
2>> Safety
This section provides a collection of safety guidelines and safety-related statements
relevant to the safe and effective operation of the LightForce® FX laser device.
Additional statements and protocols regarding safety appear elsewhere in this
document. Use this laser device according to all printed guidelines, cautionary
statements, and protocols.
Notice
1. Pushing the red Emergency Laser Stop button will terminate all electrical power to the laser
device’s microprocessor and laser-emitting components.

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2.3 Safety Strategy
1. 3 Minutes Unattended Protection
If the laser device is left in Ready Mode and does not receive any input for 3 minutes, the laser
will switch back to Standby Mode.
2. Internal Laser Energy Monitor
This is an internal device that monitors the intensity of laser energy generated during
emission. This monitor aborts laser emission if the laser device is unable to maintain the laser
energy output set by the user.
3. Laser Eye Protection
The protective laser eyewear has an optical density rating > 5.0 for 810 nm and 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.
3.1 Classification
According to the applicable standards, the LightForce FX laser is classified as follows:
• Class I Type B device according to EN/IEC 60601-1
• Class IIa according to Council Directive 93/42/EEC
• Class III according to CMDR SOR/98-282
• Class 4 laser product according to IEC 60825-1
• Degree of protection according to EN/IEC 60601-1, IPX 0 (enclosure not waterproof);
• Ordinary protection against ingress of water
• Continuous operation
3.2 Regulatory Compliance
1. 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).
2. 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).
3>> Device Description
The LightForce FX is a compact medical laser system. The optical delivery system
consists of a flexible fiber threaded through a lightweight hand piece. Activation
occurs when the operator enables the laser and presses the finger switch. A touch-
screen display allows the operator to adjust or set the laser output level. The laser can
operate in continuous wave mode or controlled pulse mode.

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3.4 Contraindications
• Do not apply infrared light to abdominal or lumbosacral points in pregnant females.
• Do not apply infrared light to the epiphyseal lines in children.
• Do not apply infrared light to the thoracic region or over the pacemaker itself in patients with
pacemakers.
• Do not apply infrared light over the thyroid gland, ovaries or testicles.
• Do not apply infrared light to patients who are taking drugs that have heat or light sensitive
contraindications, such as but not limited to certain types of steroids.
Warning Use carefully. May cause serious burns. Do not use over sensitive skin area or in the presence of poor
circulation. The unattended use of this device by children or incapacitated persons may be dangerous.
Warning DO NOT allow any reflective objects to fall into or obstruct the path of the laser energy produced by
this device. The operator, all assistants, and the patient must remove all reflective objects (such as
rings, metal watchbands, and jewelry) prior to treatment with this device. Indirect or direct eye con-
tact with the output beam or scattered laser light from any reflective surface from the laser will cause
serious, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes.
3.5 Warnings and Cautions
Warning NEVER look directly into the distal end of the optical fiber connected to an active laser device; NEVER
aim the laser light directly into the eyes; and NEVER direct the laser beam at anything other than the
area to be treated WITH or WITHOUT the appropriate laser-emission protective eyewear. Indirect or
direct eye contact with the output beam or scattered laser light from any reflective surfaces from the
laser will cause serious damage, irreparable corneal and/or retinal damage, and possible blindness to
one or both eyes.
Warning AVOID THE USE of flammable solvents, anesthetics, oxidizing gases such as nitrous oxide (N2O) and
oxygen, or endogenous gases. The high temperatures produced during normal use of the laser
equipment may ignite some material, such as cotton or wool, when saturated with oxygen. The
solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed
to evaporate before the laser equipment is used.
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.
It is also indicated for promoting relaxation of the muscle tissue and for temporarily
increasing local blood circulation.
CAUTION Federal law (USA) restricts this device to sale by or on the order of a physician.

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LBL000097A LightForce FX User Manual, DCN: O
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Warning DO NOT remove protective eyewear until the operator returns the laser device to Standby Mode.
Warning DO NOT use the system controls or performance of procedures other than those specified in this
manual. Doing so may result in hazardous radiation exposure.
Warning DO NOT attempt to gain access to any internal component. THERE ARE NO USER-SERVICEABLE
COMPONENTS inside this laser device. Doing so may cause serious and/or irreversible injury.
Warning FAILURE TO COMPLY with all safety instructions and warnings may expose all participants to harmful
levels of laser radiation and/or dangerous levels of electrical current.
Caution NEVER allow untrained personnel to operate this device unless directly supervised by a properly
trained and experienced individual.
Caution The protective laser eyewear supplied with this device has an optical density rating > 5.0 for 810 nm
and 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.
Caution Select a secure, properly equipped, and well-ventilated location in which to install and
operate the laser.
Caution ALWAYS place“Laser In Use”signs at location entrances where people will use the laser.
Caution ALWAYS put the laser in Standby Mode or turn the device OFF prior to adjusting or connecting/
disconnecting the hand piece or fiber optic.
Caution NEVER leave this device in the Ready Mode unattended. Reference the Standby and Ready Mode in
the operations section of this manual.
CAUTION Federal law (USA) restricts this device to sale by or on the order of a physician.
Warning DO NOT pretreat tissue (e.g., with a heating pad or wet compress) before laser treatment. Tissue to be
treated must be dry and at normal temperature before laser treatment begins.

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Caution ALWAYS Turn the device off before lifting, moving or relocating the device.
Caution DO NOT allow any nonessential personnel into the treatment area during any laser procedure.
Caution DO NOT press the finger/foot switch without first verifying the safe orientation and proper positioning
of the hand piece and distal end of the optical fiber and ensuring compliance to all safety precautions.
Caution NEVER allow untrained personnel to operate this device unless directly supervised by a properly
trained and experienced individual.
Caution ALWAYS clean the SMA fiber tip before inserting into the SMA emission port. A dirty tip could result in
damage to the device.
3.6 Fire and Explosion Hazards
Health care professionals should be aware of the following safety considerations and potential fire
hazards when using the laser:
1. The laser beam can ignite most nonmetallic materials.
2. 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.

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LBL000097A LightForce FX User Manual, DCN: O
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Term Definition
CW, Continuous Emission, or Continuous Mode Continuous laser emission
Pulse, Pulse Emission or Pulsed Mode Pulsed laser emission (pulsed mode)
Duty Cycle Percentage of time in Pulsed Mode that laser energy is
being generated during laser emission
Frequency Laser pulse repetition rate
Hertz Measuring unit for frequency (pulses per second)
Remote Interlock Safety device that stops laser radiation when the
Remote Interlock Circuit is opened
Joule Unit of measure for emitted energy
Watt Unit of measure for laser power
Stop End of treatment or treatment break
4>> Glossary and Abbreviations
Abbreviation Definition
cm2Square Centimeter
Hz Hertz
s Second
W Watt
J Joule
nm Nanometer
V Volt
IR Infrared
NOHD Nominal Ocular Hazard Distance
According to IEC 60825-1

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Touch Screen
Interface
5>> Features
>> Front View
Emergency
Laser Stop
Display LED
Indicator
Warranty Seal Label
Finger Switch &
Optical Port
>> Bottom View
Power Switch
Fiber Managment System

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LBL000097A LightForce FX User Manual, DCN: O
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>> Back View
Foot Switch Receptacle
Remote Interlock Receptacle
DC Power Cord Receptacle
USB Port

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6.1 Receipt and Unpacking
Using the LightForce® FX packing list, unpack the device and its accessories from the shipping
carton. Check for missing parts and inspect the unit carefully for damage, such as cracks, dents
or bent parts. If items are missing or any physical damage is apparent, please call LiteCure® at
302.709.0408 or 877.627.3858 (for US and Canada) for assistance. Notify the carrier if the damage
appears to be the result of a shipping mishap.
If Warranty Seal Label is not found on device or is broken, please do not operate this
device and call LiteCure at 302.709.0408 or 877.627.3858 (for US and Canada) immediately
for assistance.
6.2 Usage Prerequisites
RECOMMENDATION
Individuals planning to use the laser system should attend laser orientation and
education sessions to achieve operational proficiency.
Every facility or institution utilizing this device is encouraged to adopt an ongoing
training and safety program.
6.3 Set-Up/ Location
1. Select a secure, properly equipped, and well-ventilated location in which to install
and operate the laser device.
2. Ensure that the surface will properly support the entire device.
3. Place the device within 6 feet of an available 100-240 V electrical outlet.
4. Ensure adequate airflow around the device. The laser device is air-cooled and designed
for use in a well-ventilated environment.
a. There must be a minimum 4”clearance around the rear and sides of the device.
5. Locate and uncoil the power cord and adapter.
6. Plug the power adapter into the DC input on the rear of the laser device.
7. Plug the AC power cord into the adapter and a grounded electrical outlet.
8. Connect the finger/foot switch to the rear of the LightForce FX laser device.
6>> System Set-Up
WARRANTY
VOID
IF SEAL
IS BROKEN

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6.4 Optical Fiber Connection
The dust cap is installed by the manufacturer as a means to prevent dust and debris from
contaminating the emission port during shipping and before device installation and is not
intended as the primary means to protect the emission port connector during normal use.
Fiber Connection Procedure
1. Remove protective cap from optical port on rear of unit
2. Remove the hand piece and optical fiber from the protective foam packaging
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
Caution If the optical port or the fiber tip is contaminated, then the device can be damaged during beam
emission. Do not remove the hand piece fiber from the emission port once it has been secured,
unless the device is being packaged or transported to another location. Repeated insertion and
removal of the hand piece fiber before and after every procedure will increase the chance of emission
port and fiber tip contamination.
Note Your laser may have come with the optical fiber already connected. If not, please follow these steps.

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CAUTION
Do not remove the hand piece fiber from the emission port once it has been
secured, unless the device is being packaged or transported to another location.
Repeated insertion and removal of the hand piece fiber before and after every
procedure will increase the chance of emission port and fiber tip contamination.
If the emission port or the fiber tip is contaminated, then the device might be
damaged during beam emission.
The dust cap is installed by the manufacturer as a means to prevent dust and
debris from contaminating the emission port during shipping and before device
installation and is not intended as the primary means to protect the emission
port connector during normal use.
We Recommend The Following Procedure:
1. Before using the device for the first time, install and secure the optical fiber
in accordance with the User Manual.
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.

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7>> Empower™ Delivery System
7.1 Preparation of Patient for Laser Therapy Treatment
1. The area to be treated must be exposed. (Do not treat through clothing or bandages.)
2. The treatment area should be clean and free of surface dirt or oils.
3. Isopropyl alcohol solution may be used to clean all instrument surfaces that contact the
patient (refer to Section 11).
Caution DO NOT use hand piece head until alcohol solution used in cleaning procedure completely
evaporates. Doing so may cause the laser to ignite alcohol solutions or vapors.
Hand Piece and Finger Switch
7.2 Empower™ Delivery System Descriptions
1. The Empower DS is composed of a double sheathed optic fiber and a hand piece with
interchangeable treatment heads.
Warning This laser device is not intended for operation in areas subject to explosion hazards such as flammable
materials, gases or substances. A fire or explosion could occur.
Do NOT use without a
treatment head attached
Do NOT use with treatment
head improperly attached
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.

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Page 5
2. Exchange Hand Piece Head.
Head Type Spot Size (diameter) Nominal Ocular Hazard
Distance (NOHD)
Small Cone 100 mm with 10cm from the patient skin 4.7m
Small Ball 15mm 9.5m
Large Ball 30mm 37m
Large Cone 120mm with 8cm from the patient skin
140mm with 10cm from the patient skin 4.7m
Large Ball Large ConeSmall BallSmall Cone
Small Cone Small Ball Large Ball Large Cone
2. Exchange treatment head, securely tighten the new hand piece head to hand piece handle.
Laser Hand Piece Style NOHD (meters) Beam Divergence
Small Cone 1.8 m Full Angle (degrees) 47
Large Cone 1.8 m Full Angle (degrees) 47
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
Table 7.1
Flat Window

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LBL000097A LightForce FX User Manual, DCN: O
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Hand Piece with Finger Switch
and Small Cone
This treatment head is for general use and applications where fine control
with no contact or soft tissue manipulation during treatment is desired.
This head should be perpendicular to the skin and not approaching at
an angle. The area to be treated and a significant surrounding margin
should be covered evenly in a “painting” or “serpentine” motion. The
Small Cone Head can be used at power settings up to 6 W, 10 cm from
the skin of the patient.
Hand Piece with Finger Switch
and Small Ball
This treatment head is for use in applications where contact and soft tissue
manipulation during treatment are desired. Examples of appropriate
applications for the small ball are muscular or tissue injuries in tight spaces
or near sensitive areas. The small ball is not recommended for use over bone,
open wounds, non-intact skin or areas that would be sensitive to contact.
This head should be perpendicular to the skin and not approaching at
an angle. The area to be treated and a significant surrounding margin
should be covered evenly in a “painting” or “serpentine” motion.
The Small Ball can be used at power settings up to 6 W.
Hand Piece with Finger Switch
and Large Cone
This treatment head is for general use and applications where no contact
or soft tissue manipulation during treatment is desired. This head
should be perpendicular to the skin and not approaching at an
angle. The area to be treated and a significant surrounding margin
should be covered evenly in a “painting” or “serpentine” motion.
The Large Cone Head can be used at power settings up to 15 W,
8 cm from the skin of the patient.
Hand Piece with Finger Switch
and Large Ball
This treatment head is for use in applications where contact and soft tissue
manipulation during treatment are desired. Examples of appropriate
applications for the large ball are muscular or deep soft tissue injuries.
The large ball is not recommended for use over bone, open wounds,
non-intact skin or areas that would be sensitive to contact. This head
should be perpendicular to the skin and not approaching at an
angle. The area to be treated and a significant surrounding margin
should be covered evenly in a “painting” or “serpentine” motion.
The Large Ball can be used at power settings up to 15 W.
Recommendation Not to be used in a
non-contact mode.
Recommendation Not to be used in a
non-contact mode.
Hand Piece with Finger Switch
and Flat Window
This treatment head is for general use and applications where fine
control with no contact or soft tissue manipulation during treatment
is desired. This head should be perpendicular to the skin and not
approaching at an angle. The area to be treated and a significant
surrounding margin should be covered evenly in a “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.

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Warning Wear laser safety eyewear provided with the laser before operating the laser device.
Caution Do not remove the Empower™ Delivery System fiber from the emission port once it has been secured
unless required. Repeated insertion and removal of the fiber will increase the chance of emission port
and fiber tip contamination. If the emission port or the fiber tip is contaminated, the device can be
damaged during laser beam output emission.
The dust cap is installed by the manufacturer as a means to prevent dust and debris from
contaminating the emission port during shipping and before device installation and is not intended
as the primary means to protect the emission port connector during normal use.
We recommend the following procedure:
1. Before using the device for the first time, install and secure the hand piece fiber into the laser
emission port in accordance with section 6.4.
2. Use the device as required.
3. When done using the device, power off and leave the hand piece connected.
4. If the tip is contaminated clean it with the fiber cleaning paper provided with the device.
Bending Limits of the Hand Piece Cable:
The light transferred within the hand piece cable goes through a very small diameter glass rod (an
optical fiber). It can be damaged if bent too sharply. The maximum permissible bending radius of the
optical fiber is 5 cm.
Laser Hand Piece Troubleshooting:
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.