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Doc. No. DYMTHERMA-a Rev. No. 2 Date Mar 10, 2009 THERMA B PLUS Manual DAEYANG MEDICAL CO., LTD. Contents General Information ………………………………… Warranty………………………………………………… Precautionary Instructions ………………………… Caution ………………………………………………… Warning ……………………………………………… Danger ………………………………………………… Introduction …………………………………………… Hyperthermia ………………………………………… What is Therma B Plus? ……………………………… The Principle of RF Diathermy………………………… Technical Specification……………………………… Safety Precautions ………………………………… Features of Therma B Plus ………………………… Rear…………………………………………………… Accessories …………………………………………… How to use …………………………………………… Round Type Electrode………………………………… Hyperthermia Methods ……………………………… Therme B Plus Hyperthermia…………………………… Biological Effects……………………………………… Therma B Plus Hyperthermia Applications…………… The Electronic Recuperator ………………………… Introduction…………………………………………… Time per Session………………..……………………… Products To Be Used………………………………… About Programs……………………………………… Therma B Plus Method……………………………… Application Method………………………………..…… Conductive Gel………………………………………… Indication……………………………………………..… Times and Application Guidelines……………………… Remarks……………………………………………………… FAQ……………………………………………………………. Guarantee……………………………………………… 2 2 2 3 3 4 5 5 5 5 6 7 8 9 10 11 11 14 15 15 15 16 16 18 19 19 20 23 24 25 25 27 28 30 2 General Information This section provides Safety information critical to use of the Diathermy Systems. Read, understand and follow all of the Safety Precautions found in this section and throughout this manual prior to System use. Stay current with the latest clinical developments in the fields of RF Therapy. Observe all applicable precautionary measures for treatment. Keep informed on appropriate indications and contraindication for the use of RF Therapy. Warranty This product is warranted against defects in materials and workmanship for a period of two years from the date of shipment. The Company will at its option, repair or replace components which prove to be defective during the warranty period, provided that the repairs or replacements are carried out by the Company or its approved agents. The Company will consider itself responsible for the effects on safety, reliability and performance of the product :-only if assembly operations, re-adjustments, modifications or repairs are carried out by persons authorised by it, only if the product is used in accordance with the instructions for use, only if the electrical installation of the relevant room complies with the appropriate national requirements. Should the product be returned to the Company for repair it must be sent carriage paid. Consumable items, for example, electrodes and plate are not excluded from the above warranty. Precautionary Instructions The precautionary instructions found in this section and 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; =CAUTION Text with a “CAUTION” indicator will explain possible Safety infractions that could have the potential to cause minor to moderate injury or damage to equipment. =WARNING Text with a “WARNING” indicator will explain possible Safety infractions that will potentially cause serious injury and equipment damage. =DANGER Text with a “DANGER” indicator will explain possible Safety infractions that are imminently hazardous situations that would result in death or serious injury. NOTE:- Throughout this manual “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described. 3 CAUTION Read, understand and practice all precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation ,ultrasound device or any other device. Observe all precautionary and operational decals placed on the System and optional modules. • DO NOT operate the Therma B Plus when connected to any unit other than DAEYANG MEDICAL devices. • DO NOT operate the unit in an environment of short-wave diathermy use. • The high frequency generator should be routinely checked before each use to determine that all controls function normally, especially that the intensity control does properly adjust the intensity of the power output in a stable manner. Also, determine that the treatment time control does actually terminate power output when the timer reaches zero. • DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel as damage may result. • This System, optional modules and associated accessories should be operated, transported and stored in temperatures between 59° F and 104° F (15° C and 40° C), with Relative Humidity ranging from 30%-60%. • Electrodes with care. Inappropriate handling of the applicator may adversely affect its characteristics. • Before each use inspect applicator for cracks, which may allow the ingress of conductive fluid. • Inspect electrode, cables and associated connectors before each use. • The Therma B Plus, optional modules and some associated accessories are not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the System and therefore create a risk of injury to the patient. WARNING This device should be used only under the continued supervision of a physician or licensed practitioner. • For continued protection against fire hazard, replace System fuses only with ones of the same type and rating as found in the specifications section of this manual. • Make certain the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes. • This device should be kept away from children. • Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous conditions causing damage to the System, optional modules, associated accessories and hazardous exposure to energy. • To prevent electrical shock, disconnect the unit from the power source (electrical outlet) before attempting any maintenance procedures to the System. • Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns. • Pads should not be used with plate. The plate must not be contacted with any part of patient’s skin when pads are used. • Do not use cracked electrode when it have any crack on the surface. 4 DANGER • A user shall avoid using the product in the following cases of for the specific regions or person ; - The case where such as aid as implant, pace maker or ant other artificial organ inside the body - Pregnancy - A patient with a coagulation disorder or bleeding tendency - When the patient does not feel thermal changes - A hypertensive - A burn or care after such a burn Contraindication • This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • This device should not be used when cancerous lesions are present in the treatment area. • Other contraindication are patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers. • This device should not be used over or near bone growth centers until bone growth is complete. • This device should not be used over the thoracic area if the patient is using a cardiac pacemaker. DANGER Patients with an implanted neurostimulation device must not be treated with or be in close proximity to any radio frequency diathermy, shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their body. Energy from diathermy (RF, shortwave, microwave, ultrasound and 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 "off." 5 Introduction HYPERTHERMIA The therapeutic effects of Hyperthermia on the human body have been well- known since the 19th Century, mainly being indicated for inflammatory processes, usually accompanied by pain. Methods used made it very difficult to obtain deep, controlled and harmless thermal increase and some required "invasive" techniques. What is Therma B Plus? Theram B Plus is intended for therapeutic diathermy to produce deep heating without excessive temperature elevation of the skin surface and subcutaneous tissue. Therma B Plus is applied to any part of the human body without pain, musclar contraction or disagreeable sensation of any kind. The principle of RF Diathermy • The treatment sith is placed between the plates of a capactor and becomes the dielectric. • The RF energy is diffused through the part of the body located between the plate electrodes. • The oscillating fields produce distortion of molecules, rotation of dipoles and vibration of ions. • The movement of the molecules and ions generates heat within the tissues. • These action have been shown to have positive clinical effects on enhancing blood flow. 6 Technical Specification. General Power Input………………………………………………………………………………………110-240 Vac 50/60 Hz Maximum Power Consumption……………………………………………………………………………………200W Classification (EN60601-1) …………………………………………………………………………Class 1, Type BF Mains Fuses………………………………………………………………………………………2 x T2A (5 x 20 mm) Size (height x width x depth) …………………………………………………………………1000 x 370 x 450 mm Weight………………………………………………………………………………………………………………30 kg Output Parameter Carrier Frequency…………………………………………………………………………………0.3MHz and 0.5MHz Maximum Intensity……………………………………………………………………………………………80mA RMS Ouut Modes………………………………………………………………………Round Electrodes / Rectangle Type Treatment Timer…………………………………………………………………………………………0 to 60 minutes Safety Device…………………………………………………………………………………Zero Start, Safety Switch The Therma B Plus is designed to operate from any 50/60Hz single phase supply between 110 and 240 Vac. All information on model, serial number, and month/year of manufacture is located on the rear panel. The Therma B Plus have been designed to meet the requirements of BS EN 60601-1:1990 (BS5724:Part 1:1989) "Medical Electrical Equipment, Part 1:General requirements for Safety". Environmental Conditions for Transport and Storage • Temperature -10 to +35 C • Relative Humidity 5 to 95% • Atmospheric Pressure 500 to 1060 hPa 7 Safety Precautions Must not be applied to brain, backbone, eye, heart, testicles, ovary, pregnant womb, good or bad tumor and tuberculosis. Not suitable for the application to the following : bleeding, circulation troubles ( thrombus arterial sclerosis, etc.), acute inflammation of joint and bone, suppuration of soft tissues, etc. Patients with Heart pacemakers bad/or other electronic implants Electro Therapies or diagnoses should never be employed on patients with electronic implants, such as heart pacemakers, without obtaining prior approval of a specialist. Use only certified-safe accessory items. Use only those accessory items listed in the equipment’s instruction manual. Any other accessory items employed should be certified as safe for such use by a testing authority. Pads should not be used with plate. The plate must not be contacted with any part of patient’s skin when pads are used. It could result in improper stimulation or skin burns. 8 Features of Therma B Plus Unit 4 1 2 3 No. Name 1 LCD display for control 2 Sub On/Off Switch 3 Handle 4 Accessory 9 Rear Panel Do not use the CET with the application electrode that is not insulated No. Name 1 On/Off Switch 2 Connector for Active cable for Capacitive 3 Connector for Neutral Plate (Rectangular Type) 4 Connector for Active cable for Resistive 5 Fuse (2 x T2A ) 6 Connector for safety switch 7 Power Inlet Electrodes Electrodes 10 Accessories 5 6 7 3 1 4 2 No. Name 1 Active cable for Capacitive Electrodes 2 Resistive Electrodes(70, 60, 40mm) 3 Active cable for Resistive Electrodes 4 Capacitive Electrodes(70, 60, 40, 25mm) 5 Neutral Plate (Rectangular Type) 6 Safety switch 7 Thermo Active Cream(500ml) 11 User Interface 1 2 3 6 4 5 No. Name Function 1 Frequency Select Output Frequency (0.3 or 0.5MHz) 2 Mode Select Program (CET or RET) 3 Intensity Displayed Output Power 4 Applicator Indicate Applied Applicator 5 Time 6 Stop/Wait Displayed for Treatment Time Treatment time is increased by 5 minute Turn off the Intensity by press the stop 12 How to use The operation of Therma B plus is extremely simply. Application Method for Round Type Electrode The Therma B Plus method has two electrodes connected to a high frequency generator. A return electrode (generally in the form of a plate) that is placed in a fixed position in contact with the person to be treated and an active mobile electrode, which is applied on the area to be treated. It is essential to apply a thin layer of a specific moisturizing and conductive product over the area where the active electrode is applied. For correct application : Sufficient pressure must be exerted to maintain a perfect electrical contact over the entire electrode surface but one that at the same time allows smooth movement. (Similar to the pressure exerted when using a large eraser). The electrode must be moved in small circles, each one advancing 50% (half) of the diameter of the electrode. The movement is slow and uniform but without stopping (one circle per second approximately). It is better to reduce the power if it is unbearable and then increase it gradually, rather than using a high power that compels quick movement to be made. If body treatment is conducted, the highest bearable temperature must be selected. On facial treatments the temperature must be relaxing. Active electrode position : The entire electrode surface must be in perfect contact with the skin, i.e. the electrode must not be tilted but must be completely flat throughout the whole application. 13 How to Use Operation Method 1) Preparation to use (1) Check whether this equipment has all accessories necessary to stimulate such as stimulus conductors, etc. If the connector of stimulus conducting wire is loose or do not make good connection, then ask to the agent where you purchased it. (2) Turn on power switch located at rear part of equipment. 2) How to Use - MonoPolar The operation of MonoPolar is extremely simple. (1) Check whether the connector of RF applicator is connected to the proper position of the equipment. (2) Applicator Preparation : Clean applicator before each therapy session. (3) Examine the treatment area for any wounds and clean the skin. The Neutral Plate surface must be in perfect contact with the skin before power “ON” (4) Apply enough cream for RF treatment to desired part. (5) Apply the plate on the patient’s back, making sure the plate is in complete contact with the skin. (6) Select the desired Program(CET or RET). When you set the RET mode, the frequency will be located at 0.5MHz. (7) Select the desired Frequency (0.3MHz or 0.5MHz) by Mode. When you set the CET mode, the frequency can be select one alternative of 0.3MHz or 0.5MHz. (8) Increase slowly the output intensity to a proper level and then try to massage moving the probe in circular way on desired part. Do not use the CET with the application electrode that is not insulated 14 Hyperthermia Methods Systems used to produce Hyperthermia dating back over a century were extremely varied. Attempts were made to increase the temperature at a deeper level using external heat sources (conduction), thus generating the serious risk of skin burns. Different methods have been used to create Hyperthermia. For example: The "natural" method of increasing fever using drugs. Methods of "global corporal hyperthermia" using immersion were developed. Ultrasounds producing deep heat but with the risk of creating "hot spots" on bone structures and of therefore producing energy dispersion upon reflection. Microwaves (300 - 2450 MHz) and RF (>2MHz) produce an internal thermal increase by molecular friction but with the resulting destructive effect on the tissue. They can be useful on surface lesions but in deep lesions invasive methods are required - interstitial treatment with coaxial antennae or electrodes -, with complex guiding methods, strict temperature controls and in some cases with associated refrigeration systems. Externally induced magnetic fields create internal thermal increases by non-invasive methods but they run the risk of increasing the oedema in some tissues, especially in the brain. The non-invasive Therma B Plus method gives rise to an internal thermal increase with none of the disadvantages of the previously mentioned systems. 15 "CET - RET" Therma B Plus Hyperthermia Capacitive Electric Transfer (CET) is a method that allows the RF electrical current to be transferred "by capacity" (principle of the electrical capacitor) to the patient's body via a moveable external application electrode. This is covered with an insulating film which acts as dielectric and the body acts as a second plate of the capacitor. A return plate closes the circuit. The electric circulation through the resistive medium formed by the live tissues increases its temperature. The Resistive Electrical Transfer (RET), introduced in 1994, is different from the CET in that basically the application electrode is not insulated, allowing the current to be transferred directly to the patient with less dispersion, thus obtaining an increase in temperature at a greater depth. Biological Effects 1. Increase of arterial circulation - vasodilatation -, giving rise to increased oxygenation and a decreased acidity of the tissues. 2. Increase of venous drainage with greater re-absorption of catabolites and decreasing of the oedema in areas with inflammatory processes. 3. Increase of the permeability of the cellular membrane, allowing better transfer of metabolites through it. 4. Stimulation of the immune system and decrease of free radicals. Therma B Plus Hyperthermia Applications The Therma B Plus method is currently being applied in most medical specialities, particularly in: Traumatology and Rehabilitation. Rheumatology. Sports Medicine Pain Clinics. 16 The Electronic Recuperator INTRODUCTION Hyperthermia application in electrocosmetics has become a fundamental treatment in cosmetic centres around the world since the arrival of the Electronic Recuperator in 1985. Its vasodilator effect activates blood flow in the treated area, nourishing and revitalising the skin cells. The treated skin has a radiant and healthy aspect. It has been applied successfully in treatments for the complexion, facial flaccidity, reshaping of glutei and stomach. Its firming effect has an outstanding effect on breasts. Its effectiveness has been demonstrated in reduction of cellulite, in post liposuction treatments, wrinkles, scars, etc. Hyperthermia treatment by virtue of the Electronic Recuperator means greater effectiveness in subsequent cosmetic treatments due to its dilatory effect on the pores, allowing greater product penetration. The application is pleasant and relaxing. Results can be seen after the first session. It is no exaggeration to say that the introduction of the Electronic Recuperator to the International market has initiated a new era in the field of aesthetics and cosmetic medicine. First of all, it must be made clear that the Therma B Plus method cannot be confused with heat. Heat is the consequence of a movement that causes friction of the aqueous molecules which, colliding into each other cause a calorific effect and, as we all know, heat is contraindicated for eyes, scalp, varicose veins, scars, bruises, etc... However, the Therma B Plus method has no known contraindications or side effects in any of the aforementioned. The Therma B Plus method is not friction. It is the result of a transformation of cold energy of relative high frequency (0.3MHz and 0.5 MHz) in internal temperature. Each tissue cell takes on part of this energy and transforms it into temperature that goes from the interior to the exterior (of the body), i.e., it is not the electrode that heats the skin, but the reverse, the skin heats the electrode. 17 The Therma B Plus Recuperator has two versions, the models designed solely on the C.E.T. function (Capacitive Electric Transfer) with insulated electrodes, and the models which in addition to C.E.T. have R.E.T. (Resistive Electric Transfer) incorporated in the same device with stainless steel electrodes. When both methods are used, both in facial and body areas, the treatment results improve outstandingly, especially on the body and for problems of deep cellulite or high flaccidity, such as after a liposuction or postpartum period. Although C.E.T. can penetrate to any part of the body, it does so with much less energy than R.E.T., i.e., the degree of transformation of electric energy in internal temperature by cm3 is much greater using R.E.T. For this reason it is advisable, but not essential, to first of all apply C.E.T. in order to create an initial drainage and subsequently to apply R.E.T. in order to perform a complete treatment. The C.E.T. was the original Therma B Plus method and the one that made it popular in both medicine and aesthetics. As the years have gone by, the C.E.T maintains its qualities and has even been improved. However, with the incorporation of the R.E.T. it has developed much further and has resulted in a new step forward in terms of aesthetics and cosmetic medicine 18 Time per Session The length of treatment depends on the size of the electrode used. The estimated recommended time is as follows, bearing in mind that it is of no importance if the time is exceeded. The largest electrode that the area to be treated allows should be selected. The maximum diameter used with each device will depend on the power of the device. Minimum TIME OF APLICATION 2 To treat a surface of 70cm (7×7 cm) CET insulated capacitive electrode Diameter 25mm ∅ 40mm ∅ 60mm ∅ 70mm ∅ Minutes 10 5 2 1 RET Metallic resistive electrode Diameter 40mm ∅ 60mm ∅ 70mm ∅ Minutes 3.5 1 0.5 Example of application : To treat an abdominal area measuring 20 x 30 cm, using a capacitive electrode 65 mm in diameter. 2 2 The surface to be treated measuring 20 x 30 = 60 cm , i.e. 6 times the reference 60 cm in the table. The table indicates 2 minutes, which, multiplied by 6 gives an application time of 15 minutes. Using a resistive electrode of 60 mm (the table indicates 1 minute), the same area would be treated for 6 minutes. If the treatment is carried out on an area that, because of its structure means the complete surface of the electrode cannot be in contact with the tissue in treatment, (for example a knee) a smaller diameter electrode should be chosen that adapts correctly to the area to be treated. In this case, the times will be applied in accordance with the new diameters. The larger electrode may still be used but the application times should be taken into account corresponding to the smaller, more suitable electrode. The time established as a reference is the required minimum in order to obtain the desired effect. Increasing these times will improve the efficacy of the system. There are no known harmful effects of high doses, as long as the temperature is maintained at bearable levels. 19 Products To Be Used If the product used during treatment with the device does not fulfill some minimum conditions of electrical conductivity, results obtained will not be as favorable as expected. If the product has these characteristics, it will allow the current to penetrate deeper and therefore the result will be much better and more efficient. It is a great error to think that any product can be used with this method. To see whether a product is suitable or not, the following test can be carried out : An inappropriate product will form a crown around the electrode during application once the normal working temperature is reached. Instead, when the product is suitable, it spreads and penetrates. About Programs 20 Therma B Plus Method Therma B Plus Hyperthermia Method Before going into detail about the two methods created and developed by Therma B Plus, it is essential to look back at some general basic concepts that will ensure a better understanding of the method. 1. The effects of the RF currents are in relation to their Frequency and Power. 2. Above 0.3 – 0.5 MHz. "heat" starts to be produced by molecular friction, which causes tissue destruction, as with microwave generators. 3. Frequencies lower than 0,3 MHz produce unwanted stimulation in the nervous system. 4. All living tissues have a certain degree of resistance or impedance to the passing of a current. The development of the Therma B Plus system required a long experimental phase based on : 1. Measuring of the impedances of the different tissues and organs of the human body in the course of a considerable number of surgical operations of different specialities. The study showed that a frequency band between 0,3 - 0,5 MHz. only induced an endogenous thermal increase, without producing "heat" by molecular friction. 2. Verification of the harmlessness of the method using extensive histological studies with animal experimentation. 3. Measuring of the temperature at different depths during application of RF, using catheters connected to an electronic thermometer shielded from RF to determine the power limit parameters in order to reach internal temperatures no higher than 41 - 42 º C in all body tissues. 21 The Therma B Plus system can be defined as: "The application of an RF current (0.3-0.5MHz) that, by traversing the different living tissues (which behave like electrical resistances inversely depending on their water content), produces an electrical power in them that creates an internal thermal increase." CAPACITIVE ELECTRIC TRANSFER ( CET ) Therma B Plus has made a momentous contribution to medicine with its mechanism for local application of high frequency current. It is based on the electric capacitor and its "capacitive" effect, from where the name of this technique derives. The active or application electrode (1) (see fig. 1) is equivalent to a capacitor plate and is covered by an insulating film (2) that acts in dielectric mode. The second plate of the capacitor (3) is the patient himself, connected to a return electrode that has a larger surface than the active electrode. When high frequency is applied to the electrode the current circulates through the dielectric, passing through the different tissues until it reaches the return electrode, which closes the electrical circuit. (Figure 2). The specialist initiates the application by spreading a fine layer of conductive moisturising cream over the area to be treated and then sliding the electrode over the area (applying suitable pressure). Partially superimposed circles are drawn, covering the whole surface to be treated. After a few minutes a thermal increase will be felt on the skin - exteriorisation of the temperature created inside. The power knob of the generator can be regulated in order to obtain the maximum heat level that can be tolerated on the skin. RESISTIVE ELECTRIC TRANSFER (RET) In 1994 Therma B Plus included the RET in its generator. This creates an internal thermal increase based on the same electrical principles as the CET. However, the capacitive interface is replaced with the use of the resistive characteristic of tissues for the direct application of high frequency (as the application electrode is not insulated), thus obtaining less dispersion of energy and a deeper temperature increase. (Fig. 3) The method of application is similar to the CET but without requiring the continual moving of the electrode. It is therefore easier to use and can be applied to skin lesions. With this technique a deeper internal thermal increase is produced. A greater therapeutic efficacy has been demonstrated in many pathologies. Using both techniques, firstly the capacitive and afterwards the resistive, improves results. 22 THERMAL EFFECTS Tissue subjected to the passing of high frequency current raises its temperature as a result of the Joule effect. The electric field route is conditioned by the resistivity of the area's tissues. A highly vascularized tissue is much more conductive than a bony tissue with a high resistance, and therefore the vascularized area will receive more current and generate more heat there. The circulating blood flow conveys the heat by conduction to nearby areas such as joints that do not generate it due to their bony structure. The refrigeration produced by the blood flow of the area treated allows the temperature to be maintained at bearable limits. The high frequency applied (fig. 4) is a cold energy (1) that generates a temperature increase in the inside of the tissue that reaches the surface (2). This also heats the electrode (3) (not the other way around, as was previously thought). Contraindications Although the contraindications for the application of the hyperthermia equipment should be laid down by the corresponding specialist, there are a series of circumstances where precautions must be fully respected. 1. Electric and electronic implants, internal or externally connected to batteries or radio control for example : pacemakers, neurostimulators, drug dosifiers, cochlear implants and external monitoritations. 2. Internal haemorrhage processes in acute phase. 3. During pregnancy on the torso. 4. Patients undergoing de-clotting treatment. 5. In the first postoperative 48 hours in some pathologies. 23 Application Method The position of the patient will obviously depend on the area to be treated. This will also determine the best position of the neutral electrode (plate) and the area on which to work with the active electrode (capacitive). Figures 1 and 2 show the most suitable positions for applications on the torso. The return plate is situated opposite the area on which the active electrode is applied. An alternative position in treatments that do not require special depth (eg spinal column) is one where the patient is seated on the neutral return plate in direct and total contact with the skin. Some treatments require the electrodes in specific positions. For example, for treatments on the shoulder the return plate is placed in the armpit and firmly held in place by pressure from the arm. (figure 3) For treatments on the knee an alternative to the horizontal position on the stretcher with the plate under the thigh is the position shown in fig. 4. Figures 5,6,7 and 8 are only for application with RET The position in fig. 5 is excellent for treatment on the ankle. The position shown in fig. 6 is suitable for focusing hyperthermia on the toes. Similar to the above, figures 7 and 8 show positions for the treatment of the wrist and fingers. In Fig. 7 the cylindrical electrode is used as return electrode. In each case, and in particular those shown in figures 3 to 8, the moisturising cream applied to the area of the active electrode must not come into contact with the neutral plate as, being conductive, it would divert the current flow to the surface. 24 For correct application the following factors should be taken into account : PRESSURE Sufficent pressure must be applied in order to maintain perfect electrical contact over the whole surface of the electrode, whilst allowing it to be moved smoothly. (Similar to the pressure exerted with a large eraser). Capacitive (CET) Resistive (RET) If the area to be treated is small and the electrode covers it, the electrode is maintained inthis position. A light circular movement of the electrode will allow the patient to tolerate a The electrode is moved in a circular SPEED motion, advancing half the diameter of the electrode. It moves at a speed of 1 circle every 1-2 seconds. higher temperature. In order to cover areas larger than the electrode, you can either: Keep the electrode still and when the maximum bearable liit is reached, move it to an adjacent area. This is continued until the whole area is covered. Move the electrode forming circles as in the CET but more slowly, advancing 1 centimetre per second. TEMPERATURE A tolerably high temperature should be selected. It should not be too uncomfortable. The length of the treatment depends on different factors, such as the size of the area TIME to be treated, the nature of the tissue in the area or the capacity of the patient to accept different degrees of temperature. The specialist should always determine the treatment time. The entire active electrode surface should always be kept in contact with the skin. Conductive Gel 25 A conductive and moisturising gel should be used which will improve movement and electrical contact of the electrode. It should liquefy with the temperature. Therma B Plus has developed and supplies a gel that complies with these requirements. Indication A thorough description of the applications of the Therma B Plus method within general pathology would be extremely lengthy. Clinical indications - areas of application, type of method, CET and/or RET, number of sessions and distribution guidelines in the time and length of each session - should always be indicated by the corresponding specialist. However, it is valuable to provide a general idea of the possible applications and some overall concepts that may be useful. Areas of application : 1. If you have a device with CET and RET, it is always advisable to apply both systems. In this case the treatment will start with the CET as its surface vasodilator effect allows greater heat dissipation and therefore a greater skin temperature tolerance, thus providing a deeper effect of the RET. 2. In the spinal column, pain due to arthrosis processes is treated locally. When there is a radiculomedullar problem, neurological exploration and complementary examinations will determine the precise spinal level on which the treatment should be applied. Times and application guidelines : In skeletal muscle inflammations and acute and chronic joint processes the specialist will establish the frequency and number of sessions depending on the evolution after a series of 3 or 4 treatments on consecutive days and another 2 or 3 additional treatments on alternate days. This generally allows the efficacy of the treatment to be predicted. The length of each treatment will depend on : The size of the surface to be treated. The size of the active electrode used. The technique applied (CET or CET+RET), depending on the model of device available. 26 2 As a reference value, the "minimum" time required to treat a surface of 100 cm with a CET electrode of 70 mm. in diameter at the maximum bearable temperature, is 45 seconds. (0.75 minutes) 2 For example : to treat a lumbar area measuring 40 x 30 cm (1200 cm ), the minimum treatment time using a capacitive electrode (CET) 70 mm in diameter should be 9 minutes (1200 / 100 x 0.75) The electrode with the largest diameter should always be used, as the device permits. Table I indicates the time values to be applied using diameters different from the reference value (70 mm.) If you have a device that incorporates both CET + RET techniques, the CET is applied first and then the RET. 2 The minimum reference times in this case to treat 100 cm of surface will be: CET - using an insulated electrode of 80 mm in diameter at the maximum bearable temperature, treat for 30 seconds. (0.5 minutes) RET - Using a non-insulated electrode of 90 mm in diameter at the maximum bearable temperature, treat for 15 seconds. (0.25 minutes) If the resistive electrode (RET) used is a different diameter from the reference electrode (70 mm), adjust the application time as shown in table II. If the treatment is performed on an area where, due to its structure (for example a knee) the complete surface of the electrode cannot enter in contact with the tissue to be treated, an electrode with a smaller diameter that adapts better to the area should be used. In this case tables I and II can be used to adjust the times in accordance with the new diameters. The larger electrodes can still be used but the application times that would correspond to the smaller most appropriate electrode must be taken into account. The reference time established is the minimum time required to obtain the therapeutic effect. Increasing these times will improve the efficacy of the system. No harmful effects have been recorded from high doses, as long as the temperature is kept at bearable levels. In treatments that require reaching a greater depth, the application times should be increased, particularly in the resistive mode (RET). ELECTRODE TIME (MINUTS) DIAMETER 70 mm 1 2 3 4 5 6 7 8 9 10 12 60 mm 1.5 2.5 4 5 6.5 8 9 10.5 12 13 16 50 mm 2 3.5 5.5 7 9 11 12.5 14 16 18 22 40 mm 2.5 5 8 10 13 15.5 18 20.5 23 26 31 30 mm 4 8 12 16 20 24 28 32 36 40 48 27 Remarks One of the most outstanding effects of the system is the increase of blood flow in the area treated. If the patient has a reduced vascularization in the treated area, intense pain and a sensation of inflammation may be felt at the beginning of the treatment. The session should be stopped and treatment restarted again with less intensity, extending the application to the surrounding areas in order to improve the venous drainage of the area. After a few days the system itself improves the flow and the treatment can be performed normally. Bi-system devices that have CET and RET have an indicator level of the RET current that circulates through the patient. The conductivity of the muscle tissue is directly related to the level of vascularization. If this level is very low, it is possible that at maximum power the RET intensity indicator hardly shows the presence of any current. In this case, the return plate should be moved as near as possible to the area to be treated, thus increasing the passing of the current and improving the blood flow of the area. In posterior treatments the plate will be moved away until it is positioned in the place originally considered optimum. In cases of potential lost of skin sensitivity, this possibility must be checked before applying the treatment. Should there be insensitivity, the electrode should be tested in the nearest area with normal sensitivity. Once the appropriate tolerable levels have been established, treatment can be applied on the insensitive area. 28 FAQ What are the differences between the capacitive and resistive methods in the RF system? The capacitive method causes the temperature to increase more rapidly in the epidermis (superficial depth area) but it penetrates less energy internally than the resistive method. The internal benefit is directly related to the amount of energy absorbed by the body. Also, the resistive method uses 100% of the current. Which model of equipment provides the deepest treatment? All models reach exactly the same depth, since all have a closed circuit from the application electrode through the plate or return electrode. The main difference is that the total amount of power supplied and, therefore, that absorbed by the body, is greater with a more powerful device and this applies even more to the resistive mode. What temperature is achieved with the RF system? Depending on the sensitivity of the area being treated, the temperature in the epidermis can reach 44-45 ºC, whether in capacitive or resistive mode. Internally, this will depend on the degree of blood circulation; the better it is, the lower the temperature will be and vice versa. For example: an increase in temperature is achieved far more rapidly in an inflamed area than in that same area when not inflamed. The calculation can be made from the increase in temperature in one minute in one cubic cm of tissue. At a depth of 5 mm in healthy tissue and in the liver, the increase can be up to 4.2 ºC in resistive mode and 2 ºC in capacitive mode. What size of electrode provides the greatest benefits with the resistive method in the RF system models? If the resistance needs to be increased according to the graph, you should use the 60 mm electrode. If it needs to be reduced, use the 90 mm electrode. Does application in certain areas hurt when using the resistive mode? If so, why? If it sometimes hurts, this is due to poor vascularisation in the affected area. The area does not have sufficient drainage capacity therefore creating pressure internally. This is what causes the discomfort; however it does not occur with the capacitive method as it is a more superficial treatment. Why is it that when there is inflammation, the power supplied is very low, but the temperature rises very quickly? Because as the circulation is adversely affected, the level of cooling is quite reduced and the power tolerated is also very low. 29 Why is it that if you gently touch someone being treated it can feel like you have received an electric shock? Part of the energy (a very small amount, about 2 or 3 watts) absorbed by a body is transmitted to another body, and if the contact is brief, this small concentration of energy can cause discomfort. This problem is solved by simply making the contact firmer. Can I be negatively affected by the radiation when giving the treatment? Absolutely not. Firstly, the power transmitted is very low, and secondly, considering that the effects of the type of current from our machines are very beneficial for the tissues, the effect is always beneficial, never negative. Why do you heat the plate in resistive mode and not in capacitive mode? Because the power supplied by the resistive method is much higher than in the capacitive. Why, when applied to the forehead, does the resistive method cause contractions and the capacitive not? The resistive method does not penetrate the brain and the current is concentrated in the scalp, leading to over-circulation which results in the contractions. This does not represent a problem but the discomfort can be avoided by reducing the output power of the equipment. As the capacitive method has the power to penetrate the skull, the effect described does not occur. What can be done about the slight dizziness which occurs when treating the neck? It should be stressed that this only occurs in people with hypotension, and one solution is to recommend that they have a cup of coffee 10 minutes before the treatment. Can any product be used to enhance a treatment? No. When applying the treatment, the products recommended by DAEYANG must be used. Afterwards, to take advantage of the vasodilatation of the pores, any products considered appropriate may be used with a manual massage. Why is there sometimes an apparent over-inflammation in the treatment area, especially in the joints? This is due to poor drainage in the treated area and is not caused by inflammation, but an accumulation of blood. Treatment should not continue in the affected area, but all around the periphery, in order to create good drainage. For example, with a knee injury, the treatment should be applied to the calf and the thigh and not be continued on the knee itself. Instead, it can be gently massaged after the corresponding drainage has been carried out. Can the resistive method be used on the hair? No. As the resistive method has a direct action with no isolation, it would produce sparks from the hair, which would be very unpleasant. 30 Can one take a shower after treatment with the RF system without losing some of the treatment's benefits? The only recommendation is to try to regulate the temperature of the water so that it is warm or not excessively cold. It should be said that, if wished, the water can be turned to cold for 15 or 20 seconds at the end of the shower without decreasing the benefit obtained from the treatment. Can external metals cause burns during treatment with the RF system? Only pendants and chains can cause problems if close to the application electrode since they do not have firm contact with the skin. It is therefore recommendable to remove all metallic objects not in firm contact with the skin. In the case of watches, bracelets, rings, etc., they are not a problem as long as they do not interfere with the treatment at a mechanical level. 31 GUARANTEE All DaeYang Medical units are guaranteed against defects in material and workmanship for a period of One years after the date of purchase – with the exception of accessories and subject to normal wear. Should your unit develop a fault, please return it to the distributor in the country where the unit was purchased. Local Distributor DISTRIBUTOR MANUFACTURER DAE YANG MEDICAL CO. LTD. #1656-1, DONGHWARI, MUNMAKEUP, WONJUSI, GANGWONDO, KOREA Phone No. : 82-33-747-4466 http://www.daeyangmed.com 32