LASERMED Prestige Line Users Manual rev 3.3 Oct 2010

TABLE OF CONTENTS Table of Contents Introduction Properties of laser light Components of laser systems Laser radiation features Information on the manual Writing conventions Warranty In general Preliminary Notes Unpacking Setting up Electrical connections Safety key (Interlock) and Smart-Card Lighting of the device Accessories Description of the equipment Control Panel Front Panel Back panel Contraindications How to Use the Equipment Designated use Best use Settings Display Probe Various Language Free Procedure Loading programmes Application of the therapy Laser test Setting up programmes Maintenance Technical problems Electro-magnetic interferences Troubleshooting chart Technical specifications Appendices A - Environmental protection B – Labels C - List of programmes D – Electro-magnetic compatibility tables

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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.

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 .

Basically, laser is a system whereby energy contained in some substances is transformed into electromagnetic radiation when stimulated electrically. PROPERTIES OF LASER LIGHT 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.

“Normal light” (from the sun or a lamp) comprises different wavelengths, radiating in all directions.

Before describing the laser process, we should explain some basic electromagnetic wave terminology:

The phases of the different waves emitted from the source are not related to one another.

- Wavelength (λ) - Frequency (ν) - Period (T) - Speed of light (c) - Refraction index (ρ)

On the other hand, laser radiation has some properties that do not exist in other types of electromagnetic radiation :

The wavelength (λ, lambda) è la distanza tra due punti adiacenti di un'onda che hanno la stessa fase: per esempio la distanza tra due picchi adiacenti dell'onda. The frequency (ν, ni) is the number of oscillations the wave makes per second. The formula relating these two parameterss is : c=λ xν

1) Mono-chromaticity:: 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. colours On the other hand, the laser beam is composed of only one of these colours .

The minimum time interval between two successive points with the same phase is the period (T)..

2) Coherency:: is the property whereby all the photons emitted vibrate in phase concordance .

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 :

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.

v = c/ρ This equation is used as the definition of the refraction index ρ (rho):

ρ = speed of light in a vacuum/speed of light through the material = c/v The refraction index of gases, including air, is generally considered to be the same as that of a vacuum :

ρ0 =1.

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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 th 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 electrom radiation, since the divergence is in the order of milli-radians. milli LASERMED - rev.3 - 01 / 10 / 2012

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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 milli-radian = 1 mrad=0,057 ° ) –

The divergence of laser radiation is in the order of millimilli radians. The beam is practically always parallel and laser radiation can propagate for very long distances. The laser beam has actually been en 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. unit This equipment gives the highest intensity possible per space unit. The space can be as small as a few microns.

semiconductor lasers: according to the material that they are made of, junction lasers: when they are made of a pn junction, injection lasers: when electrons are injected into the junction by applying voltage. voltage

Evenn 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 (photo(photo pumping), pumping with an electron beam, or pumping with a pn junction. The most common technique is by the p-n p junction.

COMPONENTS OF LASER SYSTEMS The pn junction refers to a “p” “ type semiconductor attached to an “n” type. In general, lasers comprise four structural units : This junction conducts electricity in a preferred direction. 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. structure

Semiconductor diode lasers:

Diode lasers are all made of semiconductor material and have the typical electrical properties of electric diodes . Therefore, diode lasers rs have other names such as :

The increased directional conductivity is the th 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 p-n junction, and the negative pole of the generator is connected to the n side, a current runs through the p-n junction changing the population of the energy band. The layers of semiconductor nductor 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.

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The base structure of a simple laser diode is shown in the following figure . Laser diodes are widely used in communication technology, in compact disc readers, r 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. Figura a: outline structure ructure of a laser diode . by A. Vasta:: i lasers terapeutici...Marrapese ed.. Roma 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. 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 differentt 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.

The most ost widespread diode is the Gallium-Arsenide that emits at 905 nm .

Wavelength Beam diameter Beam divergence Parameter indicators

Average output power

Peak power Pulse duration Number of diodes Emission frequency Type of emission Guide light ANSI safety standard Method of treatment

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 controll the electric current that passes through the pn junction. junction

The radiation emitted is a linear function of the current and can reach modulation rates in the order of GHz (!).

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Display Areas of use

808 nm – 905 nm 5 mm to 10 mm from the tissue 9° Frequency – Treatment time – Energy supplied (J) – Emission level According to the number of diodes from 25mW to a few Watts (500mW limited class 3B) Up to 800 Watts 100 nsec. 1 – 8 or more Up to 10,000 Hz CW – Pulsed He He-Ne (red) or green 3B and 4 Single Single-multiple diode handpiece, scanning Backlit LCD Dermatology Laser injections Sports medicine Neurology Dentistry Ophthalmology phthalmology Orthopaedics Rheumatology Analgesic therapy

Table 1 : Main features of GaAs lasers (IR) used in medicine. By A. Vasta: therapeutic lasers...Marrapese pub. Rome 199 199.

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LASER RADIATION FEATURES

Laser bean parameters

4. Peak power: is the maximum power that a single laser pulse can reach.

1. Frequency: this determines the average power of the laser and therefore the capacity of therapeutic lasers to penetrate tissue.

Above a certain value of between 10 and 20 W, the increase in peak power exceeds the th critical energy threshold, saturates the superficial layer of the epidermal tissue, and causes burning of the skin (thermic effect).

The higher the frequency, the greater the penetration energetic density

It can be harmful to the tissue.

Clearly therefore, choosing low frequencies for analgesic purposes and high frequencies for anti--inflammatory purposes does not make scientific sense .

The power of laser beams (both therapeutic and surgical) is higher at the centre of the he beam and falls off towards the edges in a bell shaped curve (Gaussian).

2. Pulse duration :

The power weakens towards the edges of the beam with lesser effects on the tissue hit.

1. continuous emission:: radiation produced by lasers is emitted without any pauses between the pulses. pulses 2. pulsed emission:: (see following paragraph) paragr

This is also true in laser surgery (which explains less pain and lower inflammation when surgical s procedures are done by laser instead of normal surgery). This is called the “alfa alfa effect”. effect

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).

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.

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 pulses/sec), the average power is : Pm = 20 W x 200 nsec. x 5 KHz = 20 W x 200.10 -9 sec. x 5 x 103 = 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 He-Ne laser.

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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 Rome,1998.

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Since 1 J = 1 W*sec, sec, the amount of radiation D can be calculated in the following manner : P (W) x t (s) D (J/cm2) = ------------------A (cm2) Where

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) ser) 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 powe 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 (J/Area), or more commonly per cm2 (J/cm2).

D = amount of laser (J/cm2) P = power of laser transmitted to the tissue (W), or the average verage power (mW/1000), t = radiation time (s) A = surface area treated (cm2) The treatment time necessary can also be calculated from this : D(J/cm2) 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 15/1000 = 0.015 W.

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.).

If 1J = 1Ws, then 1W= 1J/s.

One Joule of energy is equal to 1 Watt tt x second, i.e. it represents the energy generated when 1 Watt (W) of power radiates for 1 second (s) :

In 10 sec the emission equals 10 x 0.015 = 0.15 J.

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 g 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 J/cm2.

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Therefore if a laser has 15 mW m of power, it emits a laser energy of 0.015 W = 0.015 J/s.

Class 3B B 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 3B 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 pulse/second (Hz) frequency must be noted by the manufacturers.

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The average power of a single pulse laser depends on its frequency (F), and the energy/pulse ratio (E/i), as shown in the following table of a GaAs laser with different frequencies :

For example, if a 10000 Hz pulsed laser emits 5 Ju/pulse, its average power is 10000 x 5 / 1000 mW = 50 mW.

2. The bio-stimulating stimulating effect is cumulative: suitable, repeated amounts given at relatively frequent intervals give a cumulative effect. Small, repeated amounts given at 1-77 day intervals provide as powerful an effect as if the same amount of radiation was given in one treatment session only.

Generally single pulsed lasers are ineffective if the pulse frequency is less than 1000 Hz.

The optimal weekly radiation amount for He-Ne He laser therapy seems to be about 1 J/cm2.

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.

With a laser that emits an average aver output power of 3 mW, 333 seconds/cm2 are necessary. If the average power is 60 mW, 16.5 seconds/cm2 is necessary.

(The The power in mW is calculated as Ei x F/1000). F/1000

If an area of cm2 5x5 needs a laser amount of 1 J/cm2, the exposure time should be the following: DxA t = -----------P

1 x 25 t = --------------- = 250000s 0.0001

D= amount required (J/cm2) ; A= area treated (25 cm2); P = average power (0.1 mW=0.0001W)

3. For the best results on acupuncture points, the amount recommended by the Soviet literature is for about 0.1 J/Acupuncture point. With a laser that radiates an average output power of 3 or 60 mW, 33 or 1.65 seconds/AP point respectively would be necessary

INFORMATION ON THE MANUAL therefore t = 4167 minutes. This shows that a laser with an average power of 0.1 mW is not practical for laser therapy.

This document provides valuable information regarding the installation, set up and use of LASERMED series .

It also shows that you at least need to know the average power (or the pulse frequency and the power/pulse ratio) of the laser in order to calculate the radiation amount needed to provide effective treatment.

It is a useful and essential reference guide for the user.

The following concepts are also important in order to gain optimal therapeutic benefits in laserr therapy:

1. For best bio-stimulation stimulation 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.

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 th 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 availablee 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.

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WRITING CONVENTIONS Underlining - Certain sections of the manual ual 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 use damage to the machine and/or its accessories.

! WARNING ! This signals operations or situations, which, if unknown to the operator, or incorrectly carried out, may harm the operator..

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. package Before re 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 mall technical problems which can often be easily solved by the user himself. A simple call to EME srl 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.

WARRANTY

EME srl guarantees the quality of its products for a period of 24 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.

We therefore recommend that you use the original packing materials.

When re-packing packing the equipment for return to the manufacturer, proceed as follows: follows

ent of faulty parts. The guarantee covers the replacement The warranty does not however, include the replacement of the equipment.

-

The warranty does not cover any malfunction or damage caused by : -

-

Incorrect connection and installation Incorrect use due to non-compliance compliance 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 non-original accessories

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-

Unplug the machine and any connections, devices, evices, applicators etc; 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 T.U.S. 81/2008 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 a save time on repair;

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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 LASERMEDLASERMED series equipment is of the highest quality. The equipment LASERMED-series series were planned and built in manner that their use, e, if it happens at the conditions indicated, doesn’t compromise the health and safety of the patients, of the users and of third, taking into consideration the benefit to the patient.

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; n.1 mains power supply cable; cable n.2 f spare fuses (see technical specifications) ; n.1 laser probe ( see paragraph “accessories” ) n.2 pairs of safety goggles. goggles

Check the contents of the package and should any of the items be missing then contact your local authorized EME srl dealer .

CAUTION Such equipment are not bound to diagnosis, prevention, monitoring, compensation mpensation of injury or handicap, substitution or modification of the anatomy, control of the conception, support / vital support of functions but allow to treat special pathologies and to reduce the illness. A special intervention is not required in the event of failure of the medical device , but just a normal maintenance / repair .

PRELIMINARY NOTES

UNPACKING

Save the original box and all the packing materials in case ase you need to return the equipment to the manufacturer or your dealer. dealer

SETTING UP

Installation of the laser therapy equipment is fast and simple . If the client requires an external safety interlock is necessary to expect a twisted pair cabling of diameter 0.6mm minimum, 20m max, with screen connected to ground .

LASERMED-series series equipment is specially packaged for transport in a single pack complete with filling which has been specifically studied for safe transportation and storage.

At the side safety circuit it necessary to plan the creation of a micro-switch switch to a via normally closed .

To remove the equipment from the pack, place the box on a smooth, flat surface.

Such circuit is an external safety accessory: it allows to interrupt the laser therapy herapy treatments if the door of the treatment room has been opened . If the treatment room has only one door, the referring diagram is the following one :

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! WARNING !

If you want to install an extern interlock circuit , contact exclusively qualified technicians and supply them the scheme correspondent to the room used for the emission of the treatment. treatment A bad installation tallation of the device can to generate serious ocular lesions .

Fig. D

If the treatment room has more than one door, the referring diagram is the following one :

The following environmental conditions are ideal when installing the LASERMED-series series units :

room temperature humidity level

from +10° to +40°C from 10% to 80% condensation avoid void direct exposure to sunlight, chemical and vibrations

without products

CAUTION Do not use LASERMED-series LASERMED equipment wherever there is a risk of either the external or internal parts of the unit becoming wet

ELECTRICAL CONNECTION

Fig. E

The power entryy module can be found on the back of the unit and consists of a three-pole pole socket for the cable set, an extractible fuse box with two fuses (see technical specifications) and the main switch. Insert the three-pole pole plug of the cable set into the power entry module correctly.

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!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 de 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.

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 AND SMART-CARD SMART

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

!WARNING! For safety purposes the cable set is provided provid with an earthed plug. Make sure that power supply socket has been earthed. earthed 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. persons

The equipment WILL NOT WORK WITHOUT IT !

You can keep the safety contacts at a distance thanks to the socket. way micro-switch micro that is normally You must use a 1-way turned off, for the safety interlock. interlock

CAUTION If an extension lead is used with LASERMED-series series and other equipment, make sure that the total ampere absorption bsorption of all the devices together does not exceed that consented for that type of cable, and in any case does not exceed 15A.

ey works by cutting off both the invisible The safety key laser emission, and the Led targeting power in red . The Smart Card is supplied as an accessory, in order to save up personalized programmes . The device must be used exclusively with its smart-card smart .

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! WARNING ! The two pointer-LED LED diodes , of red colour, they delimit the action-area area of the spot relative to the laser emission ; use the spots of the pointer-diodes diodes as reference drive for the revealing of the position of the spot of the laser beam .

This code has been set with the default number of 1234. Press the function ction buttons near the number on the video to type it ( see fig. 3 ) :

LIGHTING OF THE DEVICE

! WARNING ! It is recommended not to start the emission of treatment if the device isn’t in perfect mechanical conditions .

When the Unit is switched on, the LCD display lights up and LASERMED-series series unit is ready for use . The following will appear on the screen ( see fig .2 ) :

Fig. 3

This code can not be modified by the user. user The first page will appear when you press the Encoder knob ( see Fig.4 ) . You can choose from one of the four operating modes by pressing the appropriate function key. key

Fig. 2

Following that screen, another will be loaded in which the user is asked to enter an access code. Fig. 4

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ACCESSORIES The device can be used with the following accessories : CAUTION accessories list INTERLOCK Connector laser protection goggles MLA1/25 probe MLA1/50 probe MLA1/100 probe MLA1/500 probe MLA3/75 probe MLA3/150 probe MLA3/300 probe MLA5/125 probe MLA5/250 probe MLA5/500 probe MLA8/200 probe MLA8/400 probe MLA8/800 probe

Model MLA1/25 MLA1/50 MLA1/100 MLA1/500 MLA3/75 MLA3/150 MLA3/300 MLA5/125 MLA5/250 MLA5/500 MLA8/200 MLA8/400 MLA8/800

Probe with a laser diode Probe with a 3 laser diodes Probe with a 5 laser diodes Probe with a 8 laser diodes

supplied 1 2 1

optional

X X X X X X X X X X X X

Total peak power 25 W 50 W 100 W 500 W 75 W 150 W 300 W 125 W 250 W 500 W 200 W 400 W 800 W

Do not use different accessories from those provided : they could damage the unit and cause the warranty to lapse. If theree are problems or installation difficulties, please contact the EME srl technical assistance department.

DESCRIPTION OF THE EQUIPMENT

LASERMED-series equipment for laser therapy has a well-engineered engineered control panel ideal for use in the specific field of application for which it was designed. 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. key

Fig. 5: Control front panel

CAUTION The perfect functionality of the LASERMED-series LASERMED device is guaranteed in the respect of the standards of installation and use pointed out, only with the accessories and the original parts of exchange. If there are problems or installation difficulties, please contact the EME srl technical assistance department.

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Key: 1) 2) 3) 4) 5) 6)

Name of unit LCD graphic display Right side function buttons Left side function buttons START button Encoder knob with functions : select/confirm button 7) STOP/PAUSE button 8) Sensore test manipolo Laser

Fig. 7.1 : Supply module

Buttons 3 and 4 take on the function that is on the screen .

FRONT PANEL

Key :

The front panel can be seen in fig.6 with its corresponding key. . Fig. 6 : Front panel

1. 2. 3. 4. 5.

Fuse block Bipolar ipolar ON/OFF power switch Three pin plug for mains power cable earthing terminal INTERLOCK connector

Fig. 7.2 : Socket for safety key

Key : 1. 2. 3. 4.

Slot for Smart-Card insertion Connettore per collegamento seriale Connettore uscita 1 Connettore uscita 2 (solo per LASERMED 2200)

N.B. LASERMED 2100 has one output channel. LASERMED 2200 has two independent output channels .

Key Safety contacts acive on the last releases 1-2 Normally closed safety contacts (Contact A) 3 Not connected (Contact B)

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 .

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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 gog (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 vaso-dilatation dilatation 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 .

HOW TO USE THE EQUIPMENT

This section provides important information and instructions on how to make the best use of the LASERMED-series series equipment for laser therapy. All the control functions and the machine itself are handled and co-ordinated ordinated by a microprocessor : apart from making pre-memorised memorised 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 oper 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 raphs illustrate the procedures to be carried out and the technical specifications of the LASERMED-series unit . They also deal with the different options available, from the selection of a pre-memorised memorised programme for use in specific treatments as well as how to determine the correct working parameters for “personalised” application”.

! WARNING ! 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 f 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 laserr treatment .

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It is recommended not to start the emission of treatment if the device isn’t in perfect mechanical conditions or don’t present laser emission characteristics characteristic in compliance with the purpose (see the table of specifications) .

! WARNING ! Ass the laser radiation that escapes from the laser-probes probes for the emission of the laser-therapy therapy treatments is invisible , the probes foresee on board the assemblage of two diodes led, of red colour colo .

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! WARNING ! The device of target pointing of the probe supplied to the device is characterized by two drive-lights lights (led diodes), what they have a driving function , in conformity to the EN 60601-2-22 22 standard standa .

! WARNING ! The red led-diodes diodes light on with the activation of the laser emission from the operator, and everyone of them they emits a pointer beam . The pointer-beams beams produce some red spot on the point of impact, and they delimit the region regi where it will revert the spot of the laser beam , that is invisible to human eye. The laser beam is always found to the centre of the axis of symmetry of the two red spots .

! WARNING ! It is recommended to clean with caution the equipment and nd the accessories supplied after every treatment and before their use on other patients . The cleaning and relative disinfection must have effected in a systematic way , before the execution of the therapeutic treatment which to submit the patient .

The operator, in fact, should be qualified to be able to use such equipment, ipment, and he should have passed an adapted training, or should operate under the control of a medical adequately qualified to the use of the equipment, in order to guarantee safety conditions to the patient. Such equipment can be used in hospital environment enviro outpatient, but also at home; nevertheless, it is important to know that the user follow the medical instructions to use the equipment or that he follow the indications present in the user’s manual. Different types of pain in different areas . Inflammatory flammatory disorders of the tendons and soft tissues (tendonitis, bursitis, enthesitis), insertional disorders, superficial limb pain. Assists in the treatment of ulcers and bedsores. In scars and treatment of oedema .

BEST USE

! WARNING ! In order er to guarantee an absolutely safe operation of the unit on the patient,, it is advisable to carry out periodical inspections (at 2 years intervals). intervals)

! WARNING ! DESIGNATED USE

The LASERMED-series unit is a electro-medical medical device that delivers laser-therapy treatments, with the help of mono-diode and multi-diode probes for the provision of treatment . The use of LASERMED-series unit is reserved , under the supervision rvision and responsibility of an expert in the problems of the laser radiation, for operators that , by their training, provide assurance of proper use and safe for the patient .

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Do not use your LASERMED-series LASERMED unit in the presence of flammable anaesthetic an mixture ; in the event of default , EME srl shall not be consider responsible for any accidents

! WARNING ! Do not use your LASERMED-series LASERMED unit in the presence of flammable materials ( for example , paper ) ; in the event of default , EME srl shall not be consider responsible for any accidents

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! WARNING ! Do not use your LASERMED-series series unit in the presence of oxygen-rich rich environments ; in the event of default , EME srl shall not be consider responsible for any accidents

! WARNING ! The laser therapy treatments must be provided, under the strict control of the operator, to patients conscious , able to interact with the operator in response to stresses transmitted by the device ; in case of default to the indications given , EME srl shall not be consider responsible for any accidents .

After having installed and correctly positioned the machine as per the instructions described in the previous sections and connecting the laser applicator correctly, correctl plug the machine into a 230Vac wall socket and switch on using the ON/OFF main switch on the back panel of the unit. Once turned on, the LCD display lights up and LASERMED-series series unit is ready for use (see .2 ) . Following that screen, another will be b loaded in which the user is asked to enter an access code ( see fig .3 ) . When you have typed this code , it is loaded the main screen ( see Fig.4 ) , that it allows to choice among 4 operative modes by pressing the relative function taste .

! WARNING !

NOTE

It is important that the operator ensures the machine’s correct electrical installation before turning on the device.

Thee following figures refer specifically to LASERMED 2200 , however the LASERMED 2100 unit functions can also be inferred from them as it has only one channel and is therefore even simpler.

! WARNING ! It is recommended not to start the emission of treatment if the device isn’t in perfect mechanical conditions .

If you want to use the Smart-Card Smart to create new customised programmes grammes or to run those already stored, insert it as shown in the following figure :

CAUTION Itt is not possible to define for the devices LASERMED-series a number of suggested sessions for to evaluate the effectiveness of the generic treatment, since they are tied up to the power emitted to the patient submitted to the treatment. The medician must to decide the number of therapeutic sessions which to submit the patient depending on the specific cases , with the purpose to guarantee to the patient the execution of an effective fective treatment in the time and developed under conditions of absolute safety .

Fig.8

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