Chattanooga LIGHTFORCE FXi User manual

Deep Tissue Laser Therapy™System
with influence® Technology
INSTRUCTIONS FOR USE
LIGHTFORCE®FXi

INSTRUCTIONS FOR USE
Product Family: LightForce®Laser Systems
Models:
LTC-1510-L-B6 LightForce®FXi
Read the entire User Manual before attempting to operate the device. The
most current electronic version of this document can be found at the
following URL:
https://www.lightforcemedical.com/therapy-laser-user-manuals/
IFU ID:RSR-000886-000 (1)
Effective Date: 2021-June-01
©2021 by LiteCure, LLC. All rights reserved.
No part of this document may be copied or reproduced in any form, including an electronic retrieval system or be made available on the
Internet, a public network, or otherwise, without the prior written permission of LiteCure, LLC.

RSR-000886-000 (1) Page 2of 40
Table of Contents
1. Safety.........................................................................................................................................................4
1.1. Terminology...........................................................................................................................................4
1.2. Laser Safety...........................................................................................................................................4
1.3. Laser Treatment Controlled Area (LTCA)..............................................................................................4
1.4. Fire and Explosion Hazards ..................................................................................................................5
1.5. Safety Features .....................................................................................................................................5
1.5.1. Emergency Stop Button......................................................................................................................5
1.5.2. Password Entry...................................................................................................................................5
1.5.3. Remote Interlock Connector...............................................................................................................5
1.5.4. Laser Emission Indicators...................................................................................................................5
1.5.5. Unattended Protection 100 Seconds..................................................................................................6
1.5.6. Internal Laser Energy Monitor ............................................................................................................6
1.6. Laser Eye Protection .............................................................................................................................6
2. System Set-Up...........................................................................................................................................7
2.1. Location .................................................................................................................................................7
2.2. Unpacking and Initial Set-up..................................................................................................................7
2.3. Battery Use and Charging .....................................................................................................................8
2.4. Replacing the Battery ............................................................................................................................9
2.5. Connecting the Beam Delivery Assembly ...........................................................................................10
3. Device Description...................................................................................................................................12
3.1. Indications for Use...............................................................................................................................12
3.2. Contraindications.................................................................................................................................12
3.3. Maximum Permissible Exposure (MPE)..............................................................................................12
3.4. Laser Console Diagrams .....................................................................................................................13
3.5. Empower™ Delivery System...............................................................................................................14
3.5.1. Quick Disconnect Treatment Heads.................................................................................................15
3.5.2. Treatment Head Attachments...........................................................................................................16
3.6. Fiber Management...............................................................................................................................16
3.7. Laser Safety Eyewear..........................................................................................................................17
3.8. Medical Grade Power Cord .................................................................................................................17
4. Operation .................................................................................................................................................18
4.1. Safety Precautions...............................................................................................................................18
4.2. Patient Preparation..............................................................................................................................19
4.3. Device Operation.................................................................................................................................20
4.3.1. Power On..........................................................................................................................................20
4.3.2. Main Menu........................................................................................................................................20
4.3.3. Setup.................................................................................................................................................20
4.3.3.1. Standard Settings .........................................................................................................................20
4.3.3.2. Language Setting..........................................................................................................................21
4.3.4. Protocols...........................................................................................................................................21
4.3.5. Operation..........................................................................................................................................22
4.3.6. Laser Emission .................................................................................................................................22
4.4. Laser Treatment Procedure.................................................................................................................24
4.4.1. Pigment Considerations....................................................................................................................24
4.4.2. Dose..................................................................................................................................................24
4.4.3. Setting Treatment Expectations........................................................................................................24
4.4.4. Treatment Technique........................................................................................................................25
5. Maintenance.............................................................................................................................................26
5.1. Cleaning...............................................................................................................................................26
5.1.1. Cleaning the Console .......................................................................................................................26
5.1.2. Cleaning the Large Massage Ball.....................................................................................................27
5.2. Before You Call—Troubleshooting......................................................................................................28
5.3. Calibration Check Procedure...............................................................................................................28
6. Quality and Regulatory ............................................................................................................................30
6.1. Quality Systems...................................................................................................................................30

RSR-000886-000 (1) Page 3of 40
6.2. Device Classification............................................................................................................................30
6.3. Declaration of Conformity (EU)............................................................................................................30
7. Specifications and Environmental Conditions..........................................................................................31
7.1. System Specifications (LightForce FXi)...............................................................................................31
7.2. Spare Parts..........................................................................................................................................32
7.3. Electromagnetic Compatibility (EMC) Tables......................................................................................32
7.3.1. Emissions Test Summary.................................................................................................................33
7.3.2. Immunity Test Summary...................................................................................................................33
7.3.3. Recommended Separation Distances..............................................................................................34
7.3.4. Guidance and Manufacturer’s Declaration – Immunity –For Non-Life-Supporting Equipment .......34
7.4. FCC......................................................................................................................................................34
7.5. ISED.....................................................................................................................................................35
7.6. Radio Equipment Directive (RED).......................................................................................................36
7.7. Disposal...............................................................................................................................................36
8. Labeling....................................................................................................................................................36
8.1. Explanation of Symbols.......................................................................................................................36
8.2. Medical Laser Label.............................................................................................................................38
8.3. Non-Interlocked Protective Housing Label..........................................................................................39
8.4. Warranty Seal......................................................................................................................................39
8.5. Additional Warnings Label...................................................................................................................39
8.6. Unique Device Identification (UDI) Label.............................................................................................39
9. Contact Information..................................................................................................................................40

RSR-000886-000 (1) Page 4of 40
1. Safety
1.1. Terminology
Various Warnings, Cautions, Recommendations, and Notes are presented throughout this
manual and will be presented in the following manner:
Warning: Specific or potential danger. If ignored or compromised, the situation could
result in serious injury.
Caution: Possible problem with the device associated with its use or misuse.
Problems include, but are not limited to, device malfunction, device failure, or damage
to the device.
1.2. Laser Safety
Each facility and user of the laser device should follow all local laser safety requirements.
Federal, state, and local regulations as well as national and international standards should
be considered when developing laser safety programs.
Each person using the laser system must have completed basic laser safety orientation and
proficiency training prior to operating the laser system.
1.3. Laser Treatment Controlled Area (LTCA)
Select a secure and well-ventilated location in which to install and operate the laser system.
The location should be “light-tight” (not have windows or viewing ports) and should have a
single lockable door access. The access door should be closed and locked from the inside
throughout the entire treatment with the laser system.
If the door is equipped with an interlock switch, the door can be connected to the remote
interlock on the laser system –See Section 1.5.3. When the treatment door is opened during
a treatment, the laser will stop emission, produce an error message, and return to Standby
mode.
Recommendation: Offers guidance for the optimal application and usage of the device.
Note: Describes the conditions or exceptions that may apply to the subject matter
presented.
Recommendation: Designate at least one person at each facility that uses this laser
system as the Laser Safety Officer, responsible for providing training on all operating
and safety procedures and for monitoring and overseeing control of all laser hazards.

RSR-000886-000 (1) Page 5of 40
If you choose to set up your laser system in a multi-use area, a blocking barrier, screen, or
curtain, certified for blocking the laser beam, must be used to create a smaller area inside a
larger room. The barrier should be set up to simulate a “light-tight” room with single entry
access as described above.
Warning: Always post a laser safety sign on the outside of the treatment room door
or single access point when the laser is in use.
1.4. Fire and Explosion Hazards
Warning: Do not operate this laser system in areas that have explosion hazards such
as flammable materials, gases or substances. A fire or explosion could occur. The
laser beam can ignite mostnonmetallic materials. A fire extinguisher should be readily
available.
1.5. Safety Features
The laser system has multiple safety features. All individuals who use this laser system
should be trained and made aware of the following features:
1.5.1. Emergency Stop Button
The button (Figure 1) is located on the front of the laser system and is
illuminated when the machine is on. Push the button to turn off all
electrical power to the device’s microprocessor and stop the laser-
emitting components.
1.5.2. Password Entry
The laser system is equipped with password entry as the key control, which is required after
powering on the device, to prevent unauthorized system access.
1.5.3. Remote Interlock Connector
The laser system is equipped with a remote interlock connector
(Figure 2) located on the bottom of the device. The remote interlock
connector stops laser emission when the plug is removed or when the
terminals of the connector are open.
The laser system is shipped with a mating connector (as shown in Figure 2). The mating
connector MUST be inserted (or remote interlock circuit with closed door) for the laser
system to emit.
1.5.4. Laser Emission Indicators
The state of the laser system is shown on the touch screen and front bezel and indicated
through audible alerts and the aiming beam.
Figure 2
Figure 1

RSR-000886-000 (1) Page 6of 40
When the laser system is emitting, an EMISSION!
indicator (Figure 3) will appear on the touch screen
and flash. See Section 4.3.6 for a full description of
the transitions of this indicator based on the laser
mode (i.e. Standby, Ready, or Emission).
The amber LED (Figure 4) next to the power button on
the front bezel illuminates to indicate the state of the
laser. When off, the laser is considered to be in a safe
state - Standby. While transitioning from Standby to
Ready mode, the LED blinks. When in Ready mode,
it is constantly illuminated. While emitting, it blinks.
In addition, there is a red aiming beam that emits from the hand piece while in Ready and
Emission modes that provides a visible indication of laser state and the treatment location.
This aiming beam flashes during the transition from Standby to Ready mode.
Lastly, there is an audible indication during Emission that is a steady tone, or continuous
beep, depending on the system settings. The audible alert sounds six times during the six
second transition from Standby to Ready mode.
1.5.5. Unattended Protection 100 Seconds
If the laser system is left in Ready mode without enabling laser emission, the system will
automatically return to Standby mode.
1.5.6. Internal Laser Energy Monitor
To prevent over-exposure hazards due to excessive laser power, the laser system
continuously monitors the output current of the diodes to ensure they are within the factory
calibration settings. If it is detected that the electrical current levels exceed the upper or
lower limits that would result in power levels outside of the ±20% thresholds, the laser will
stop emission and return to Standby mode. To clear the error message and reset the laser
system, the operator must press the EXIT button on the touch screen.
1.6. Laser Eye Protection
ANYONE in the Laser Treatment Controlled Area
(LTCA) during laser treatment MUST wear the laser
safety eyewear that is provided with the Laser System.
The eyewear has an optical density (OD) rating >5.0 for
808 nm AND 980 nm wavelengths, as identified on the
lenses (Figure 5). Additional protective eyewear can be
purchased from the company webstore.
Figure 3
Figure
Figure 5

RSR-000886-000 (1) Page 7of 40
2. System Set-Up
Caution: ALWAYS turn the laser system OFF and unplug the power cord from the
wall outlet before lifting, moving, or relocating the laser system.
2.1. Location
Select a secure and well-ventilated location in which to install and operate the laser system
(see Section 1.3 for description of Laser Treatment Controlled Area).
•The device should be within 1.8 meters (6 feet) of an available 100-240 V electrical
outlet.
•Select a flat hard surface that can adequately support the laser system.
•Ensure adequate airflow around the laser system. The laser system is air-cooled and
designed for use in a well-ventilated location. There must be a minimum 10 cm (4 in)
clearance around the back of the device.
•An appropriate fire extinguisher should be readily available.
Warning: Do not operate the laser system in areas with explosion hazards such as
flammable materials or gases.
2.2. Unpacking and Initial Set-up
Step 1. Carefully unpack the laser system and its accessories from the shipping carton.
Step 2. Inspect the laser system carefully for any damage, such as cracks, dents or
bent parts.
Step 3. If items are missing or damaged, call Customer Care. Also, please notify the
carrier if the damage appears to have occurred during shipping and retain
packaging for evidence.
Caution: If the Warranty Seal Label (Figure 6) is not found on the
bottom of the device or is broken, DO NOT operate the device. Call
Customer Care.
Step 4. Fully charge the battery before using this laser system. When
connecting the external power supply to the laser system,
make sure that the cord is correctly aligned. With the flat side of the cord facing
up (Figure 7), plug the external power supply into the DC input on the back of
the laser system (Figure 8).
Figure 6

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Caution: Do not force the external power supply cord into the DC input in the incorrect
orientation (e.g., upside down). This will damage the pins and the unit will not charge
properly.
Step 5. Plug the AC power cord into the power supply.
Step 6. Once the power connection is secure, plug the AC power cord into a 100-240
V grounded outlet. A green light on the power supply should illuminate
(signaling active source power connection). Ifthe laser system is off, the battery
will charge provided the laser system is correctly plugged into the power supply
and the wall outlet. The charging time is approximately 3 hours.
2.3. Battery Use and Charging
Warning: Do not modify the battery or attempt to insert foreign objects into it.
Warning: Do not short circuit the battery, keep away from metallic items.
Warning: Do not immerse the battery in water or get the battery wet.
Recommendation: Charge the battery before use. The laser system ships with the
battery only partially charged.
Note: When the external power supply is connected to the laser system, the battery icon
will blink green to indicate it is charging the battery. To determine the battery charge
level, the power supply must be unplugged from the rear of the device.

RSR-000886-000 (1) Page 9of 40
Caution: Use of this battery in other devices could result in damage to the device or
battery.
Caution: The temperature range for charging this battery is 10 °C to 32 C (50 F to
90 F). Do not charge the battery outside of this range.
Caution: Do not store the battery at temperatures above 70 C (158 F), such as
inside a car on a hot day or in direct sunlight; this may damage the battery.
Caution: Avoid dropping the battery. If you suspect the battery or device is damaged,
contact Customer Care.
Caution: Do not disassemble, open, crush, bend, deform, puncture, shred or burn
the battery.
When the laser system is turned on, there is a battery icon in the upper right corner of the
display screen. The battery icon will indicate the amount of charge in the battery when the
laser system is not connected to AC power (mains/wall outlet). The icon will also change
color from green to amber to red as the charge is depleted. When the battery icon is red and
blinking, the battery needs to be recharged.
2.4. Replacing the Battery
Caution: Replace the battery only with an authorized replacement battery. These
batteries have been tested in accordance with applicable safety standards.
Warning: Discarded batteries may create a safety hazard. Before disposal, cover the
battery contacts with electrical insulating tape.
If the battery is not charging as expected, contact Customer Care to go through
troubleshooting to determine if a replacement battery is needed.
If the battery needs to be replaced, follow the steps below for removal and replacement of
the battery.
Step 1. Turn the laser over and place it on a flat surface.
Remove the battery cover by turning the finger
locks. (Figure 9)
Finger locks

RSR-000886-000 (1) Page 10 of 40
Step 2. To remove the old battery, grab the removal
strap and pull straight up. (Figure 10)
Step 3. With the arrow on the battery pointing to the
front of the unit (Figure 11), insert the new
battery into the battery compartment.
Step 4. With even pressure, fully seat the battery into
the battery compartment.
Step 5. Replace the battery cover and secure the finger
locks. The battery cover will fit tightly to hold the
battery in place.
2.5. Connecting the Beam Delivery Assembly
Caution: Do not remove the hand piece fiber cable from the emission port once it
has been secured (unless the optical fiber cable needs to be replaced).
Caution: Repeated insertion and removal of the hand piece fiber cable will increase
the chance of emission port or fiber tip contamination. If the emission port or the fiber
tip is contaminated, the optical fiber can be damaged during laser emission.
Caution: If the fiber must be removed, use the dust cap to help prevent dust and
debris from contaminating the emission port. Do not leave the port unprotected.
Step 1. Unscrew metal fiber connector until loose and gently pull
fiber away from unit Figure 12.
Figure 12
Note: The laser system will be delivered with the optical fiber
already connected. If it needs to be replacement, then follow Steps
1-6 below to disconnect the old and connect the new handpiece to
the console.
Removal strap

RSR-000886-000 (1) Page 11 of 40
Step 2. After removing fiber, unplug finger switch cord by pulling plug
away from unit.
Step 3. Remove the new assembly from the protective foam
packaging.
Step 4. Secure the finger switch connector by carefully pushing it
into the finger switch port (Figure 13).
Step 5. Remove the protective dust cap from the end of
the new optical fiber cable.
Step 6. Open the hinged door covering the emission port and
insert the fiber tip straight into the emission port
(Figure 14). Twist the metal connector clockwise onto
the threaded emission port until tight.
Emission port
(behind hinged cover)
Finger Switch port
(USB-C port)
Figure 13
Figure 14

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3. Device Description
The laser systems include a therapeutic laser console and optical delivery system. The
optical delivery system consists of a flexible optical fiber connected to a hand piece with
interchangeable treatment heads. A custom software application allows the user to select
from built-in treatment protocols that adjust dosage and wavelength based on the patient's
characteristics and condition. The device also provides the ability to set custom treatment
parameters including output power, treatment time, and pulse rate. Once the user has
selected the desired treatment parameters, activation of laser emission requires that the
operator follow a sequence of predetermined steps.
3.1. Indications for Use
810 nm and 980 nm wavelength:
The laser system emits energy in the visible and near-infrared spectrum to provide
topical heating for the purpose of elevating tissue temperature for a temporary relief
of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm;
the temporary increase in local blood circulation; the temporary relaxation of muscle.
The device is meant for professional use only by licensed practitioners.
Caution: Federal, national, or local laws may restrict this device to sale by or on the
order of a licensed practitioner licensed by the applicable authorities to use and/or
prescribe use.
3.2. 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.
3.3. Maximum Permissible Exposure (MPE)
Maximum Permissible Exposure (MPE) is the highest power density (in W/m2) from a light
source that does not require clinical evidence to be considered safe. For the laser radiation
from the laser system, the MPE for ocular and skin exposure is determined by the
wavelength, beam divergence, and exposure time. For times between 10 and 3000 seconds,
the ocular MPE is 418.9 W/m2and the skin MPE is 3027.1 W/m2.

RSR-000886-000 (1) Page 13 of 40
3.4. Laser Console Diagrams
4
3
2
1
5
6
8
9
7
10
11
13
14
15
16
12
18
17
21
20
22
19

RSR-000886-000 (1) Page 14 of 40
Figure 15
3.5. Empower™ Delivery System
Caution: Do not bend the optical fiber too sharply: the minimum permissible bending
radius is 40 mm. Mishandling of the fiber may lead to damage to the fiber or delivery
system and/or harm to the patient or laser operator.
Warning: If any part of the Empower Delivery System overheats or produces smoke,
immediately power off the Laser System, discontinue operation, and contact
Customer Care for assistance.
Warning: The use of accessories and/or optical fiber cables not specified for use
with this Laser System may result in unsafe emissions or damage to the Laser
System.
The Empower Delivery System is composed of a double-sheathed optic fiber and a hand
piece with interchangeable treatment heads. The laser emission is controlled with a finger
switch on the hand piece. During Emission, the LED indicator will illuminate. (Figure 15).
The functionality of the finger switch is influenced by the “Override” setting in
Setup. When the operator is administering a treatment with Override Off, the
finger switch must be held down continuously to enable emission. When Override
is On, the finger switch acts as an ON/OFF switch allowing the operator to press
once and release to enable continuous emission.
Warning: The Override On setting for the finger switch should only be used by a
qualified laser technician.
To end emission, the operator will then press and release again, which
will return the laser to Ready mode. The laser system will remain in
Ready mode until the operator resumes the treatment or selects
Standby on the touchscreen to return to Standby mode.
Warning: DO NOT press the finger switch without first verifying
the safe orientation and proper positioning of the distal end of the
optical fiber and hand piece. Ensure compliance with all safety
precautions.
Warning: DO NOT operate the laser system without a treatment
head (Figure 16). This can cause serious injury.
Figure 16
Figure 17
Finger Switch
Distal End
LED Indicator

RSR-000886-000 (1) Page 15 of 40
Warning: DO NOT operate the laser system with an improperly attached or loose-
fitting treatment head (Figure 17). This can cause serious injury.
3.5.1. Quick Disconnect Treatment Heads
To attach a treatment head, locate the metal insert on the inside of the opening. Line up the
slot within the metal insert with the bearing on the mating end of the hand piece (Figure 18).
The hand piece and treatment heads are keyed so they will only fit and attach in this
orientation.
Once they are lined up, push the attachment
onto the end of the hand piece so it is fully
seated. Then while holding the hand piece,
rotate the attachment clockwise until it clicks.
This indicates the attachment is fully engaged,
locked in, and ready for use. (Figure 19)
Figure 18
PUSH
Figure 19
Recommendation: As the aiming beam passes down the same delivery system as the
working beam, it provides a good means of checking the integrity of the delivery system.
If the aiming beam is not present at the distal end of the delivery system, its intensity is
reduced or it looks diffused, this is a possible indication of a damaged or malfunctioning
delivery system.

RSR-000886-000 (1) Page 16 of 40
3.5.2. Treatment Head Attachments
Beam divergence and the Nominal Ocular Hazard Distance (NOHD) for each of the treatment heads
are listed in the below table. NOHD is defined in ANSI Z136.3 as “the distance along the axis of the
unobstructed beam from the laser to the human eye beyond which the irradiance or radiant exposure
during normal operation is not expected to exceed the appropriate Maximum Permissible Exposure
(MPE).” At distances greater than the NOHD, the beam intensity becomes lower than the MPE.
Nominal Ocular Hazard Distance (NOHD) Table
Name
Image
Divergence
(radians)
NOHD (meters)
OFF-CONTACT
Flat Window
0.815
0.6
Small Cone
0.815
0.4
Large Cone
0.815
0.4
ON-CONTACT
Small Massage Ball
0.226
1.1
Large Massage
Ball
0.057
4.9
3.6. Fiber Management
The side of the FXi console has an easy-to-use Fiber Manager Spool and Hand Piece Clip
that allows the user to store the beam delivery assembly while not in use. When therapy is
discontinued or between treatment cycles, the user may rest the hand piece in the Hand
Piece Clip. For long term storage and during transport, the user may also wrap the fiber
around the Fiber Manager Spool to avoid damage to the fiber.

RSR-000886-000 (1) Page 17 of 40
When wrapping the hand piece fiber around the fiber manager spool, the first fiber wrap
should be fed into the Fiber Slot so the plastic Bifurcator, which couples the finger switch
and fiber optic cables, snaps into the slot. Five more wraps (for a total of six) should be
made tightly around the spool to provide enough length for the hand piece to feed into the
Hand Piece Clip (Figure 20).
3.7. Laser Safety Eyewear
Warning: ALWAYS wear the protective eyewear supplied with this laser system
when operating the device.
Additional protective eyewear can be purchased from company webstore.
Warning: All personnel who are in the laser treatment controlled area MUST wear
laser safety eyewear.
Warning: DO NOT remove protective eyewear until the operator returns the laser
device to Standby mode.
Warning: If you suspect injury, such as direct exposure to the eyes, seek medical
attention immediately.
3.8. Medical Grade Power Cord
Caution: Do not use any power cord other than the one provided with the system.
If a replacement is needed, additional power cords can be purchased from the company
webstore.
Figure 20
Fiber
Slot
Snap
in
Bifurc
Hand
Piece
Clip
6th &
final
wrap

RSR-000886-000 (1) Page 18 of 40
4. Operation
4.1. Safety Precautions
Anyone in the laser treatment controlled area during laser operation (including the operator,
all assistants, and the patient) MUST wear the protective eyewear supplied with this laser
system.
Warning: The protective laser eyewear has an optical density (OD) rating > 5.0 for
810 nm AND 980 nm laser emission (see specification sheet with eyewear). ONLY
wear the protective eyewear supplied with this laser system.
Warning: All personnel in the laser treatment controlled area MUST wear laser safety
eyewear.
Warning: Replace any protective laser eyewear with eyewear from the manufacturer
if there is any damage.
Warning: NEVER look directly into the distal end of the optical fiber connected to an
active laser device WITH or WITHOUT the appropriate laser-emission protective
eyewear.
Warning: NEVER aim the laser light directly into the eyes.
Warning: NEVER direct the laser beam at anything other than the area to be treated.
Direct or indirect eye contact with the output beam can cause serious damage,
irreparable corneal and/or retinal damage, and possible blindness to one or both
eyes.
Warning: If you suspect injury, such as direct exposure to the eyes, seek medical
attention immediately.
Warning: FAILURE TO COMPLY with all safety instructions and warnings may
expose everyone in the controlled laser treatment area to harmful levels of laser
radiation and/or dangerous levels of electrical current.
Warning: FAILURE TO COMPLY with the application techniques listed in the
manual may lead to exposure to harmful levels of laser radiation.
Recommendation: DO NOT allow any nonessential personnel into the laser treatment
controlled area during any laser procedure.
Recommendation: NEVER allow untrained personnel to operate this laser system
unless directly supervised by a properly trained and experienced individual.

RSR-000886-000 (1) Page 19 of 40
Warning: AVOID THE USE of flammable solvents, anesthetics, and oxidizing gases
such as nitrous oxide (N2O) and oxygen. The high temperatures produced during
normal use of the laser system may ignite some materials, such as cotton or wool.
Warning: After cleaning any treatment head with alcohol solution, DO NOT use until
the alcohol solution completely evaporates. Doing so may cause the laser to ignite
alcohol solutions or vapors.
Take the following steps to secure the treatment room, or the controlled area:
•Alert patients and personnel of laser safety precautions before they enter the laser
treatment controlled area. Post a laser safety sign on the outside of the treatment
room door when the laser is in use.
•Close the treatment room door during operation of the laser. The remote interlock
connector can be connected to the treatment room door through an interlock circuit
so laser emission stops when the treatment room door is opened.
4.2. Patient Preparation
Warning: Use carefully. May cause serious burns. Do not use over sensitive skin
areas or in the presence of poor circulation. The unattended use of the 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 while it is emitting. Direct or indirect eye contact with scattered laser light from
any reflective surface can cause serious, irreparable corneal and/or retinal damage,
and possible blindness to one or both eyes.
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.
Before a treatment, do the following preparation:
•The operator, all assistants, and the patient must remove all reflective objects (rings,
metal watchbands, and jewelry) prior to treatment.
•The area to be treatedmust beexposed. DO NOT treat through clothing orbandages.
•The treatment area should be clean and free of surface dirt or oils.
•Isopropyl alcohol solution (70% alcohol) may be used to clean all instrument surfaces
that contact the patient (see Section 5.1). Remember to allow the alcohol solution to
completely evaporate before initiating the Laser System.