COMPANION CTS-DUO User manual

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Companion Animal Health
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Companion Animal Health
CTS-DUO
Laser System
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RSR-000715-000 (2) User Manual – CTS-DUO Page 1 of 26
Companion Animal Health
®
CTS-DUO User Manual
Read the entire User Manual before attempting to operate this device.
User Manual PN: RSR-000715-000 (2)
Applicable Software Version: 4.0+
Effective Date: 2021-08-30

RSR-000715-000 (2) User Manual – CTS-DUO Page 2 of 26
Table of Contents
1.Safety.................................................................... 3
1.1.Terminology .......................................................... 3
1.2.Laser Safety.......................................................... 3
1.3.Laser Treatment Controlled Area (LTCA).............. 3
1.4.Fire and Explosion Hazards.................................. 3
1.5.Safety Features..................................................... 3
1.5.1.Emergency Stop Button............................... 3
1.5.2.Password Entry ............................................ 3
1.5.3.Remote Interlock Connector........................ 3
1.5.4.Laser Emission Indicators ............................ 4
1.5.5.Unattended Protection................................. 4
1.5.6.Internal Laser Energy Monitor...................... 4
1.6.Laser Safety Eyewear ........................................... 4
2.System Set-Up ..................................................... 4
2.1.Location ................................................................ 4
2.2.Unpacking and Initial Set-up ................................ 4
2.3.Delivery System Connection ................................ 5
2.4.Fiber Management................................................ 5
3.Device Description................................................ 6
3.1.Indications for Use................................................ 6
3.2.Contraindications ................................................. 6
3.3.Maximum Permissible Exposure (MPE)................ 6
3.4.Laser Console Diagrams ...................................... 7
3.5.Empower IQ™ Delivery System ........................... 7
3.6.Quick Disconnect Treatment Heads..................... 8
3.7.Treatment Head Attachments .............................. 8
3.7.1.Treatment Head Parameters........................ 9
4.Device Operation ................................................ 10
4.1.Safety Precautions ............................................. 10
4.2.Treatment Information ........................................ 10
4.3.Stored Protocols................................................. 10
4.4.Patient Preparation ............................................. 10
4.5.Treatment Considerations .................................. 11
4.6.Contact Technique ............................................. 11
4.7.Laser Treatment Procedure................................ 11
4.8.Skin Color and Other Pigment Considerations .. 11
4.9.Dose.................................................................... 11
4.10.Treatment Technique.......................................... 12
4.11.Error Messages................................................... 12
4.11.1.Operation Errors ................................................. 12
4.11.2.System Errors ..................................................... 12
5.Power On............................................................ 13
5.1.Main Menu .......................................................... 13
5.2.Setup .................................................................. 13
5.2.1.System Setup............................................. 13
5.2.2.Handpiece Setup ....................................... 13
5.2.3.Localization Setup...................................... 14
5.3.Protocol Selection...............................................14
5.4.Operation Screen (Protocols)..............................14
5.5.Operation Mode ..................................................15
5.6.Operation Screen – Ready ..................................15
5.7.Operation Screen – Emission..............................15
5.8.Operation Screen – Perfect Protocol™...............15
6.Resources ...........................................................16
7.Patient Tracker ....................................................16
8.Maintenance........................................................16
8.1.Cleaning ..............................................................16
8.1.1.Cleaning the Console..........................................17
8.1.2.Large Deep Tissue Applicator Cleaning..............17
8.1.3.XL Deep Tissue Applicator Cleaning...................17
8.2.Before You Call—Troubleshooting .....................17
8.2.1.If the laser system will not turn on: .....................17
8.2.2.If there are scratches on the massage ball: ........18
8.3.Calibration Check Procedure..............................18
8.4.Laser Power Calibration Check Instructions:......18
9.Quality and Regulatory........................................18
9.1.Laser Product Regulations..................................18
9.2.Device Classification...........................................18
9.3.Declaration of Conformity (EU) ...........................19
10.Specifications and Environmental Conditions ....19
10.1.Device Specifications..........................................19
10.2.Accessories.........................................................20
10.3.Electromagnetic Compatibility (EMC) Tables .....20
10.4.Table: Guidance and Manufacturer’s Declaration –
Emissions ............................................................................21
10.5.Immunity Test Summary – For All Equipment and
Systems 21
10.6.Guidance and Manufacture’s Declaration –
Immunity– For Non-Life-Supporting Equipment .................21
10.7.Table: Recommended Separation Distances .....21
10.8.Disposal ..............................................................22
11.Labeling...............................................................22
11.1.Explanation of Symbols ......................................22
11.2.Laser Product Label ............................................23
11.3.Therapy Laser 25W Label ...................................23
11.4.Warranty Seal......................................................24
11.5.Additional Warnings Label ..................................24
12.Warranty Details..................................................24
12.1.Warranty Information...........................................24
12.2.Packaging Instructions........................................24
12.3.Cancellation Fees................................................25
12.4.Coverage and Exclusions ...................................25
12.4.1.Standard Warranty ..............................................25
12.4.2.Extended Coverage ............................................25
13.Contact Information ............................................25

RSR-000715-000 (2) User Manual – CTS-DUO Page 3 of 26
1. Safety
1.1. Terminology
Various Warnings, Cautions, Recommendations and Notes are presented throughout this manual. Explanations and the corresponding symbols
are:
Warning: Specific or potential danger. If ignored or compromised, the situation could result in serious injury. Warning statements are
preceded with a yellow symbol.
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. Caution statements are preceded by a black-and-white symbol.
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.
Warning: This laser device is sold solely for VETERINARY, INDUSTRIAL, OR SCIENTIFIC purposes only! Under NO circumstances
should this laser system be employed as a medical device for human use.
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.
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
This button (Figure 1) is located on the front of the laser system. Push the button to turn off all electrical power to the device’s
microprocessor and laser-emitting components in case of an emergency.
1.5.2.Password Entry
The
laser system is equipped with a password entry as the key control that is required after powering on the device, to prevent unauthorized
access to the system.
1.5.3.Remote Interlock Connector
The laser system is equipped with a remote interlock connector (Figure 2) located on the back of the device. The
remote interlock connector stops laser emission when the terminals of the connector are open.
The mating connector (as shown in Figure 2) MUST be inserted (or remote interlock circuit closed / door closed) for
the laser system to emit.
Figure 1
Figure 2
Note: Describes the conditions or exceptions that may apply to the subject matter presented.
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.

RSR-000715-000 (2) User Manual – CTS-DUO Page 4 of 26
1.5.4.Laser Emission Indicators
When the laser system is emitting, an EMISSION! indicator (Figure 3) will appear on the touch screen and flash.
The 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 which provides
a visible indication of the treatment location.
Lastly, there is an audible warning during Emission that is a stead tone, or continuous beep, depending on the system settings. The audible
warning sounds six times during the six second transition from Standby to Ready mode.
1.5.5.Unattended Protection
If the laser system is left in Ready mode for 100 seconds without any input, 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 limit that would result in 20%
greater power output than selected, the laser will stop emission, display an error message, and return to Standby mode.
1.6. Laser Safety Eyewear
ANYONE in the Laser Treatment Controlled Area (LTCA) during laser treatment MUST wear the laser
safety eyeware 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). Animal patients may
wear protective laser eyewear provided by the manufacturer, i.e. Doggles, (Figure 6) or may have their
eyes covered with other completely opaque shielding. Additional protective eyewear can be purchased
from the company webstore.
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.
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.
Step 4. Plug the female end of the power cord into the AC input at the back of the laser system (Figure 8).
Step 5. Plug the male end of the AC power cord into a 100-240 grounded electrical outlet
.
Figure 8
Figure 3
Figure 4
Figure 6
Figure 5

RSR-000715-000 (2) User Manual – CTS-DUO Page 5 of 26
Caution: If the Warranty Seal Label (Figure 7) is not found on the bottom of the device or is broken, DO NOT
operate the device. Call Customer Care.
Caution: Do not force the external power supply cord into the DC input in the incorrect orientation (i.e. upside down).
This will damage the pins and the unit will not charge properly.
2.3. Delivery System Connection
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).
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 beam emission causing a loss in
output and potential damage to the emission port.
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.
Do not bend the optical fiber too sharply: the minimum permissible bending radius is 40 mm.
Step 1.
Step 2.
Step 3.
Step 4.
Step 5.
Step 6.
Unscrew metal fiber connector counter-clockwise until loose and gently pull fiber away from unit.
After removing fiber, unplug finger switch cord by pulling plug away from unit (Figure 11).
Remove the new assembly from the protective foam packaging.
Secure the finger switch connector by carefully pushing it into the finger switch port.
Remove the protective dust cap from the end of the new optical fiber cable (Figure 12).
Insert the fiber tip straight into the emission port. Twist the metal connector clockwise onto the threaded emission port until
tight (Figure 13).
2.4. Fiber Management
The top of the laser console has an easy-to-use Fiber Manager and Handpiece Clip that provide storage for the Empower IQ Delivery System
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.
Figure 14
Figure 7
Figure 11 Figure 12 Figure 13
Note: The laser system will be delivered with the beam delivery assembly already connected. If a replacement is needed, follow the steps
below to disconnect the old and attach the new beam delivery assembly.
Finger Switch Port Emission Port

RSR-000715-000 (2) User Manual – CTS-DUO Page 6 of 26
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 14).
3. Device Description
The laser system includes a therapeutic laser and optical delivery system that is used for the treatment of minor muscle and joint pain, muscle
spasm, pain and stiffness associated with arthritis and for promoting relaxation of the muscle tissue and for temporary increase in local blood
circulation. The optical delivery system consists of a hand piece with interchangeable treatment heads attached to a flexible optical fiber. A custom
software application allows the operator to select from built-in treatment protocols, or to adjust and set the system’s optical output power and
treatment times with minimal effort. Once the operator has selected the desired treatment parameters, activation of laser emission requires that
the operator follow a sequence of predetermined steps to activate laser emission. These steps are detailed in Section 5.
3.1. Indications for Use
810 nm and/or 980 nm wavelength:
This laser system is indicated for emitting energy in the visible and near-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 to temporarily increase local blood circulation.
The laser system is intended to be used by licensed veterinarians, or other practitioners, to provide animal patients photobiomodulation therapy
to promote healing and reduce inflammation.
Caution: Federal law (USA) restricts this device to sale by or on the order of a veterinarian, or other practitioner licensed by the law of
the State to use and/or prescribe use of the device.
Warning: This laser device is sold solely for VETERINARY, INDUSTRIAL, OR SCIENTIFIC purposes only! Under NO circumstances
should this laser system be employed as a medical device for human use.
3.2. Contraindications
Contraindications for laser therapy are based upon prudence as opposed to experimental or clinical data. The following contraindications are
presented as a precaution for safe and effective treatment. Laser therapy should not be administered in the following situations:
Hemorrhaging: Do not apply laser light to any actively hemorrhaging lesion.
Eyes: Direct irradiation of the eyes. Lasers are potentially harmful to the retina of the eye. Never shine laser light into the eye at
any time, even while wearing safety goggles.
Testicles: Do not apply laser light to the testicles of the animal.
Injectable Medications: Do not apply laser light directly over any area recently injected with any medication, vaccines, etc.
Photosensitive Medications: Use caution in any animal currently receiving photosensitive medications.
Epiphysitis: When applying laser light to epiphysitis, use a low dose initially and use only those treatments necessary to reduce
swelling.
Cancer or Malignancy: Do not use laser over any known primary or secondary lesions. Laser application to horses with
Melanomas and Sarcoids should only occur under the supervision of a veterinarian.
Pregnancy: Do not apply laser light directly over the pregnant uterus.
Treatment Over Sympathetic Ganglia, the Vagus Nerves & Cardiac Region In Animals With Heart Disease: Laser therapy
may significantly alter neural function, and is therefore contraindicated over these regions in patients with heart disease.
3.3. Maximum Permissible Exposure (MPE)
Maximum Permissible Exposure (MPE) is the highest power density (in W/cm
2
) from a light source that is considered safe. For the infrared radiation
from this laser system, the MPE at the cornea for direct ocular exposure is determined by the wavelength, beam divergence, and exposure time.
For exposure times between 10 and 3000 seconds, the MPE at the cornea for this laser system is 418.9 W/m
2
. For exposure times between 10
and 30,000 seconds, the skin MPE is 3027.1 W/m
2
.

RSR-000715-000 (2) User Manual – CTS-DUO Page 7 of 26
Figure 19
3.4. Laser Console Diagrams
1. PowerButton
2. EmissionIndicatorLED
3. EmergencyStopButton
4. TouchscreenDisplay
5. FrontVent&Speakers
6. Non‐interlockedProtectiveHousingLabel
7. UDILabel
8. ProductLabel
9. RemoteInterlock
10. WarrantySeal
11. RearVents
12. FootSwitchReceptacle
13. VGAPort(ForMfgUseONLY)
14. AdditionalWarningsLabel
15. USBPort
16. PowerCordReceptacle
3.5. Empower IQ™ Delivery System
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.
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.
Caution: Do not bend the optical fiber too sharply: the minimum permissible bending radius is 40 mm.
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 (Figure 19).
Warning: DO NOT operate the laser system without a treatment head. This can cause serious injury.
The finger switch is an ON/OFF button for laser emission. When the operator is administering a treatment, the finger switch must be held down.
Releasing the finger switch stops the laser emission and returns the laser to Ready mode. The laser system will remain in Ready mode until the
operator holds the button down again to resume the treatment. If there is no input to the laser system by the finger switch for 100 seconds, then
the laser system will automatically return to Standby mode.
There is a finger switch OVERRIDE setting that can be used by advanced users who do not want to hold the finger switch down throughout the
entire treatment. More information on finger switch settings can be found in Setup.
Warning: The Override setting for the finger switch should be used by experienced operators only
When in Ready, the Emission Indicator Ring (Figure 19) will illuminate yellow. During emission, the Emission Indicator Ring 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 or yellow condition (Figure 20). During laser system shutdown, the Emission
Indicator Ring will flash red.
Distal End
Finger Switch
Figure 17
Figure 16
Figure 15
LED Emission
Indicator Ring

RSR-000715-000 (2) User Manual – CTS-DUO Page 8 of 26
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.
3.6. Quick Disconnect Treatment Heads
Prior to initiating any treatment, the shipping dust cap must be removed. To remove the dust cap or any treatment head attachment, hold the
base of the hand piece with one hand and grasp the attachment with the other. Rotate the attachment counterclockwise approximately 1cm to
unlock the attachment. Then, pull straight down to disengage and keep pulling to fully disconnect the attachment (Figure 21).
To attach a treatment head attachment, locate the metal insert on the inside of the attachment. Line up the slot within the metal insert with the
bearing on the mating end of the hand piece (Figure 22). The hand piece and attachments 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 23)
Warning: DO NOT operate the laser system with an improperly attached treatment head. This can cause serious injury.
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.
3.7. Treatment Head Attachments
The following table lists the treatment heads included with the laser system and provides a description of when to use each.
Figure 22
Unlocked Disengaged
Fully engaged,
locked
Fully
disconnected
Line Up &
Insert
Rotate to
“Click”
Ready to
Treat
Figure 21
Figure 23
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 5.2.2 for more details.
Figure 20

RSR-000715-000 (2) User Manual – CTS-DUO Page 9 of 26
Treatment Head Name and Description
Small Non-Contact Treatment Head (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. Indications for use of the small cone are very small
wounds in tight spaces or near sensitive areas (such as the mouth). The area to be treated and a
significant surrounding margin should be covered evenly in a “painting” or “serpentine” motion. The
Small Cone is recommended for use only at power settings of 3W or below for optimal
patient comfort and should NOT be held in place without movement during treatment,
however it can be used at power settings up to 6W safely if proper technique is used. The
small cone lens should NOT be allowed to come in direct contact with the hair coat and
should be held 1-2 inches from the skin of the patient.
Small Contact Deep Tissue Applicator (Small Ball)
This treatment head is for use in applications where contact and soft tissue manipulation during
treatment are desired. Indications for use of the small ball are muscular or tissue injuries in tight
spaces or near sensitive areas. The small ball is not recommended for use over open wounds, non-
intact skin or areas that would be sensitive to contact. This head should be held 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 is recommended
for use only at power settings of 3W or below for optimal patient comfort, however it can be
used at power settings up to 6W safely if proper technique is used.
Large Contact Deep Tissue Applicator (Large Ball)
This treatment head is for use in applications where contact and soft tissue manipulation during
treatment are desired. Indications for use of the large ball are muscular or deep soft tissue injuries,
arthritis, edema/swelling and other deep tissue conditions. The large ball is not recommended for
use over open wounds, non-intact skin, or areas that would be sensitive to contact. This head
should be held 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 18W.
Large Non-Contact Treatment Head (Large Cone)
This treatment head is for general use and applications where no contact or soft tissue manipulation
during treatment is desired. Indications for use of the large cone are wounds, otitis externa,
pyotraumatic dermatitis, postsurgical incisions and other superficial tissue conditions. It may also be
used in place of either of the contact treatment heads for therapy over areas that are hypersensitive
to direct contact, such as over bony prominences or in patients with thin skin or hyperesthesia. The
Large Cone Head can be used at power settings up to 23.5W, 1-2 inches from the skin of the
patient.
Note: DO NOT comb the scalloped edges through hair/fur of patient.
XL Contact Deep Tissue Applicator (XL Ball)
This treatment head is for use in applications where contact and soft tissue manipulation during
treatment are desired and treatment power exceeds 15W. Indications for use of the extra-large deep
tissue applicator are muscular or deep soft tissue injuries, edema/swelling and other deep tissue
conditions requiring more than 15W of power. The extra-large deep tissue applicator is not
recommended for use over open wounds, non-intact skin, or areas that would be sensitive to contact.
This head should be held 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.
3.7.1.Treatment Head Parameters
Beam divergence and the Nominal Ocular Hazard Distance (NOHD) for each of the treatment heads are listed in the following 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.
Treatment Head
Beam Divergence
Full Angle
Radians Degrees
NOHD (m) NOHD (ft’ inches”)
Small Cone 0.8148 47 0.4 1’ 4”
Small Ball 0.2258 13 1.1 3’ 8”
Large Cone 0.8148 47 0.4 1’ 4”
Large Ball 0.0566 3 5.4 17' 9"
XL Contact 0.1860 10.7 1.5 4’11”

RSR-000715-000 (2) User Manual – CTS-DUO Page 10 of 26
4. Device Operation
4.1. Safety Precautions
Anyone in the Laser Treatment Controlled Area (LTCA) 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 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.
All personnel in the LTCA must wear laser safety eyewear.
Replace any protective laser eyewear with eyewear from the manufacturer if there is any damage or photo-bleaching resulting
from laser exposure.
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.
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.
If you suspect injury, such as direct exposure to the eyes, seek medical attention immediately.
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.
FAILURE TO COMPLY with the application techniques listed in the manual may lead to exposure to harmful levels of laser
radiation.
AVOID THE USE of flammable solvents, anesthetics, oxidizing gases such as nitrous oxide (N
2
O) and oxygen. The high
temperatures produced during normal use of the laser system may ignite some materials, such as cotton or wool, when
saturated with oxygen.
DO NOT use treatment head until the alcohol solution used for cleaning 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 (LTCA). Post the included
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 that laser emission stops when the treatment room door is opened.
4.2. Treatment Information
The proper use of the laser system requires appropriate laser safety practices and knowledge of laser/tissue interaction. In addition, an
understanding of laser wavelength, frequency, target tissue, and anatomy are essential.
4.3. Stored Protocols
Preset protocol will begin with CW (Continuous Wave) and may cycle through multiple frequencies.
Depth of penetration is determined by spot size, tissue type being treated, wattage, and wavelength.
An understanding of veterinary anatomy and laser tissue interaction is imperative for safe, optimal treatments.
Once complete, the operator may reactivate the laser and repeat a protocol by pressing the finger switch.
4.4. Patient Preparation
Warning:
Use carefully. May cause serious burns. Do not use over sensitive skin area or in the presence of poor circulation.
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.
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.
Note: The NOHD for the entire Laser System is determined by the treatment head with the longest NOHD.
Recommendation: DO NOT allow any nonessential personnel into the LTCA during any laser procedure.
Recommendation: Proper diagnosis and treatment plans are to be completed by or under the direct supervision of a licensed
p
rofessional.

RSR-000715-000 (2) User Manual – CTS-DUO Page 11 of 26
The following guidelines should be used when preparing patients for laser therapy treatments:
The area to be treated must be exposed (do not treat through bandage material).
The treatment area should be clean and free of surface dirt or oils. Any topical sprays, ointments, or lotions should be shampooed and
rinsed off completely prior to treatment.
If cleaning treatment head prior to administering laser therapy to patient, make sure to use only isopropyl alcohol of 70% alcohol or
less. Ensure all alcohol is completely evaporated and treatment head completely dry prior to use on patient (see Section 7.1).
Warning: Ensure alcohol on the instrument has fully evaporated/dried before activating the laser.
Examine treatment head surface (ball surface, cone lens) to ensure it is free of cracks, burn marks, blemishes, or residue prior to use.
Thermal effects vary with hair coat and pigmentation – darker pigments absorb more. If patient appears uncomfortable and/or haircoat
feels excessively warm, increase distance and/ or move the handpiece more rapidly, and/or reduce power.
4.5. Treatment Considerations
Treatments can be done in conjunction with stretching or gentle range-of-motion exercises.
Monitor for superficial thermal discomfort.
Keep beam perpendicular to skin surface at all times.
Treat muscles connecting to a painful joint in addition to tendon attachments.
For edema/swelling, treat area from proximal to distal to facilitate lymphatic drainage.
Treat biomechanically connected muscles and joints in the kinematics chain.
Post-operative or acute injuries use shorter times and/or lower power.
4.6. Contact Technique
Treatments can be done on contact or at a slight distance from the skin.
Monitor for superficial thermal discomfort.
Continuously move probe in grid pattern (Figure 23).
Treat 1-2 inches, or 3-5 cm, of surrounding healthy
tissue.
4.7. Laser Treatment Procedure
This section contains information about the protocols and settings on this device. The following treatment
recommendations are provided for guidance only. The practitioner is the person who determines the settings and
protocol to use when treating each individual patient.
4.8. Skin Color and Other Pigment Considerations
This laser system will deliver a dual wavelength of 810 nm and 980 nm light which has been found to provide therapeutic relief of pain. This laser
system allows the operator to choose skin color for the patient. Since darker skin will absorb 810 nm light more than lighter skin, the software in
the device will adjust the output so that it contains 100% 980 nm when the dark skin, or dark hair coat, setting is selected. Another circumstance
when it may be appropriate to use this setting, include areas of mixed pigmentation, such as areas with a both dark and light-colored skin patches.
4.9. Dose
The laser energy dose delivered during a treatment is measured in joules. This number is recorded on the screen during a treatment and is
calculated by multiplying the power (in watts) by treatment time (in seconds). Laser treatment should be applied to an area using a scanning
application.
General guidelines are for the total dose to an area to be 4-15 J/cm
2
(actual dose will depend on area, condition, body type). The software in this
laser system is programmed to deliver a dose appropriate for the treatment area and conditions input by the operator. It is recommended that
treatment information (protocol and input setting or power, energy delivered, treatment time, treatment area) be recorded for each treatment.
In general, doses are delivered to the area of pain, the surrounding tissues, and along the nerve pathway for the specific area
experiencing the pain.
Treat muscles connecting to a painful joint in addition to tendon attachments.
Recommendation: For patients with excessively long or thick haircoats, user may part the hair while treating with your hands or clip/shave
the fur.
Figure 23
Recommendation: For patients with mixed pigmentation, select the characteristic setting for darker pigmentation.

RSR-000715-000 (2) User Manual – CTS-DUO Page 12 of 26
4.10. Treatment Technique
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, metal collars, and jewelry)
prior to treatment with this device. Indirect or direct eye contact with scattered laser light from any reflective surface from the
laser can cause serious, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes.
Use carefully. May cause serious burns. Do not use over sensitive skin area or in the presence of poor circulation.
During treatment, it is important to observe feedback from the patient concerning their comfort level. The laser provides a soothing
warmth. Be cautious in cases where the patient has limited sensation or is not able to respond to increases in temperature and consider
treating at a lower power setting. If the patient expresses any discomfort; the power output should be reduced.
Treatment should be delivered to exposed skin. Do not treat through fabric or bandages.
The treatment area should be clean and free of surface dirt or oils.
Treatments can be performed on or off contact.
For optimal delivery of the dose, keep the treatment head perpendicular to the skin.
Continuously move the treatment head at a rate of approximately 3-10 cm/sec (1-3 in/sec).
To ensure an even distribution of the dose to the treatment area, continuously move the treatment head over the area first moving
continuously back-and-forth horizontally, and then moving back-and-forth vertically in a grid pattern. Make sure to cover the entire area
to be treated in a painting motion.
For application to joints, it is recommended that 25 to 50% of the dose be applied while gently moving the joint through its range of
motion.
4.11. Error Messages
4.11.1. Operation Errors
The laser system will display error messages to caution the operator to fault conditions. If any of the following errors occur, the laser system will
remain in Standby mode, or return to Standby mode, produce an audible warning and display the related message describing the fault condition.
The following are examples of these fault conditions:
Optical fiber is not properly inserted,
Remote interlock is not properly installed,
Finger/foot switch is depressed.
To proceed, correct the error and press the exit button.
4.11.2. System Errors
The 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 limit that would result in 20% greater power output than selected, the laser will produce an error
message and audible alert, stop emission and return the laser to Standby mode.
The laser system will not enter or remain in Emission if the laser system is not within the operating temperature range. If temperatures exceed
safety limits:
There will be an audible warning.
There will be an error message: Laser temperature is out of range.
Press the exit button to return to Standby mode.
Make sure that the ambient temperature of the laser system is within the operating temperature range of the device, which is 5°C to 40°C (41°F
to 104°F).
Note: When the laser pulse rate is CW, the real laser output power is the same as the power setting on the display within operating tolerances.
Note: When the laser pulse rate is not CW (e.g. 10 Hz), the average output power is 50% of the power setting on the display, within operating
tolerances.

RSR-000715-000 (2) User Manual – CTS-DUO Page 13 of 26
5. Power On
After pressing the power button on the front of the console, there will be an audible beep and after initializing, the software displays the (Figure
24).
During initialization, the Emission Indicator Ring around the finger switch will flash blue three times (3x) to indicate successful connection to the
Empower IQ™ Delivery System.
5.1. Main Menu
After entering the default password and pressing “enter,” the user is taken to the Main Menu, which can be accessed in other screens by
pressing the home icon in the upper left corner. User may also access the system using new Operator IDs created in Setup.
5.2. Setup
In Setup, the software allows the operator to change the aiming beam, unit volume, operation mode (finger/foot switch settings) and
override settings. The user can also customize the language, measurement units, date/time/time zone to localize the device.
5.2.1.System Setup
Aiming Beam – small pilot beam that provides the operator with a visual indication (red light) of the
location of treatment beam. The aiming beam can be set to Steady or Pulsed.
Unit Volume – sets the sound that will occur during laser emission. The unit volume can be set to Low, Medium, or
High with the option of a steady Tone or a Beep.
Operation Mode – sets how the operator controls the ON/OFF of laser emission. The operation mode can be set to
Foot Pedal or Finger Switch.
Operator ID – allows user to create, edit or delete custom Operator IDs.
5.2.2.Handpiece Setup
Override - The Override can be used by advanced users who do not want to hold down the finger switch throughout
the entire treatment. If the finger switch OVERRIDE setting is ON, pressing the finger switch for the first time will turn
the laser emission on and laser emission will continue to emit until the finger switch is depressed a second time (or until
the time remaining for laser emission counts down to zero).
Visual and Vibration Feedback –The Empower IQ has LED’s that illuminate and the handle will vibrate to guide proper
dosing technique. If Visual Feedback is turned Off, then the LED will remain white during emission. If Vibration
Feedback is turned Off, then the hand piece will not vibrate when proper dosing technique is not followed. When both
are turned On, the Empower IQ will behave as described in Section 3.5.
Figure 24
Note: If a small treatment head is attached to an Empower IQ and the treatment power setting is above 6W, then the LED will illuminate Red
re
g
ardless of the Visual Feedback settin
g
. If Vibration Feedback is Off, thou
g
h, the Empower IQ will not vibrate in this, or an
y
, condition.
Note: If the indicator does not flash, then the delivery system will need to be reconnected to the laser through Setup – see Section 5.2.2
for details.
Note: Operator ID Numbers 9000-9999 are reserved for existing or future administrative features and may not be selected by Users as
Operator ID Numbers.

RSR-000715-000 (2) User Manual – CTS-DUO Page 14 of 26
Set EIQ- If the Empower IQ is not illuminating or a new Empower IQ needs to be connected to the laser, then perform
the following steps:
Step 1. Proceed to the Setup screen and press the “Set EIQ ID” button on the right side of the screen.
Step 2. On the following screen, enter the Empower IQ ID from the distal end of the hand piece and press Enter.
5.2.3.Localization Setup
Language – Allows user to select from English, Chinese, French, German, Japanese, Portuguese or Spanish.
Measurement – Allows user to between Imperial or Metric
systems of measurement.
Set Date/Time – Allows user to customize the date and time settings.
5.3.Protocol Selection
After selecting Protocols on the Main Menu screen, the Select Species screen will prompt the user to select the species of the
patient.
Next, the Patient Characteristics screen will prompt the user to enter patient characteristics that can affect the absorption or
penetration of the light to the target tissue, including weight, body type, coat length, coat color, and skin color.
After the selection of patient characteristics, the user will be prompted to select the condition to treat.
Based on the condition selected, the user will be prompted to either:
1) Select the Area by Size,
2) Select Area(s) by Anatomy, or
3) The user will be taken directly to (Operation screen) Standby mode
The software will determine the appropriate treatment power, treatment time and pulse frequency for the patient characteristics, selected area,
and condition. Press Next or to proceed to Standby mode with the settings determined by the software. The selected parameters will
appear on the right side of the screen.
5.4. Operation Screen (Protocols)
When using the preset protocols, the only parameter the user can modify is the Power Setting.
Each species/condition (protocol) selection also has recommended treatment heads programmed in that will be displayed underneath the power
dial when the user reaches the operation screen. The colored rings around the treatment head icons indicate the appropriate treatment head(s)
for the selected protocol and power setting. The following table summarizes the recommendation icons and their meanings:
Meaning
Extra Large
Contact Large Ball Large Cone Small Ball Small Cone
Recommended
(Green)
Exhibit caution
(Yellow)
These attachments will
only appear Red or Green
based on the protocol and
power selection.
Not Recommended
(Red)
Note: Only certain conditions will require selection of anatomic location – Arthritis, Pain/Trauma, and Edema/Swelling.
Note: If a treatment head is attached to the Empower IQ, it must be removed to reveal the ID. The ID will be alphanumeric and a maximum
of 4 digits.

RSR-000715-000 (2) User Manual – CTS-DUO Page 15 of 26
During a multiple area treatment, after the treatment for one area commences, a pop-up screen will appear to prompt the user to move to the next
area and resume treatment. If the area being treated, has the option of treating bilaterally, the user will be prompted once all of the one-sided
treatments are complete.
The protocols are based on a series of Continuous Wave (CW) or Pulsed Rate combinations. The “Time” section on the left side of
the screen will display the time for the specific Pulsed Rate combination. The total time remaining will be displayed at the bottom of the
screen.
By selecting Max TX, which turns the Max TX button red (Figure 25), all of the Pulsed Rate (if any) settings will be converted to
Continuous Wave (CW). This will result in reduced treatment time.
5.5. Operation Mode
Pressing Operation on the Main Menu will take the user to the Operation Screen and put the system in Standby Mode.
In Standby mode, the software allows the operator to change the treatment time, power, pulse frequency, and to reset the energy
counter (Figure 26).
5.6. Operation Screen – Ready
In Ready mode, the laser will emit when the finger/foot switch is activated. The purpose of Ready mode is to wait for the user to press the
finger/foot switch to start laser emission. The software has a 6 second delay (6 beeps) to warn the user of the transition from Standby to Ready
mode.
Also, the Empower IQ™ Emission Indicator Ring will flash yellow during the transition from Standby to Ready. While in Ready, the light will
remain yellow to indicate the laser state at the hand piece.
Warning: NEVER leave this device unattended in Ready mode.
To start laser emission, press the finger switch. To stop emission, remove finger from the finger switch or press finger switch again.
5.7. Operation Screen – Emission
During Emission (Figure 27), the word “EMISSION!” blinks on the screen and the software does not allow the user to change any settings or exit
the Operation screen. In addition, the laser system produces beeps or a steady audible tone, according to the audio settings chosen in Setup.
5.8. Operation Screen – Perfect Protocol™
In Operation mode, the Perfect Protocol button allows the operator to generate custom protocols (Figure 28). The Perfect Protocol Calculator
allows the operator to enter target treatment information (treatment area, treatment power, and target energy density) and the patient’s coat color
and skin color, and then calculates the appropriate treatment time and wavelength blend.
Note: If the unit is set up with finger switch override on, each time the finger switch is pressed, it will act as an on/off switch.
Figure 27
Figure 25
Figure 26

RSR-000715-000 (2) User Manual – CTS-DUO Page 16 of 26
The treatment area (in cm
2
) should be entered in whole numbers.
The treatment power can range from 1.0 W to 15 W in increments of 0.5 W.
The energy density (in J/cm
2
) should be entered in whole numbers.
After pressing calculate or =,the software proceeds to Standby mode with the selected settings.
6. Resources
The laser system contains a library of resources that are available for educational purposes. Press Resources on the Main
Screen to access the Resources menu.
Press User Manual for instructions on how to view User Manual.
Press 3D Anatomy for high-resolution anatomical diagrams of the selected anatomy consisting of bone, muscle, and
nerves for canine, equine, or feline species.
Press Video for user training and patient education videos.
7. Patient Tracker
Pressing Patient Tracker on the Main Menu will take the user to the Patient Tracker Menu. This menu gives the user access
to the following options:
Add a New Patient
Search for Existing Patient
oEdit or Print Patient Information
A folder named Patient Tracker Reports will be created on the USB drive and a PDF file containing the patient
information and characteristics will be added.
oView/Edit Patient Characteristics
oDelete Patient
oStart a New Treatment
oView, Print, or Repeat Treatment
Reports
Delete, Backup or Restore Database
Patient Tracker Settings
oSave All Treatments, Track Operator IDs Settings
8. Maintenance
Warning: DO NOT attempt to gain access to any internal component. Doing so may cause serious and/or irreversible injury. THERE
ARE NO USER-SERVICEABLE COMPONENTS inside this laser device.
8.1. Cleaning
Warning:
Always turn off the laser system and unplug the power cord from the wall outlet before cleaning.
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
DO NOT use treatment head until alcohol solution used in cleaning procedure completely evaporates. Doing so may cause the
laser to ignite alcohol solutions or vapors.
Note: Once assigned, a PIN cannot be changed and may only be permanently deleted. Deleting an Operator ID will delete all treatments
associated with that PIN.
Figure 28
Note: Once an Operator ID Number has been assigned, this new PIN (or the default “Guest” PIN “1234”) may also be used to login to the
laser at startup.
Note: The only way to save a treatment to Patient Tracker is by initializing the treatment by starting a new treatment through Add New
Patient OR by starting a new treatment or repeating a previous treatment from Search for Existing Patient.

RSR-000715-000 (2) User Manual – CTS-DUO Page 17 of 26
Caution: DO NOT clean the lens inside the hand piece. Doing so may damage the lens during laser emission.
8.1.1.Cleaning the Console
Step 1. Before cleaning the console, turn off the laser system and unplug the power cord from the wall outlet.
Step 2. The exterior surfaces on the unit and treatment heads can be cleaned by wiping with a soft, non-fibrous wipe (e.g., Kimwipes
®
)
moistened with isopropyl alcohol solution.
Ensure the solution is only 70% alcohol. Solutions of more than 70% alcohol can cause product damage.
Avoid using soiled or gritty cloths.
Step 3. After cleaning, ensure that all cleansers have been removed and the parts are dry before use.
8.1.2.Large Deep Tissue Applicator Cleaning
Step 1. Remove the elastic band from the large deep tissue applicator treatment head (Figure 29).
Step 2. Unscrew the top portion of the large deep tissue applicator treatment head (Figure 30).
Caution: Dropping the ball may damage the ball.
Step 3. The ball can now be removed for cleaning. Use a soft, non-fibrous wipe (e.g., Kimwipes
®
) moistened with 70
% isopropyl alcohol solution. Do not wipe with a dry cloth. Always dampen the cloth before wiping.
Step 4. Ensure that all cleansers have evaporated and the parts are dry before re-assembly and use.
Step 5. Reassemble treatment head by replacing the spacer ring, massage ball and screwing the top
portion securely on the treatment head.
8.1.3. XL Deep Tissue Applicator Cleaning
Step 1. Remove the elastic band from the XL deep tissue applicator treatment head.
Step 2. Unscrew the top portion of the extra-large deep tissue applicator treatment head.
Caution: Dropping the hemisphere may damage it.
Step 3. The hemisphere can now be removed for cleaning. Use a soft, non-fibrous wipe (e.g., Kimwipes
®
) moistened with 70 %
isopropyl alcohol solution. Do not wipe with a dry cloth. Always dampen the cloth before wiping.
Step 4. Ensure that all cleansers have evaporated and the parts are dry before re-assembly and use.
Step 5. Reassemble treatment head by replacing the hemisphere and screwing the top portion securely on the treatment head.
8.2. Before You Call—Troubleshooting
If you are having a problem with your laser system, please check the list below of common conditions that can occur that you may be able to
resolve without having to contact Customer Care.
8.2.1.If the laser system will not turn on:
Make sure that the power cord is correctly attached and plugged into a functioning power outlet or that the battery is sufficiently charged.
Make sure that the remote interlock on the bottom of the laser system is properly inserted and wire loop is not damaged.
Figure 29
Figure 30
Note: Do not discard the spacer ring (Figure 31). If the ring is upside-down or removed, the ball
will rotate. It is recommended for the ball not to move for veterinary applications.
Spacer ring
Figure 31
Recommendation: Be careful when unscrewing the top portion of the treatment head. It is
recommended that this be done over a table to reduce the chance of dropping the ball directly on
the floor.
Recommendation: Clean the contact treatment heads (large and small deep tissue applicators) between each treatment.
Note: The laser system uses solid-state laser technology. It is important to keep the unit and accessories free from dust.
Recommendation: Be careful when unscrewing the top portion of the treatment head. It is recommended that this be done over a table
or close to a soft surface to reduce the chance of dropping the ball directly on the floor.

RSR-000715-000 (2) User Manual – CTS-DUO Page 18 of 26
8.2.2.If there are scratches on the massage ball:
There may be minor scratches on the massage ball resulting from normal use. These will not affect the efficacy of the laser treatment. Figure 32
shows a massage ball treatment head with a ball that has some minor scratches. If the scratches on the massage ball become significant, then
the massage ball treatment head should be replaced (see Figure 33).
To minimize scratches, make sure that you use a soft, non-fibrous wipe (e.g., Kimwipes
®
) moistened with 70% isopropyl alcohol solution when
cleaning the massage ball between patients. Do not wipe with a dry cloth: always dampen the cloth before wiping.
8.3. Calibration Check Procedure
Regulatory agencies require that manufacturers of US FDA CDRH Class IIIb and IV laser products supply their customers with instructions for
verifying the measurement system within the laser meets the requirements of 21 CFR1040.11. The instructions below provide steps for performing
a calibration “check” that may be performed with certified, NIST traceable equipment.
This procedure is recommended to be performed once a year but is not required unless there is evidence of significant damage or diminished
output.
If during the execution of this procedure, the stated requirements are not met, then factory maintenance and re-calibration may need to be
performed on the device. Factory calibration must be performed by certified Service Personnel.
Caution: Adjustment to any internal components by anyone other than certified Service Personnel voids any existing manufacturer’s
warranty on the Laser System.
Warning: ALWAYS wear laser safety goggles when performing the laser calibration check procedure and follow all laser safety
guidelines.
Warning: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous
radiation exposure. Avoid eye or skin exposure to direct or scattered radiation when open.
8.4. Laser Power Calibration Check Instructions:
Equipment Needed: Certified traceable power meter and detector with appropriate wavelength and power measurement capabilities
Step 1. Turn off the laser.
Step 2. Inspect and attach optical fiber. Make sure the optical fiber is clean and free of any dust, fluid or other contaminants.
Step 3. Turn on the laser system and enter Standby mode.
Step 4. Increase the power setting until it reaches the maximum wattage setting.
Step 5. Place the laser in Ready mode.
Step 6. Using the aiming beam, direct the distal end of the fiber into the active area of the power detector. Keep the fiber tip 2-3 cm
away from the surface of the active area of the power detector.
Step 7. Activate the laser and record the value in watts from the power meter display. The laser power reading should be within ± 20%
of the power setting.
a. If the results are outside the 20% range, ensure that: all of the light from the fiber is entering the detector, the fiber
is connected correctly, and the fiber is not damaged. Replace with a new fiber if necessary and repeat.
b. If the results are still outside the 20% range, discontinue this procedure and contact Customer Care for assistance.
9. Quality and Regulatory
9.1. Laser Product Regulations
The Companion
®
laser system complies with 21 CFR Chapter 1, Subchapter J, as administered by the Center for Devices and Radiological Health
(CDRH) of the US Food and Drug Administration (FDA).
9.2. Device Classification
According to the applicable standards, the laser system is classified as follows:
Class I Type B device per EN/IEC 60601-1
Class 4 laser product according to IEC 60825-1
In order to safely perform its intended use, the system requires the following Class I accessories:
Empower IQ™ Delivery System
Laser Safety Eyewear
Figure 33
Figure 32

RSR-000715-000 (2) User Manual – CTS-DUO Page 19 of 26
9.3. Declaration of Conformity (EU)
PRODUCT IDENTIFICATION
Product name Model/number Description
Companion
®
CTS-DUO LTS-2501-C-S8 Therapeutic laser system for animal use only
MANUFACTURER
Name of company Address Representative
LiteCure
®
,LLC 101 Lukens Dr, Suite A
New Castle, DE 19720
USA
Quality & Regulatory Manager
LiteCure, LLC (the parent company of Companion
®
) declares under sole responsibility as the regulatory
representative and legal manufacturer that the above-mentioned product is delivered in conformity with the
following Council Directives as transposed in the national laws of the Member States through determination of
compliance with the following standards:
CONFORMITY ASSESSMENT
Legislation applied Standards applied
Low Voltage Directive (2014/35/EU)
Electromagnetic Compatibility Directive (2014/30/EU)
Safety: IEC 60601-1:2005+A1:2012
EMC: IEC 60601-1-2:2015
Usability: IEC 60601-1-6:2010+A1:2013
Laser: IEC 60601-2-22:2007+A1:2013
Laser: IEC 60825-1:2014
10. Specifications and Environmental Conditions
10.1. Device Specifications
Model Name Companion
®
CTS-DUO
Model Number LTS-2501-C-S8
Device Classifications
Electrical Equipment Class I Type B device per EN/IEC 60601-1
Laser Product Class 4 laser product per IEC 60825-1
User Interface
Touch Screen Display 10” HD Display with Touch Screen
Emission Indicator Audible Signal (50 to 75 dB), LED (front display)
Mechanical Specifications
Dimensions 43 cm (L) x 26 cm (W) x 28 cm (H) │17 in x 10 in x 11 in
Weight 8.6 kg │19.6 lb
Environmental Specifications
Operation temperature 10°C to 35°C
Storage temperature -20°C to 70°C
Humidity ≤80% RH Non-Condensing
Pressure 70-106 kPa
Cooling Thermal Electrically Cooled with Forced Air
Optical Specifications
PBMT
Treatment Wavelengths 980 nm ± 20 nm & 810 nm ± 20 nm
Skin/Coat Color Adjustments Light (I, II) or Medium (III, IV) Dark (V, VI)
Maximum Output Power 25 W 25 W
Wavelength Ratio 80% of 980 nm + 20% of 810 nm 100% 980 nm
PTT
Photothermal Therapy (PTT)
Output & Wavelength Up to 12 W of 810 nm only
Aiming Beam Output Red Diode Laser, <4.0 mW
Aiming Beam Wavelength 650 nm ± 20 nm
Operating Modes CW or Pulsed
Pulse Frequency 2, 10, 20, 100, 200, 500, 1000, 2500, 5000, 10000 Hz
Pulse Duration 50% duty cycle at any given pulse frequency setting
Laser Safety Goggles OD5+ 808nm & 980nm
Electrical Specifications
Input Voltage 100-240 VAC; 50/60 Hz
Input Current ≤400 VA
Beam Delivery Assembly (BDA) Specifications
BDA Model Empower
™
IQ Delivery System
Handpiece Assembly (-S8) Smart hand piece (SHP) with 800μm fiber core
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