PhotoEnergy Comparison Booklet

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    What you should know when

    evaluating competitive devices.

    - The difference between LED and Laser Technology

    - How to calculate energy density

    - Evaluating different infrared light therapy attributes

    - Infrared light therapy device comparison tool

    - How to assess what you need for your practice

    A Field Guide To

    Evaluating Infrared LightTherapy Devices

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    Cold Lasers, Low Level Laser Therapy (LLLT), Soft Lasers and LEDs: Lasers deliver collimated, coherent light. This simply means that the infrared light is focused

    in a column and does not disperse as much over the treatment area. Lasers also are monochro-

    matic by denition, meaning they only emit one wavelength of light.

    A light emitting diode (LED) is a semi-conductor device that emits incoherent narrow-spectrum

    light. Some LED devices are also monochromatic, such as Anodyne Therapy.

    The infrared light from both lasers and LEDs disperse once the infrared light contacts tissue,so they look and act identically once they penetrate tissue. The depth to which they penetrate

    has nothing to do with whether the light is lased, but rather has to do with the wavelength and

    energy density.

    Output from LEDs possess all the attributes of laser radiation except coherence. Findings at the

    cellular level would imply that the property of coherence is largely unnecessary for the clinical

    effects of these devices.

    Wavelength:The rst law of photochemistry, known as the Grotthus-Draper Law, states that only light that is

    absorbed can produce a biochemical effect. Wavelengths are measured in nanometers (nm). Shorter

    wavelengths such as Ultraviolet are absorbed only in the surface of the tissue and thus the effects(tanning, sunburn, melanoma) are at the surface of the skin. Longer wavelengths, such as infrared,

    penetrate deeper into tissue, but they are absorbed in the hemoglobin at various depths throughout

    the tissue. Visible red, green, blue and orange are shorter wavelengths and will have less penetration

    than infrared. Some LED devices are monochromatic and some are polychromatic, which means they

    deliver multiple wavelengths.

    Wavelength of Anodyne Therapy System

    890 nm, monochromatic, infrared only

    Pulse Rate:

    Most infrared light therapy devices pulse their infrared light to reduce tissue accommodation. Thispulse rate is measured in Hz or pulses per second. Different pulse rates may have different effects

    and therefore, one cannot compare clinical research from one device that uses one pulse rate to

    another device that uses a different pulse rate and conclude that they will produce the same effects.

    Pulse Rate of Anodyne Therapy System

    292 Hz

    Infrared Light Therapy Terminology

    Evaluating infrared light therapy devices can be confusing. There are many types of devices, all

    claiming similar effects of increased circulation, decreased pain, etc. In theory, these devices work

    under the same principles and laws of photobiomodulation. However, they are very different in terms

    of their methods (wavelength, pulse rate, intensity, etc.) and applications (handheld or attachable).

    This guide highlights the methods and application of the Anodyne Therapy System, and also provides

    a infrared light therapy comparison tool to aid you in comparing different devices.

    Introduction to Infrared Light Therapy

    2

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    Intensity and Time of Illumination: The Bunson-Roscoe Lawof physics states that A biologicaleffect is proportional to the intensity and time of illumination of the tissue. Intensity is usually measured

    in joules per cm2. The formula to calculate this is: Joules/cm2 = (watts x time in seconds) divided by

    treatment area (cm2). In order to calculate infrared light intensity, you need to know three things:

    Watts of energy delivered:Most manufacturers report this in milliwatts, so you need to divide by 1000. Think of watts like a

    light bulb. A 40 watt light bulb does not deliver the same light as a 150 watt light bulb, so it will

    not light up the tissue as much nor will it have as great a molecular/biological effect. The watts

    delivered will be affected by the duty cycle, which determines what portion of the time the light

    is on. Many devices have a 50% duty cycle, which indicates the light is only on half the time

    and cuts the infrared light output in half! This is done to reduce the amount of heat produced.

    Finally, to make things even more confusing, it is important to note that just because a manufacturer

    uses 100 mw diodes, doesnt mean the actual infrared light therapy delivered is 100 mw.

    Time of illumination in seconds:

    In general, as the Bunson-Roscoe Lawindicates, the longer the treatment time, the greater the energydelivered, all other things being equal. Will some patients respond in 5 minutes? Absolutely. The

    problem is, no one knows which ones will! Your objective is to get treatment efcacy that approaches

    80% so that physicians will believe in the effectiveness of your therapy and patients will get the best

    possible outcomes.

    Treatment area in square centimeters:

    Only include the area where infrared light therapy is actually delivered not all the empty space in be-

    tween the diodes. Some manufacturers claim their area is bigger, but there is so much space between

    the diodes that there is not a uniform effect of the infrared light over the surface of the tissue.

    Total Energy Density For

    Anodyne Therapy Systems

    8 Pad Pro set at 10 bars for 45 minutes: 122.4 Joules/cm2

    4 Pad Pro set at 10 bars for 45 minutes: 122.4 Joules/cm2

    4 Pad Home pre set at 8 bars for 30 minutes: 104.4 Joules/cm2

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    Proximity of Infrared Light to Tissue:To complicate things further, energy density is not the entire story. The Inverse Square Lawstates that Light

    degrades as a function of distance; maximum light is delivered in direct contact with and perpendicular to

    the target tissue. What this means is that diodes that are in direct skin contact and perpendicular to the

    tissue will have a greater effect than diodes behind glass, as light will degrade and reect the further it is

    moved away from the target tissue.

    Non-Contact TechniqueThis technique is utilized by devices with diodes or laser behind

    glass. As the picture depicts, because the light source is held

    away from the skin, some of the infrared light is reected, so

    not all the infrared light is being absorbed into the body where

    it has its biological effects. According to T. Ohshiro in his book

    Low Level Reactive Laser Therapy,this technique serves to

    only irradiate the upper dermal and intradermal lymphocapillary

    network, and smaller blood vessels.

    Woodpecker TechniqueAnodyne Therapy utilizes this application technique where

    the diodes are in direct contact with the skin. The diodes are

    pointed and pushes into the skin, so that the maximum amount

    of energy is absorbed into the skin, and not lost or refracted.

    As compared to the Non-Contact Technique, the WoodpeckerTechnique allows for the maximum absorption of the infrared

    light. Ohshiro states, that this method allows for deeper dermal

    and lymphatic penetration than the Non-Contact method. It

    also ensures minimal loss of energy by backscatter and air

    distortion. This skin-contacting delivery method is protected by

    Anodyne Therapys registered patents.

    What conditions do you want to treat? You should select a device that is proven and

    exible enough in design to treat all those conditions easily.

    What are you trying to accomplish with infrared light therapy? Increase referrals?

    Improve outcomes? Select a company who can help you meet your objectives.

    Do you do your own marketing? Do you have the resources to develop your own

    marketing materials? Would you like to do more community marketing? Do you need

    marketing support from the manufacturer?

    Are physicians in your area skeptical of new treatments? If so, it is helpful to have

    published clinical studies to provide them to ensure referrals.

    4

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    After evaluating all the attributes of light therapy devices, the one question you must ask yourself is

    whether the particular specications of a light therapy device will produce the clinical effects you want

    to provide in your practice. Anodyne Therapy has gone to extensive expense to provide you research

    on the efcacy of our particular combination of light therapy specications. There are no guarantees

    that other brands of light therapy delivered in different congurations with different wavelengths,

    milliwatts, application methods, pulse rates, etc. will produce the same clinical results, and in manycases they are more expensive when you analyze the cost per milliwatt! Consider the evidence below

    of one such device that claims to emit 100 mw per diode.

    Anodyne 45 mw diodes - Circulation increase after 45 minutes

    Average increase in microvascular circulation = 231%

    Patient #1 PreScan Post Scan

    Right foot +251.5%

    Left foot +138.8%

    Patient #2 PreScan Post Scan

    Right foot +254.5%

    Left foot +279.7%

    Competitive 100 mw diodes - Circulation increase after 45 minutes

    Average increase in microvascular circulation = 3%

    Patient #1 PreScan Post Scan

    Right foot +11.5% Left foot +25.8%

    Patient #2 PreScan Post Scan

    Right foot -13.6%

    Left foot -11.5%

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    1. Anodyne Therapy is clinically proven and the only infrared light therapy system with

    published clinical efcacy data in peer reviewed journals (13 peer-reviewed studies; 15 total

    studies).

    Anodyne Therapy has been published in Diabetes Care, Endocrine Practice, Journal of the American

    Podiatric Medical Association, Journal of Geriatric Physical Therapy, Journal of Diabetes and its

    Complications, Physical and Occupational Therapy in Geriatrics,Age and Ageing, Chinese Journal ofDiabetes Education,Advances in Wound Care and Advances in Skin and Wound Care.

    Nearly 5,000 patients have been involved in Anodyne Therapy clinical studies.

    Research-based clinical protocols have been tested in over 13 years of professional use and millions

    of patient treatments in more than 6,000 clinical sites.

    More than 10,000 physicians have referred for Anodyne Therapy home Systems.

    2004 WOCN Practice Guidelines mention Anodyne Therapy as an adjunctive treatment to increase

    circulation and reduce pain.

    2. AnodyneTherapy offers signicant marketing and clinical support and generates patient referrals.

    Method Patent No. 6,607,550 issued August 19, 2003 for treatment of a painful, circulatory

    condition with a infrared light therapy device Anodyne Therapy Step Up Program, DVD/Video and web-based training materials

    Clinical Assessment tools and guidelines

    Care Center Locator for U.S. and international providers at www.anodynetherapy.com

    Marketing support in password-protected Provider Resource Website

    Patient and physician marketing brochures

    Community and referring provider educational PowerPoint presentations

    3. Anodyne Therapy is one of the most cost-effective infrared light therapy devices and is easy

    to use, clean and maintain.

    All Anodyne Systems have higher energy output than nearly any other infrared light therapy system

    available.

    8000+ mw delivered over 180 cm2 in 8 pad Professional System 4000+ mw delivered over 90 cm2 in 4-pad Professional

    3000 mw delivered in 4-pad 120 Professional and 120 Home Systems

    Low cost per milliwatt of infrared light therapy delivered

    All systems have a two year warranty.

    Flexible therapy pads do not restrict treatment to one area and allow users to place the therapy pads

    all over the body, including feet, legs, back, neck, face and arms without constant attendance.

    Neither operators treating with, nor patients receiving Anodyne Therapy, must use protective eye wear.

    Nonporous pads allow for easy disinfecting.

    4. Anodyne Therapy has completed rigorous regulatory approvals.

    FDA Clearance for increasing circulation and reducing pain (#K931261, 3/31/94)

    OSHA Safety Certied to the UL/CSA 60601-1 Medical Device Standard

    ISO 13485 Certication a rigorous quality system standard

    CE Certied

    Health Canada Approval

    5. Home systems are available for patients with chronic conditions.

    Anodyne Therapy is not a cure for any condition; however, it is a drug free treatment for patients with

    chronic circulatory conditions whether due to diabetes, or another disease manifestation. Patients who

    do not have ongoing treatment may eventually regress. Anodyne Therapy home systems offer a long-

    term solution to patients chronic painful circulatory conditions.

    6

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    Anodyne Therapy Model 480

    8 Pad System

    Comparison Device

    Clinical Efcacy Proven clinical protocols in 15published studies, 11 of which arein peer-reviewed journals

    Diodes 480 Infrared Aluminum galliumarsenide high-speed superluminousLEDs

    Wavelength 890 nm

    Energy Photo-thermal Energy- 1020 mw per array

    - 8160 mw (8 array)

    Treatment Time 20-45 minutes

    Size of Treatment

    Area

    22.5 cm2 per array180 cm2 (8 arrays)

    Energy Density 122.4 Joules/cm2 in 45 minutes

    Marketing and

    Clinical Support

    - Web-Based Training Program- STEP UP Program with Clinical

    and Marketing Support

    - Provider Only Resources Website- Patient and Referring ProviderBrochures

    - Marketing and Training DVDs- Patient Referral Program

    Patents 2 (US, Canada, Europe)- Infrared Light Therapy Device- Method for treating certain

    painful, circulatory conditions

    Medical Community

    Acceptance

    - Over 6,000 clinical treatment

    facilities worldwide, includingmany major teaching institutions

    - Prescribed by over 10,000 physi-cians

    Cost - Calculate the cost per milliwatt bydividing the total cost by thenumber of mw delivered.

    This tool is to assist you in comparing Anodyne Therapy Systems to another Infrared Light

    Therapy Device.

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    Anodyne Therapy and MIRETM

    are registered trademarks of Anodyne Therapy, LLC.US Patent No. 5,358,503. Canada Patent No. 2,181,467.

    European Patent No. 0741594

    2010 AnodyneTherapy, LLCAll Rights Reserved

    14105 McCormick DriveTampa, FL 33626

    United States

    Website: www.anodynetherapy.comEmail: [email protected]

    800-521-6664

    800-835-4581

    Customer Care:Customer Care Fax:

    MR-09033 Rev E 08/06/10