VCA sound SMART RLT Sport User manual

UM0000001 Rev_0 (2019/11/25) Page 1of 36 Copyright 2019 Sound Technologies
5810 Van Allen Way, Carlsbad CA 92008
800.268.5354 | soundvet.com
USER MANUAL
Regenerative Laser Therapy
SMART RLT Sport is a BWF-5 Series laser manufactured by B&W TEK, Inc. for Sound
Technologies, Inc.

UM0000001 Rev_0 (2019/11/25) Page 2of 36 Copyright 2019 Sound Technologies
5810 Van Allen Way, Carlsbad CA 92008
800.268.5354 | soundvet.com
Sound Technologies, Inc
5810 Van Allen Way, Carlsbad, CA 92008
Contact/Technical Support: 800-268-5354
http://www.Soundvet.com
Email: [email protected]
B&W TEK, Inc.
18 Shea Way, Suite 103, Newark, DE 19713
Tel: [phone]
http://www.bwtekmed.com

UM0000001 Rev_0 (2019/11/25) Page 3of 36 Copyright 2019 Sound
Technologies
5810 Van Allen Way, Carlsbad CA 92008
800.268.5354 | soundvet.com
WARNING!
This laser device is sold solely for VETERINARY purposes only! Under NO circumstances should
this laser system be used as a medical device for use on Humans or companion animals!
CONTENTS
1CONVENTIONS USED................................................................................................ 4
2PRECAUTIONS........................................................................................................... 4
3WARNINGS!................................................................................................................ 5
4RECOMMENDATION.................................................................................................. 6
5INTRODUCTION.......................................................................................................... 6
5.1 Device Description................................................................................................. 6
5.2 Protective Eyewear................................................................................................ 7
5.3 Environmental Safety............................................................................................. 7
6SAFETY....................................................................................................................... 7
6.1 Guidelines............................................................................................................ 10
6.2 Laser Safety Supervision ..................................................................................... 11
6.3 Laser Safety......................................................................................................... 11
6.4 Labels and Symbols............................................................................................. 11
6.5 Safety Devices..................................................................................................... 14
6.6 Laser Eye Protection............................................................................................ 16
6.7 Electrical Safety ................................................................................................... 17
6.8 Electromagnetic Compatibility.............................................................................. 17
6.9 Sources for Additional Information and Assistance on Laser Safety.................... 20
7SYSTEM SET-UP...................................................................................................... 21
7.1 Receipt and Unpacking........................................................................................ 21
7.2 Setup.................................................................................................................... 21
8OPERATION.............................................................................................................. 22
8.1 Main Menu Display............................................................................................... 22
8.2 Search for Patient ................................................................................................ 22
8.3 Creating a Patient ................................................................................................ 23
8.4 Treatment Calendar............................................................................................. 24
8.5 Patient Reporting ................................................................................................. 25
8.6 Treatment............................................................................................................. 26
8.6.1 Treatment Planning.....................................................................................................26
8.6.2 Treatment Icons ...........................................................................................................27
8.6.3 Performing Treatment .................................................................................................30
8.7 Operator Management......................................................................................... 32
8.8 User Maintenance................................................................................................ 33
8.8.1 User Spare Parts List.....................................................................................................35
9SPECIFICATIONS..................................................................................................... 36

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5810 Van Allen Way, Carlsbad CA 92008
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1CONVENTIONS USED
Various precautions, warnings, recommendations and notes are presented throughout this document.
Explanations of the categories are as follows:
CAUTION! A PRECAUTION describes measures that if properly followed beforehand, will prevent
harm.
WARNING! A WARNING calls the reader’s attention to specific danger in advance. If ignored or
compromised, the situation could result in serious, irreversible personal injury or product damage.
RECOMMENDATION: A RECOMMENDATION offers guidance that may be worthy of
acceptance or trial within a specific area of SMART RLT Sport’s application and may serve to
optimize overall SMART RLT Sport utilization.
NOTE: A NOTE describes the conditions or exceptions that may apply to the subject matter
presented.
2PRECAUTIONS
•Never allow untrained personnel to operate this device unless directly supervised by a properly
trained and experienced individual.
•The protective eyewear supplied with this device has an optical density rating >5 in the 1064
nm region. All personnel present during device operation must wear this eyewear. Contact
Sound Technologies, Inc. at 800-268-5354 Option 1 to purchase additional sets of protective
eyewear for this device.
•Select a secure, properly equipped, and well-ventilated location in which to install and operate
the laser.
•Place “Laser Safety Warning”signs at location entrances where people will use the SMART
RLT Sportlaser device.
•Always put the laser in Standby mode or switch the device off prior to adjusting or preparing
the hand piece or fiber optic.
•Never leave this device in the READY mode unattended. See the STANDBY to READY
Mode in the Operations section of this manual.
•Log off the laser when not in use to prevent unauthorized and/or unqualified use of the device
as well as inadvertent laser emissions.

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5810 Van Allen Way, Carlsbad CA 92008
800.268.5354 | soundvet.com
•Turn the device off before relocating equipment in the same vicinity.
•Never press the hand-switch without first verifying the safe orientation and proper positioning
of the hand piece and distal end of the optical fiber and ensuring compliance to all safety
precautions.
•During any laser procedure, do not allow any nonessential personnel into the treatment area.
3WARNINGS!
•This laser device is sold solely for VETERINARY purposes only! More specifically for
equine species! Under NO circumstances should this laser system be used as a medical device
for Human use or companion and other animals!
•This laser device produces 1064 nanometer near infrared laser energy that is invisible and can
be an extreme hazard to the eyes of any living being. Irreparable corneal and/or retinal
damage may occur if a person exposes one or both eyes to direct or indirect (reflected) laser
energy.
•IMPROPER USE OF SYSTEM CONTROLS or performance of procedures other than those
specified in this manual may result in hazardous radiation exposure.
•FAILURE TO COMPLY with all safety instructions and warnings may expose all participants
to harmful levels of laser radiation and/or dangerous levels of electrical current.
•NEVER direct the laser beam at anything other than the area to be treated.
•NEVER allow the eyes of any living being to look directly into the distal end of the optical
fiber connected to an active laser device - WITH or WITHOUT wearing appropriate laser-
emission protective eyewear.
•DO NOT allow any reflective object to fall into or obstruct the path of the laser energy
produced by this device. Scattered or reflected laser energy can cause serious damage to eyes
and skin. The operator, all assistants, and the patient must remove all reflective objects (such
as rings, metal watchbands, and jewelry) prior to treatment with this device.
•NEVER open or operate the system if damaged or not operating properly.
•THERE ARE NO USER-SERVICEABLE COMPONENTS inside this laser device.
Therefore, do not attempt to gain access to any internal device component. Doing so may
cause serious and/or irreversible injury and void the warranty. For service, contact Sound
Technologies, Inc. at 800-268-5354 Option 3.

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5810 Van Allen Way, Carlsbad CA 92008
800.268.5354 | soundvet.com
•DO NOT remove protective eyewear until the operator returns the laser device to Standby
mode. To do this, the operator releases the hand -switch at completion of the treatment or
cancels treatment by pressing “Laser Ready” button and waiting until the operator visually
observes the laser device returning to Standby.
•AVOID THE USE of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O)
and oxygen. The high temperatures produced in normal use of the laser equipment may ignite
some material, for example cotton or wool, when saturated with oxygen. The solvents of
adhesives and flammable solutions used for cleaning and disinfecting should be allowed to
evaporate before the laser equipment is used. Attention should also be drawn to the danger of
ignition of endogenous gases.
If the laser fails to operate properly, contact Sound Technologies, Inc. at 800-268-5354 Option 3.
4RECOMMENDATION
Designate at least one person at each facility that utilizes this device as laser safety officer,
responsible for providing training on all laser operating and safety procedures.
5INTRODUCTION
The SMART RLT Sport system is classified as a class 4 laser device.
5.1 Device Description
The SMART RLT Sport system is designed for therapeutic treatment of the equine species, and more
specifically tissue regeneration. The laser reaches deep into the body through intact skin to stimulate
the body to achieve a highly beneficial result. The laser therapy increases circulation, reduces pain
and inflammation, and promotes cellular metabolism in tissue. The regenerative aspect stems from
photo-acoustic wave generation that modulates the extra-cellular matrix, releasing growth factors that
revitalize injured tissue. Operating at a wavelength of 1064nm in the near infrared portion of the
spectrum and delivered in short, energetic pulses, it has a vital combination of penetration and energy
conversion.
The system is housed in a rugged case to protect the laser hardware and the tablet is mounted on the
interior lid plate. There is a two meter fiber optic cable going to a hand piece with a button and a LED
indicator. The interior deck has the main emergency stop button and LED indicators reflecting power
and laser emission.
The laser source of this device is a sold-state laser system. It produces invisible laser energy at the
1064 nanometer (nm) wavelength. The delivery system consists of a flexible optical fiber threaded
through a lightweight hand piece. Activation occurs when the operator enables the laser and presses
the hand-switch. There is a visible red aiming beam (650 nm) that is used to visualize the laser on the

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5810 Van Allen Way, Carlsbad CA 92008
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treatment area. Release the finger -switch to deactivate the laser. Depending on laser system
configuration, the finger-switch can function as on/off switch. A convenient and easy-to-use touch-
screen design allows the operator to set and adjust laser output level with minimal effort. The laser
can operate at controlled pulse mode. The device features selection of treatment areas that when
selected bring up presets for treatment parameters which include: energy, Hertz (frequency), dose,
and calculate the time necessary to perform the treatment.
5.2 Protective Eyewear
All Individuals present during the operation of this device must wear protective eyewear with an
optical density of 5.0 or greater at 1064nm wavelength. Three (3) pairs are included with this device.
For additional pairs of protective eyewear, contact Sound Technologies, Inc. at 800-268-5354 Option
1.
5.3 Environmental Safety
The laser system must be stored, transported and operated in accordance with the environmental
conditions provided in this manual.
The laser device is air-cooled and designed for use in a well-ventilated area that maintains relative
humidity and temperature conditions conducive to conventional human productivity.
This laser device has specific requirements for environmental conditions for transportation, storage
and operation.
Temperature Humidity and Air Pressure
Condition
Temperature
Humidity
Air Pressure
Transportation
and storage
-5-45⁰C (23-113⁰F)
10-95% non-
condensing
700 hPA-1060-hPA
(10-.5 lb/in2, 0.7-1.0
atm)
Operation
10-32⁰C (50-90⁰F)
30-75% non-
condensing
700 hPA-1060-hPA
(10-.5 lb/in2, 0.7-1.0
atm)
6SAFETY
This section provides a collection of safety guidelines and safety-related statements relevant to the
safe and effective operation of the SMART RLT Sport system. Additional statement and protocols
regarding safety appear elsewhere in this document. Use this laser device according to all printed
guidelines, cautionary statements, and protocols.

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5810 Van Allen Way, Carlsbad CA 92008
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Laser Safety
Laser therapy is extremely safe when basic protocols are followed by the laser operator and support
staff. As with all therapeutic procedures, some element of risk is present through negligence or
accident. These hazards are easily prevented or reduced with safety protocols for each application.
Every clinic using a laser should have an individual trained in safe operation of laser therapy and
regularly use a safety checklist. This individual (often the doctor), is the Laser Safety Officer (LSO).
Eye Protection
Class 4 Therapy Lasers can emit both visible and invisible radiation. Protective eyewear is necessary
for both Class 3 and Class 4 lasers where irradiation of the eye is possible.
Required Users
• Administrator of the laser therapy treatment
• Patient (If treating near the head area of the horse, using a towel or blinkers to block any potential
laser exposure is recommended.)
• Any other individuals in the room or treatment area
Safety Goggles
Not all Safety Goggles are the same. The protective eyewear that came with your laser
is manufactured specifically for the wavelengths emitted by the laser. Do not use protective
eyewear from other manufacturers as they may not provide the appropriate level of protection.
Technical Specifications for proper usage include:
• Wavelength Specific
• Blocks 1064nm

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• Meets ANSI Safety Standards
Using Safety Goggle Correctly
Laser safety glasses are vital for eye protection in the presence of laser radiation. Since accidental
laser radiation exposure can cause irreversible damage to the human eye, protective measures must
not be taken lightly. Ensure that the eyewear has appropriate optical density for the wavelength of
operation. Remove all reflective objects (such as rings, metal watchbands, and jewelry) prior to
treatment with the laser. Indirect or direct eye contact with the laser beam or with scattered laser light
from any reflective surfaces will cause serious damage, irreparable corneal and/or retinal damage, and
possible blindness to one or both eyes. Do not allow any reflective object to fall into, or obstruct the
path of the laser beam. Always wear protective eyewear. Any person present during the laser
operation must wear protective eyewear.
Never look directly into the end of any laser hand piece.
Never direct the laser light directly into the eyes, or direct the laser beam at anything other than the
area to be treated with or without the correct Safety Goggles.
Do not remove the Safety Goggles until the administrator of the laser has turned off the laser or
notified the patient that it is safe to remove them.
Laser Safety Warning Signs
Lasers require the use of specific Warning Signs for the safe operations of each laser system. Warning
signs must be in view outside and inside the room or treatment area where the laser treatment is being
performed. Warning signs must meet ANSI recommendations.

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Laser Safety Checklist
Checklist for the Laser Operator and Laser Safety Officer
•Appropriate warning signs posted
•Access to laser and treatment area is secure and controlled
•Visually inspect and clean all optical connectors for dirt, debris, etc.
•Inspect laser for proper function
•Visually inspect and clean all Safety Goggles
•Safety Goggles available for all persons in Nominal Ocular Hazard Zone
•Extra Safety Goggles placed outside treatment room if necessary
•Sources of potential laser beam reflection and scatter controlled
•Treatment protocol established for patient
•Laser injury management protocol in place for accidental injury
•Document laser treatment and post-treatment outcome
Contraindications
•Do not apply over an implanted device, i.e. a pacemaker. (pet microchip OK)
•Do not apply over the thyroid gland, ovaries or testicles.
•Do not treat over any cancer/malignancy.
•Do not treat over an actively hemorrhaging area.
Safety
•Familiarity with safety shutoff devices on laser
•Eye protection, specifically supplied goggles
•Patient- goggles and/or eye shields
•Attending therapists within the treatment room
•Others such as pet owners, etc. within the treatment room
•Post the “Laser Safety Warning” sign(s) in appropriate location(s)
•Consideration of therapy in a safe laser environment
6.1 Guidelines
Sound Technologies, Inc. user information is in compliance with EN / IEC 60825-1:2014 and FDA
Laser Notice No. 56.

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6.2 Laser Safety Supervision
Designate at least one person at each facility that utilizes this device as Laser Safety Officer,
responsible for providing training on all operating safety procedures.
6.3 Laser Safety
Precautions
Please refer to Section 2. PRECAUTIONS.
Warnings
Please refer to Section 3. WARNINGS.
6.4 Labels and Symbols
The following labels appear on the SMART RLT Sport laser.
Manufacturer (Factory) Identification Label –Located on the lower side of the deck. The label
indicates the manufacturer, model number, serial number (S/N i.e.: 191006-004) and date of
manufacture (DOM = Month/Year i.e.: October 2019) of the SMART RLT Sport.
Explanatory and classification label –Located on the lower side of the deck. These labels indicate
the laser classification and laser safety warning.

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Aperture label and Aperture Icon–Located on the hand piece. This label indicates the laser
aperture. The laser emission can only be emitted from the laser aperture on the hand piece.
International Laser Hazard Symbol –This icon denotes a laser product located on the lower side of
the deck

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Non-interlock protective housing label –Located on the deck close to the fiber cable port. The label
indicates the laser safety warning when the panel is open.
Warranty Seal Label –Located on the lower side of the deck. Any attempt to open the top plate of
this device will break this seal voiding the system warranty
Certification Label –Located on the lower side of the deck this label denotes Compliance with
CDRH requirements.
Sound Label –Located on the outside of the system adjacent to the power entry module this label
indicates electrical power requirements and additional regulatory information.

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Type B Applied Part
Refer to User Manual
WEEE: Waste Electrical and Electronic Equipment
6.5 Safety Devices
The following component devices have specific safety-related features. All individuals who use this
laser device should be familiar with the purpose and the operation of these components.
Emergency Power off Switch: This switch is located on the deck of the SMART RLT Sport.
Pushing the switch down terminates all electrical power to the laser device’s microprocessor and
laser-emitting components. Resetting the switch restores power. To reset the Emergency Power Off
Switch, the user must press, twist, and rotate in the direction indicated by the arrows, then release it as
the switch pops out, returning it to its normal position. SMART RLT Sport software must be stopped
and restarted.
Model: SmartRLT Sport
Input Power:
100-240V ~ 2.5A 50/60Hz
Contact Information:
5810 Van Allen Way
Carlsbad, CA 92008
760.918.9626
SOUNDVET.COM
Assembled in USA
Model: SmartRLT Sport
Input Power:
100-240V ~ 2.5A 50/60Hz
Contact Information:
5810 Van Allen Way
Carlsbad, CA 92008
760.918.9626
SOUNDVET.COM
Assembled in USA
Model: SmartRLT Sport
Input Power:
100-240V ~ 2.5A 50/60Hz
Contact Information:
5810 Van Allen Way
Carlsbad, CA 92008
760.918.9626
SOUNDVET.COM
Assembled in USA
Model: SmartRLT Sport
Input Power:
100-240V ~ 2.5A 50/60Hz
Contact Information:
5810 Van Allen Way
Carlsbad, CA 92008
760.918.9626
SOUNDVET.COM
Assembled in USA

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Power On/Off Visual Indicator: Located on the top plate of the laser device, the green LED
indicator is illuminated continuously whenever the system is powered on, the tablet is running and the
emergency power off switch is disabled.
Laser-Emission LED Indicator: The red LED on the top plate of the laser system will be
illuminated flashing when the laser emission is ON.
Laser-Emission Audio Indicator: The laser will have an audio beeping sound when the laser is
emitting. This audio comes from the tablet speakers so sound should never be muted on turned below
an audible range on the tablet.
Remote Interlock: The purpose of the remote interlock connector is to permit the user to connect a
remote barrier interlock, emergency stop switch, or similar device. The connector must be in place for
the unit to function or a remote interlocking system is connected to the unit.
WARNING!
The operator should never mute or turn off the
audio on the tablet. This audio is used as an
additional indicator when the laser is in
emission mode.

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Laser-Emission Hand Piece LED Indicator: There is an LED on the hand piece that will flash
when the laser is in emission mode.
On Screen Emission Indicator: The system software on the tablet will have a flashing red indicator
that appears as follows on the screen during emission:
Watchdog Timer: The laser firmware will automatically halt laser emission if the tablet software
does not message the firmware once every half second during laser operation. This is to prevent a
loss of communication to the firmware preventing a hazardous situation.
6.6 Laser Eye Protection
The protective laser eyewear supplied with this device has an optical density rating > 5.0 for 1064nm
laser emission. All personnel present during device operation must wear this eyewear. Contact Sound
Technologies, Inc. at 800-268-5354 Option 1 to purchase additional sets of 1064-nm protective
eyewear.
Laser Emission Indicator
Laser Hand Switch

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6.7 Electrical Safety
This device meets the general requirements for basic safety and essential performance per IEC/EN
60601-1:2012.
Electrical power sufficient to cause injury or death is present inside the Laser System components
whenever they are connected to AC power. Take appropriate safety a precaution, use safety
disconnects (such as fuses or breakers) wherever possible, and disconnect AC supply cables from
components prior to removing covers for maintenance or service.
Do not block or restrict airflow into or out of the Laser System. Adequate air cooling is required to
prevent overheating the components inside the enclosure.
Apply measures to prevent liquids, particularly toxic or hazardous fluids form coming into contact
with the Laser system components and equipment. When cleaning the Laser System, do not spray or
pour fluid directly onto the equipment surfaces. Gently dry dust the inner deck and tablet with a tissue
to remove visible dust and contamination
When electrical components must be replaced, use only components that are appropriately rated for
the application. Replace fuse, switches or connectors only with components of the same type and
rating as the original equipment. (Refer to Section 8.8.1 for replacement parts and components)
To avoid electrical shock, the Laser system must be powered form an AC supply circuit that includes
an adequate earth ground.
WARNING!
The Laser system and its components are designed to be connected to a properly grounded AC supply
sufficient to support system operations. Using power strips or other multiple-socket outlets that are
not specifically approved for use with the Laser system may compromise safety grounding or present
other power-related safety hazards.
6.8 Electromagnetic Compatibility
This device complies with IEC/EN 60601-1-2:2014 –General Requirements for electromagnetic
compatibility of equipment and systems. Prevent the potential risk of electromagnetic interference
between this equipment and other devices by following the recommendations here:

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Immunity
Test Type
Compliance
Level
Comments
Electrostatic
Discharge
IEC/EN 61000-4-
2
+/- 8 kV contact
discharge
+/- 2, 4, 8, 15 kV
air discharge
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%
Radiated
Electromagnetic
Field Immunity
IEC/EN 610000-
4-3
3 V/m, 80 - 6000
MHz 80%, 1 kHz,
AM Modulation
Spot
Frequencies 385
–5785 MHz
Pulse
Modulation
Portable and mobile RF communications equipment should be
used no closer to any part of the Smart RLT Sport, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = (3.5 / E1)√P 80 MHz to 800 MHz
d = (7 / E1)√P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Conducted Immunity:
d = (3.5/V1)√P
Field strength from fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than the compliance
level in each frequency range. Interference may occur in the
vicinity of equipment marked with the following symbol.
Conducted
Immunity (AC
Power) (I/O
Lines) IEC/EN
61000-4-6
3Vrms & 6Vrms
in ISM &
Amatuer Radio
Band 0.15 - 80
MHz, AC Mains
3Vrms & 6Vrms
in ISM &
Amatuer Radio
Band 0.15 - 80
MHz, I/O Ports
Electrical Fast
Transient / Burst
Immunity
IEC/EN 61000-4-
4
±2 kV on AC
Mains
±1 kV on I/O
Ports
Mains power quality should be that of a typical commercial or
hospital environment
Surge Immunity
IEC/EN 61000-4-
5
±2 kV CM Line-
Gnd
±1 kV, DM Line-
Line
N/A on I/O Ports
Mains power quality should be that of a typical commercial or
hospital environment
Power
Frequency
Magnetic Field
Immunity
IEC/EN-61000-4-
8
30 A/m @
50/60Hz
3 Orthogonal
Orientations
Video display terminal and other electron-beam devices (e.g. X-
ray image intensifiers) may use a justification for lower IMMUNITY
COMPLIANCE LEVELS as allowed by 6.2.1.10.
Voltage Dips &
Interruptions
IEC/EN 61000-
4-11
0% During .5
Period
0% During 1
Period
70% 25 Periods
0% During 250
Periods
If the user of the Smart RLT Sport requires continued operation
during mains interruption it is recommended that the Smart RLT
Sport be powered from an uninterruptable power supply or a
battery

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Emissions
Test Type
Compliance Level
Comments
Conducted Emissions
EN 55011 CISPR11
IEC/EN 55032
Class A,
150 kHz –30 MHz
The Smart RLT Sport uses RF energy for its internal
function. Nearby electronic equipment may be
affected
Radiated Emissions
EN 55011 CISPR11
IEC/EN 55032
Class A,
30 –1000 MHz
Power Harmonics
IEC/EN 61000-3-2
Limit
None
Voltage Fluctuation
IEC/EN 61000-3-3
Limit
None
WARNING!
Use of accessories and cables other than those specified or provided by the manufacturer of Smart
RLT Sport device could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
WARNING!
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30cm (12 inches) to any part of the Smart RLT Sport device,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.

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6.9 Sources for Additional Information and Assistance on Laser Safety
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue WO32-5245
Silver Spring, MD 20993 USA
Tel: [phone]
https://www.fda.gov/about-fda/office-medical-products-and-tobacco/center-devices-and-radiological-
health
Laser Institute of America
13501 Ingenuity Drive, Suite 128
Orlando, FL 32826 USA
Toll Free: 1-800-345-2737
Tel: [phone]
https://www.loa.org