Introduction - Spectra Therapy

Transcript

1 . Always seek medical advice if there is any doubt of how to care for yourself or your loved ones. Take the time to complete the Product Registration Either on-line at www.SpectraTherapy.com or Mail in Registration Card to the address below. Use this area of the manual for notes: Spectra TherapyTM , LLC 3863 Rochester Rd. Troy, MI 48083-5245 USA 1 248-524-6300 – Phone 1 248.524-2983 – Fax www.SpectraTherapy.com Patent Pending - Spectra Therapy A1000 unit, Spectra Stim PackTM & Spectra StimWrapTM ©2009 Spectra TherapyTM,, LLC all rights reserved., 2 INDEX INTRODUCTION ……………………………………………………. 4 Benefits and Features…………….………………………………………5 Precautionary Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .…..6 Cautions …………………………………………………………………7 Warnings . . . . . . . . . . . . . . . . . . . . ………………………………….......8 Background of Laser Light Therapy . . . . . . . . . . . . . . . . . . . . . . . . .. …. 9 Background Laser Terminology. . . . . . . . . . . . . . . . . . . . . . ………….10 Indications & Contraindications…………………………………….11-12 Risks & Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. . .13 Laser Terms…………………………………………………………… 14 TECHNICAL SPECIFICATIONS . ………………………………..…15 Device Description . …………………………………………………... 16 Charging the Unit. . . …………………………………………………. 17 Charge Status of the Unit………………………………………………18 Operation Instructions………………………………………………….19 Cleaning and Care …………………………………………………….20 Laser Probe Technical Specifications & Protective Eyewear………...21 Monitoring Devise Functions………………………………………….22 Preparing the Skin for Laser Therapy.....……………………………...23 Methods For Delivering Treatment…………………………………....24 OVERVIEW OF THERAPY TREATMENTS …………………….....25 Treatment Recommendations …………………………………………26 Treatment Programs. . . . . …………………………………………27-31 Key Protocol Programs ………………………………………………30 Alternative Laser Protocols for pain………………………………..…31 Warranty……………………………………………………………….33 Service…………………………………………………………………34 List of Parts & Accessories ……………………………………….…..35 TABLE OF CONTENTS 3 INTRODUCTION INTRODUCTION This manual has been written for the users of the Spectra Therapy® Laser. It contains general instructions for operation, precautions, instructions and maintenance recommendations. In order to obtain maximum life and efficiency from your Spectra Therapy® Laser, and to assist in the proper operation of the unit, read and understand this manual thoroughly. The specifications put forth in this manual were in effect at the time of publication. Check our internet site for any updates. Before administering any treatment to yourself or another, you should become acquainted with the operating procedures, as well as the indications, contraindications, warnings and precautions. Consult other resources for additional information regarding the application of therapeutic laser light. Product Description The Spectra TherapyTM Laser as designed offers a fully portable dimension in clinical laser light therapy made possible by advanced accurate frequency control of the lasers. The product is designed to utilize the latest state-of-the-art technology. The Spectra Therapy Low-Level Laser is designed to lessen pain by using laser diodes and super luminous light emitting diodes (LEDs) that generate infra-red energy in the form of low level light to deliver a therapeutic effect. It is important to emphasize that therapy with the Spectra Therapy Low-Level Laser does not exclude other conventional medical treatment. Effectiveness of this treatment is dependent upon correct use. When treatment times are exceeded, the therapy may not provide more positive results. Disclaimer The information is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as a medical advice. It is intended as a sharing of knowledge and information from the research and experience of Spectra Therapy, LLC. and encourages you to make your own health care decisions based upon your own research and in partnership with a qualified health care professional ©2008 Spectra TherapyTM,, LLC all rights reserved., Index 4 BENEFITS AND FEATURES The Spectra TherapyTM A1000 Laser offers the user the following benefits • Clinical Indications -An efficient approach for setting up a treatment using preset or custom treatments performed by a doctor to reduce pain. - Go to the chart, determine that you have that type of pain, review this users guide completely, then try the therapy. . Background Laser Light Therapy -The therapy is light energy absorbed into the patient’s tissue that triggers biological changes at a cellular level to provide topical healing for the temporary increase in local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles and relief of muscle spasms; temporary relief of minor pain and stiffness associated with arthritis. The dose and frequency of treatment can be adjusted to produce the desired effect by selecting a protocol. Further information is contained later in this manual on how to select the right protocol. • Fully Portable, Battery Powered The Spectra Therapy® Laser is a truly portable laser unit that does not confine you to cords or stationary lamp type holders for use. • Pocket Size Major benefits of the Spectra Therapy® Laser are its compact size and ease of operation, which make it versatile in any type of environment. It is so small that any practitioner can carry it in their pocket and treat a patient anywhere. No other multiple diode LLLT device can make that claim and it is completely made and assembled in the USA • Single button to operate. ON/SELECT/OFF If one presses this button repetitively, it will just advance to the next therapy number. Press the button again, it will turn the unit OFF. • User Protocols -Practitioner protocols allow them to set, save and change the parameters of each program (protocols) to meet the patients’ specific needs. Fifteen (15) storage slots are available for user protocols. - The unique key programmable feature provides a means for the practitioner to customize and optimize the unit for the individual patient’s needs. - You, as the user, just plug in the key, then press the ON/SELECT/OFF button. INDEX 5 ABOUT LASER THERAPY Precautionary Instructions The precautionary instructions found throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows: . NOTE: A Note is helpful information to aid in the particular area or function being described • Read these instructions, including all warnings, and practice the precautionary and operating instructions before using the Spectra Therapy Low-Level Laser . • Know the limitations and hazards associated with using any laser light device. • Use this device while following the safety precautions and operating instructions in this Users Manual. It is important to keep this manual handy. The Users Manual should be studied and reviewed periodically by users of Spectra Therapy Low-Level Laser. • DO NOT use sharp objects, such as a pen, to operate the buttons on the control panel as damage may result. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to laser light energy. • Inspect the unit and clean as required before each use. • DO NOT disassemble, modify or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire or personal injury. • Failure to use and maintain the Spectra Therapy® Laser and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty. Index 6 ABOUT LASER THERAPY Caution • DO NOT remove the cover. This may cause unit damage, malfunction, electrical shock or personal injury. There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately and consult the dealer for repair service. • DO NOT permit any foreign materials or liquids to enter the unit. Take care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the unit. These may cause unit damage, malfunction, electrical shock, fire or personal injury. • If you have difficulty operating the unit after carefully reviewing this users manual, contact your Spectra Therapy® dealer for assistance. • Before each use, clean the plastic lens with cleaner. Apply with a clean cloth. Failure to clean the lens between patient therapy sessions could cause beam distortion. •The Spectra Therapy Low-Level Laser should be maintained and serviced only by Spectra Therapy personnel, or other qualified personnel approved, in writing, by Spectra Therapy. • U.S. federal law restricts the use of this device by a minor without adult supervision.. INDEX 7 ABOUT LASER THERAPY Warning • This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause minor interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off, then try to correct the interference using one or more of the following: Reorient or relocate the receiving device, increase the separation between the equipment, connect the equipment to an outlet on a different circuit from that to which the other device(s) are connected and/or consult the factory field service technician for help. • Be sure to read all instructions for operation before treating yourself. • Do not drop the Spectra Therapy Low-Level Laser, as it could be damaged and will not function properly. Do not submerge the probe or unit in water. All of these conditions will damage the probe and unit. Damage resulting from these conditions is not covered under the warranty. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to laser light energy. • This device should be kept out of the reach of children. Do NOT use on children under the age of 16 without the recommendation/supervision of a physician or therapist. • This device should be used only under the continued supervision of a licensed practitioner, parent or legal guardian. • Dispose of all products in accordance with local and national regulations and codes. • DO NOT use the Spectra Therapy Low-Level Laser in or around water. Water inside the unit could cause the unit to stop functioning. • DO NOT look directly at the light source. The Spectra Therapy Low-Level Laser emits high intensity light. Prolonged (greater than 30 seconds) direct exposure of your eyes to the light emitted by the Spectra Therapy Low-Level Laser may cause damage to your vision. Damage could possibly occur even with your eyes closed, therefore, never point the laser at the eyes directly. • DO NOT allow the unit to contact broken skin. The device is not sterile and may cause infection.. If used on broken skin, infection may result and further medical attention may be needed. • DO NOT use the Spectra Therapy Low-Level Laser to treat the abdominal area if you are pregnant in order to avoid potential injury to the developing fetus. • DO use any computer USB power port as a means to charge your Spectra Unit, or the switching supply shipped with the unit.. INDEX 8 BACKGROUND LASER LIGHT THERAPY Background Laser Light Therapy Low Level Laser Light has unique physical properties that no ordinary light has. This is the key to why laser light is so effective compared to other kinds of light in healing. There are hundreds of double-blind positive studies confirming the clinical effect of LLLT (Low Level Laser Therapy). Thousands of research reports are published. Possibly, the most authoritative text on low-level laser therapy is a book by Jan Turner and Lars Hode, entitled “Laser Therapy Clinical Practice and Scientific Background”. This book contains over a thousand references. The authors note: “Today, we can safely say that therapeutic lasers have an important biological effect and a very positive one, at that.” 1. 2. 3. 4. 5. “We believe that lasers have a tremendous and, as of yet, untapped potential in the field of healthcare.” “Therapeutic lasers have no undesirable side effects in the hands of a reasonably qualified therapist.” “Lasers are sterile, painless, and often less expensive than methods already in use and do not have side effects, as does pharmacotherapy.” “Laser therapy of wounds is ideal since it promotes healing and reduces pain at the same time.” “Laser light increases the cell’s ATP energy.” There is no exact limit with respect to the penetration of the light. The light gets weaker the further from the surface it penetrates. Fat tissue is more transparent than muscle tissue. Some laser applicators may cause a noticeable heat sensation, particularly in hairy areas and on sensitive tissues such as lips. Low Level Laser Light differs from ordinary light in four ways. Briefly, it is much more intense, directional, monochromatic and coherent. Most lasers consist of a column of active material with a partly reflecting mirror at one end and a fully reflecting mirror at the other. The active material can be solid (ruby crystal), liquid or gas. INDEX 9 ABOUT LASER THERAPY Background Laser Light Therapy The therapy is light energy absorbed into the patient’s tissue and this triggers biological changes at a cellular level to provide topical healing for the temporary increase in local blood circulation; temporary relief of minor muscle and joint aches, pains and stiffness; relaxation of muscles and relief of muscle spasms; as well as temporary relief of minor pain and stiffness associated with arthritis. The dose and frequency of treatment can be adjusted to produce the desired effect. by selecting a protocol. The Physiological Effects of low level laser therapy are How has Low Level Laser Therapy (LLLT) worked for others? * Reduces inflammation * May relieve certain acute and chronic pains * Increases the speed, quality and tensile strength of tissue repair * Increases blood supply * Stimulates the immune system * Stimulates nerve function * Develops collagen and muscle tissue in certain cases * Helps generate new and healthy cells and tissue * Promotes faster wound healing and clot formation According to the WHO (World Health Organization), many acute and chronic conditions can be improved temporarily with low-level laser use, including: 1. Bio-stimulation · Improved metabolism · Increase of cell metabolism 2. Improved blood circulation and vasodilatation 3. Reduces or eliminates pain 4. Anti-inflammatory and anti-edematous effects 5. Stimulation of wound healing * Pain Relief * Wound Healing * Arthritis * Migraine headaches * Lower back pain * Repetitive Stress Injuries (RSI) * Carpal Tunnel Syndrome (CTS) * Tendonitis * Fibromyalgia * Sprains and strains * Post-operative pain * Tennis Elbow * Golfer's Elbow * TMJ * Soft tissue injuries * Post-operative wounds * Swelling * Burns * Pressure sores * Herpes simplex * Acne INDEX 10 INDICATIONS & CONTRAINDICTIONS Indications for Laser Light TM The Spectra Therapy Laser is indicated to provide topical healing for the following: • temporary increase of local blood circulation. • temporary relief of minor muscle and joint aches, pains, and stiffness. • temporary relaxation of muscles. • temporary relief of muscle spasms. • temporary relief of minor pain and stiffness associated with arthritis. Adjunctive Use The Spectra TherapyTM Laser may be used adjunctively for the following: • symptomatic relief of minor pain • minor muscle and joint pain • minor muscle spasms • relief of associated minor stiffness and pain associated with arthritis • promoting relaxation of muscles Additional Precautions Additional precaution should be used when the laser light is used on patients with the following conditions: Contraindications The Spectra TherapyTM Laser should NOT be used: • for direct aim into the eyes of humans or animals. • over areas injected with steroids in the past 2-3 weeks. • over areas that are suspicious or contain potentially cancerous tissue. • over areas of active hemorrhage. • over a pregnant uterus. • over the neck (thyroid or carotid sinus region) or chest (vagus nerve or cardiac region of the thorax). • directly over areas with open wounds, unless covered with a clear protective barrier. • treatment over sympathetic ganglia. • for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • on patients suspected of carrying serious infectious disease and/or disease where it is advisable, for general medical purposes, to suppress heat or fevers. • where analgesia may mask areas of pain. • over or near bone growth centers until bone growth is complete. • over the thoracic area if the patient is using a cardiac pacemaker. • over or applied to the eye. • on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis may result. • Over an area of the spinal cord following a laminectomy, i.e., when major covering tissues have been removed. • Over anesthetic areas. INDEX 11 CONTRAINDICITONS (cont) Contraindications [ continued] • DO NOT ALLOW unattended use of the Spectra Therapy LowLevel Laser by children under age 16 with out direction from a licensed practitioner or incapacitated persons. • Keep the Spectra Therapy Low-Level Laser away from children that are not supervised. • During treatment, avoid direct exposure of the treated area to other intense light sources such as a UV sun lamp. Exposure to other high intensity light sources may cause excess heating and slight burns on the skin. Excessive use of the Spectra Therapy Low-Level Laser will not result in burns; however, use of the Spectra Therapy Low-Level Laser with other heat sources could cause slight burns on the skin. • • On patients with hemorrhagic diatheses. Patients with an implanted neurostimulation device must not be treated with or be in close proximity to any Laser therapy anywhere on their body. Energy from diathermy (laser) can be transferred through the implanted neurostimulation system, can cause tissue Damage and can result in severe injury or death. Injury, damage or death can occur during diathermy therapy, even if the implanted neurostimulation system is turned to "OFF." Preventing Adverse Effects Perform the following procedures to avoid the negative effects of laser light therapy: Patient Susceptibility Some patients are more sensitive to laser light output and may experience a reaction similar to a heat rash. Be sure to inspect the treatment area during and following treatment and discontinue if an adverse reaction does occur. Factors that Affect Treatment The following factors may affect laser light treatment: • Color of skin (light or dark) • Age of lesion • Depth of lesion • Sensitivity of patient • Type of tissue INDEX 12 RISKS / BENEFITS Risks/Benefits Risks • There is a risk of damage to your vision from prolonged exposure (longer than 30 seconds) to the light emitted by the he Spectra Therapy Low-Level Laser Therapy device. Damage to your vision could occur upon looking directly at the light source for longer than 30 seconds. Your vision could be damaged whether you looked at the light source with central vision or peripheral vision, or possibly with your eyes closed. Damage to your vision can be prevented by avoiding looking directly at the light source, wearing the supplied eyewear and never pointing the laser directly at your eyes. • The Spectra Therapy Low-Level Laser Therapy device is programmed to deliver a limited amount of energy to the skin, to protect against overheating that may cause discomfort. When the device is used, as directed, the skin may be heated only to temperatures of 104 - 113 °F (40-45 °C). Repeated treatments of a single part of the body or continuous treatment will not cause the skin to be overheated. However, to prevent discomfort, the Spectra Therapy Low-Level Laser Therapy Device should not be used on any area of your body that you are concerned may be overly sensitive to heat (i.e., on a sunburned area). • There is a risk of infection if the Spectra Therapy Low-Level Laser Therapy Device contacts broken skin. Infection can be avoided by using the unit on intact skin. The Spectra A1000 can be placed in a clean transparent baggie, and then placed on skin.. Benefits • Use of the Spectra Therapy Low-Level Laser makes it easy to administer treatment at home. • Treatment with the Spectra Therapy Low-Level Laser can be combined with treatment via conventional medicine. • Most patients should expect to feel pain relief and/or muscle relaxation promptly after initial treatment . If after 6 days of Spectra Therapy Low-Level Laser treatment (one day’s treatment consists of 2 sessions of 15 minutes each)., then your condition is not responsive to Low Level Laser treatment. The first three days treatment should consists of 2 sessions of 15 minutes each per day. After this is followed up by treatment of one or two sessions of 15 minutes per day for 3 more days. • However, some patients may feel a noticeable reduction of pain immediately after their first treatment and relaxation of stiff muscles • With temporary removal of pain by using the laser, persons are able to exercise. This exercise strengthens weak muscles and causes less pinching of the nerves. This is the prime object for laser therapy. . INDEX 13 LASER TERMS Collimating: The shape of the laser light beam. While neither focused nor dispersed, this laser light beam resembles a column when applied from the unit through the applicator. Continuous Mode: The output of the laser light is not interrupted during the treatment time. Dosage: A measure of the intensity of the laser light energy over the treatment area. The unit of measure is Joules or Joules/cm2. Energy: Measured in Joules, energy equals the treatment time multiplied by the power. More importantly, Energy Density equals the power output multiplied by the treatment time and divided by the spot size (cm2). This gives a more specific measurement of energy delivered. Frequency: Number of times that the light wave oscillates per second (The number of periods of oscillations per second HZ). Pulsed frequencies are selectable from one every 10 seconds to 2,000,000 Hz. IEC 60825-1: “Safety of laser products - Part 1: Equipment classification, requirements and users guide”, an internationally recognized standard containing laser safety requirements. Infrared radiation: Invisible electromagnetic radiation with wavelengths which lie within the range of 0.70 to 1000 micrometers (microns). This region is often broken up into IR-A, IR-B, and IR-C. LED’s SLD: These Light Emitting Diodes used to generate visible and infra-red energy at different wavelengths, allowing the user to treat topical or surface symptoms. Laser Diode: This mechanism generates different wavelengths of light that allow the user to treat various, deeper penetrating symptoms of muscle bone and nerve tissue. LED Indicator (Output Power): This yellow light illuminates when IR light energy is being distributed by the Spectra Therapy® Laser unit. Laser LED Cluster: The clear lens face of the bottom of the unit that is directed over the patient’s skin. It consists of laser diodes with LED’s or SLD’s, (depending on the unit). Power: Measured in Watts (Milli Watts), power wattage is directly proportional to the treatment time and penetration of the laser light energy. Highpowered diodes will reduce the patient’s treatment time and give a higher amount of energy at a deeper depth. Power output can be either continuous or pulsed. mw: MilliWatts are units of measure for electrical input power. 1mw = .001 watt nm: The unit of measure for the length of the light wave (wavelength), which is defined as the shortest distance at which the wave pattern fully repeats itself, usually measured from crest to crest. The wavelength of light in the visible spectrum determines its color. Pulse laser power: Energy delivered by a laser in the form of a single or train of bursts (pulses). VDC: Direct Current Voltage. Wavelength: Measured in nanometers (nm), wavelength is the key component in obtaining effective therapy as different wavelengths bring about different physiological effects. Superficial skin disorders have been found to be most effectively treated at wavelengths 600-700 nm, while deeper muscular or ligament lesions and joint conditions are better treated at higher wavelengths of 700-1000 nm. INDEX 14 TECHNICAL SPECIFICATIONS Technical Specifications AVERAGE POWER: MEASURES = .8 MW/CM2 @ 10 CM FROM SURFACE 40 MW – 660NM RED LED’S 40 MW – 830NM IR (INFRA RED) LED’S 1 – YELLOW – (POWER INDICATOR LED ) 4 – MAGNETS 25MT 4 MW – 745NM IR LASERS 4 MW – 660 NM RED LASERS Wavelength of: 8 – 660nm Red LED’s 8 – 830nm IR (Infra Red) LED’s 1 – Yellow IR (Infra Red) Indicator LED 4 – 745NM IR Lasers 4 – 660 NM Red Lasers Power Source: Medical Grade Switching Power Adaptor (supplied) Input: 100-204 V 50/60 Hz, 0.55-03A Output: 5V max .5A Class II equipment Applied Part Type Laser class IM (IEC 60825-1) 5 Vdc; max. 0.5A Supply ratings: Continuous Operation Mode of operation: Inherent safe unit being battery operated. Supply ratings apply to charging of unit. Operating environment: 10ºC to 40ºC (50ºF to 104ºF) 700-1060 hPa Storage environment: -20ºC to 50ºC (4ºF to 122ºF) 700-1060 hPa Humidity: 15-95% RH Dimensions: 4.44”Hx2.73”W x.874” D [110.4 x 69.5Wx 22.2D]cm Weight: 5 oz. / 142 g INDEX 15 DEVICE DESCRIPTION Figure 1. Spectra Therapy Low-Level Laser Index 16 CHARGING AND POWERING OPERATION CHARGING THE SPECTRA THERAPY® UNIT The internal battery pack is automatically charging the unit whenever the main power is connected. Internal circuitry charges the unit properly and leaving it connected does not overcharge the unit. A fully charged battery will provide 5-8 hours of treatment, depending on the power, pulsed mode and frequency, as well as probes used. [It takes approximately 2 hrs. to fully charge a battery ] Charge Light Indicator – Located on the top front side of the Spectra Therapy® unit, this indicator light will remain lighted while being powered by the wall charger or a computer’s USB port. NOTE: When the unit is connected to a power source, it can be operated and the battery is being charged, if needed. INDEX 17 CHARGE STATUS OF THE UNIT Battery Power Level • To identify the remaining level of power in the battery, simply press the On / Select / Off button , [wait for a digit to appear and a second to pass], press again, and while the unit is powering down / turning off , the battery level will be displayed. • The battery level will be indicated by numbers from (8) which indicates fully charged, to (1), indicating a low battery power level. • The battery has an estimated charge level of eight hours under normal operation conditions. The battery may be recharged or operated on continuous charge from the USB port on your computer or from the wall charger provided with your unit. It is recommended that you try not to let the battery run completely down and that a full or half full charge be maintained. INDEX 18 OPERATING INSTRUCTIONS OPERATING INSTUCTIONS Your Spectra Therapy Low-level Laser has been designed to be durable, compact and easy to use. The unit has only one switch- On / Select / Off to ensure safe and dependable operation for many years to come. Basic Pre-programmed Operation Turning On the Unit To operate your Spectra Therapy Low-Level Laser press the ON / Select / Off button on the front of the unit. This will display the last program run on the device. The unit is set with a two second delay and will then operate on the selected program indicated by the number in LED display. • The laser will emit a short beep at the beginning of the selected program sequence. When the Spectra unit emits a long beep; it will turn off automatically, marking the end of the selected program, when completed. Selecting a Sequence • To operate under a different program simply press the On / Select / Off button to select the desired program. To increment to the next program, simply press the On / Select / Off button and watch the sequence number. There will be a two second delay and then the unit will run the program that was selected. • The unit will emit a short beep at the beginning of the program and at the beginning of each frequency change. • Upon completion of the selected program, the unit will emit a long beep and then will turn off automatically. The Spectra unit can be quickly and effectively turned off at any desired time by pressing the On / Select / Off button once the program starts to run. INDEX 19 CLEANING AND CARE • • Wipe the Spectra Therapy Low-Level Laser with an alcohol swab or cotton moistened with 70% isopropyl alcohol before and after each use. Use only a soft dry cloth to clean the body of the emitter (if necessary). Never use an abrasive cleanser or submerge the emitter in water or any other liquid. • Do not expose the Spectra Therapy Low-Level Laser to extreme temperatures or humidity. • Cleaning should only be done after making sure that the Spectra Therapy Low-Level Laser is not plugged into the power adaptor. The cleaning solution could wet the power adaptor, which will damage the unit. • Do not allow the emitter or the connecting port for the power adaptor to become wet. The user should ensure that these components are dry prior to use of the Spectra Therapy Low-Level Laser. If the emitter connector does become wet, please contact the manufacturer for instructions on how to continue use of the Spectra Therapy Low-Level Laser. • Do not expose the device to extreme temperatures, humidity or direct sunlight. Store at room temperature. The Spectra Therapy Low-Level Laser may not operate properly if it is exposed to extreme conditions. • One of the design features of the Spectra Therapy Low-Level Laser is that there is no maintenance required by the user, other than keeping the products clean and stored in the proper environment, as described above. All repair and/or service to the Spectra Therapy Low-Level Laser must be done by the manufacturer. Any opening or disassembly of the emitter immediately voids the warranty of the Spectra Therapy Low-Level Laser. • *To contact Service Department Call 1-248-524-6300 • Please contact your closest Spectra Therapy Low-Level Laser dealer should you experience any other problem. Please call *248-524-6300 NUMBER if you have any questions or problems with Spectra Therapy Low-Level Laser. • *The toll free number will be inserted prior to commercial distribution. INDEX 20 PROBE ATTACHMENT The Spectra Therapy Low-Level Laser unit can be used with laser probes shown in Figure 4, and various shaped lens tips (optional) as seen in Figure 5. The probes offered are 660nm Red, 830nm Infrared (IR), 950nm IR Probes. Figure 4. Laser Probes Figure 6. Mini USB Port Figure 5. Lens Tips An individual laser probe can easily be activated by connecting it to the main unit next to the power supply cord in the mini USB port as shown in Figure 6. Make sure the laser device is in the OFF position when attaching the selected probe to the smaller port on the main unit. Care should be exercised when plugging in the probes. Please exercise caution so that the output cable is correctly connected to the probe with a twist clockwise and the probe “snaps” the connector securely into place. Note: If a probe is being used, the main unit's output array (multiple diodes on the bottom of the laser main unit) may be disabled under program control by the practitioner along with selection of the proper lens Tip for the application. LASER PROBE SPECIFICATIONS -ALL PROBES < 1.OO(w/cm 2 ) gt 10 cm are by prescription only 2 PROBE Wavelength (nm) 660 nm - 765nm DUAL 660 nm Power Density (W/cm2) 4 mw 100 mW Power Density 2 (w/cm 2) gt 10 cm <.1.00 1.44 Diode Type GaAlA GaAlA GaAlA 830 nm 100 mW 1.44 GaAlA 950 nm 100 mW 1.60 GaAlA Protective Eye Wear must be worn with laser probes. In yellow Index 21 MONITORING DEVICE FUNCTION • If the Spectra Therapy Low-Level Laser is operating properly, the patient will feel a gentle warming of the skin surface in the area when receiving treatment. • The single digit display on the top side will be lighted and the RED Lasers and/or LEDS will be activated • The emitter consists of 16 LED’s [ 8 red LEDS and 8 IR LEDS not visible light] and 4 dual laser diodes (in metal Tubes). When the emitter is activated, 8 red LED’s light up or the 4 lasers. • Do not look directly at the emitter head checking the device operation. Radiation from the other 8 LED’s and the laser diode are invisible to the eye. Effect of Device Failure on Patient If the Spectra Therapy Low-Level Laser fails prior to commencement of treatment, the emitter will not turn on and first plug the unit into a charger using the USB Cable . If there is an equipment failure during the course of the treatment, the emitter will shut off, recharge the battery. If the emitter does not shut off at the end of the treatment session, the user should position the unit so that the emitter cannot cause vision irritation. Contact the equipment dealer as soon as possible for further instruction. INDEX 22 PREPARING THE SKIN FOR LASER THERAPY PREPARING THE SKIN FOR LASER THERAPY Before applying laser light therapy to the patient, you must first prepare the patient’s skin. By properly preparing the patient’s skin for laser light therapy, you will allow more laser light energy to reach the targeted areas and reduce the risk of skin irritation. To prepare the patient’s skin for laser light therapy, do the following: 1. Thoroughly wash the skin on the areas that you intend to laser with mild soap and water. 2. Dry the skin thoroughly. PREPARING THE SPECTRA UNIT FOR USE Before each use, clean the plastic lens with a soft cloth with plastic lens cleaner. Make certain to apply with a clean cloth. Failure to clean the lens between therapy sessions could cause beam fragmentation, which may reduce the effectiveness of the treatment. PREPARING THE USER FOR LASER THERAPY After reviewing all the contraindications for your immediate need, next review the overview of Treatment programs to select the most appropriate protocol for use. INDEX 23 METHODS FOR DELIVERING TREATMENT Methods for Delivering Treatment • In general, the emitter should simply be held in the place where the pain or discomfort is being felt. Once the laser is over an area that the patient indicated “pain”, it is best to keep the laser over that area or point long enough to allow the particular area to receive and absorb an adequate dose of photonic energy from the laser probe, acting as an infrared heat lamp. In cases where the area of treatment is more general, “sweep” the area by moving the laser device both vertically & horizontally, making several passes over the entire location, as shown. This is the easiest means to accurately treat any area, large or small, making sure all surrounding tissues are stimulated. The “sweeping “ motion with the laser will cover the entire area, making sure the treatment is adequate to stimulate a positive response from the patient. Sweep area in both directions twice to ensure that larger areas [greater than the size of the emitter window] are covered. NOTE: FIXED TIME PERIOD FOR EACH PROTOCOL IS INIDCATED ON CHART THE A1000 TIMES OUT AUTOMATICALLY. INDEX 24 OVERVIEW OF THERAPY TREATMENTS Overview of The Spectra Therapy Treatment Programs The pain you are feeling can be divided into two areas, localized pain (shallow pain felt near the surface of your body or pain confined to one area) or radiating pain (for example, pain radiating from your neck to the arm), which typically is internal (deep) pain felt along your nerves. Pain is defined as physical discomfort or suffering associated with a bodily disorder. Stiffness is defined as an area of the body that is inflexible or rigid and cannot be moved easily with/or without pain. When you are feeling pain that seems like minor muscle pain or a muscle spasm, identify the location of the pain and focus the Spectra Therapy Low-Level Laser beam directly on it. For joint pain/ arthritis, focus the beam on the joint-line area. (The joint-line area is the area where the two bones meet). The Spectra Therapy Low-Level Laser is supplied with six pre-programmed treatment programs that have been established to treat different conditions (see Table 1 & 2). A program is selected by pushing the On/Off button. The duration of all of the treatment programs are shown below; Each program uses different pulse frequencies, as summarized in the table below. Variation of the pulse frequencies alters the depth of penetration of the laser light based on tissue type. As with any pain, a physician or medical person should be consulted on the onset of pain. Advise them of your plans to use the SPECTRA Therapy laser. The course of treatment may be as follows: • An initial treatment cycle consists of up to three days treatment (one day’s treatment is defined as three 10-15 minute sessions) for either program 1 or 2, couple with a 3,4 or 5 - specific to stiffness, pain or muscle problem • Three-day treatment cycles can be repeated, by applying treatment three times a day on each individual point for no more than 21 consecutive days, if pain persist consult a physician . • Patients should expect to feel relief of pain and/or stiffness within 6 days of commencing treatment, although some patients begin to feel beneficial affects following the first treatment • Upon completion of a full course (21 days) of the single treatment course, a further course can be undertaken after a 3-day break. • Consult with a practitioner as you see fit. Some forms of arthritis are chronic. If the Spectra A1000 offers some temporary pain relief for this type of chronic problem , this is a good sign that your condition is responsive to this therapy. | INDEX 25 TREATMENT RECOMMENDATIONS TREATMENT RECOMMENDATIONS Contact To obtain the most effective results, the Light source should be in contact with the skin. Light Source Position Based on the characteristics of laser light, the angle at which the light enters the patient’s skin is very important. Therefore, the light source lens should always be parallel to the treatment area. Treating Joints If you are applying laser light therapy to a joint, it is more effective to apply the laser light energy into the joint by positioning the joint in an open position (e.g., knee in flexed position). Do not attempt this method if it is uncomfortable. Selection of Light Source. Unit or Probe If the injury you intend to treat is a small area, you should may treat the area with a single diode probe. If the area surrounding the treatment area is sensitive, it is recommended that you apply therapy with a single diode probe at then use the Spectra unit cluster for the surrounding area. Cold and Heat If you intend to apply cold or heat in conjunction with laser light therapy, use the following guidelines: • Use cold before laser light therapy. Cold slows the flow of red blood cells, thus, less energy flows from the area. • Use heat after the treatment. This speeds the flow of red blood cells, thus, more energy can be removed from the area. INDEX 26 TREATMENT PROGRAMS TREATMENT PROGRAMS The indications contained in this section are to be used only as guidelines. Each patient should be individually assessed to determine the appropriateness of the parameter setting prior to use. The unique benefits of Spectra TherapyTM Low Level Laser are that it automatically steps through to the defined frequencies in Programs 0-5 and A- F. This automatic function makes it extremely easy for a patient to stimulate the cells over a range of specific frequencies to provide complete pain therapy. To select an indication for a patient, select one of the following: modes / protocols. TABLE 1 TREATMENT PROGRAMS Index 27 TREATMENT PROGRAM DESCRIPTIONS MODE 0 –-Arthritis Anti-Inflammatory . -Skin undergoes changes in response to the aging process, bruising or injury, or illness. These changes can include: Thinning of the outer layer., Loss of collagen production, Loss of oxygenated blood, Physiological changes to the skin due to a gradual reduction in the cycle of skin renewal. Reduction in the skin’s elasticity due to changes in the skin’s fibers and loss of liquid. Reduction in sweat and fat secretion. Low-level laser therapy assists in the rejuvenation of skin cells, and either slows or reduces the aging of the skin by increasing the skin’s flexibility and elasticity. Instructions: Sweep the Spectra Unit over the affected area touching the skin. Two consecutive sessions are recommended for all treatments. The sweeping motion should be around 2 cm per second, (about one eighth of an inch), with each area being passed over around 10 times in the course of a treatment. Treatments should be repeated for every 10 centimeters or 4 inches of affected skin area. MODE 1 – Chronic Pain Syndrome - Pain can inflict disorders that complicate relaxation and routine sleep while increasing levels of stress. This protocol has the Beta Wave frequenct to assist the body to regenerate and allow for relaxation while eliminating minor pain. MODE 2 – Relief of Stiffness Out of balance DNA can inflict disorders that complicate recovery from pain since it constricts blood supply by being tense. With the Spectra Unit, as in Mode 0, use a sweeping motion around 2 cm per second, (about one eighth of an inch), with each area being passed over around 10 times in the course of a treatment. Treat areas which are tense ,stressed or painful . Treatments should be repeated for every 10 centimeters or 4 inches of affected skin area. MODE 3 – Relax Muscle Tissue - The frequencies used in this protocol enables the laser to penetrate deeper into the body, enabling the treatment of chronic pain resulting from damage to cells or muscles well below the surface of the skin. This treatment Protocol can also be used to significantly accelerate the recovery process following fractures. Instructions:As in Protocol 0, Hold the Spectra Unit against the skin and sweep it slowly around the area of the pain. Consecutive daily sessions are recommended for most treatments but not necessarily required.. MODE 4 - Temporary relief of sever pain - Reduction in pain is one of the most significant results of Low level laser therapy. Bio-stimulation and the conversion of tight energy into chemical energies allow for this success. Instructions: As in Protocol 0,Hold the Spectra A1000 Cluster LED against the skin and sweep it slowly around the pain area. Consecutive daily sessions, twice a day morning and evening are recommended for most treatments. Tendonitis, arthritis, sprains, strains, athletic injuries, inflamed or infected muscles MODE 5 - Swelling reduction - Low-level laser therapy has a significant impact on regeneration of healthy cells. This occurs primarily through enhancement of peripheral nerve regeneration after injury; stimulation of the rate of mitosis in repair mechanisms; increased microcirculation; reduction or elimination of scar tissue formation; and reduction in swelling. In most cases, skin status will improve significantly, or even clear completely. Laser care combines treatment under Protocols 0 and 5, with Protocol 0 focusing on the cells well below the surface of the skin, and Protocol 5 treating cells within the different layers of the dermis. INDEX 28 Instructions: Sweep the Spectra Unit over the affected area. Where possible, make sure the unit comes in direct contact with the skin. If the skin or wound is open it is suggested that you place the Spectra Unit in an open zip lock baggie to ensure it will remain clean when treating the area. Consecutive daily sessions are suggested for most treatments but not required as each individual responds differently. For open wounds, post operative wounds, diabetic ulcers and burns, daily treatment should consist of 2-4 sessions - 2 consecutive treatment sessions sweeping over the area the wound using Protocol 5, followed by an additional 2 consecutive sessions using light therapy found in Protocol 0. The twelve basic programs contained in the Spectra Therapy A1000 when shipped, provide excellent treatments for practitioner use. Those who desires to extend therapy durations, as well as customize Frequency Specific Therapy’ s can unleash true power of the Spectra by going toe Spectra Therapy.com and follow the instructions, down loading the Spectra Light Programmer. INDEX 29 KEY PROTOCOLS KEY PROTOCOL PROGRAMS Alternative, additional or specialized timed singular program therapies may be run by the Spectra Therapy Low-Level Laser by inserting an electronic program Key. Keys may be purchased or provided by the practitioner. As an example, the operator can program a Key, so that when inserted into the Spectra unit, the unit will only run as follows: 1) Run only the single pain program of various frequencies defined below for Dawn that is called Program A- Bone Pain. 2) Spectra Unit will run/operate for a total of 4 hours. Then the Key must be reprogrammed by the authorized person with the proper access codes. Limited Time Operation Using Key Singular Program Mode - Demonstrates limited Access Key programLooking at Table 2 for Jim, Program B “Edema & Swelling”, the Spectra Unit will run 8 different frequencies with a duration of 120 seconds each. After running the sequence totaling 8 hrs, the Spectra unit will not operate until the key is reactivated by plugging it into a computer, using proper access codes. The Key will then reactivate the Spectra unit. INDEX 30 ALTERNATIVE LASER LIGHT THERAPY PROGRAMS Alternative Pain & Muscle Programs Five pre-programmed therapies shown below demonstrate the uniquely patented Key concept of the Spectra Therapy Low-Level Laser unit. Frequencies are automatically cycled in various modes versus self-timed operations. Spectra Unit Key & Port Table 3. Treatment Programs Using Key The Spectra unit Key feature can be purchased separately. With this Key, along with the associated Spectra PC software, available through a practitioner, your therapy time and frequency setting can be altered, limited or inhibited on either the Spectra Therapy Low-Level Laser unit or Key. Instructions for the Software reside fully with the Software in its Help menu. INDEX 31 ALTERNATIVE THERAPY PROGRAM DESCRIPTIONS . MODE A – Moderate Pain Bio-stimulation and the conversion of tight energy into chemical energies allow for this success. As in Protocol 0, hold the Spectra A1000 Cluster LED against the skin and sweep it slowly around the pain area. Consecutive daily sessions, twice a day morning and evening are recommended for most treatments. Tendonitis, arthritis, sprains, strains, athletic injuries, inflamed or infected muscles. MODE B – Stress Pain can inflict disorders that complicate relaxation and routine sleep while increasing levels of stress. This protocol has a Beta Wave frequencies to assist the body to regenerate and allow for relaxation while elevating pain. As in Protocol 0, move Spectra A1000 Cluster LED against the skin and sweep it slowly around the pain area. Consecutive daily sessions, twice a day morning and evening are recommended for most treatments. MODE C – RELIEF OF STIFFNESS. Temporary Out of balance DNA can inflict disorders that complicate recovery from pain since it constricts blood supply by being tense. With the Spectra Unit, as in Mode 0, use a sweeping motion around 2 cm per second, (about one eighth of an inch), with each area being passed over around 10 times in the course of a treatment. Treat areas which are tense, stressed or painful. Treatments should be repeated for every 10 centimeters or 4 inches of affected skin area. MODE D- JOINT PAIN Temporary Relief The frequencies used in this protocol enables the laser to penetrate deeper into the body, enabling the treatment of chronic pain resulting from damage to cells or muscles well below the surface of the skin. This treatment Protocol can also be used to significantly accelerate the recovery process following fractures. As in Protocol 0, hold the laser against the skin and sweep it slowly around the area of the pain. Consecutive daily sessions are recommended for most treatments. Probe pens may be used as instructed, Insert probe into Spectra Unit, and use pen and focus intense light beam on desired area, One can either place directly on area, or hold a 1/16th “ away. Try not to touch open wound which may cause physical disturbance to healing cells. Hold just slightly off skin surface. . MODE E- Relax Muscles - The frequencies used in this protocol enables the laser to penetrate deeper into the body, enabling the treatment of chronic pain resulting from damage to cells or muscles well below the surface of the skin. This treatment Protocol can also be used to significantly accelerate the recovery process following fractures. As in Protocol 0, hold the laser against the skin and sweep it slowly around the area of the pain. Consecutive daily sessions are recommended for most treatments but not necessarily required. MODE F- Muscle Pain Temporary Relief Reduction in pain is one of the most significant results of Low level laser therapy. Bio-stimulation and the conversion of tight energy into chemical energies allow for this success. Instructions: As in Protocol 0,, Hold the Spectra A1000 Cluster LED against the skin and sweep it slowly around the pain area. Consecutive daily sessions, twice a day morning and evening are recommended for most treatments. Tendonitis, arthritis, sprains, strains, athletic injuries, inflamed or infected muscles. Use probe pen with applicable tip to get into hard to reach areas like elbow crevice or where area is very tender and stiff, knotted muscles. INDEX 32 WARRANTY Warranty Spectra TherapyTM LLC , hereinafter called the Company, guarantees that Spectra Therapy Low-Level Laser will operate in the manner described in this manual for a period of 12 months from the date of purchase, when used and maintained in accordance with the instructions herein. Defects or damage due to misuse or abuse are not covered by this warranty. Please have this warranty information available, along with the date of purchase and the Spectra Therapy Low-Level Laser in the event of a complaint. The Company shall not be liable in any manner in respect to bodily injury and/or property damage arising from the use of the Spectra Therapy Low-Level Laser, where such use is not in strict compliance with the instructions and safety precautions contained in the Spectra Therapy Low-Level Laser Users Manual, including all supplements thereto, in all product labels, and according to the terms of warranty and safety of this equipment, nor if any changes unauthorized by the Company are made to the Spectra Therapy Low-Level Laser. This Warranty Does Not Cover: • ANY MALFUNCTION OR FAILURE IN THE PRODUCT CAUSED BY PRODUCT MISUSE, INCLUDING, BUT NOT LIMITED TO, DROPPING THE UNIT OR PROBE AND FAILURE TO PROVIDE REASONABLE AND NECESSARY MAINTENANCE OR ANY USE THAT IS INCONSISTENT WITH THE PRODUCT USERS MANUAL. • Replacement parts or labor furnished by anyone other than the Company, the selling dealer or a certified Company service technician. • Defects or damage caused by labor furnished by someone other than Company, the selling dealer or a certified Company service technician. COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. To obtain service from Company or the selling dealer under this warranty: 1. A written claim must be made within the warranty period to the Company or the selling dealer. Written claims made to the Company should be sent to: Telephone:248-524-6300 – US FAX: 248-524-2983. 2. The Product must be returned to the Company or the selling dealer by the owner. This warranty gives you specific legal rights and you may also have other rights, which vary from state to state or location to location. The Company does not authorize any person or representative to create for it any other obligation or liability in connection with the sale of the Product. Any representation or agreement not contained in the warranty shall be void and of no effect. THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OR MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INDEX 33 SERVICE SERVICE All units returned to the factory for service must include the following: WARRANTY REPAIR/OUT OF WARRANTY REPAIR 1. Written statement containing the following information: • Return Authorization (RA) Number - Obtain from Factory • Unit Model Number • Unit Serial Number • Contact person with Phone and Fax Numbers • Billing Address (for Out of Warranty Repair) • Shipping Address (Where to Ship Unit after Repair) • Detailed Description of Problem or Symptoms 2. Copy of original invoice issued at purchase of the unit. 3. Ship the unit to address specified by an authorized service technician. Date of Purchase: ________________ /Model # ____________.¸ Place of Purchase,_____________, Serial #______________ . Name ___________________________________________ Address _________________________________________ City _________________________, State_______ Zip _____________ Mail Warranty Card or Register on line at www.SpectraTherapy.com Spectra Therapy, LLC -- 3863 Rochester Rd. -- Troy, MI 48083 Ph 248-524-6300 Fax 248-524-2983 Distributor Information INDEX 34 List of Parts & Accessories INDEX 35 STIM WRAP & STIM PACK – USE INSTRUCTIONS To used for the back, insert the extra Velcro Strap, in the Wraps “D ring” as shown, Then convenient use like a belt affixing it the Stim Wrap’s other strap. 1) Just unzip the Spectra Wrap to begin your therapy . . One may use the Spectra Wrap’s “D ring to feed it through and cinch it. around a leg or arm. For other applications, the simple Velcro strap may be the best solution for the positioning just the Spectra A1000 Unit for therapy. 2) For applications other than the back, slip the unitw and any surplus cable, into one of the pockets of the Stim Wrap for convenient use and storage. 3) As required, affix Velcro strap around Spectra Unit and then affix with unit in wrap. The wrap provides a convenient means to position Spectra unit during long therapy sessions & insures proper positioning of treatment. 36