Catalogue,thông số kỹ thuật Thiết bị laser điện trị liệu LIS 1050

LIS 1050 Business Line User’s manual TABLE OF CONTENTS Table of Contents 2 Introduction 3 Properties of laser light 3 Components of laser systems 4 Laser radiation features 5 Information on the manual 8 Writing conventions 8 Warranty 8 In general 9 Preliminary Notes 9 Unpacking 9 Setting up 9 Electrical connections 10 Safety key 11 Lighting of the device 11 Accessories 12 Description of the equipment 12 Control Panel 12 Front Panel 12 Back panel 13 Contraindications 13 How to Use the Equipment 14 Designated use 14 Best use 14 Setup 14 Display 14 Probe 15 Miscellaneous 16 Language 17 Direct Procedure 17 Loading programmes 18 Application of the therapy 18 Setting up programmes 19 Maintenance 20 Technical problems 21 Electromagnetic interference 21 Troubleshooting chart 22 Technical specifications 23 Appendices 24 A – Environmental protection 24 B – Labels 25 C – List of programmes 26 INTRODUCTION We will start by explaining the physical properties of laser in order to provide a better understanding of how it works in a medical context. Basically, laser is a system whereby energy contained in some substances is transformed into electromagnetic radiation when stimulated electrically. Laser beam electromagnetic radiation can be produced in different parts of the spectrum, including the visible spectrum, the ultraviolet spectrum (UV), the infrared spectrum (IR), etc. Before describing the laser process, we should explain some basic electromagnetic wave terminology: Wavelength (λ) Frequency (ν) Period (T) Speed of light (c) Refraction index (ρ) The frequency (ν, ni) is the number of oscillations the wave makes per second. The formula relating these two parameters is: c = λ x ν The minimum time interval between two successive points with the same phase is the period (T). When the electromagnetic radiation (light) passes through a material with a refraction index of ρ, its velocity (v) is less than the velocity of the light in a vacuum (c), and is given by this equation: v = cρ This equation is used as the definition of the refraction index ρ (rho): ρ = speed of light in a vacuumspeed of light through the material = cv The refraction index of gases, including air, is generally considered to be the same as that of a vacuum ρ0 =1 The refraction index of many transparent materials in the visible spectrum is between 1.4 and 1.8. It is higher in the infrared (IR) spectrum and is between 2.0 and 4.0. PROPERTIES OF LASER LIGHT “Normal light” (from the sun or a lamp) comprises different wavelengths, radiating in all directions. The phases of the different waves emitted from the source are not related to one another. On the other hand, laser radiation has some properties that do not exist in other types of electromagnetic radiation: 1) Monochromaticity: means that the laser has only one wavelength, and therefore only one vibration frequency. It also has only one colour defined by the active medium that produces it. In order to understand the term, we will look at “white light” which is what the mind understands when all the colours of the spectrum are seen together. When white light is passed through a prism it separates into all the component colours. On the other hand, the laser beam is composed of only one of these colours. 2) Coherency: is the property whereby all the photons emitted vibrate in phase concordance. The light from an incandescent lamp for example, is composed of different waves. They propagate randomly without any order between their phases or between their wavelengths. Laser radiation on the other hand is composed of waves with the same wavelength that leave at the same time and keep their phases constant in the direction of propagation. 3) Collimation: radiation is emitted from the laser in one direction only, and is diffused with a definite angle of divergence (q). The angular diffusion of a laser beam is very small if compared to other sources of electromagnetic radiation, since the divergence is in the order of milliradians. The divergence angle is the complete angle of opening of the laser beam (basically its width). The formula relating radians and degrees is: 360°= 2π Radians (1 radian =57.3 °; 1 milliradian = 1 mrad=0.057 ° ) The divergence of laser radiation is in the order of milliradians. The beam is practically always parallel and laser radiation can propagate for very long distances. The laser beam has actually been used to measure the distance from the earth to the moon, with an error margin of less than a centimetre. 4) Brilliance: is the power emitted per surface unit. This equipment gives the highest intensity possible per space unit. The space can be as small as a few microns. COMPONENTS OF LASER SYSTEMS In general, lasers comprise four structural units: 1. an active laser medium, 2. an excitation mechanism (source of energy, called pump source) 3. an optical cavity, comprising two mirrors and the space in between them; 4. an output mechanism; 5. and obviously a mechanical support structure. Semiconductor diode lasers: Diode lasers are all made of semiconductor material and have the typical electrical properties of electric diodes. Therefore, diode lasers have other names such as: 2. semiconductor lasers: according to the material that they are made of, 3. junction lasers: when they are made of a pn junction, 1. injection lasers: when electrons are injected into the junction by applying voltage. Even though all these devices operate close to the infrared spectrum, nowadays laser diodes are also made with visible light. One useful feature is that many can be adjusted by changing the current applied, the temperature, or by applying an external magnetic field. The semiconductors can be used as a small and highly effective source of photons which can be pumped using a variety of techniques. They include pumping with other optical sources (photopumping), pumping with an electron beam, or pumping with a pn junction. The most common technique is by the pn junction. The pn junction refers to a “p” type semiconductor attached to an “n” type. This junction conducts electricity in a preferred direction. The increased directional conductivity is the normal mechanism that all diodes and transistors in electronics work on. The distribution of the energy bands in the junction is the basis of the laser diode action. The highest level of energy occupied by the electrons is called the Fermi level. When the positive pole of the generator is connected to the p side of the pn junction, and the negative pole of the generator is connected to the n side, a current runs through the pn junction changing the population of the energy band. The layers of semiconductor material are placed in such a way so as to create an active region in the pn junction where photons are generated by a recombination process. The base structure of a simple laser diode is shown in the following figure. Figure a: outline structure of a laser diode. By A. Vasta: therapeutic lasers...Marrapese pub. Rome 1998. A laser generator can be connected by a metallic layer to the external surface of a stack of layers. The side of the crystalline semiconductor is cut in such a way as to allow it to be used as an optical cavity mirror. The voltage is applied to the metal on the external layers of the semiconductor. Since the laser diode is so small, it has a special covering that means it can be easily handled. There are different types of covering, but the standard one is similar to transistor containers. It incorporates a collimated lens that is essential for the creation of a usable beam (see figure). Special types of laser diodes have been developed to get high power laser diodes. These special diodes emit synchronised radiation: an output power of a few Watts can therefore be obtained. Diode lasers have numerous advantages: – highly effective (more than 20 % of the input energy is emitted as laser radiation) – high reliability and safety – long lasting (about 100 years estimated in continuous operation) – low cost (laser diodes are manufactured using mass production techniques in the electronics industry) – ability to carry out direct modulation of the emitted radiation, and control the electric current that passes through the pn junction. The radiation emitted is a linear function of the current and can reach modulation rates in the order of GHz (). Laser diodes are widely used in communication technology, in compact disc readers, in optical readers, in printers, and in physical therapy and analgesic therapy. They are also now being used in ophthalmology, to measure distances, as sensors, and in fax communications. Most diode lasers can operate in continuous waves. The most widespread diode is the GalliumArsenide that emits at 905 nm. Table 1 : Main features of GaAs lasers (IR) used in medicine. By A. Vasta: therapeutic lasers...Marrapese pub. Rome 1998. LASER RADIATION FEATURES Laser bean parameters 1. Frequency: this determines the average power of the laser and therefore the capacity of therapeutic lasers to penetrate tissue. The higher the frequency, the greater the penetration Æ energetic density Clearly therefore, choosing low frequencies for analgesic purposes and high frequencies for antiinflammatory purposes does not make scientific sense. 2. Pulse duration: 1. continuous emission: radiation produced by lasers is emitted without any pauses between the pulses. 2. pulsed emission: (see following paragraph) 3. Average power (Pm): this is a function that varies according to the size of the pulse (peak power Pc), the duration of the pulse (ti), and its frequency (f)=(number of times per second that a pulse is emitted). Average power is calculated as follows: Pm = Pc x ti x f Therefore, you can calculate for example, that with a laser with peak power of 20 Watts, a pulse duration of 200 nsec (which is normal for an IR laser) and a frequency of 5 KHz = (5000 pulsessec), the average power is: Pm = 20 W x 200 nsec. x 5 KHz = 20 W x 200.10 9 sec. x 5 x10 3 = 0.02 Watt = 20 mWatt The evolution towards pulse lasers is very favourable from the therapeutic point of view and for the average power, since laser penetration into the body is improved. The total energy applied is therefore much higher than with HeNe laser. 4. Peak power: is the maximum power that a single laser pulse can reach. Above a certain value of between 10 and 20 W, the increase in peak power exceeds the critical energy threshold, saturates the superficial layer of the epidermal tissue, and causes burning of the skin (thermic effect). It can be harmful to the tissue. The power of laser beams (both therapeutic and surgical) is higher at the centre of the beam and falls off towards the edges in a bell shaped curve (Gaussian). The power weakens towards the edges of the beam with lesser effects on the tissue hit. This is also true in laser surgery (which explains less pain and lower inflammation when surgical procedures are done by laser instead of normal surgery). This is called the “alfa effect”. Therefore the “low power” part of the beam (in laser therapy “cold”) is the reason that there is less pain and inflammation in the injuries. Figure b: peak power and critical threshold of power in the therapeutic laser effects. Skin becomes saturated with energy above the critical threshold and can only be permeated at lower peak power. If power higher than 20 Watts is used, it can lead to photothermal effects which give rise to skin burning. By A. Vasta: therapeutic lasers….Marrapese Pub. . Rome,1998. Figure c: illustration of a typical Gaussian distribution of laser beam power. The energy density is high at the centre of the beam (surgical laser) and decreases gradually towards the edges (therapeutic effects). By: A.Vasta: Therapeutic lasers. Published by Marrapese. Rome,1998. 5. Quantity of radiation (energy density): The quantity of radiation is the most important parameter in low power laser therapy. It is even more important than the type of laser used (visible or invisible, pulsed or continuous) (see paragraph 3). The quantity is measured in Joules (J) per area treated (JArea), or more commonly per cm2 (Jcm2). It is important to make both types of calculation of the amount, according to whether the laser has to be applied to specific areas (trigger, acupuncture points, local areas, etc.) or to larger tissue areas (sores, ulcerous areas, etc.). One Joule of energy is equal to 1 Watt x second, i.e. it represents the energy generated when 1 Watt (W) of power radiates for 1 second (s): J = W x sec. The amount of radiation is the amount of energy that is transmitted into the tissue. It is very important to know if this energy is going to be transmitted through a small area (lets say 1 mm2) or through an area that covers more than a few cm2 of tissue. Therefore in the treatment of areas like sores, ulcers, etc. it is better to express the amount in the form of density of energy in Jcm2. Since 1 J = 1 Wsec, the amount of radiation D can be calculated in the following manner: P (W) x t (s) D (Jcm2) = A (cm2) Where D = amount of laser (Jcm2) P = power of laser transmitted to the tissue (W), or the average power (mW1000), t = radiation time (s) A = surface area treated (cm2) The treatment time necessary can also be calculated from this: D(Jcm2) x A (cm2) t (sec) = P(W) In order to calculate the exposure time needed to treat a certain tissue area (A), the average laser power must be converted into Watts: e.g. laser power of 15 mW emits 151000 = 0.015 W. If 1J = 1Ws, then 1W= 1Js. Therefore if a laser has 15 mW of power, it emits a laser energy of 0.015 W = 0.015 Js. In 10 sec the emission equals 10 x 0.015 = 0.15 J. Class IIIB lasers, emitting an average output power of 60 mW can release an amount of 2 J in 33 seconds; while a class A laser, emitting a power of 3 mW, requires 11 minutes and 8 seconds to release the same amount (2 J). This means that the class IIIB lasers have a distinct advantage over the others as the treatment time is significantly reduced. If a GaAs laser is set up to work on low frequency single pulse mode, its average power is very low. In order to directly compare the various pulsed model lasers, their output energy (Ju)pulse and their pulsesecond (Hz) frequency must be noted by the manufacturers. The average power of a single pulse laser depends on its frequency (F), and the energypulse ratio (Ei), as shown in the following table of a GaAs laser with different frequencies: (The power in mW is calculated as Ei x F1000). For example, if a 10000 Hz pulsed laser emits 5 Jupulse, its average power is 10000 x 5 1000 mW = 50 mW. Generally single pulsed lasers are ineffective if the pulse frequency is less than 1000 Hz. For example, a laser with a pulse energy of 1 Ju and a pulse frequency of 1 KHz (=1000 Hz) has an average power of only 0.1 mW. If an area of cm2 5x5 needs a laser amount of 1 Jcm2, the exposure time should be the following: D x A 1 x 25 t = t = = 250000s P 0.0001 D= amount required (Jcm2) ; A= area treated (25 cm2); P = average power (0.1 mW=0.0001W) therefore t = 4167 minutes. This shows that a laser with an average power of 0.1 mW is not practical for laser therapy. It also shows that you at least need to know the average power (or the pulse frequency and the powerpulse ratio) of the laser in order to calculate the radiation amount needed to provide effective treatment. The following concepts are also important in order to gain optimal therapeutic benefits in laser therapy: 1) For best biostimulation effects (in treatment of sores, burns, bruises, etc.) the radiation dose has minimum and maximum limits. The optimal amount is between these limits. If the amount is too low, the treatment may not be effective, if the amount is too high the treatment may be either ineffective, or provoke negative effects. 2) The biostimulating effect is cumulative: suitable, repeated amounts given at relatively frequent intervals give a cumulative effect. Small, repeated amounts given at 17 day intervals provide as powerful an effect as if the same amount of radiation was given in one treatment session only. The optimal weekly radiation amount for HeNe laser therapy seems to be about 1 Jcm2. With a laser that emits an average output power of 3 mW, 333 secondscm2 are necessary. If the average power is 60 mW, 16.5 secondscm2 is necessary. For the best results on acupuncture points, the amount recommended by the Soviet literature is for about 0.1 JAcupuncture point. With a laser that radiates an average output power of 3 or 60 mW, 33 or 1.65 secondsAP point respectively would be necessary. INFORMATION ON THE MANUAL This document provides valuable information regarding the installation, set up and use of LIS 1050 . It is a useful and essential reference guide for the user. Read the contents of the manual carefully before installing the equipment and keep it on hand at all times for future reference. It is of vital importance that you strictly adhere to the recommendations contained within the manual in order to avoid malfunction, which may cause damage to the equipment and consequent annulment of the validity of the warranty. Furthermore, in order to obtain the highly efficient technical service available from the manufacturer, it is essential that any handling of the equipment be in accordance with the instructions provided. N.B. The Therapy Application Manual is available upon request. WRITING CONVENTIONS Underlining Certain sections of the manual have been underlined in order to highlight their importance. Notes These contain important information and useful tips for operating the equipment CAUTION The CAUTION message appears before operations, which, if not correctly performed, may cause damage to the machine andor its accessories. WARNING This signals operations or situations, which, if unknown to the operator, or incorrectly carried out, may harm the operator. WARRANTY EME Srl guarantees the quality of its products for a period of twelve months from the date of purchase, when information contained in this manual regarding installation, use and maintenance is strictly adhered to and the warranty coupon is returned within 15 days of purchase. The guarantee covers the replacement of faulty parts. The warranty does not however, include the replacement of the equipment. EME srl does not assume liability for malfunctioning or damages resulting from: – Incorrect connection and installation – Incorrect use due to noncompliance with instructions contained in this manual – Use of the machine in environmental conditions which do not conform with those specified for the product – Improper or inadequate maintenance – Unauthorised opening of the outer casing – Tampering or unauthorised modifications – Use of nonoriginal accessories EME Srl registered offices provide the warranty. Should you need to return the goods then please note the packing instructions as follows . Enclose a copy of the purchasing receipt. You should insure the postal package. Before sending the machine back for suspected malfunction, we recommend that first you carefully consult sections regarding MAINTENANCE and TROUBLESHOOTING of the manual, as a large part of the problems and faults are usually due to inadequate maintenance or small technical problems which can often be easily solved by the user himself. A simple call to our technical department may prove to be the solution to the problem. CAUTION The customer is responsible for any damage caused by incorrect packing of the equipment when returning it to the manufacturer. We therefore recommend that you use the original packing materials. When repacking the equipment for return to the manufacturer, proceed as follows: Unplug the machine and any connections, devices, applicators etc.; carefully clean and disinfect all parts of the machine and accessories which have been in contact with patients; any equipment which the technical department does not consider hygienic (Italian law 62619.09.1994 on safety in the workplace) will not be accepted; disassemble accessories and any mechanical supports; use original box and packing materials; enclose detailed information regarding the nature of the problem in order to facilitate the technical department’s intervention and save time on repair. IN GENERAL EME srl has recently developed a complete series of apparatus, accessories and equipment, designed and manufactured according to the highest standards of quality, making use of the latest technology and fully adhering to current directives and norms. Particular attention has been paid to the design, easy operation, function and safety of the equipment and the final result is this modern, compact unit, which offers an extremely logical operative sequence supported by a clearly legible display. A wide range of therapeutic applications, and guaranteed patient and therapist safety ensure that LIS 1050 equipment is of the highest quality. PRELIMINARY NOTES UNPACKING LIS 1050 equipment is specially packaged for transport in a single pack complete with filling which has been specifically studied for safe transportation and storage. To remove the equipment from the pack, place the box on a smooth, flat surface. Open the top of the box and remove the polystyrene filling. Be very careful when removing the contents of the pack. The unit and accessories are wrapped in transparent sheets of polyethylene protection and contains the following: the User’s Manual – no. 1 mains power supply cable; – no. 2 spare fuses (see technical specifications); no.2 pairs of safety goggles. Check the contents of the package and should any of the items be missing then contact your local authorized EME srl dealer. Save the original box and all the packing materials in case you need to return the equipment to the manufacturer or your dealer. SETTING UP Installation of the laser therapy equipment is fast and simple. If an external interlock safety circuit is required you must provide a shielded, earthed duplex cable, minimum diameter 0.6 mm, maximum length 20 m. A oneway microswitch is provided on the safety circuit side which is normally turned off. This circuit is an external safety device: it allows the laser treatment to be suspended if a door is opened in the room where the treatment is being applied. If there is only one door in the room where the treatment is being applied, the layout will be as follows: Fig. D If there is more than one door in the room where the treatment is being applied, the layout will be as follows: Fig. E ATTENTION If you wish to install the external interlock circuit use qualified technicians only and provide the technician with the layout of the room where the treatment is being applied. If it is not installed correctly, serious eye injury may result. The following environmental conditions are ideal when installing the unit: room temperature from 10°C to 40°C; humidity level from 10% to 80% without condensation; avoid direct exposure to sunlight, chemical products and vibrations. CAUTION Do not use LIS 1050 equipment wherever there is a risk of either the external or internal parts of the unit becoming wet. ELECTRICAL CONNECTION The power entry module can be found on the back of the unit and consists of a threepole socket for the cable set, an extractible fuse box with two fuses (see technical specifications) and the main switch. Insert the threepole plug of the cable set into the power entry module correctly. WARNING Before plugging the cable set into the mains, check to make sure the equipment has not undergone any damage during transport and make sure the voltage corresponds to that of the unit (see the rating plate on the side of the unit). WARNING The power supply to the unit is VERY DANGEROUS Make sure that the cable has been unplugged from the mains supply before connecting or disconnecting from the unit. WARNING For safety purposes the cable set is provided with an earthed plug. Make sure that power supply socket has been earthed. WARNING The equipment must only be connected to power supply units that comply with all safety directives in force. When using an extension lead, make sure that it has been earthed Failure to comply with the above instructions may lead to dangerous electrical discharge causing machine damage and harm to persons. CAUTION If an extension lead is used with LIS 1050 and other equipment, make sure that the total ampere absorption of all the devices together does not exceed that consented for that type of cable, and in any case does not exceed 15A. Once you have checked that installation and assembly have been carried out according to instructions provided up to this point in the manual, switch on the machine making sure that the display screen is turned on correctly. SAFETY KEY The unit is supplied with an (INTERLOCK) safety key comprising a DIN plug to plug into the DIN socket on the back. (Fig.1) Fig. 1 : Interlock The equipment WILL NOT WORK WITHOUT IT You can keep the safety contacts at a distance thanks to the socket. You must use a 1way microswitch that is normally turned off, for the safety interlock. The safety key works by cutting off both the invisible laser emission, and the Led targeting power in red. LIGHTING OF THE DEVICE When the Unit is switched on, the LCD display lights up and LIS 1050 is ready for use . The following will appear on the screen ( see fig. 2 ) : Fig.2 Following that screen, another will be loaded in which the user is asked to enter an access code. This code has been set as default to < Press the buttons as indicated in the sequence for to type the access code ( see fig. 3 ) . Fig.3 This code can not be modified by the user , and its taping admits LIS 1050 to its functioning , by loading the main page ( see Fig.4 ) . You can choose from one of the four operating modes by pressing the appropriate function key. Fig.4 ACCESSORIES The device can be used with the following accessories: Model Total peak power MLA125 25 W All working parameters are handled and controlled in real time by a sophisticated microprocessor electronic circuit which clearly displays its functions accompanied by acoustic signalling . CONTROL PANEL The front panel of the unit, which comprises the controls and signals, can be seen in fig. 1 with corresponding key. Fig.5 Control front panel MLA150 MLA1100 Probe with 1 laser diode 50 W 100 W MLA1500 (supplied) 500 W MLA375 MLA3150 Probe with 3 laser diodes 75 W 150 W MLA3300 (optional) 300 W MLA5125 MLA5250 Probe with 5 laser diodes 125 W 250 W MLA5500 (optional) 500 W MLA8200 MLA8400 Probe with 8 laser diodes 200 W 400 W Buttons 3) and 4) take on the function that is on the MLA8800 (optional) 800 W screen. DESCRIPTION OF THE EQUIPMENT LIS 1050 equipment for laser therapy has a well engineered control panel ideal for use in the specific field of application for which it was designed. FRONT PANEL The front panel can be seen in fig. 6 with its corresponding key. Fig. 6: Front panel Key 1. Connector output BACK PANEL The back panel hosts the socket for safety key and the integrated power board containing the power switch, the fuse block, and the connector for the mains power cable plug, as shown in Fig. 7.1 and Fig. 7.2 with its key . Fig. 7.1 : Power board Key: 1. Fuse block 2. Bipolar ONOFF power switch 3. Three pin plug for mains power cable Fig. 7.2 : Socket for safety key Key: 1 and 2 Normally closed safety contacts 3 Not connected CONTRA INDICATIONS 1. Direct eye radiation: class 3B lasers are potentially harmful to the retina – although retina damage is extremely improbable. The special safety goggles (supplied) must always be worn by both the patient and the operator. 2. Pregnancy: the laser should not be used over a pregnant woman’s uterus. It can be used on pregnant women on condition that there is no radiation over the abdomen. 3. Neoplasy: do not use the laser over primary or secondary wounds that have not been diagnosed. Laser treatment may be used to relieve pain in the final stages of the illness. It should only be performed with full patient consent. 4. Thyroid: laser must never be used over the thyroid. 5. Haemorrhages: indirect laser vasodilatation may worsen the haemorrhaging. 6. Immunosuppressive therapy: do not use laser therapy on patients undergoing this type of pharmacological treatment. 7. Treatment over the sympathetic nervous system, the vagus nerve and the heart area in patients with heart disease: laser therapy can significantly modify neural functions and should not be used over these areas of the body in patients with heart disease. CAUTION: • Photosensitive reactions: patients who use certain types of medicine can display photosensitive reactions. It is not fully understood how the combination of laser and medicine trigger these reactions. Patients who may be at risks for allergies, or who have a history of these reactions, should first be “tested” by applying treatment for a minimal time period. • Means of attachment, metallic or plastic plates or pacemakers CAN be used with lasers, and patients with metallic and plastic implants, stitches, or with pacemakers can safely avail of laser treatment. HOW TO USE THE EQUIPMENT This section provides important information and instructions on how to make the best use of the LIS 1050 equipment for laser therapy. All the control functions and the machine itself are handled and coordinated by a microprocessor: apart from making prememorised programmes available for application, the microprocessor ensures that the machine can be personalised and operated in a highly safe and efficient manner. Interfacing allows for the operator to communicate with the unit by means of a large, clear graphic backlit liquid crystal display screen (LCD) through which all operational messages required by the operator, work status during operation, and errors are visualised. The following paragraphs illustrate the procedures to be carried out and the technical specifications of the LIS 1050 . They also deal with the different options available, from the selection of a prememorised programme for use in specific treatments as well as how to determine the correct working parameters for “personalised” application. DESIGNATED USE LIS 1050 equipment has been designed specifically for use by professionals who have undergone training in laser therapy and can guarantee total safety to their patients. Different types of pain in different areas. Inflammatory disorders of the tendons and soft tissues (tendonitis, bursitis, enthesitis), insertional disorders, superficial limb pain. Assists in the treatment of ulcers and bedsores. After having installed and correctly positioned the machine as per the instructions described in the previous sections and connecting the laser applicator correctly, plug the machine into a 230Vac wall socket and switch on using the ONOFF main switch on the back panel of the unit. Once turned on, the LCD display lights up and LIS 1050 is ready for use (see fig. 2) . Following that screen, another will be loaded in which the user is asked to enter an access code ( see fig .3 ) . Once you have taped this code , the main page has loaded ( see Fig.4 ) , and you can choose between four operative modes by pressing its taste function . ATTENTION Please stop the treatment if any disturbance occurs during its application. SETUP This enables the basic settings to be memorised and saved within the machine memory and will automatically be called up each time the machine is turned on. You can also set the language of the unit, prepare it for correct operation and carry out the laser test . Use the UP and DOWN buttons to choose the option. Press the OK button to confirm ( see Fig.8 ) . In scars and treatment of oedema. BEST USE WARNING DISPLAY Fig.8 It is important that the operator ensures the machine’s correct electrical installation before turning on the machine. If you press on OK, the option will be highlighted and can be selected and then set using the UP and DOWN buttons. If you press on OK again (or wait for a few seconds), the item will no longer be highlighted and any modifications made can be saved or cancelled. If you select the DISPLAY option, you access the following screen (see fig. 9) Fig.9 In order to memorise the settings that best suit the visibility conditions of room, press the SALVA button. Otherwise press the ANNULLA button which will bring you back to the previous page ( see fig. 8 ) . PROBE If the OK button is pressed on this function, the following screen will appear ( see Fig.10 ) : Fig. 10 You can select the following on this screen: • The type of emission to supply treatment with (continuous emission, manual emission, automatic emission) • The type of probe to use (see paragraph on “accessories”) • The area to treat “Continuous” emission is where the probe emits the power set by the operator in a continuous manner. “Manual” emission is where the probe supplies the power set by the operator as long as the operator exerts pressure on the metallic plate that acts as a contact sensor. “Automatic” emission is where the probe emits the power set by the operator after having made contact with the skin in the area to treat. At this point, save the required settings by pressing on the SALVA function at the side: a window will appear noting that the required settings were saved. However, if you press on the ANNULLA function, the settings will not be saved. In both cases you return to the screen shown in fig. 8. Fig. 11 Following this, return to the main menu, enter direct procedure and then press START: the unit will start emitting radiation in “CONTINUOUS” mode by default and the icon showing progress of the treatment will be a triangle with the vertex pointing right. . Alternatively, if you select the MANUAL or AUTOMATIC emission modes, save the desired settings, enter direct procedure and press START: now the unit is working in “MANUAL” or “AUTOMATIC” mode (according to the selection made) and goes into standby. This is shown by the icon showing progress of the treatment which is now in the shape of a little hand (fig. 13). Fig. 12 Fig.13 This icon indicates that it is waiting for the operator to press on the contacts of the TOUCHSWITCH sensor. When this is done the icon will change into a triangle again with the vertex pointing towards the right. . If you press on STOP, the icon will turn square shaped again (see fig. 14). Fig.14 If you press on EXIT , you return to the screen shown in fig. 4. NOTE Any time a different probe is used, it must be set within this section. NOTE You must also enter the area of the part to be treated. In the “Area” menu the surface area to be treated must be entered. The power emitted will be adjusted in inverse proportion to the area. MISCELLANEOUS The same functioning logic as with the display settings works with the following functions ( see fig. 15 ) . Activate or turn off the acoustic warning signal. Fig.15 Fig.16 The screens shown in figs. 15 and 16 are obtained by repeatedly pressing the OK button. This lets you deactivate or reactivate the warning beep. It’s also possible to execute the formatting of the user memory , that it’s the only memory usable for to save the customized programs . You can also to use the “Formatta Memoria” function fot to cancel it completely . In order to avoid accidental deletion, you are asked to confirm the operation. Fig.17 If you press on the ANNULLA function, you return to the screen shown in fig. 15 or fig. 16. If you press on the FORMATTA function, a window will appear which shows progress of the formatting operation (see fig. 18). Fig.18 and finally a screen that shows when the formatting operation has finished (see fig. 19). Fig.19 If you press on the SALVA function ( see fig. 15 or fig. 16 ), the settings selected will be saved and will come up again every time the unit is turned on. On the other hand, if you press the ANNULLA function , the settings selected will be not saved . In both cases you return to the previous screen of fig. 8 . LANGUAGE To select the language you wish to view the messages and commands : • select the language required using the UP and DOWN buttons • confirm the language selected by pressing on OK Press on the SAVE function to enable the new language ( see fig. 20 ) If you press on ANNULLA , the new language setting will be cancelled. In both cases you return to the screen shown in fig. 8. Fig. 20 After a short wait while the new dictionary is loading, the menu will appear in the selected language. You can repeat the procedure at any time to change the language. DIRECT PROCEDURE This means you can create customised programmes on the spot. They cannot however be stored ( see Fig.21 ) . Fig.21 The type of probe entered will also be noted. If a channel is in use, you obviously cannot set a new programme until it finishes. Before starting the therapy you can modify any of the parameters: however, the modified programme cannot be stored. With UP and DOWN buttons you can choose from among the parameters , by pressing the OK button it’s possible to modify their values . N.B.: the parameters are highlighted in black if they are being modified. You cannot modify other parameters or exit the function if you don’t first confirm by pressing the OK button , or wait a few seconds until the item is no longer highlighted. . The following parameters can be modified: FREQUENCY: the frequency emitted from the knob is noted and the corresponding power calculated in mW; PULSED: The percentage value that defines the “Pulsed” mode is the percentage of active time compared to the entire duration of the operative cycle (1 second). So 100% means continuous activity, while 50% means that the active stage and the following pause stage both last for the same amount of time; TIME: expressed in minutes. It indicates the total time that the therapy should take ; this tratment time is calculated in relation to the probe used for the therapeutical treatment emission . LOADING PROGRAMMES If you access this section, you can choose from the pre set therapy programmes stored in the unit’s memory ( see Fig. 22 ). You cannot delete these programmes. You can temporarily modify them but the modifications will not be stored in the memory. By pressing the OK button in the CARICA PROGRAMMI menu ( see fig. 4 ) you enter in the programs that areloaded in the main memory ( see fig.22 ) . Fig.22 By pressing the MEMORIA UTENTE button ( see Fig. 22 ), you select customised programmes that are stored in the user memory nd created with the “Crea Programmi” function ( see fig.23 ) . Fig.23 In this case the MEMORIA UTENTE button is highlighted , and this means that the visualized programs are realtive to this memory area . If you press it again you will go back to Fig. 22 . The user programs , that are customized by the operator and are storable exclusively in the user memory , can’t be renominated once has been created . The stored programmes reflect the fruit of many years experience supporting expert professional operators. Appendix C shows a list of the programmes available. If a channel is in use, you obviously cannot set a new programme on it until it finishes. After pressing OK on the work program selected (for example, acne) the following screen will appear (see fig. 24): Fig.24 Once the chosen treatment programme appears on the display, press the START button to start it up. APPLICATION OF THE THERAPY Once you press the START button, a countdown will start on the timer . This is also noted by an arrow next to the channel (a square indicates non active channels). Fig.25 ATTENTION Please stop the treatment if any disturbance occurs during its application. N.B.: the parameters are highlighted in black if they are being modified. You cannot modify other parameters, exit the function, or start the therapy if you don’t first confirm by pressing the knob, or wait a few seconds until it is no longer highlighted. The countdown and the emission continue until: a) the set time finishes: when the system will sound intermittent signal tones for a few seconds. Fig.26 b) when the STOP button is pressed: the emission cycle is paused ( see Fig. 27 ) Fig.27 – the unit will take up again from the point where it was interrupted when you press the START button. if you press the STOP button again, the emission will be stopped completely ( see Fig.28 ) . Fig.28 As previously noted, the LIS 1050 is an IR diode laser beam designed and manufactured in full accordance with national and international safety standards (see Appendix). It is classified as a CLASS III B LASER: This equipment should always be used with caution in order to reduce any risk (although the risk is contained due to the specific power from IR diode radiation) that may arise from a laser source which is inherently distinguished by mono chromaticity, collimation, coherency and brilliance. WARNING Laser radiation from the equipment is inherently dangerous: always use safety goggles. Do not look at the beam with your naked eye or with any optical instrument. Do not expose the beam unless it is being strictly controlled; avoid exposing the eye to direct or diffuse radiation. Direct exposure to laser radiation for a fraction of a second is not dangerous, however prolonged exposure can be harmful. The damage is directly proportional to the power emitted. SETTING UP PROGRAMMES This function can only be used with the user’s memory as it is the only memory available for storing new programs. For to create a new program , you select the CREA PROGRAMMI menu with UP and DOWN buttons , so you press the OK button to confirm the choice ; it appears this page ( see fig. 29 ) : Fig.29 By pressing on ESCI , you return to the page of fig. 8 . On the other hand , by pressing the OK button on the highlighted menu , it appears this page ( see Fig.30 ) : Fig.30 From here you can modify: • the frequency • the pulse percentage • the treatment duration • and the name to give the program if desired Use the UP and DOWN buttons to move the cursor until you get the menu you want to modify, then press OK on the menu selected. If you press the SALVA function, the customised features will be linked to the program which will be stored in the user’s memory with the name assigned. If you press on the ESCI function, the modifications will not be saved and you return to the screen shown in fig. 29. If you only want to modify the 3 parameters and keep the name, just press on the SAVE function after changing the settings. Otherwise, once this is done, you can rename the program by pressing OK on the name as follows: 1. move the cursor to the name field using the UP and DOWN buttons (see fig. 30) 2. press on OK and the following screen will appear (see fig. 31) Fig.31 3. press OK on the character indicated by the cursor: the character selected will be highlighted and can therefore be modified 4. select the character required using the UP and DOWN buttons 5. confirm the character chosen by pressing on OK. At this point the highlighting will disappear and the character can no longer be modified 6. take the cursor to the next character using the UP and DOWN buttons and repeat operations 1 to 5 7. When finished typing the name, press on OK to confirm the new name given to the program (see fig. 31). 8. the screen shown in fig. 30 will appear with the new name assigned to the program If you press on ESCI , you cancel the renomination of the customized program . On the other hand , by pressing on SALVA , the customized program has renommed and has saved in the user memory . MAINTENANCE The LIS 1050 machine for laser therapy does not require any particular maintenance operations. WARNING Before carrying out any maintenance or cleaning procedures on the equipment, MAKE SURE TO TURN OFF the unit with the switch on the rear panel and unplug it from the mains. When cleaning the outer part of the equipment, make sure to use a soft, clean cloth dampened with lukewarm water or very mild non inflammable detergents. The front panel can be cleaned in the same way. Contact authorised dealers of EME srl for information regarding original spare parts or components. CAUTION When cleaning the outer part of the equipment, do not use diluents, detergents, acid solutions, abrasive or aggressive solutions, or inflammable substances. Use of any of the above mentioned substances or improper use of the accessories will cause irreparable damage to the equipment and the guarantee will be no longer valid. Do not spray or pour liquid onto the external parts of the equipment, or into the air holes on the casing. Do not immerse the unit in water. After cleaning the external part of the equipment, make sure to dry it perfectly before turning on the unit. The unit must under no circumstances be opened or dismantled in order to clean or check inner parts – LIS 1050 equipment does not require cleaning of inner parts and in all cases, only specialised technicians or EME srl authorised personnel should carry out such operations. CAUTION Check the integrity of the cable set and the cables connecting the handpieceapplicator at frequent intervals: they should never be damaged or display signs of wear and tear TECHNICAL PROBLEMS If any of the following situations occur, disconnect the machine and contact EME srl authorised service centres: the cable set or rear supply panel show signs of wear and tear or are damaged; liquid has entered the equipment; the equipment has been exposed to rain. ELECTROMAGNETIC INTERFERENCE LIS 1050 lasertherapy equipment has been designed and manufactured using highly advanced technology and first class components for reliable and efficient performance. However, should you meet with any operational problems, we recommended that you consult the following guide before contacting any of our authorised service centres. WARNING DO NOT OPEN LIS 1050 equipment as HIGH VOLTAGE ELECTRICITY is present and may prove VERY DANGEROUS. WARNING DO NOT OPEN the handpieceapplicator : this will cause damage to the accessories and cause the warranty to lapse CAUTION Only EME srl authorised technicians may carry out service on the internal parts of the equipment. LIS 1050 lasertherapy equipment has been designed and manufactured according to the ELECTROMAGNETIC COMPATIBILITY DIRECTIVE 89336CEE with the aim of providing adequate protection from harmful interference when installed in homes and health establishments. All the necessary measures and tests were carried out at the EME srl Testing and Measure Laboratory (LPMC) and in external specialised laboratories. The customer, upon prior request, may view the reports relative to EMC measures within the company. The LIS 1050 laser therapy equipment does not generate significant radio frequency energy and is adequately immune to radiated electromagnetic fields. Therefore it does not detrimentally interfere with radio electric communications, electromedical equipment for monitoring, diagnosis, therapy and surgery, office electronic devices such as computers, printers, photocopiers, fax machines, etc. or any electric or electronic equipment used in these environments, as long as said equipment complies with the ELECTROMAGNETIC COMPATIBILITY directive. In any case, in order to avoid any interference problems, we recommend that you operate the therapy equipment far enough away from critical equipment for monitoring vital patient functions, and that you be careful when applying therapy to patients with pacemakers. The equipment contains an IR LASER SOURCE which emits dangerous radiation For repairs and further information, contact EME srl – MEDICAL Italia or authorised service centres. TROUBLESHOOTING CHART PROBLEM POSSIBLE CAUSE SOLUTION LCD display on front panel does not light up Plug incorrectly inserted into socket. Check that the socket is working correctly. Unit does not function Power cable incorrectly inserted into the connector on the rear of the unit. Cable is worn, damaged or blocked. Insert the plug correctly into the socket. Replace the worn out or damaged power cable. The switch on the rear of the unit is turned off. Fuses missing, blown or blocked. Turn on the switch. Replace any missing, blown or interrupted fuses. Electronic control circuit does not work. Contact EME srl Service centre. No power reaching the socket. LCD display on front panel does not light up Presence of faulty components on electronic control card Contact EME srl Service centre Some of the buttons on the front control panel do not function correctly Faulty keys or buttons. Electronic control circuit malfunction Contact EME srl Service centre The unit lights up but does not emit energy Parameters not set correctly. Laser source does not function or has run out. Check that the parameters have been set correctly. Check laser source emissionis operating. Faulty components on electronic control circuit. Faulty supply on laser circuit. Contact EME srl Service centre The unit functions normally but with a significant decrease in efficiency of treatment. Faulty or depleted laser source. Possible break down in power generator circuit of the unit.. Contact EME srl Service centre The equipment starts up, or seems to work normally, but there is no emission. No safety key or the interlock circuit is open. Insert the DIN safety key into the back socket or ensure the SmartCard is inserted, reset the safety conditions. TECHNICAL SPECIFICATIONS LIS 1050 Mains voltage: 230 Vac, 5060Hz, ±10% 115 Vac, 5060Hz, ±10% Max. Power absorption: 15 VA Double fuse protection: 230 Vac 250 mA Rit. 5 x 20 mm 115 Vac 500 mA Rit. 5 x 20 mm Interlock socketSafety key (contacts normally closed) 3 contact DIN socket Backlit LCD Display, to visualise and control operating parameters: graphic 240 x 64 pixel Programmable treatment time: up to 99 minutes Diode Laser wave length emission 905 nm Classification III B EMP 5032.06 J . m2 LEA 77.1 mW (class limit 3B) Divergence 107 mrad DNRO (direct light) 2.89 metres DNRO (scattered light) 0.00 metres Sensor for detecting IR radiation of the external handpiece on the front Programmable pulse frequency 200 10000 Hz Pulse duration 100 nsec. Automatic scanning 5 frequencies per decade Pulsed mode 10 100% Peak power for single diode 25 W Total peak power depends on probeapplicator (See accessories) Output channels 1 Stored protocols 20 Storable protocols 10 Table container in plastic, external size (width x height x depth) 39 x 14 x 30 cm Unit body weight 3,25 Kg on demand APPEND I C ES Appendix A ENVIRONMENTAL CONSIDERATIONS LIS 1050 laser therapy equipment has been designed and manufactured to have minimal negative environmental impact, in line with its operational and safety requirements. Rigorous standards were followed in order to minimise the amount of waste, use of toxic materials, noise, nonrequired radiation and energy consumption. In accordance with careful research, the unit has been designed to optimise power consumption in keeping with energy saving principles. This symbol means that the product should not be disposed of as domestic waste. The user must dispose of scrap equipment by taking it to a recognised electrical and electronic recycling centre. Appendix B LABELS Label with the device specifications (attached to the back of the device) Label showing devices sensitive to electrostatic charges, placed near the serial connection connector Label on the laser handpiece showing its properties Appendix C List of programs Laser Therapy Treatments Duration (min.) Frequency (Hz) Pulsed (%) 1) ACNE 5 5000 100 2) SMALL JOINT ARTHRITIS 5 5000 100 3) CERVICALGIA 5 5000 100 4) CERVICAL ARTHROSIS 5 5000 100 5) SCARS 5 5000 100 6) CHONDROMALACIA PATELLAE 15 10000 100 7) COXARTHROSIS 15 10000 100 8) DORSALGIA 10 10000 100 9) ARTICULAR OEDEMAS ARTICOLARI 3 10000 100 10) HAEMATOMA 2 5000 100 11) ESCHAR BED SORES 2 1000 100 12) GONARTHROSIS 3 10000 100 13) HERPES SIMPLEX ( chronic phase ) 1 500 100 14) LUMBAGO 3 10000 100 15) SCIATIC NEURALGIAS ( on algic and Valleix points ) 2 10000 100 16) BURNS 2 5000 100 17) PAINFUL SHOULDER 2 5000 100 18) MUSCLETENDONS SPRAINS 2 5000 100 19) EPICONDYLITIS 2 1000 100 20) TENDINITIS 3 5000 100 Via degli Abeti 881 – 61100 Pesaro – Italy Tel. +39.0721.400791 (6 linee r.a.) Fax +39.0721.26385 www.emesrl.com