ATTENTION: TABLE OF CONTENTS General care with the equipment………………………...........................2 Explanation of the symbols used................................................................3 Preliminary observations……………………………………..……………...….5 SONOPULSE III 1.0 MHz/ 3.0 MHz – Description………………………..….6 SONOPULSE III 1.0 MHz/ 3.0 MHz - Power supply…………….…………....8 SONOPULSE III 1.0 MHz/ 3.0 MHz – SONOPULSE III 1.0 MHZ MANUFACTURED BY IBRAMED. THIS MANUAL OF INSTRUCTIONS REFERS TO Controls, Indicators and Instructions for use………….……………………......9 Learning to use SONOPULSE III 1.0 MHz/ 3.0 MHz ………………………..14 Ultrasound Introduction ……………………………….………………………20 Effects produced by Ultrasound…………………………………………….....21 Directions for Ultrasound therapy…………………………….……………..…23 Table of absorption coefficient……………………………….………….…….24 Ultrasound transducers…………………………………………………...……25 Ultrasound in cellulitis……………………………………...……………...….. 26 PLEASE READ THIS MANUAL CAREFULLY BEFORE USING THE EQUIPMENT AND ALWAYS REFER TO IT WHENEVER DIFFICULTIES APPEAR. KEEP THIS MANUAL ALWAYS AT HAND. Special Applications of Ultrasound …………………………………………...30 Indications and counter indications…..……………...…………….…………. 34 Biocompatibility………………………………………………….…...……….36 Transducer Cleaning / Maintenance / Warranty………………….……….…...36 Warranty Terms ……………………………..…………………………...……38 SONOPULSE III 1.0 MHz/ 3.0 MHz - Accessories………..……….…...……39 Operation Manual for SONOPULSE III 1.0 MHz/3.0 MHz– 1st edition (06/2007) SONOPULSE III 1.0 MHz/ 3.0 MHz - Technical characteristics………..…...39 Bibliography………………………………………………………………….42 Electromagnetic Compatibility………………………………………….……44 Commercial survey……………………………………………………...…….50 1 2 GENERAL CARE WITH THE EQUIPMENT CAUTION! RISK OF ELECTRICAL SHOCK DO NOT OPEN IT ♦ Avoid places exposed to vibration. ♦ Install the equipment on a firm and horizontal surface, in a site with perfect ventilation. The lightning bolt symbol inside a triangle is a warning about the presence of “dangerous voltage”, without insulation in the internal part of the equipment which may be strong enough to cause risk of electrical shock. ♦ In case of a built-in cupboard, make sure that there is no obstacle for the free air circulation on the back of the equipment. ♦ Do not lay it on carpets, rugs, cushions or other soft surfaces that can obstruct the ventilation. ♦ Avoid humid, hot and dusty places. This equipment is not protected against harmful water penetration. An exclamation mark inside a triangle alerts the user about the existence of important operation and maintenance instructions (technical service) for this equipment. ♦ Place the cable in order to leave it free, out of places where it can be trodden on, and do not place any furniture over it. ♦ Do not insert objects into equipment orifices and do not place recipients with liquid on it. ♦ ATTENTION: In order to avoid electric shock, do not use the product plug with the extension cord, or other kinds of outlet, unless the blades can be fully inserted into the receptacle. Disconnect the product plug when the unit is not used for longer periods. ] Do not use volatile substances (benzene, alcohol, thinner and solvents in general) to wipe the equipment cabinet because they can damage the finishing. Use only a soft, dry, and clean piece of cloth. ♦ Do not use volatile substances (benzene, alcohol, thinner and solvents in general) to wipe the equipment cabinet because they can damage the finishing. Use only a soft, dry, and clean piece of cloth. 4 3 EXPLANATION OF THE SYMBOLS USED On the transportation box: - FRAGILE: The content in this package is fragile and should be handled with care. ATTENTION! Check and follow the instructions in this manual. - Equipment CLASS II. The protection against electric shock is not based only in the basic insulation but also incorporates additional safety precautions, such as double or reinforced insulation, not holding grounding resources protection or depending on installation conditions. - - THIS SIDE UP: Indicates the correct position to ship the package. Equipment with BF applied part. 50ºC TEMPERATURE LIMITS: Indicates the limit temperatures for transportation and storage the package. 5ºC - Indicates sensitivity to electrostatic discharge. - Risk of electrical shock. KEEP IT AWAY FROM THE RAIN: This package should not be shipped under rain. IPX1 - Equipment is protected against water dripping. - Transducer V~ - Volts in alternating current ~ line - Alternating current power line 5 - MAXIMUM STACKING NUMBER: The maximum number of identical packages which can be stacked. For this equipment, the limit stacking number is 5 units. SONOPULSE III 1.0 MHz/ 3.0 MHz 6 5 PRELIMINARY OBSERVATIONS SONOPULSE III 1.0 MHz/3.0 MHz Appliance Description Sonopulse III 1.0 MHz/ 3.0 MHz is a modern piece of equipment which uses microcontroller technology. It is designed for all kinds of ultrasound therapy. SONOPULSE III 1.0 MHz/ 3.0 MHz corresponds to a CLASS II BF- applied part equipment of safety and protection against electrical shock. It should be operated only by qualified professionals and in properly authorized medical departments. The use of these units is not prescribed in places where there is risk of explosion, such as anesthesia departments, or in the presence of inflammable anesthetic mixture with air, oxygen or nitrous acid. Electromagnetic Interference – If the patient, the equipment and/or cables are connected next to the area of influence of emission of a high frequency surgical device, of micro wave or short wave diathermy device, the possibility of danger to the patient is not ruled out. Normally, a distance of 2 to 3 meters is sufficient. The simultaneous use of SONOPULSE III 1.0 MHz/ 3.0 MHz with high frequency surgical devices or diathermy may be dangerous to the patient and cause damage to the equipment. To prevent electromagnetic interference, we suggest that a group of the electrical power line is used for the SONOPULSE III 1.0 MHz/ 3.0 MHz and another separate group is used for the short wave or micro wave equipment. IBRAMED With a modern design, the SONOPULSE III 1.0 MHz/ 3.0 MHz cabinet was designed following the existing medical device construction norms. The equipment is in accordance with technical norms NBRIEC 60601-1, NBRIEC 60601-1-2, and NBRIEC 606001-2-5. It has a frontal panel with slight inclination which allows the therapist to adjust the device while standing up. Essential performance: SONOPULSE III 1.0 MHz/ 3.0 MHz was developed for ultrasound therapy in physiotherapy, having as application field the inflammatory rheumatic affections, peripherical nervous system, inflammatory affections, peripherical circulatory problems, inflammatory affections of superficial skin zones, degenerative alterations of the skeleton, specially vertebral column, contractions, periarthritis, cellulitis, phonophoresis, post-operative, etc. Besides allowing the choice of functioning in 1.0 or 3.0 MHz, the equipment allows the choice of ultrasound emission mode between continuous or pulsed. There are six types of pulses: Frequency of pulse repetition of 100 Hz Duty Factor 50% - with ON duration time of 5,0 ms and OFF pulse pause time of 5,0 (1/2). Duty Factor 20% - with ON duration time of 2,0 ms and OFF pulse pause time of 8,0 ms (1/5). Frequency of pulse repetition of 48 Hz Duty Factor 50% - with ON duration time of 10,5 ms and OFF pulse pause time of 10,5 (1/2). Duty Factor 20% - with ON duration time of 4 ms and OFF pulse pause time of 17 ms (1/5). Frequency of pulse repetition of 16 Hz Duty Factor 50% - with ON duration time of 31 ms and OFF pulse pause time of 31 (1/2). Duty Factor 20% - with ON duration time of 12 ms and OFF pulse pause time of 50 ms (1/5). 7 Inside the SONOPULSE III 1.0 MHz/ 3.0 MHz Ultrasound transducer there is a temperature sensor which will be verifying and keeping the duty temperature of the piezoelectric crystal and consequently the temperature of the transducer aluminum face constant, thus avoiding to the patient that disagreeable sensation of excessive heat. This sensor is programmed so that the temperature in the aluminum does not exceed 41 degrees Celsius. During the treatment, especially when the coupling gel is not of the best quality, the temperature may rise above 41 degrees centigrade. Whenever it happens, the equipment will “freeze” the timer programmed time, turning off the ultrasound emission. At this point, a sound beep will be heard and the display (5) will indicate: 8 SONOPULSE III 1.0 MHz/ 3.0 MHz also has a screen called “PROGRAM”, which allows the choice of several ready treatment programs (recorded on the memory of the equipment). At the end of the programmed time, sound beeps are emitted and the ultrasound emission is interrupted. All the functions such as timer (timer device), emission mode (continuous or pulsed) and intensity (W/cm2 ) are programmed by touch keyboard and indicated on the alpha numerical liquid crystal display. SONOPULSE III 1.0 MHz/ 3.0 MHz - Electrical Feed SONOPULSE III 1.0 MHz/ 3.0 MHz works with power line tensions in the band of 100 – 240 volts 50/60 Hz. Therefore, concerns about the tension of the local power supply line are not necessary. It is enough to plug in the equipment to the power plug and it will select 110/220 volts automatically. The power supply cable is detachable. The equipment uses the power supply plug as a resource to separate electrically its circuits in relation to the power line in all the poles. EXCESS OF TEMPERATURE The professional should keep “passing” the transducer as if nothing had happened, for after a few seconds the temperature will go back to normal. The equipment will automatically “revert freeze” time returning to its original program. Note: it is common, when testing the equipment, to place some drops of water on the transducer aluminum face to watch the effect of nebulization (water cavitation). The conduction medium of emitted ultrasound at this moment (drops of water/ air) is very precarious. This will cause a rapid rise in temperature, to more than 41 degrees Celsius. The ultrasound emission will be interrupted, avoiding damage to the piezoelectric crystal placed inside the transducer. ATTENTION: On the rear part of the equipment, is located the protection fuse. To replace it, turn the equipment off, unplug it from the power outlet and, with a small screwdriver, take the protective lid off, disconnect the fuse, perform the replacement and put the lid back to its original place. Place the adequate fuse, model 20 AG: Use 5.0A fuse SECURITY RISKS MIGHT OCCUR IF THE EQUIPMENT IS NOT PROPERLY INSTALLED. 9 10 SONOPULSE III 1.0MHz/3.0 MHz Controls, indicators, and operation REAR VIEW UPPER VIEW LOWER VIEW FRONT VIEW 11 VIEW OF THE ULTRASOUND TRANSDUCER, CABLE, AND ATTACHMENT CONNECTOR: 12 9 – Connection for combined therapy input. 10 – Ultrasound Emission Transducer connection. 11 – Power cable connection to be connected to the power supply line. 12 – Protection fuse: never use fuses of different values from the original. Read SONOPULSE III 1.0 MHz/ 3.0 MHz - electrical feed in this manual. 13 – General characteristics board. Transducer cable attachment connector Ultrasound transducer Always tighten the attachment screws of the connector. Attention: The transducer cable attachment connector has screws which should be tighten to the output connector (10) situated on the panel of the equipment. Always tighten the screws of this connector. 1 – ON/OFF switch. 2 – “ON” indicator LED. 3- BACK and NEXT control switch. 4 – SET – and SET + control switch. 5 – Alpha numerical liquid crystal display. 6 – STAR/STOP switch. 7 – UP/DOWN ultrasound intensity switch. 8 –PROGRAM control switch. 14 – Label with the ultrasound output characteristics. 13 14 All the parameters are programmed by touch keyboard and indicated on a liquid crystal display. Therefore, below there is the description and the necessary steps to operate the equipment: Learning to use the SONOPULSE III 1.0 MHz/3.0 MHz: Step 1: ON/OFF switch (1). When you turn on the equipment, the liquid crystal display (5) will show for a few seconds the following introduction messages: After this introduction, the display (5) will start operation indicating: The field destined to the choice of ultrasound EMISSION MODE; continuous or pulsed. Field destined to the indication of ultrasound frequency: 1 MHz or 3 MHz. Field destined to the choice of pulse frequency when in pulsed mode: 100 Hz, 48 Hz, or 16 Hz. Field destined to the choice of pulse type: duty factor of 50% or 20%. Available only when the mode chosen is PULSED. W Note that there is a cursor flashing in the field destined to the choice of ultrasound emission. Field destined to the choice of EFFECTIVE INTENSITY of emitted ultrasound. Step 2: BACK/NEXT switch (3). Select the necessary parameters for the treatment. Pressing the NEXT switch you will be advancing to another parameter. Pressing the BACK switch you will be returning to the previous parameter. Note that at each selection you make through the BACK and NEXT switches, the chosen parameter will have a flashing cursor. Field destined to the EFFECTIVE POTENCY of emitted ultrasound. Step 3: SET – and SET + switches (4). These switches let you chose the values of each parameter necessary for the therapy. SET + (increasing values) SET – (decreasing values) Field destined to the choice of TIMER. It allows selecting the timer from 1 to 30 minutes. 15 Step 4: START/STOP control switches (6). Once you have selected and chosen the respective parameters and values (as described in the previous paragraphs), press the START switch. Note then that the flashing cursor has disappeared. The program will be in execution at this point. Chose the ultrasound intensity necessary for the treatment now. If you wish to interrupt the application, just press the STOP switch. The ultrasound emission will be interrupted and the flashing cursor will appear again so that a new programming could be made. At the end of the programmed time, a sound signal will be heard (several beeps) and the ultrasound will be interrupted. Press now the STOP switch so that the sound signal is turned off and the equipment returns to the programming condition (flashing cursor). As you have noticed, the same switch has two functions: START – start the treatment and STOP – stop the treatment. Step 5: UP/DOWN switch (7). INTENSITY; once you press the START switch, the equipment will start executing the parameters chosen by the operator. At this point these switches UP/DOWN will start operating, increasing or decreasing the effective potency and the intensity of ultra sound: Continuous Mode: Ultrasound effective intensity from 0,1 to 2,0 W/cm2. Ultrasound effective potency: 0,3 to 7,0 W. Pulsed Mode: Ultrasound effective intensity: ½ (50%) – from 0,1 to 2,0 W/cm2 1/5 (20%) – from 0,1 to 2,0 W/cm2 Ultrasound effective Potency: ½ (50%) – from 0,3 to 7,0 W. 1/5 (20%) – from 0,3 to 7,0 W. 16 Control switch PROGRAM (8) – This switch allows the operator to select ultrasound treatment protocols. They are ready-made treatment ultrasound programs, which are stored in the equipment memory. SONOPULSE III 1.0 MHz/3 MHz will allow you to choose the following protocols: Treatment Program Protocol for 3.0 MHz Ultrasound Treatment Cellulitis degree 1 Cellulitis degree 2 Cellulitis degree 3 Immediate post operative Late post operative Immediate Ritidoplasty Late Ritidoplasty Phonophoresis Note: Cellulitis degree 3 is the most severe condition; the post operative refers to the various types of plastic surgery (mammoplasty, abdominoplasty, and liposuction.) The immediate post operative condition can only be treated in case the bandages could be removed, if not, the laser is the most indicated in that phase, in the sense of incrementing cicatrization. 17 Ultrasound Treatment Program Protocol for 1.0 MHz TISSUE Tendon Ligament Muscle DEPTH Nature of Lesion Superficial Acute Bursa Synovial Membrane Bone Chronic 18 2 – Once you have chosen the treatment, press the PROGRAM switch again. Note that the equipment can be self-programmed. You just have to press the START switch for the SONOPULSE III 1.0 MHz/ 3.0 MHz to execute the chosen program. Exemplifying how to choose ultrasound treatment protocols for 1.0 MHz: Profound 1 – Press the PROGRAM switch (8). The liquid crystal display (5) will start to indicate: Cartilage Exemplifying how to choose ultrasound treatment protocols for 3,0 MHz: 1 – Press the PROGRAM switch (8). The liquid crystal display (5) will start indicating TENDON TISSUE Note the flashing cursor. 2 – If you now press the SET + switch, TENDON will be flashing. Press again and you will have MUSCLE flashing. Once more and you will have BURSA/M. SYNOVIAL flashing. You have noticed that you are choosing types of tissues. We still have Bone and Cartilage. CELLULITIS DEGREE Note the flashing cursor. Through the SET + switch, you will also be able to choose CELLULITIS DEGREE 2, CELLULITIS DEGREE 2, IMMEDIATE POST OPERATIVE, LATE POST OPERATIVE, IMMEDIATE RITIDOPLASTY, LATE RITIDO PLASTY, and PHONOPHORESIS. 3 – If you now press NEXT, DEPTH the word PROFOUND appears, with the cursor flashing. Press SET +< and SUPERFICIAL will appear with the flashing cursor. Press NEXT again and NATURE LESION and CHRONIC will appear, with the cursor flashing. Finally, through the switches NEXT/BACK and SET +/SET –, you will be able to choose the type of TISSUE (tendon, ligament, cartilage, bursa/ synovial membrane, bone or cartilage), DEPTH (profound or superficial) in which the tissue is located and the NATURE OF LESION (chronic or acute one). 19 Note: 1 – SONOPULSE III 1.0 MHz/ 3.0 MHz has several types of protection system which guarantee its good functioning. Consequently, if any time when turning on the equipment, or in case of power cut, the liquid crystal display (5) shows malfunction, or displays any kind of pieces of information that differs from the ones shown in this manual, do as follows: turn off the equipment and wait for approximately 5 seconds. Turn it on again and it will return to normal. 2 – If during the program you forget to set up the timer, a sound signal (beep) will also be emitted, indicating an operational error. At this point, the display (5) will indicate: 20 ULTRASOUND INTRODUCTION: For more than thirty years the ultrasound has been widely used by professionals of medical area (Lehmann and Krusen, 1958). As the name suggests, they are sound waves, mechanical vibrations in an elastic medium. These longitudinal waves make the tympanic membrane vibrate, which produces the sound vibrations. The frequency range the human ear can hear is approximately between 20 Hz and 20,000 Hz. Frequencies below 20 Hz are the sub sounds or the infra sounds. So, we can say the ultrasound therapy is a medical treatment through mechanical vibration of frequencies above 20,000 Hz (20 KHz). So, we can define ultrasound as being a medical treatment by mechanical vibration with frequency above 20,000 Hz (20 KHz). CONTINUOUS OR PULSED ULTRASOUND SET UP THE TIMER Press the STOP switch (6) and note that the error message has disappeared. In the field destined to the choice of TIMER the cursor will appear, flashing. Choose then the time necessary for treatment and go on with your application. 3 – If the operator wishes to interrupt the treatment or chooses a new timer after the sounding of the beep, he should then press the STOP switch (6) so that the equipment returns to the condition of new parameter programming. 4 – If by any chance there is a power cut, or any kind of interruption of electricity supply (blackout), the equipment is turned off automatically. Therefore, when the electricity supply is restored you should execute the programming necessary for the treatment again. The use of pulsed ultrasound instead of continuous ultrasound results in a midlevel reduction of tissue heating, but keeping the same instantaneous level of the mechanical stimulus in the tissue. This allows the increase of non-thermal effects of the ultrasound in tissues (Summer and Patrick, 1964). In the continuous ultrasound therapy, the energy issued by the transducer produces a continuous increment in the tissues heating and the treatment can become intolerable to the patient, especially in cases of more acute and recent traumas where the ultrasound can be very efficient. In the pulsed ultrasound therapy, the transducer creates wave pulses of preset periods that issue energy periodically, where, through the rest of time between pulses, the blood circulation cools the treated area, preventing overheating. Thus, there are physiological effects resulting from a non-thermal process. Many authors recommend different periods of pulse duration, the most common and most frequently used being 2.0 ms “ON” pulses for 8.0 ms “OFF” pulses duty factor 20% (1/5). 21 22 ULTRASOUND EFFECTS Chemical Reaction: Just as a test tube is agitated in the lab to accentuate chemical reactions, the ultrasound vibrations stimulate the tissue to increase local chemical reactions and processes, and ensure the circulation of the necessary elements and radicals through recombination. Biological Reactions: The membrane permeability is increased by the ultrasound, which accentuates the fluid and nutrient transference to tissues. This quality is important in the phonophoresis process, when molecules are literally “pushed” into the skin by therapeutic sound waves. Mechanical Effects: Due to longitudinal vibrations, a pressure gradient is developed in each individual cell. As a result of this positive and negative pressure variation, the cell elements are forced to move on, then experiencing a micro massage effect. This effect increases cellular metabolism, blood flow, and oxygen supply. Thermal Effects: Along with the micro massage, a temperature rise occurs, resulting from the conversion of kinetic energy into heat by tissues. This effect can produce an increase in collagen extensibility, therefore it is recommended for the therapy of pathology caused by the contraction of tendons, ligaments, and capsular joints. The treatment is strongly recommended when there is movement limitation. Nevertheless, it is important to remember that the heat formation from the ultrasound occurs in tissues which are directly under transducer. Since the accepted technique is to keep the transducer in movement during the treatment, significant therapeutic heating is improbable. However, an undesirable heating may occur if there is no transducer movement or if the intensity is very high. The pulsed ultrasound offers the physician a technique with lower risk of heat formation. The clinical experience shows that the surface heat sensation should be used as a warning to prevent an overdose. A “hot” transducer is not just uncomfortable to the patient; it may also be a sign of eminent danger. Cavitation: Irradiating ultrasound in liquids leads to the formation of 10–6 meter diameter bubbles. Under the action of the ultrasonic field, these bubbles increase and decrease (Stable Cavitation), or can collapse (Transitory Cavitation). Both cavitation types produce movement in the liquid around the bubble. The stable cavitation can be therapeutic and the transitory type can cause damages to the tissue. The high frequency ultrasound vibration (1.0 MHz) deforms the molecular structure of substances that are not strongly joined. This phenomenon is therapeutically useful to produce sclerolytic effects, in an attempt to reduce spasms, increase the movement amplitude due to the action in adhered tissues and break the calcium deposits, mobilizing adherences, scar tissues, etc. If used with maximum power and duration, this deforming mechanism may destroy the molecule of the substances. Stationary Waves: Caution! These waves are result of the interaction between the reflected wave and incident wave, which creates high density areas in a specific point of the tissue. The formation of these waves may be avoided through the continuous and proper movement of the transducer. If the stationary technique is used, apply only the pulsed ultrasound. 24 23 INSTRUCTIONS FOR ULTRASOUND THERAPY TABLE OF ABSORPTION COEFFICIENTS (a) FOR 1MHz AND 3MHz WAY The area to be treated (according to Lehmann) should be approximately from 75 to 100 cm2, using 1 minute time per cm2. The maximum duration of the treatment should not exceed 15 minutes per therapy session. Longer times neither accelerate nor produce the specific desirable effects. To determine the intensity, we should evaluate the affected area, taking into account that the ultrasound suffers an energy loss in its course, and therefore the requested intensity should sometimes be higher in the tissue surfaces, especially on the skin, subcutaneous connectives, and superficial muscular layers. THE ULTRASOUND DOSE The dose is the product of the intensity during the treatment time. So: DOSE = I x T Blood Blood Vessels Bone Tissue Skin Cartilage Air (20o C) Tendon Muscular Tissue (perpendicular beam)) Muscular Tissue (parallel beam) Adipose Water (20o C) Nervous Tissue COEFFICIENT OF ABSORPTION 1.0 MHz 0.028 0.4 3.22 0.62 1.16 2.76 1.12 3.0 MHz 0.084 1.2 1.86 3.48 8.28 3.36 0.76 2.28 0.28 0.84 0.14 0.0006 0.2 0.42 0.0018 0.6 THE ULTRASOUND ABSORPTION When the ultrasound penetrates into the tissues, there are biological effects due to the energy absorption. Then, the ultrasound intensity decreases. The absorption coefficient (a) is used as a measure of absorption in different organs. For longitudinal waves and perpendicular incidences we can use this formula: I (x) = Io . e −ax Where: I(x) = intensity in W/cm2 at the depth of x (cm) Io = intensity in W/cm2 on the body surface e = 2.7 (base of decimal logarithms) a = absorption coefficient (cm-1) EXAMPLE: Apply 1 W/cm2 on the body surface and the medium through which the ultrasound goes through is the tendon. What is the intensity at 1 cm depth? The following data is known: tendon (medium): a = 1.12 Io = 1 W/cm2 e = 2.7 If we use the formula I(x) = Io . e –ax, then we will have: I (1cm) = 1* 2.7 -1.12*(1) = 0.32 W/cm2 Therefore, the intensity at 1cm depth is 0.32 W/cm2. Therefore the intensity in 1cm depth is 0.32 W/cm 2 . I (1 cm) = ? 25 ULTRASOUND TRANSDUCERS In plain words, transducer is a device that turns a type of energy into another. The ultrasonic transducer turns electrical energy into mechanical energy (acoustics). These devices use piezoelectric crystals, and when they receive adequate alternating current generate ultrasound waves in a frequency determined by the crystal. So, this transducer will issue (generate) what we call acoustic field, which is characterized by two regions: - 26 ATTENTION: 1As we have seen in previous paragraphs, inside the transducer there is the piezoelectric crystal, which is responsible for the generation of ultrasonic waves. These crystals have a tolerance range for the resonance frequency. Example: an ultrasound transducer of 1.0 MHz can have a tolerance range of about 10%, that is, the transducer can issue ultrasound between 0.9MHz (-10%) and 1.1MHz (+10%). Thus, the SONOPULSE III 1.0 MHz/3.0 MHz transducer has the “transducer number”. This number is the same as the equipment serial number. This is important, because each transducer should be connected with its corresponding equipment. Therefore, it is not possible to interchange different transducers in the same equipment. Always check if the “transducer number” is the same as the equipment serial number. Cylindrical Adjacent Field (Fresnel zone) Conical Distant Field (Fraunhofer zone) The therapeutic effects of the ultrasound occur in the adjacent field zone. The length of the adjacent field depends on the transducer diameter and the ultrasound frequency. Note that in applications with gel, where the transducer is in touch with the patient, the distance between the skin and the aluminum face is some millimeters, therefore within the adjacent field. In sub aquatic applications we suggest a distance between the aluminum face and the patient skin of approximately 2 to 3 cm. NOTE: We suggest the periodic preventive maintenance of the ultrasound equipment. The transducer of IBRAMED ultrasound units is waterproof. Check regularly for ruptures (cracks) on the transducer body that can allow penetration of liquids. Inspect also the transducer cable and connectors. After some time of use, the transducer aluminum face can become rough. If it happens, the equipment should be sent to maintenance, because the technical characteristics of the transducer can be altered. 2 - We advert that the incorrect handling of the transducer may affect its characteristics. Therefore, avoid “bumping” and “mechanical shocks”. Use only proper ultrasound conductor gel. Ultrasound in Cellulitis For centuries, the ideal type of woman was the overweight woman, with a clear presence of cellulitis, that just the realism characteristic of the Baroque period in the Arts was able to show. The ideal concept of beauty at the end of the second millennium has changed a lot. The presence of the adipose tissue is little accepted and the irregularities of this tissue, the cellulitis, is the modern women’s great fear. However, cellulitis, the great villain of woman beauty, is present in 80% of the Western women. It has been appearing earlier and earlier in women’s lives, affecting young women and adolescents, even in slim women. The modern photographers and movie directors, successors of old realist painters, do not have the same esthetic ideal of the past, and nowadays they characterize beauty as women who are skinny, athletic, and with no cellulitis. What is cellulite? How can it be treated and prevented? 27 The fatty tissue is situated under the skin and on the muscles. The cells that form this tissue are the adipose reserve in the organism. When someone eats more than necessary, they increase as if they were rubber balloons. That is because the organism tries to keep as much food as possible in the body, “imagining” a possible lack of food. In the process of increasing the fatty volume, alternations of the microcirculation occur, increasing the fibrous tissue, and cellulitis appears. The characteristic undulation is observed on the skin, and the orange-peel skin aspect. Cellulitis has different scientific names, such as: Geloid Fibro-Edema, Gynoid Lipodystrophy, Edemato-Fibrosclerotic Lipodystrophy or Edemato-Fibrosclerotic Panniculopathy. Lipodystrophy means the adipose tissue has an abnormal increase, Gynoid refers to the female sex, and Panniculopathy is the disease of the fatty tissue under the skin, Edemato-Fibrosclerotic means swelling, retraction and hardening. These scientific names explain what happens with the cellulitis, but are difficult to use in practice. Everybody knows what cellulitis is and that is the name we are going to use. Cellulite is different from adipose; we can say that women have two different types of adipose: the normal adipose and the adipose with cellulitis. The cellulitis is an alteration of the woman’s fatty tissue. It is adipose, but it is unhealthy and altered. Cellulite location: cellulite can be found in different regions of the body. There is a predilection for the gluteus region, the lateral part of the thigh, the internal and posterior faces of the thigh, the abdomen, the nape, the posterior and side parts of the arms and the internal face of the knees, but in case of people with this tendency, it can also affect the ankles. Cellulitis Treatment with Ultrasound: In cases of cellulitis, 3.0 MHz ultrasound is an effective tool to produce the mucopolysaccharide depolymerization of the fundamental substance, through its thixotropic action on gels, that is, transforming colloids from gel state to solid state. Besides, it produces an increased capillary permeability, improving the blood and lymphatic irrigation, stimulating the tissue re-absorption and ion displacement. The use of ultrasound in the Geloid Fibro-Edema treatment is linked with its physiological effects associated with its substance transportation capacity, through the skin phonophoresis. Among other effects, we can highlight neurovascularization with following circulation increase, rearrangement and increase of the collagen fiber extensibility, and the improvement of the mechanical proprieties of the tissue. The tissue metabolism can be modified. It was also experimentally observed that a remarkable increase in the biological membrane 28 Permeability, and alternations in the membrane potential can be produced. It was observed that the biological membrane permeability is the main factor that enables the pharmaceuticals penetration into the body. Non-thermal effects are the main responsible agents for the substance permeation. The timer and the ultrasonic radiation intensity should be measured. As a general rule, a two-minute period can be established for the areas close to 10 cm2. The intensity varies according to the desired effect and the tissue to be stimulated: the deeper its action, the greater its intensity. There is a close relation between the application and the ultrasonic beam intensity, which are inversely proportional. In order to minimize the risk of cell lesion, the exposure and intensity times should be the lowest possible, as long as the desired therapeutic effects are produced (GUIRRO & GUIRRO, 2001). SUGGESTED TREATMENT: Both continuous and pulsed ultrasound modes can be used, both of them produce the already mentioned effects. Using the continuous ultrasound mode, it is possible to perform the phonophoresis that is the percutaneous administration of substances through ultrasound. The most used substances for the cellulitis treatment are: mucopolysaccharidase or hyaluronidase, which acts on the mucopolysaccharide (glycosaminoglycan); or Asian Centella. The hyaluronidase enzyme is the most indicated to perform the phonophoresis. The suggestion is to mix the ultrasound gel with the hyaluronidase enzyme in a proportion of about 1 part of gel for 1 part of enzyme. It is recommended that the intensity be low, starting from about 0.5W/cm2 During the treatment, if the patient reports pain or discomfort, reduce the intensity step by step until the pain disappears. Due to the mechanical/thermal ultrasound effects, the structures of the enzymes disnatures at around 40ºC. Then, taking into account that the average body temperature is 36ºC, the best recommended intensity for the application can vary from 0.1W/cm2 to 0.3W/cm2, which will later increase the transducer temperature from 0.5 to 0.9ºC, with timer of about 5 to 8 minutes/region. 30 29 ULTRASOUND IN PLASTIC SURGERY Ultrasound Treatment Setup Suggestions for 3.0 MHz Ultrasound Every surgery produces hematoma in a higher or lower degree, and if it is not properly treated, it can develop into several levels of fibrosis. There are many techniques to help the hematoma re-absorption, such as the ultrasound. Treatment CELLULITIS DEGREE 1 CELLULITIS DEGREE 2 CELLULITIS DEGREE 3 IMMEDIATE POST OPERATIVE LATE POST OPERATIVE IMMEDIATE RITIDOPLASTY LATE RITIDOPLASTY PHONOPHORESIS Hematoma re-absorption is of great importance in this first phase, as its evolution can provoke fibrosis formation. In case the repair process is concluded and there are adherences and fibrosis, the ultrasonic power can be used as an adjuvant in the reduction of these sequela, increasing the conjunctive tissue elasticity. In these cases, the employed ultrasonic power should be higher, increasing the timer and/or the intensity. The use of ultrasound in the immediate postoperative period is directly linked with the cicatrisation process, as its efficiency has already been proved by various studies 32,33,34,35, being the most effective protocols started immediately after the lesion occurrence considered as the most effective ones, that is, during the inflammatory phase. The objective of the early use of this type of energy is to promote an improvement in both blood circulation and the lymphatic circulation, thus allowing a better cell nutrition. The pain reduction is also required in this phase (GUIRRO & GUIRRO, 2001) W/cm2 0,4 0,6 0,8 0,4 0,8 0,2 0,4 0,8 T (min.) 15 15 15 10 10 6 6 15 Mode C C C P 20% C P 20% C C Note: Cellulitise level 3 is the most severe level; postoperative refers to various kinds of plastic surgery (mammoplasty, abdominoplasty, liposuction). The immediate postoperative period can only be treated with ultrasound in case the medical dressing is removable; otherwise, the laser is mostly indicated for this phase, in order to speed up the cicatrisation phase. Special Applications of Ultrasound The frequency determines the depth the ultrasonic beam can reach. So, for surgeries in regions with little muscular mass, as the lifting regions, higher frequencies are more recommended. COMBINED THERAPY – It is nothing more than the simultaneous application of two stimuli, that is in this case, of ultrasound with low or medium frequency. It combines analgesic effects of low and medium frequency currents. It combines analgesic of low and medium frequencies with thermal and mechanical effects of the ultrasound. The combination should be performed: - If the combination of the stimuli has therapeutic and diagnostic effects different from the separate stimuli. If there is advantage in the combined timer, otherwise should be applied separately for the cases where the stimuli effects are the same. 31 32 Combination of Ultrasound with Low Frequency Current Combination of Ultrasound with the Medium Frequency Currents Usually the combination is performed with diadynamic currents, however any low frequency interrupted current can be used. Hoogland (1980) reports that the combined therapy causes effects which differ from the separate stimuli: In the combined therapy, some unfavorable effects are eliminated when the ultrasound is used in combination with the medium frequency alternating currents (Hoogland – 1980). - ADVANTAGES (summary) - Location of the trigger points at very low level currents in such a way that they cannot be determined by exclusively current methods. As the ultrasound has sensitive effect in the nerves, in the combined therapy the level of current should be gradually decreased, or otherwise the sensation becomes excessive to the patient. This fact is proved as the ultrasound is turned off, where a reduction in the sensation of the current occurs (adaptation of the nervous fiber). These facts lead to the conclusion that the combined therapy is appropriate for diagnosis, especially in those cases where the disorder is not very acute and the application points have not been mapped. - IMPORTANT - DISADVANTAGES (summary) - The method is very aggressive, due to the galvanic effect of the diadynamic currents. If the conductor gel layer becomes too thin or disappears, the skin might be attacked. The ultrasound transducer (applicator) is used as a mobile electrode. When lifted and lowered again it causes discomfort to the patient because it is equivalent to open/close the electrical circuit. The method is very agreeable, not causing aggressive effects. If the electrode is correctly placed, the in-depth effect will be extensive. The deepest motor points will be easily located. When the transducer is lifted or lowered there will not be discomfort sensation to the patient. - The SONOPULSE III 1.0 Mhz/3.0 MHz Ultrasound equipment allows the performance of COMBINED THERAPY. We remind you that the combined therapy can only be performed between equipment of the same brand, that is, the ultrasound and electrical stimulators (currents) manufactured by IBRAMED. Therefore it is necessary that the professional owns both pieces of equipment (ultrasound and stimulator). The connection between them is made through a SPECIAL CABLE, which is provided as an optional accessory by IBRAMED. 33 34 DESCRIPTION OF THE SPECIAL CABLE (optional accessory) ULTRASOUND INDICATIONS The ultrasound has been used as adjunct therapy in the following general cases: 1 – DB-9 connector: This connector should be connected to channel 1 of the electrical stimulator. (IBRAMED current equipment). 2 – P-2 connector: This connector should be connected to the combined therapy input of the ultrasound IBRAMED equipment. 3 – “Banana” connector: This connector should be connected to the conductor electrode used in the therapies by current. The Ultrasound transducer will work as another electrode (mobile). Note: The picture above is merely illustrative, and the electrodes can vary according to the type of electro stimulator used. • • • • • • • • • • • • • • • • • • • • • • • • • Arthrosis (large and small joints) Bursitis Causalgy Claudication Coccygodynia Neuritis Intercostal Neuralgia Chronic Periarthritis Raynaud’s Disease Herpes Zoster Myalgia Several Types of Rheumatism Myelitis Myositis Prostatitis Tenovaginitis Ulcer, Venous stasis Sudeck’s Atrophy Lumbago Cellulitis Radiculitis Sciatica Frontal Sinusitis Maxillary Sinusitis Scalen Syndrome 35 Common cases involving athletes: • • • • • • • • • • • • Contusion Neuritis Arthritis Distension Adherence Sciatica Edemas Dislocation (muscles/tendons) Scars Traumatism Stiff neck Bursitis COUNTERINDICATIONS: Do not use the ultrasound on: • • • • • • • • • • • Uterus during pregnancy Eyeball Thrombophlebitis areas Postoperative areas Heart Electronic Implanted Device – It is recommended that a patient carrying an electronic implanted device (e.g. cardiac pacemaker) is not subjected to short wave diathermy, unless a specialized medical opinion is previously obtained. Brain Reproductive organ Acute infections Areas treated by radiotherapy Tumors Literature indications are based on researches in biophysics, which in most cases coincide with those derived from the empiricism developed by the clinical practice. 36 BIOCOMPATIBILITY of the materials in contact with the patient (ISO 109931): IBRAMED declares that the ultrasound transducer and the coupling gel provided with the equipment do not cause allergic reactions. The transducer and the gel should only be put in contact with the intact surface of the skin, respecting a time limit of duration of this contact of 24 hours. There is no risk of damaging effects neither to the cells, nor of allergic reactions or of sensitivity. Environmental protection: IBRAMED declares that there are no risks or special techniques associated with the discarding of this equipment and accessories at the end of its useful life. TRANSDUCER CLEANSING: After using the transducer, clean it in running water. Use neutral detergent or soap. Always clean it before storing it. MAINTENANCE We suggest that the user inspects the equipment and performs preventive maintenance at IBRAMED or at the sales point each 12 months the equipment is used. As manufacturers, IBRAMED is deemed responsible for technical or safety characteristics of the product only in cases when the unit has been used in accordance with the instructions contained in the user’s manual, and where maintenance, repairs or modifications have been made by the manufacturer or by expressly authorized agents, and where the components which can cause safety risks and also where components for the proper functioning of the equipment have been substituted, in case of repairs, with original substitution parts. If required, IBRAMED will be able to make available the technical information necessary for eventual repairs of the equipment (circuit schemes, list of parts and components, etc.). We do not take on any responsibility for repairs performed without our written authorization. We also suggest a transducer preventive maintenance. Read page 25 of this manual – “Ultrasound Transducers”. 37 38 Warranty Term WARRANTY IBRAMED, Indústria Brasileira de Equipamentos Médicos LTDA, herein identified to the consumer at the address and telephone number: Rua Milão, 50 – Amparo – SP, telephone number +55 (19) 38179633, guarantees this product for the period of eighteen (18) months, observed the conditions of the warranty terms attached to the documentation of this equipment. TECHNICAL ASSISTANCE If you have any doubts or problems with the functioning of this equipment, Please contact our technical department! 1) Your IBRAMED product is certified against manufacture defects, if considered the established conditions in this manual for 18 following months. 2) The period of warranty will count from the first purchase date by the consumer, even when the product is transferred to a third party. The replacement of parts and the cost in repairs of malfunctions originated from manufacturing will be comprehended in the warranty. 3) The warranty procedures will be exclusively made by IBRAMED sales points, by IBRAMED itself or by other parties specifically designated by IBRAMED. 4) WARRANTY DOES NOT COMPREHEND DAMAGES WHICH COULD OCCUR TO THE EQUIPMENT IN CASE: The equipment is not used exclusively for medical purposes. The specifications and recommendations in the user’s manual are not observed in the installation and use of the equipment. Accidents or natural hazards, connection to electrical system with inappropriate voltage, and/or excessive fluctuation or overcharge/ overvoltage occur. The equipment is not handled properly, is not taken proper care of, or suffers alterations or repairs made by not certified people or companies. Aparelho: Número de série: Registro ANVISA (M.S.): Data de fabricação: Prazo de validade : 5 anos Engenheiro responsável : Maicon Stringhetta CREA - 5062850975 There is removal or adulteration of serial number of the equipment. - Any accident in transportation occurs. 5) 5) Legal warranty does not cover: expenses with installation of product, installation of software, installation of microcomputer, transport of product to the factory or sales point, labor cost, materials, parts and adaptations necessary to the preparation of the premises where the equipment will be used, such as: electric wiring, computer technician expertise, masonry, hydraulic installations, grounding system, as well as its adaptations. The warranty does not cover either parts subjected to wear and tear such as: command switches, control keys, handles and mobile parts, power cable, connection cable to the patient, transducer cable, conductive silicone rubber electrodes, electrodes for diathermy, batteries, ultrasonic transducer (when improper use or its fall is proved), equipment cabinet. 6) No sales point of IBRAMED has authorization to alter the conditions here mentioned, or to take any commitment in the name of IBRAMED. 39 40 Frequency of pulse repetition 100 Hz – Duty factor 50%. SONOPULSE III 1.0 MHz/ 3.0 MHz Accessories supplied with the unit - 01 gel tube 01 detachable power cable 01 operation manual 01 extra protection fuse 5A 01 1.0 MHz and 3.0 MHz transducer ( ERA nearly = 3.5 cm2 ) SONOPULSE III 1.0 MHz/ 3.0 MHz Technical characteristics Emission of pulsed ultrasound with repetition frequency of 100 Hz. Modulation index of 100% with pulse duration cycles of 5,0 ms ON/5,0 ms OFF (1/2 ratio). Frequency of pulse repetition 100 Hz – Duty factor 20%. Emission of pulsed ultrasound with pulse repetition frequency of 100 Hz. Modulation Index of 100% with pulse duration cycles of 2,0 ms ON/ 8,0 ms OFF (1/5 ratio). Frequency of pulse repetition of 48 Hz – Duty factor 50%. Emission of pulsed ultrasound with pulse repetition of 48 Hz. Modulation index of 100% with pulse duration cycles of 5,0 ms ON /5,0 ms OFF (1/2 ratio). Frequency of pulse repetition of 48 Hz – Duty factor- 20%. Emission of pulsed ultrasound with pulse repetition of 48 Hz. Modulation index of 100% with pulse duration cycles of 2,0 ms ON /8,0 ms OFF (1/5 ratio). Power Supply……………………………….band from 100 – 240 V ~ (50/60 Hz) Frequency of pulse repetition of 16 Hz – Duty factor 50%. Input Power (max. consume)……………………………………………….30 V Emission of pulsed ultrasound with pulse repetition of 16 Hz. Modulation index of 1005 with pulse duration cycles of 5,0 ms ON/ 5,0 ms OFF (1/2 ratio). Equipment: Emission of pulsed ultrasound of 16 Hz – Duty factor 20%. SONOPULSE III 1.0 MHz/ 3.o MHZ is a piece of monophasic equipment design for use in continuous mode of operation, Class II with BF-applied part of safety and protection against electrical shock. The equipment is protected against water dropping (classification IPX 1). Not appropriate for use in the presence of inflammable anesthetics. Regarding limits for electromagnetic disturbance, SONOPULSE compact version 1MHz is an electro medical piece of equipment which belongs to Group 1 Class A. Emission of pulsed ultrasound with pulse repetition of 16 Hz. Modulation index of 100% with pulse duration cycles of 2,0 ms ON / 8,0 ms OFF (1/5 ratio). Effective Ultrasound potency: Continuous Mode: …………………………………0.3 to 7.0 W Pulsed Mode 100 Hz (50%) ………………………………………..0.3 to 7.0 W Frequency of ultrasound emission: 1.0 MHz and 3.0 MHz (+/- 10%) Ultrasound emission: - Continuous: form of senoidal wave in the frequency 1.0 MHz and 3.0 MHz - Pulsed: porter with form of senoidal wave in the frequency of ultrasound wave modulated by square wave with the following characteristics: Pulsed Mode 100 Hz (20%) ………………………………………..0.3 to 7.0 W Effective Ultrasound Intensity: Continuous Mode: ……………………………………………….0.1 to 2.0 W/cm2 Pulsed Mode 100 Hz (50%) ……………………………………..0.1 to 2.0 W/cm2 Pulsed Mode 100Hz (20%) ………………………………………0.1 to 2.0 W/cm2 41 Accuracy of the Indicated Values: 42 BIBLIOGRAPHY ERA (effective radiation area) – 20% Potency Intensity – 20% Acoustic Duty Frequency (3.0 MHz) – 10% BNR (non-uniformity of beam) – 30% Duration of Pulse, frequency of pulse repetition – 5% Dimensions (mm): ……………………………… 265 x 275 x 115 (W x L x H ) Weight approximately with transducer: ………………………..……… 1.1 Kg Maximum Stacking Number: ……………………………………….10 boxes Temperature for transportation: ………………………………………5 to 50º C Workplace Temperature: ……………………………………………..5 to 45° C Note: The equipment and its characteristics may suffer alterations without previous notice. 1- Allen, K. Battye, C. - “Performance of Ultrasonic Therapy Instruments” Physiotherapy, 64 (6), 174-179 (1978). 2- Antich, T.J. - “Phonophoresis”. Journal of orthop. and sports phys. therapy, 4 (1982) 2, 99-103. 3- Basset, C.A.L., “Electrical Effects in Bone”, Scient. Am. 213 (1965) 10, 18-25. 4- Basset, C.A.L., “Biologic Significance of Piezoelectricity”, Calif. tissue res., 1 (1968) 252-272. 5- Bearsy H., “Clinical Application of Ultrasound Energy in Treatment of Acute and Chronic Subacromial Bursitis”, Arch Phys. Med. Rehabil. (1953) 34:228. 6-Behari, J. en S, Singh, “Ultrasound Propagation in vivo Bone”, Ultrasonics (1981). 7- Clarke, G. Stenner, L. - “The Therapeutic Use of Ultrasound”, Physiotherapy, 62 (6), 185-190 (1976). 8- Coakley, W.T., “Biophysical Effects of Ultrasound at Therapeutic Intensities”, Physiotherapy (Eng.) 64 (1978) 6, 166-169. 9- Cosentino, A.B., D.L. Cross, R.J. Harrington, G.L. Soderberg, “Ultrasound Effects on Electroneurographic Measures in Sensory Fibers of Median Nerve”, Physical Therapy”, 63 (1983) 11. 10- Cyriax J., “Textbook of Orthopaedic Medicine”, vol 1, Baltimore, Willians & Wilkins (1975). 11-Dumoulin, J en G. de Bisschop, “Electrotherapie”4 ed., Maloine SA Paris. 12- Dyson, M, C. Franks, J. Suckling, “Stimulation of Healing of Varicose Ulcera by Ultrasound”, Ultrasonics (1976), 9. 13- Dyson, M., J. Suckling, “Stimulation of Tissue Repair by Ultrasound: A Survey of the Mechanism Involved”, Physiotherapy 64 (1978), 4. 14- Dyson, M. en J.B. Pond, “Biological Effects of Therapeutic Ultrasound”, Reumatol. and Rehab. (1973) 12, 209-213. 15- Dyson, M. Pond, J Josephy, J. Warick,R. “Stimulation of Tissue Regeneration by Means of Ultrasound”, J.Ch. Sci., 35, 273-285 (1968). 16- Fukada, E., “Mechanical Deformation and Electrical Polarization in Biological Substances”, Biorheology (1968) 5, 199-208. 17- Fukada, E. en I. Yasuda, “Piezoelectric Effects in Collagen”, Japan J. Appl. Phys, (1964) 3, 117-121. 43 18- Griffin, J.E. en J.C. Touchstone, “Ultrasonic Movement of Cortisol Into Pig Tissues, 2, Movement Into Skeletal Muscle”, Am. J. Phys. Med. 43 (1963) 77. 19- Haar, Ter G., “Basic Physics of Therapeutic Ultrasound”, Physiotherapy 64 (1978), 4. 20- Jones R. “Treatment of Acute Herpers Zoster Using Ultrasonic Therapy, Physiotherapy, 70 (3), 94-96 (1984). 21- Lehmann J.F. and others, “Therapy With Continuous Wave Ultrasound in Ultrasound Applications in Medicine and Biology, Ch. X, Ed. Francis J. Fry, Part. 2, Elsevier Publishing. Co, 561 (1978). 22- Lehmann, J.F., “Effects of Therapeutic Temperature on Tendon Extensibility”, Arch. Phys. Med. Rehab. 51, 481 (1970). 23- Lehmann, J.F., “Therapeutic Heat and Cold, 3e druk. Willians and Wilkins Baltimore, London (1982). 24- Macdonald, B. Shipster, S., “Temperature Changes Induced by Continuous Ultrasound”, South African Journal of Physiotherapy, 37 (1), 13-15 (1981). 25- Oakley, E.M., “Dangers and Contra-indications of Therapeutic Ultrasound”, Physiotherapy (Eng.) 64 (1978) 6, 173-174. 26- Patrick, M.K., “Ultrasound in Physiotherapy”, Ultrasonics, 4, (1976), 10-14. 27- Patrick, M.K., “Applications of Therapeutic Pulsed Ultrasound”, Physiotherapy 64 (1978) 4. 28- Santiesteban, Joseph A., “Physical Agents and Musculoskeletal Pain in Ortophaedic and Sports Phys. Therapy”, vol. 2, Ed. J.A. Gold Mosby Co., Toronto (1985). 29- Stewart, H.F. , J.L. Abzug, G.R. Harris, “Considerations in Ultrasound Therapy and Equipment Performance”, Physiotherapy 60 (1980) 4. 30- R. Hoogland, “Ultrasound Therapy”, Enraf Nonius Delft 44 Electromagnetic Biocompatibility: SONOPULSE III 1.0 MHz/ 3.0 MHz was designed in such a way that it complies with the requirements of NORM IEC 60601-1-2 of electromagnetic compatibility. The objective of this norm is: - Guaranteeing that the level of spurious signals generated by the equipment and irradiated to the environment are below the limits specified in norm IEC CISPR 11, Group 2, class A (Radiated Emission). - Guaranteeing the immunity of the equipment to electrostatic discharges, by air contact, stemming from the accumulation of electrical discharges acquired by the body (Electrostatic Discharge – IEC 61000-4-2). - Guaranteeing the immunity of the equipment when subjected to an electromagnetic field incident from external sources (Immunity to Irradiated RF IEC 61000 -4 -3). Precautions: - The operation at short distance (1 meter, for example) from a piece of short wave or microwave equipment may produce instability in the output of other equipment. - Radio frequency communication equipment, mobile or portable can cause interference and affect the functioning of SONOPULSE III 1.0 MHz/ 3.0 MHz. Always install this equipment according to what is described in this instruction manual. Attention: - SONOPULSE III 1.0 MHz/ 3.0 MHz complies with technical norms of electromagnetic compatibility techniques when used with the cables, transducers, and other accessories provided by IBRAMED described in this manual. (Chapter: Accessories and Technical Characteristics). - The use of cables, transducers and other accessories from other manufacturers and /or different than the ones specified in this manual, as well as substituting internal components of SONOPULSE III 1.0 MHz/ 3.0 MHz, may result in the increase in emission or decrease in the equipment immunity. - SONOPULSE III 1.0 MHz/ 3.0 MHz should not be used adjacently or stacked onto other equipment. Directions and Manufacturer’s Statement – electromagnetic emissions SONOPULSE III 1.0 MHz/ 3.0 MHz is destined for use in the electromagnetic environment specified below. The user of the equipment must ensure that it is used in such an environment Emission Assay Conformity Electromagnetic Environment- directions Group 1 The therapy equipment SONOPULSE III 1.0 MHz/ 3.0 MHz uses RF energy only for its internal functions. However, its RF emissions are very low and unlikely to cause any interference in nearby electronic equipment RF Emissions NBR IEC CISPR 11 IEC CISPR 11 RF Emissions NBR IEC CISPR 11 IEC CISPR 11 Harmonics Emission Class A Class A IEC 61000-3-2 Emissions due to tension fluctuation/scintillation Class A IEC 61000-3-3 The therapy equipment SONOPULSE III 1.0 MHz/ 3.0 MHz is adequate for use in all premises which are not residential and not directly connected to the public low tension electric power distribution line which supplies buildings appropriate for domestic use Directions and Manufacturer’s Statement - electromagnetic immunity SONOPULSE III 1.0 MHz/ 3.0 MHz is destined for use in the electromagnetic environment specified below. The user of the equipment must ensure that it is used in such an environment Immunity Assay Electrostatic Discharge (ESD) IEC 61000-4-2 Rapid electric transitory / train pulse (Burst) IEC 61000-4-4 Surges IEC 61000-4-5 Level of Assay IEC 60601 Level of Conformity ± 6 kV per contact ± 6 kV per contact ± 8 kV by air ± 8 kV by air ± 2 kV in the ± 2 kV in the Power lines Power lines ± 1 kV in the input /output lines ± 1 kV differential mode ± 2 kV regular mode ± ± 1 kV in the input/output lines ± 1 kV differential mode ± 2 kV regular mode Electromagnetic Environmentdirections The flooring must be either wooden, concrete or ceramic. If the flooring is covered with synthetic material, the humidity must be of least 30%. The quality of the power supply should be equivalent to the one of a hospital or a typically commercial establishment. The quality of the power supply should be equivalent to the one of a hospital or a typically commercial establishment. Immunity Assay Level of Assay IEC 60601 < 5% U T (> 95% of tension fall in U T ) per 0.5 cycle Tension falls, short interruptions and tension variations in the input power lines IEC 61000-4-11 40% U T (60% of tension fall in U T ) per 5 cycles 70% U T (30% of tension fall in U T ) per 25 cycles < 5% U T (> 95% of tension fall in U T ) per 5 seconds Level of Conformity < 5% U T (> 95% of tension fall in U T ) per 0.5 cycle 40% U T (60% of tension fall in U T ) per 5 cycles 70% U T (30% of tension fall in U T ) per 25 cycles 3 A/m NOTE: U T is the c.a. power feed tension before the application of the assay level. The quality of the power supply should be equivalent to the one of a hospital or a typically commercial establishment. If the user of the equipment requires continuous operation during energy interruption, it is recommended that the equipment should be fed by a source of uninterrupted power supply or a battery. < 5% U T (> 95% de tension fall in U T ) per 5 seconds Magnetic Field in the frequency of Power feed (50/60 Hz) IEC 61000-4-8 Electromagnetic Environmentdirections 3 A/m Magnetic fields in the frequency of power supply must be on the same levels characteristic of a hospital environment or a typically commercial establishment. Directions and Manufacturer’s Statement – electromagnetic emissions SONOPULSE III 1.0 MHz/ 3.0 MHz is destined for use in the electromagnetic environment specified below. The user of the equipment must ensure that it is used in such an environment Emission Assay Conformity Electromagnetic Environment- directions Group 1 The therapy equipment SONOPULSE III 1.0 MHz/ 3.0 MHz uses RF energy only for its internal functions. However, its RF emissions are very low and unlikely to cause any interference in nearby electronic equipment RF Emissions NBR IEC CISPR 11 IEC CISPR 11 RF Emissions NBR IEC CISPR 11 IEC CISPR 11 Harmonics Emission Class A Class A IEC 61000-3-2 Emissions due to tension fluctuation/scintillation Class A IEC 61000-3-3 The therapy equipment SONOPULSE III 1.0 MHz/ 3.0 MHz is adequate for use in all premises which are not residential and not directly connected to the public low tension electric power distribution line which supplies buildings appropriate for domestic use Directions and Manufacturer Statement –Electromagnetic immunity SONOPULSE III 1.0 MHz/ 3.0 MHz is destined for use in the electromagnetic environment specified below. The equipment user must assure that it is used in such an environment Assay level Conformity Immunity Assay Electromagnetic Environment- directions IEC 60601 level RF Communication equipment, portable or mobile, must not be used next to any part of SONOPULSE III 1.0 MHz/ 3.0 MHz , including cables, with a separation distance of less than the recommended, calculated from the equation applicable to the frequency of the transmitter. Separation distance recommended RF Conducted IEC 61000-4-6 3 Vrms 150 kHz up to 80 MHz d = 1.2 P 3V d = 1.2 P 80 MHz up to 800 MHz d = 2.4 P 800 MHz up to 2.5 GHz RF Radiated IEC 61000-4-3 3 V/m 80 MHz up to 2,5 GHz 3 V/m Where P is the maximum output nominal potency of the transmitter in watts (W) according to the manufacturer of the equipment, and d is the separation distance recommended in meters (m). It is also recommended that the Field intensity established by the RF transmitter, as determined by an electromagnetic inspection at the siteb should be lower than the conformity in each frequency band . Interference around the equipment marked with the following symbol might occur: NOTE 1: In 80 MHz and 800 MHz highest frequency band is applied. NOTE 2: These directions may not be applicable in all situations. The electromagnetic propagation is affected by the absorption and reflection of structures, objects and people. a The Field intensities established by the fixed transmitters, such as base radio stations, telephone (cellular/wireless) and mobile terrestrial radios, radio amateur, transmission radio AM and FM and TV transmission cannot be theoretically predicted with accuracy. To evaluate the electromagnetic environment due to fixed RF, an electromagnetic, it is recommended to check the local. If the field intensity measurement at the local where SONOPULSE III 1.0 MHz/ 3.0 MHz is used, exceeds the level of conformity used above, the equipment must be observed in order to verify whether the operation is normal. IF an abnormal performance is observed, additional procedures may be necessary, such as reorientation or the reinstalling of the equipment. b Above 150 KHz to 80 MHz frequency band, the field intensity should be lower than 3 V/m. Recommended Separation Distances between portable and mobile RF and SONOPULSE III 1.0 MHz/ 3.0 MHz SONOPULSE III 1.0 MHz/ 3.0 MHz is conceived to be used in electromagnetic environments in which RF disturbances are controlled. The user may help to prevent electromagnetic interferences by keeping a minimum distance between the portable and mobile RF communication equipment (transmitters) and SONOPULSE III 1.0 MHz/ 3.0 MHz, as recommended below, according to the maximum potency of the communication equipment. Distance of Separation in accordance with the frequency of the transmitter (m) Maximum Nominal Output potency of the transmitter W 150 KHz to 80 MHz 80 MHz to 800 MHz d = 1.2 P d = 1.2 P 0.01 0.12 0.12 0.24 0.1 0.38 0.38 0.76 1 1.2 1.2 2.4 10 3.8 3.8 7.6 800 MHz to 2.5 GHz d = 2.4 P 100 12 12 24 For transmitters with a maximum nominal output potency not listed above, the separation distance recommended in meters (m) may be determined by an equation applicable to the frequency of the transmitter, where P is the maximum nominal output potency in watts (W) according to the manufacturer of the transmitter. NOTE 1: From 80 MHz to 800 MHz, the distance of separation relative to the highest frequency band is applied. NOTE 2: These directions may not be applicable in all situations. The electromagnetic propagation is affected by the absorption and reflection of structures, objects and people. 51 52 5- Compared to your monthly wages, would you say the price of the equipment is: FREE TECHNICAL ASSISTANCE CONTRACT In order to better serve you in future, please answer the following questions: ( ( ( ( 1- Your choice for this IBRAMED product was based on: 6- Which was the payment modality? ( ( ( ( ( ( ( ) cash ( ) installment DETACH AND SEND THIS PAGE TO IBRAMED ) newspaper or specialized magazines ) sales representative advice ) friend’s advice ) exhibitor or showroom ) manufacturer’s image ) technical assistance 2- Have you already owned similar equipment before? ( ) yes, IBRAMED ( ) yes, other brands ( ) no ) inexpensive ) reasonable ) expensive ) exaggerating 7- Please, make any comments here, either positive or negative, which you find relevant: ..................................................................................................................................... ..................................................................................................................................... ..................................................................................................................................... ............................................. 3- In your opinion, what is considered as being more important in an equipment? ( ) aspect / appearance ( ) resources – versatility, assistance, technology, etc. ( ) price Name: -------------------------------------------------------------------------------------------------------------------------------- D.O.B. ----/----/--- 4- How old are you? Address: - ------------------------------------------------------------------------------------------------------------------------------------------------------- ( ) under 25 years old ( ) from 25 to 40 years old ( ) over 40 years old District: ------------------------------ City: ---------------------------------------------------------------------------------------------State: ------------ZIP code: ----------------------------------- Phone number.:-------------Equipment: --------------------------------Serial N.: ----------------------