Chattanooga LIGHTFORCE XLi User manual

Deep Tissue Laser Therapy™System
with Empower IQ™Delivery System
INSTRUCTIONS FOR USE
LIGHTFORCE®XLi / XPi

INSTRUCTIONS FOR USE
Product Family: LightForce®Therapy Lasers
Models:
LTS-2500-L-S8 LightForce®XPi
LTS-4000-L-S8 LightForce®XLi
Read this entire document 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-000885-000 (2)
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-000885-000 (2) Page 2of 42
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. Connecting the Beam Delivery Assembly........................................................................................8
3. Device Description..............................................................................................................................10
3.1. Indications for Use .........................................................................................................................10
3.2. Contraindications ...........................................................................................................................10
3.3. Maximum Permissible Exposure (MPE) ........................................................................................10
3.4. Laser Console Diagrams................................................................................................................11
3.5. Empower IQ™ Delivery System ....................................................................................................12
3.5.1. Emission Indicators.....................................................................................................................13
3.5.2. Quick Disconnect Treatment Heads ...........................................................................................14
3.5.3. Treatment Head Attachments.....................................................................................................14
3.6. Fiber Management.........................................................................................................................16
3.7. Laser Safety Eyewear....................................................................................................................17
3.8. Medical Grade Power Cord............................................................................................................17
4. Operation............................................................................................................................................17
4.1. Safety Precautions.........................................................................................................................17
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...........................................................................................................................................21
4.3.3.1. Standard Settings....................................................................................................................21
4.3.3.2. Empower IQ Settings ..............................................................................................................21
4.3.3.3. Language Setting....................................................................................................................21
4.3.4. Protocols .....................................................................................................................................22
4.3.5. Operation.....................................................................................................................................23
4.3.6. Laser Emission............................................................................................................................24
4.4. Laser Treatment Procedure...........................................................................................................25
4.4.1. Pigment Considerations..............................................................................................................25
4.4.2. Dose............................................................................................................................................25
4.4.3. Setting Treatment Expectations..................................................................................................25
4.4.4. Treatment Technique..................................................................................................................26
5. Maintenance.......................................................................................................................................27
5.1. Cleaning.........................................................................................................................................27
5.1.1. Cleaning the System...................................................................................................................27
5.1.2. Disassembly and Cleaning of the Massage Attachments...........................................................28
5.1.2.1. Large Massage Ball (Figure 25)..............................................................................................28
5.1.2.2. Rolling Pin (Figure 26) ............................................................................................................28

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5.2. Before You Call—Troubleshooting ................................................................................................29
5.3. Calibration Check Procedure.........................................................................................................30
6. Quality and Regulatory.......................................................................................................................31
6.1. Quality Systems .............................................................................................................................31
6.2. Device Classification......................................................................................................................31
6.3. Declaration of Conformity (EU)......................................................................................................31
7. Specifications and Environmental Conditions....................................................................................32
7.1. System Specifications (LightForce XPi/XLi)...................................................................................32
7.2. Spare Parts ....................................................................................................................................33
7.3. Electromagnetic Compatibility (EMC) Tables ................................................................................33
7.3.1. Emissions Test Summary ...........................................................................................................34
7.3.2. Immunity Test Summary .............................................................................................................34
7.3.3. Recommended Separation Distances ........................................................................................35
7.3.4. Guidance and Manufacturer’s Declaration – Immunity –For Non-Life-Supporting Equipment..35
7.4. FCC................................................................................................................................................36
7.5. ISED...............................................................................................................................................36
7.6. Radio Equipment Directive (RED) .................................................................................................37
7.7. Disposal .........................................................................................................................................37
8. Labeling..............................................................................................................................................38
8.1. Explanation of Symbols..................................................................................................................38
8.2. Laser Product Label.......................................................................................................................40
8.3. Non-Interlocked Protective Housing Label.....................................................................................40
8.4. Warranty Seal ................................................................................................................................41
8.5. Additional Warnings Label .............................................................................................................41
8.6. Unique Device Identification (UDI) Label.......................................................................................41
9. Contact Information............................................................................................................................42

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1. Safety
1.1. Terminology
Various Warnings, Cautions, Recommendations, and Notes are presented throughout
this document 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
Recommendation: Offers guidance for the optimal application and usage of the device.
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.
Note: Describes the conditions or exceptions that may apply to the subject matter
presented.

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during a treatment, the laser will stop emission, produce an error message, and return to
Standby mode.
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 most nonmetallic 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.
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

Page 6of 42
When the laser system is emitting, an EMISSION!
indicator (Figure 3) will appear on the touch screen
and flash. See Section 4.3.5 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 ) 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 of OD 5+
for 808 nm AND 980 nm wavelengths, as identified on the
lenses (Figure 5). Additional protective eyewear can be
purchased from the company webstore.
RSR-000885-000 (2)
Figure 3
Figure
Figure 5

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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. Plug the female end of the power cord into the AC input at
the back of the laser system.
Step 5. Plug the male end of the AC power cord into a 100-240 V grounded electrical
outlet.
Figure 6

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2.3. 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. Remove the hand piece with optical fiber
cable from the protective foam packaging.
Step 2. Remove the protective cap from the
emission port on the back of the laser system
(Figure 7).
Step 3. Remove the protective cap from the end of the
optical fiber cable (Figure 8).
Step 4. Insert the end of the fiber into the emission port being
careful not to contaminate or damage the tip. Once
seated, thread the metal adapter onto the port by
rotating clockwise until tight; do not overtighten.
Step 5. Secure the finger switch connector by carefully
pushing it into the finger switch port.
(Figure 9).
Step 6. Power on the device and press Setup on the
Main menu.
Finger Switch Port
Emission Port
Figure 7
Figure 8
Figure 9
Note: The laser system will be delivered with the optical fiber already connected. If it
needs to be replaced, follow Steps 1-5 below to connect the handpiece to the console.
If the handpiece is enabled with Empower IQ, then continue with steps 6-9 to complete
the setup.

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Step 7. Press the “Set EIQ ID” button on the right side of the screen.
Step 8. On the following screen (Figure 10), enter the Empower IQ ID from the
distal end of the hand piece (Figure 11) and press Enter.
Step 9. Press “Save >” to confirm the ID and the system will prompt the user that
the device will auto shut down and restart.
Note: If a treatment head is attached to the Empower IQ, it must be removed to reveal
the ID. The ID will be 4 alphanumeric characters. Lower-case or upper-case letters will
be accepted. If it is not connecting and unclear whether a character is the letter O or
number 0, always use the number 0. If there are still issues, contact Customer Care for
further troubleshooting.
Figure 10
ID
Figure 11

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3. Device Description
The laser system includes a therapeutic laser console and beam delivery system. The
beam delivery system consists of a flexible optical fiber connected to a hand-held
applicator, or hand piece, with interchangeable treatment head attachments. A custom
software application allows the user to select from built-in treatment protocols that adjust
treatment dosage, including 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 wavelengths:
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) isthe 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.

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3.4. Laser Console Diagrams
1. Power Button
2. Emission Indicator LED
3. Emergency Stop Button
4. Touchscreen Display
5. Front Vent & Speakers
6. Non-interlocked Protective
Housing Label
7. UDI Label
8. Product Label
9. Remote Interlock
10. Warranty Seal
11. Rear Vents
12. Foot Switch Receptacle
13. VGA Port (For Mfg Use ONLY)
14. Additional Warnings Label
15. USB Port
16.
Power Cord Receptacle

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3.5. Empower IQ™ 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 IQ Delivery System overheats or produces
smoke, immediately power off the Laser System, discontinue operation, and
contact Customer Care for assistance.
Warning: The new Empower IQ features are not meant to replace user training
or the need to observe and respond to patient feedback during treatment.
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.
Warning: When treating at higher powers (>25W), wait five minutes between
successive treatments of >15,000 Joules to prevent overheating. Ifthe handpiece
becomes uncomfortable to hold, discontinue treatment. If the handpiece
continues to produce excessive heat, then discontinue use of the device and
contact Customer Care for assistance.
The Empower IQ 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. 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.

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Warning: DO NOT operate the laser system
without a treatment head (Figure 12). This
can cause serious injury.
Warning: DO NOT operate the laser
system with an improperly attached or loose-
fitting treatment head (Figure 13). This can
cause serious injury.
3.5.1. Emission Indicators
The Emission Indicator Ring on the
Empower IQ™ will change colors
during emission based on the
dosing technique. During ideal
dosing, the LED will remain green.
When the hand piece is stopped or
moved too slow during emission,
the LED will turn red.
When the hand piece
is moved too fast
during emission, the
LED will turn yellow.
When Vibration feedback is turned
on, the hand piece will vibrate
when in the red (too slow) or yellow
(too fast) condition (Figure 14). The
handpiece will not vibrate in any condition when Vibration Feedback is Off. When
Visual Feedback is Off, the indicator ring will remain white during emission.
Figure 12
Figure 13
Figure 14
Emission
Indicator Ring
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.

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3.5.2. 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 15). 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 16)
3.5.3. Treatment Head Attachments
To confirm successful connection, the corresponding treatment head icon on the
Operation screen will be highlighted. The icon background color will be based on
whether it is recommended or not based on the current Protocol or treatment settings.
Beam divergence and the Nominal Ocular Hazard Distance (NOHD) for each of the treatment
heads are listed in the above 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
Figure 15
PUSH
Figure 16
Recommendation: If the Empower IQ is not performing as described above, check the
Empower IQ settings in Setup and reconnect the Empower IQ, if needed –see Section
2.3 for more detailed steps.
Note: Not all treatment head attachments are available with each laser system. The
device guides the user on the appropriate treatment head to use and will provide
error messages when invalid attachments are used.

RSR-000885-000 (2) Page 15 of 42
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. Worst case for the laser systems is with the Large Massage Ball at 8.0 m.
Nominal Ocular Hazard Distance (NOHD) Table
Name
Image
Divergence
(radians)
NOHD* (meters)
OFF-CONTACT
Flat Window
0.815
0.6
Small Cone
Large Cone
Extra Large (XL)
Cone
ON-CONTACT
Small Massage
Ball
0.226
1.8
Large Massage
Ball
0.057
8.0**
Rolling Pin
0.065
6.7
*Based on worst-case parameters from device with highest potential risk within the device family (40 W)
** NOHD of the system is based on this value, since it is the worse-case hazard distance
Warning: To avoid patient discomfort, keep the treatment head perpendicular to
the skin surface when performing on-contact treatments with the Large massage
ball and Rolling Pin.

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3.6. Fiber Management
The console has an easy-to-use Fiber Manager
and Hand Piece Clip that provides storage for the
beam delivery assembly while not in use. While
paused, or between treatments, the user may
store the hand piece in the Hand Piece Clip
(Figure 17).
When wrapping the hand piece fiber around the
fiber manager spool, the first 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 (Figure 18). This feature
provides strain relief for the fiber optic connection
during transport or use.
Continue with five more wraps (for a total of six)
around the spool. When wrapped tightly, there
should be enough length for the hand piece to
feed into the Hand Piece Clip.
Figure 17
Figure 18

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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.
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.
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-000885-000 (2) Page 18 of 42
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
instruction may lead to exposure to harmful levels of laser radiation.
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.

RSR-000885-000 (2) Page 19 of 42
•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 treated must be exposed. DO NOT treat through clothing or
bandages.
•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. Remember to allow the alcohol solution to
completely evaporate before initiating the Laser System.