Fisiolaser Ird

FISIOLASER IRD
FISIOLASER IRD 2
USER’S MANUAL
0476
FISIOLASER IRD EL12061 – A01

mod.14-2013.07.15-17.30-A01-gb.docx Rev.02 - 07/2018
FISIOLASER IRD2 EL12062 – A01
INDEX HOW TO USE THE EQUIPMENT ............................................. 16
DESIGNATED USE ....................................................................... 17
INTRODUCTION ............................................................................ 3
BEST USE ................................................................................................ 17
PROPERTIES OF LASER LIGHT............................................................ 3
SET UP ............................................................................................ 18
COMPONENTS OF LASER SYSTEMS .................................................. 4
DISPLAY ................................................................................................. 19
Beam diameter........................................................................................ 5
PROBE ..................................................................................................... 20
Beam divergence .................................................................................... 5
VARIOUS ................................................................................................ 23
Parameter indicators ............................................................................... 5
LANGUAGE ............................................................................................ 24
Method of treatment ............................................................................... 5
DIRECT PROCEDURE ................................................................ 24
Display ................................................................................................... 5
LOADING PROGRAMMES ........................................................ 25
LASER RADIATION FEATURES ........................................................... 5
APPLICATION OF THE THERAPY.......................................... 26
INFORMATION ON THE MANUAL ........................................... 8
LASER TEST ........................................................................................... 28
WRITING CONVENTIONS ..................................................................... 8
SETTING UP PROGRAMMES ................................................... 28
WARRANTY .................................................................................... 8
MAINTENANCE ........................................................................... 29
IN GENERAL ................................................................................... 9
TECHNICAL PROBLEMS .......................................................... 31
PRELIMINARY NOTES ................................................................ 9
ELECTROMAGNETIC INTERFERENCE .............................. 32
UNPACKING ............................................................................................ 9
TROUBLESHOOTING CHART ................................................ 33
SETTING UP ............................................................................................. 9
TECHNICAL SPECIFICATIONS ............................................... 34
ELECTRICAL CONNECTION .............................................................. 11
APPENDICES................................................................................. 36
SAFETY KEY AND SMART-CARD ..................................................... 11
Appendix A ENVIRONMENTAL CONSIDERATIONS ....................... 36
LIGHTING OF THE DEVICE ................................................................ 12
Appendix B LABELS............................................................................... 37
ACCESSORIES ....................................................................................... 13
Appendix C List of programs ................................................................... 39
DESCRIPTION OF THE EQUIPMENT .................................... 14
Appendix D Electro-magnetic compatibility tables ................................. 41
CONTROL PANEL ................................................................................. 14
FRONT PANEL ....................................................................................... 14
BACK PANEL ......................................................................................... 15
INDICATIONS ............................................................................... 15
CONTRA - INDICATIONS .......................................................... 15
2 / 39 FISIOLASER IRD/IRD 2
INTRODUCTION PROPERTIES OF LASER LIGHT
We will start by explaining the physical properties of laser in order to provide a “Normal light” (from the sun or a lamp) comprises different wavelengths, radiating
better understanding of how it works in a medical context. in all directions.
Basically, laser is a system whereby energy contained in some substances is The phases of the different waves emitted from the source are not related to one
transformed into electromagnetic radiation when stimulated electrically. another.
Laser beam electromagnetic radiation can be produced in different parts of the On the other hand, laser radiation has some properties that do not exist in other types
spectrum, including the visible spectrum, the ultraviolet spectrum (UV), the infrared of electromagnetic radiation :
spectrum (IR), etc. 1) Mono-chromaticity: means that the laser has only one wavelength, and therefore
Before describing the laser process, we should explain some basic electromagnetic only one vibration frequency. It also has only one colour defined by the active
wave terminology: 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
- Wavelength () seen together. When white light is passed through a prism it separates into all the
- Frequency () component colours.
- Period (T) On the other hand, the laser beam is composed of only one of these colours .
- Speed of light (c) 2) Coherency: is the property whereby all the photons emitted vibrate in phase
concordance .
- Refraction index ()
The light from an incandescent lamp for example, is composed of different waves.
The frequency (, ni) is the number of oscillations the wave makes per second. They propagate randomly without any order between their phases or between their
wavelengths.
The formula relating these two parameters is :
Laser radiation on the other hand is composed of waves with the same wavelength
c =  x  that leave at the same time and keep their phases constant in the direction of
The minimum time interval between two successive points with the same phase is propagation.
the period (T). 3) Collimation: radiation is emitted from the laser in one direction only, and is
When the electromagnetic radiation (light) passes through a material with a diffused with a definite angle of divergence (q) .
refraction index of  its velocity (v) is less than the velocity of the light in a The angular diffusion of a laser beam is very small if compared to other sources of
vacuum (c), and is given by this equation : electromagnetic radiation, since the divergence is in the order of milli-radians.
v = c/ The divergence angle is the complete angle of opening of the laser beam (basically
its width).
This equation is used as the definition of the refraction index  (rho):
The formula relating radians and degrees is :
 = 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 360°= 2 Radians
as that of a vacuum (1 radian =57,3 °; 1 milli-radian = 1 mrad=0,057 ° )
0 =1. The divergence of laser radiation is in the order of milli-radians.
The refraction index of many transparent materials in the visible spectrum is between The beam is practically always parallel and laser radiation can propagate for very
1.4 and 1.8. It is higher in the infrared (IR) spectrum and is between 2.0 and 4.0 . long distances.
The laser beam has actually been used to measure the distance from the earth to the The increased directional conductivity is the normal mechanism that all diodes and
moon, with an error margin of less than a centimetre. transistors in electronics work on.
4) Brilliance: is the power emitted per surface unit. The distribution of the energy bands in the junction is the basis of the laser diode
action.
This equipment gives the highest intensity possible per space unit. The space can be
as small as a few microns. The highest level of energy occupied by the electrons is called the Fermi level.
COMPONENTS OF LASER SYSTEMS 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
In general, lasers comprise four structural units :
runs through the p-n junction changing the population of the energy band.
1. an active laser medium,
The layers of semiconductor material are placed in such a way so as to create an
2. an excitation mechanism (source of energy, called "pump" source) active region in the pn junction where photons are generated by a recombination
process.
3. an optical cavity, comprising two mirrors and the space in between them;
The base structure of a simple laser diode is shown in the following figure .
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 :
– semiconductor lasers: according to the material that they are made of,
Figura a: outline structure of a laser diode .
– junction lasers: when they are made of a pn junction,
by A. Vasta: i lasers terapeutici...Marrapese
– injection lasers: when electrons are injected into the junction by applying
voltage. ed.. Roma 1998.
Even though all these devices operate close to the infrared spectrum, nowadays laser A laser generator can be connected by a metallic layer to the external surface of a
diodes are also made with visible light. stack of layers.
One useful feature is that many can be adjusted by changing the current applied, the The side of the crystalline semiconductor is cut in such a way as to allow it to be
temperature, or by applying an external magnetic field. used as an optical cavity mirror.
The semiconductors can be used as a small and highly effective source of photons The voltage is applied to the metal on the external layers of the semiconductor.
which can be pumped using a variety of techniques. Since the laser diode is so small, it has a special covering that means it can be easily
They include pumping with other optical sources (photo-pumping), pumping with an handled.
electron beam, or pumping with a pn junction. There are different types of covering, but the standard one is similar to transistor
The most common technique is by the p-n junction. containers. It incorporates a collimated lens that is essential for the creation of a
usable beam (see figure).
The pn junction refers to a “p” type semiconductor attached to an “n” type.
Special types of laser diodes have been developed to get high power laser diodes.
This junction conducts electricity in a preferred direction.
These special diodes emit synchronised radiation: an output power of a few Watts Method of treatment Single-multiple diode handpiece,
can therefore be obtained. scanning
Display Backlit LCD
Diode lasers have numerous advantages : Areas of use Dermatology
 highly effective (more than 20 % of the input energy is emitted as laser Laser injections
radiation) Sports medicine
Neurology
 high reliability and safety Dentistry
Ophthalmology
– long lasting (about 100 years estimated in continuous operation)
Orthopaedics Rheumatology
– low cost (laser diodes are manufactured using mass production techniques Analgesic therapy
in the electronics industry) Table 1 : Main features of GaAs lasers (IR) used in medicine.
By A. Vasta: therapeutic lasers.Marrapese pub. Rome 199.
– ability to carry out direct modulation of the emitted radiation, and
control the electric current that passes through the pn junction. LASER RADIATION FEATURES
The radiation emitted is a linear function of the current and can reach modulation Laser bean parameters
rates in the order of GHz (!). 1. Frequency: this determines the average power of the laser and therefore the
Laser diodes are widely used in communication technology, in compact disc readers, capacity of therapeutic lasers to penetrate tissue.
in optical readers, in printers, and in physical therapy and analgesic therapy. The higher the frequency, the greater the penetration  energetic density
They are also now being used in ophthalmology, to measure distances, as sensors, Clearly therefore, choosing low frequencies for analgesic purposes and high
and in fax communications. frequencies for anti-inflammatory purposes does not make scientific sense .
Most diode lasers can operate in continuous waves. 2. Pulse duration :
The most widespread diode is the Gallium-Arsenide that emits at 905 nm . 1. continuous emission: radiation produced by lasers is emitted without any
Wavelength 808 nm – 905 nm pauses between the pulses.
Beam diameter 5 mm to 10 mm from the tissue 2. pulsed emission: (see following paragraph)
Beam divergence 9°
Parameter indicators Frequency – Treatment time – 3. Average power (Pm): this is a function that varies according to the size of the
Energy supplied (J) – Emission pulse (peak power Pc), the duration of the pulse (ti), and its frequency (f)=(number
level of times per second that a pulse is emitted).
Average output power According to the number of
diodes from 25mW to a few
Average power is calculated as follows :
Watts (500mW limited class Pm = Pc x ti x f
3B)
Peak power Up to 800 Watts Therefore, you can calculate for example, that with a laser with peak power of 20
Pulse duration 100 nsec. Watts, a pulse duration of 200 nsec (which is normal for an IR laser) and a
Number of diodes 1 – 8 or more frequency of 5 KHz = (5000 pulses/sec), the average power is :
Emission frequency Up to 10,000 Hz Pm = 20 W x 200 nsec. x 5 KHz
Type of emission CW – Pulsed
Guide light He-Ne (red) or green = 20 W x 200.10 -9 sec. x 5 x 103
ANSI safety standard 3B and 4 = 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.
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.
Figure c: illustration of a typical Gaussian distribution of laser beam power. The energy density is
This is also true in laser surgery (which explains less pain and lower inflammation high at the centre of the beam (surgical laser) and decreases gradually towards the edges
when surgical procedures are done by laser instead of normal surgery). (therapeutic effects).
This is called the “alfa effect”. By: A.Vasta: Therapeutic lasers. Published by Marrapese. Rome,1998.
Therefore the “low power” part of the beam (in laser therapy “cold”) is the reason 5. Quantity of radiation (energy density) : The quantity of radiation is the most
that there is less pain and inflammation in the injuries. 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 (J/Area), or more commonly
per cm2 (J/cm2).
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.
Figure b: peak power and critical threshold of power in the therapeutic laser effects. Skin It is very important to know if this energy is going to be transmitted through a small
becomes saturated with energy above the critical threshold and can only be permeated at lower area (lets say 1 mm2) or through an area that covers more than a few cm2 of tissue.
peak power. If power higher than 20 Watts is used, it can lead to photothermal effects which give
rise to skin burning. Therefore in the treatment of areas like sores, ulcers, etc. it is better to express the
By A. Vasta: therapeutic lasers….Marrapese Pub. . Rome,1998. amount in the form of density of energy in J/cm2.
Since 1 J = 1 W*sec, the amount of radiation D can be calculated in the following
manner :
P (W) x t (s) (The power in mW is calculated as Ei x F/1000).
D (J/cm2) = ------------------- For example, if a 10000 Hz pulsed laser emits 5 Ju/pulse, its average power is 10000
x 5 / 1000 mW = 50 mW.
A (cm2)
Generally single pulsed lasers are ineffective if the pulse frequency is less than 1000
Where
Hz.
D = amount of laser (J/cm2)
For example, a laser with a pulse energy of 1 Ju and a pulse frequency of 1 KHz
P = power of laser transmitted to the tissue (W), or the average power
(=1000 Hz) has an average power of only 0.1 mW. If an area of cm2 5x5 needs a
(mW/1000),
laser amount of 1 J/cm2, the exposure time should be the following:
t = radiation time (s)
DxA 1 x 25
A = surface area treated (cm2)
t = ------------ t = --------------- = 250000s
The treatment time necessary can also be calculated from this :
P 0.0001
D(J/cm2) x A (cm2)
D= amount required (J/cm2) ;
t (sec) = -----------------------------
A= area treated (25 cm2);
P(W)
P = average power (0.1 mW=0.0001W)
In order to calculate the exposure time needed to treat a certain tissue area (A), the
therefore t = 4167 minutes.
average laser power must be converted into Watts: e.g. laser power of 15 mW emits
15/1000 = 0.015 W. This shows that a laser with an average power of 0.1 mW is not practical for laser
therapy.
If 1J = 1Ws, then 1W= 1J/s.
It also shows that you at least need to know the average power (or the pulse
Therefore if a laser has 15 mW of power, it emits a laser energy of 0.015 W = 0.015
frequency and the power/pulse ratio) of the laser in order to calculate the radiation
J/s.
amount needed to provide effective treatment.
In 10 sec the emission equals 10 x 0.015 = 0.15 J.
The following concepts are also important in order to gain optimal therapeutic
Class 3B lasers, emitting an average output power of 60 mW can release an amount benefits in laser therapy:
of 2 J in 33 seconds; while a class A laser, emitting a power of 3 mW, requires 11
1. For best bio-stimulation effects (in treatment of sores, burns, bruises, etc.) the
minutes and 8 seconds to release the same amount (2 J).
radiation dose has minimum and maximum limits. The optimal amount is
This means that the class 3B lasers have a distinct advantage over the others as the between these limits. If the amount is too low, the treatment may not be
treatment time is significantly reduced. effective, if the amount is too high the treatment may be either ineffective, or
provoke negative effects.
If a GaAs laser is set up to work on low frequency single pulse mode, its average
power is very low. 2. The bio-stimulating effect is cumulative: suitable, repeated amounts given at
relatively frequent intervals give a cumulative effect. Small, repeated amounts
In order to directly compare the various pulsed model lasers, their output energy
given at 1-7 day intervals provide as powerful an effect as if the same amount
(Ju)/pulse and their pulse/second (Hz) frequency must be noted by the
of radiation was given in one treatment session only.
manufacturers.
The optimal weekly radiation amount for He-Ne laser therapy seems to be about 1
The average power of a single pulse laser depends on its frequency (F), and the
J/cm2.
energy/pulse ratio (E/i), as shown in the following table of a GaAs laser with
different frequencies :
With a laser that emits an average output power of 3 mW, 333 seconds/cm2 are WARRANTY
necessary. If the average power is 60 mW, 16.5 seconds/cm2 is necessary.
CHINESPORT SpA guarantees the quality of its products for a period of twelve
3. For the best results on acupuncture points, the amount recommended by the months from the date of purchase, when information contained in this manual
Soviet literature is for about 0.1 J/Acupuncture point. regarding installation, use and maintenance is strictly adhered to and the warranty
With a laser that radiates an average output power of 3 or 60 mW, 33 or 1.65 coupon is returned within 15 days of purchase.
seconds/AP point respectively would be necessary The guarantee covers the replacement of faulty parts.
INFORMATION ON THE MANUAL The warranty does not however, include the replacement of the equipment.
This document provides valuable information regarding the installation, set up and The warranty does not cover any malfunction or damage caused by :
use of FISIOLASER IRD series .
- Incorrect connection and installation
It is a useful and essential reference guide for the user.
- Incorrect use due to non-compliance with instructions contained in this
Read the contents of the manual carefully before installing the equipment and keep manual
it on hand at all times for future reference.
- Use of the machine in environmental conditions which do not conform with
It is of vital importance that you strictly adhere to the recommendations contained those specified for the product
within the manual in order to avoid malfunction, which may cause damage to the
- Improper or inadequate maintenance
equipment and consequent annulment of the validity of the warranty.
- Unauthorised opening of the outer casing
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 - Tampering or unauthorised modifications
with the instructions provided.
- Use of non-original accessories
N.B. The Therapy Application Manual is available upon request.
CHINESPORT SpA registered offices provide the warranty .
WRITING CONVENTIONS
 Before contacting technical service, detect the "SERIAL NUMBER" on the
Underlining - Certain sections of the manual have been underlined in order to product label, or the number of the DDT / invoice. His identification saves time
highlight their importance. and improves the quality of the intervention.
 The equipment in need of repair in the Chinesport must expose on the shipping
Notes
packing the "AUTHORIZATION NUMBER" to require toTechnical Assistance,
These contain important information and useful tips for operating the equipment its identification saves time and improves the quality of the service.
CAUTION You should insure the postal package.
The CAUTION message appears before operations, which, if not correctly Before sending the machine back for suspected malfunction, we recommend that
performed, may cause damage to the machine and/or its accessories. first you carefully consult sections regarding MAINTENANCE and
TROUBLESHOOTING of the manual, as a large part of the problems and faults are
! WARNING ! usually due to inadequate maintenance or small technical problems which can often
be easily solved by the user himself.
This signals operations or situations, which, if unknown to the operator, or
incorrectly carried out, may harm the operator.. A mail to mail address assistenza@chinesport.it or a simple telephone call to the
CHINESPORT Technical Service department 0432.621699 can often solve any
difficulties you may encounter.
CAUTION Such equipment are not bound to diagnosis, prevention, monitoring, compensation
of injury or handicap, substitution or modification of the anatomy, control of the
The customer is responsible for any damage conception, support / vital support of functions but allow to treat special pathologies
caused by incorrect packing of the equipment and to reduce the illness.
when returning it to the manufacturer. A special intervention is not required in the event of failure of the medical device ,
but just a normal maintenance / repair .
We therefore recommend that
PRELIMINARY NOTES
you use the original packing materials.
UNPACKING
When re-packing the equipment for return to the manufacturer, proceed as follows:
FISIOLASER IRD-series equipment is specially packaged for transport in a single
- Unplug the machine and any connections, devices, applicators etc; pack complete with filling which has been specifically studied for safe
transportation and storage.
- carefully clean and disinfect all parts of the machine and accessories which
have been in contact with patients . To remove the equipment from the pack, place the box on a smooth, flat surface.
any equipment which the technical department does not consider hygienic Open the top of the box and remove the polystyrene filling.
(Italian law T.U.S. 81/2008 on safety in the workplace) will not be
Be very careful when removing the contents of the pack.
accepted;
The unit and accessories are wrapped in transparent sheets of polyethylene
- disassemble accessories and any mechanical supports;
protection and contains the following :
- use original box and packing materials;
 the User’s Manual;
- attach to the pack the documents that will be supplied by CHINESPORT
 n.1 mains power supply cable;
Technical Assistance. Please note the reasons for the assistance request, and
the type of fault or malfunction: this information will greatly assist us in our  n.2 f spare fuses (see technical specifications) ;
technical inspection and notably reduce repair times.
 n.1 laser probe ( see paragraph “accessories” )
IN GENERAL  n.2 pairs of safety goggles.
CHINESPORT SpA has recently developed a complete series of apparatus, Check the contents of the package and should any of the items be missing then
accessories and equipment, designed and manufactured according to the highest contact your local authorized dealer .
standards of quality, making use of the latest technology and fully adhering to
current directives and norms CAUTION
Particular attention has been paid to the design, easy operation, function and safety Please keep the original packaging of the unit: it will be needed if the unit is shipped
of the equipment and the final result is this modern, compact unit, which offers an back to Chinesport S.p.A.
extremely logical operative sequence supported by a clearly legible display .
SETTING UP
A wide range of therapeutic applications, and guaranteed patient and therapist safety
ensure that FISIOLASER IRD-series equipment is of the highest quality. CAUTION
The equipment FISIOLASER IRD-series were planned and built in manner that To avoid the risk of electric shock, this device must only be connected to power
their use, if it happens at the conditions indicated, doesn’t compromise the health supply networks with protective earth.
and safety of the patients, of the users and of third, taking into consideration the
benefit to the patient.
CAUTION If the treatment room has more than one door, the referring diagram is the following
one :
No modification of this device is allowed.
CAUTION
The manufacturer is held responsible for the fundamental safety, reliability and
performance of the device only if:
- The electrical system of the premises complies with the appropriate regulations;
- The device is used in accordance with the instructions for use.
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 .
At the side safety circuit it necessary to plan the creation of a micro-switch to a via
normally closed .
Such circuit is an external safety accessory: it allows to interrupt the laser therapy Fig. E
treatments if the door of the treatment room has been opened .
! WARNING !
If the treatment room has only one door, the referring diagram is the following one :
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.
A bad installation of the device can to generate
serious ocular lesions .
The following environmental conditions are ideal when installing the FISIOLASER
IRD-series unit :
- room temperature from +10° to +40°C
- humidity level from 10% to 80% without
condensation
- avoid direct exposure to sunlight, chemical products
Fig. D and vibrations
! WARNING ! !WARNING!
In the indicated temperature range, during normal use, laser handpieces can reach For safety purposes the cable set is provided
temperatures of 53 ° without endangering patient health.
with an earthed plug.
Make sure that power supply socket has been earthed.
CAUTION
The equipment must only be connected
Do not use FISIOLASER IRD-series equipment
to power supply units that comply
wherever there is a risk of either the external
with all safety directives in force.
or internal parts of the unit becoming wet
When using an extension lead, make sure
that it has been earthed
CAUTION
Failure to comply with the above instructions
In the event of a blockage due to the intelock connector, after reconnecting the
interlock in the appropriate connector, press the START key only after taking the may lead to dangerous electrical discharge
handpiece in hand and repositioning it on the application part. causing machine damage and harm to persons.
CAUTION
ELECTRICAL CONNECTION
If an extension lead is used with
The power entry module can be found on the back of the unit and consists of a three-
FISIOLASER IRD-series and other equipment,
pole socket for the cable set, an extractible fuse box with two fuses (see technical
specifications) and the main switch. 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.
Insert the three-pole plug of the cable set into the power entry module correctly.
!WARNING! 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
Before plugging the cable set into the mains, machine making sure that the display screen is turned on correctly .
check to make sure the equipment has not undergone SAFETY KEY AND SMART-CARD
any damage during transport and make sure the The unit is supplied with an (INTERLOCK) safety key comprising a DIN plug to
voltage corresponds to that of the unit (see the plug into the DIN socket on the back (Fig.1).
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. 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 1-way micro-switch 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 .
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 .
! WARNING !
Fig. 2
The two pointer-LED diodes , of red colour,
Following that screen, another will be loaded in which the user is asked to enter an
they delimit the action-area of the spot relative
access code.
to the laser emission ; use the spots of the
This code has been set with the default number of 1234. Press the function buttons
pointer-diodes as reference drive for the near the number on the video to type it ( see fig. 3 ) :
revealing of the position of the spot of the laser beam .
LIGHTING OF THE DEVICE

Insert code:
! WARNING !
It is recommended not to start the emission of treatment
if the device isn’t in perfect mechanical conditions .
1 3
When the Unit is switched on, the LCD display lights up and FISIOLASER IRD-
series unit is ready for use . 2 4
The following will appear on the screen ( see fig .2 ) :
Fig. 3
This code can not be modified by the 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.
v3.3 Accessories list Supplied Optional
MLA8/200 Laser probe 905nm guide light+ 8 diode 25
X
FISIOLASER IRD 2 mW (200mW total)
X
mW (800mW total)
Laser power meter 0-200 mW X
Probe for acupuncture X
Load Programs Settings Probe holder MLA1- MLA3 X
Probe holder MLA5-.MLA8 X
Create Programs Free procedure Laser goggles X
Fig. 4 Model Total peak power

ACCESSORIES MLA1/25 Probe with a 25 W
The device can be used with the following accessories : MLA1/100 laser diode 100 W
Accessories list Supplied Optional MLA3/75 75 W
Mains power supply cable 1 Probe with a
MLA3/150 150 W
Spare fuses 1 3 laser diodes
User’s manual 1 MLA3/300 300 W
INTERLOCK connector 1 MLA5/125 Probe with a 125 W
Smart-card 1
MLA1/25 Laser probe 905nm guide light+ 1 diode 25 MLA5/500 5 laser diodes 500 W
1
mW MLA8/200 Probe with a 200 W
Safety laser goggles 2
Orthostatic arm for probes MLA1-3-5-8 X MLA8/800 8 laser diodes 800 W
Conic spare lens for probe MLA/ACU X
The main features that the operator / patient safety glasses must possess are the
Circular spare lens for probe MLA1 X
following:
Circular spare lens for probe MLA3 X
 Wavelength: 808-905 nm
Circular spare lens for probe MLA5/8 X
 Gradation number: 5
mW  Optical class: 1
MLA1/100 Laser probe 905nm guide light+ 1 diode 100  Optical density (λ=808nm): 3.523
mW
X  Optical density (λ=905nm): 4.456
MLA3/75 Laser probe 905nm guide light+ 3 diode 25  CE marking
X
mW (75mW total)
MLA3/300 Laser probe 905nm guide light+ 3 diode 100 CAUTION
X
mW (300mW total)
The perfect functionality of the FISIOLASER
X IRD-series device is guaranteed in the respect
mW (125mW total)
MLA5/500 Laser probe 905nm guide light+ 5 diode 100 of the standards of installation and use pointed out,
X
mW (500mW total)
only with the accessories and the original Key:
parts of exchange. 1) LCD graphic display
2) Left side function buttons
If there are problems or installation difficulties, please contact the CHINESPORT 3) Right side function buttons
SpA technical assistance department. 4) START button
CAUTION 5) Encoder knob with functions : select/confirm button
6) STOP/PAUSE button
Do not use different accessories from
Buttons 3 and 4 take on the function that is on the screen .
those provided : they could damage the unit and cause the warranty to lapse.
FRONT PANEL
If there are problems or installation difficulties,
The front panel can be seen in fig.6 with its corresponding key.
please contact the CHINESPORT SpA technical
assistance department.
DESCRIPTION OF THE EQUIPMENT
FISIOLASER IRD-series equipment for laser therapy has a well-engineered control
panel ideal for use in the specific field of application for which it was designed.
1 2 3 4 5
All working parameters are handled and controlled in real time by a sophisticated
microprocessor electronic circuit which clearly displays its functions accompanied Fig. 6 : Front panel
by acoustic signalling. Key :
CONTROL PANEL 1) Slot for Smart-Card insertion
The front panel of the unit, which comprises the controls and signals, can be seen in 2) USB connector , used to program the processor
fig. 1 with corresponding key. 3) Connector for serial connection ( not used )
4) Connector output 1
5) Connector output 2 (only for FISIOLASER IRD 2)
N.B. FISIOLASER IRD has one output channel.
1 FISIOLASER IRD 2 has two independent output channels .
2 3
5
4 6
Fig. 5: Control front panel
BACK PANEL 4. Dermatology: in the case of pressure ulcers and diabetic, the laser accelerates
and promotes the healing process, inhibits the presence of microbial
The back panel hosts the socket for safety key and the integrated power board
superinfections, has a hyper-emetogenic with improved wound cleansing. The
containing the power switch, the fuse block, and the connector for the mains power
positive influence of low-power laser therapy on the healing time and healing
cable plug, as shown in Fig. 7.
itself is significantly positive both on the healing of venous stasis, that pain on
edema and hyperemia of the skin. The irradiation with the laser decreases the
itching sensation in the case of atopic dermatitis, improves skin rashes,
decreases in epidermal cells the biological reactions of the disease. The laser
would intervene on the pathogenesis of hypertrophic scar by inhibiting the
inflammatory response continues, which causes increased production of
connective tissue, and reducing the tension of the skin edges.
5. Neurology: proven effectiveness in cases of trigeminal neuralgia, post-herpetic
neuralgia (warning: do not treat herpes lesions in the active phase, in order to
1 2 3 4 5 avoid an increase in the rate of virus replication), carpal tunnel syndrome,
Fig. 7 : Back Panel
headache, muscle tension headache , phantom limb or facial neuralgia and
Key : causalgia.
1) Bipolar ON/OFF power switch 6. Laser acupuncture: different acupuncturists have become enthusiastic about the
2) Fuse block use of low-power laser in the stimulation of acupuncture points. The idea of
3) Three pin plug for mains power cable applying the laser in this way has an obvious interest since the treatment is
4) Protective earth terminal painless, and cost-effective in children or in those who are afraid of needles and
5) INTERLOCK connector also because there is no risk of infection or other (bleeding, fainting, seizures,
INDICATIONS anatomical damage). At the level of the acupuncture points of the
semiconductor laser seem more effective and suitable for their emission mode,
1. Rheumatology: beneficial effects of laser radiation have been reported in the more easily modulable.
case of rheumatoid arthritis, rheumatic and degenerative diseases. About the
Bechterew’s disease, that mainly affects the spine, the laser takes a therapeutic
significance in the early stages of the disease, when it has not yet come to the CONTRA - INDICATIONS
fibrosis and ankylosis of the affected joints 1. Direct eye radiation: class 3B lasers are potentially harmful to the retina –
2. Orthopedic: analgesic effects in the case of radial and ulnar epicondylitis, although retina damage is extremely improbable. The special safety goggles
analgesic action in case of tendinitis of the rotator cuff, significant pain (supplied) must always be worn by both the patient and the operator.
improvement in lumbago, discal syndromes and radiculitis. In case of pain 2. Pregnancy: the laser should not be used over a pregnant woman’s uterus. It can
syndromes of the shoulder, the laser should be made only after a careful be used on pregnant women on condition that there is no radiation over the
diagnosis, and it is effective only in the musculoskeletal forms and not in joint abdomen.
forms (biceps tenosynovitis, muscle trauma or local fibromiopatie) and articular
(inflammatory, degenerative, traumatic). On the other side, neurovascular forms 3. Neoplasy: do not use the laser over primary or secondary wounds that have not
are indicated for laser treatment such as radiculitis, carpal tunnel syndrome, been diagnosed. Laser treatment may be used to relieve pain in the final stages
cervical brachialgia. All other forms should avoid laser treatment because not of the illness. It should only be performed with full patient consent.
effective. 4. Thyroid: laser must never be used over the thyroid.
3. Bruises: are treated with laser those with sequelae, the most serious or that you 5. Haemorrhages: indirect laser vaso-dilatation may worsen the haemorrhaging.
want to solve as soon as possible.
6. Immunosuppressive therapy: do not use laser therapy on patients undergoing this ! WARNING !
type of pharmacological treatment..
It is recommended not to start the emission of 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 if the device isn’t in perfect mechanical conditions or don’t present laser emission
neural functions and should not be used over these areas of the body in patients characteristics in compliance with the purpose (see the table of specifications) .
with heart disease . ! WARNING !
8. Coagulation problems. As the laser radiation that escapes
9. Epilepsy. from the laser-probes for the emission of the
CAUTION : laser-therapy treatments is invisible , the probes
 Photosensitive reactions: patients who use certain types of medicine can foresee on board the assemblage of
display photosensitive reactions. It is not fully understood how the
combination of laser and medicine trigger these reactions. Patients who may be two diodes led, of red colour
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 CAN be used with lasers, and ! WARNING !
patients with metallic and plastic implants, stitches can safely avail of laser
treatment . The device of target pointing
HOW TO USE THE EQUIPMENT of the probe supplied to the device
This section provides important information and instructions on how to make the is characterized by two drive-lights
best use of the FISIOLASER IRD-series equipment for laser therapy. (led diodes), what they have a driving function ,
All the control functions and the machine itself are handled and co-ordinated by a in conformity to the EN 60601-2-22 standard .
microprocessor: apart from making pre-memorised programmes available for
application, the microprocessor ensures that the machine can be personalised and ! WARNING !
operated in a highly safe and efficient manner. The red led-diodes light on with the activation
Interfacing allows for the operator to communicate with the unit by means of a of the laser emission from the operator,
large, clear graphic backlit liquid crystal display screen (LCD) through which all and everyone of them they emits a pointer beam .
operational messages required by the operator, work status during operation, and
errors are visualised. The pointer-beams produce some red spot on
The following paragraphs illustrate the procedures to be carried out and the technical the point of impact, and they delimit the region
specifications of the FISIOLASER IRD-series unit . where it will revert the spot of the laser beam ,
They also deal with the different options available, from the selection of a pre- that is invisible to human eye.
memorised programme for use in specific treatments as well as how to determine the
correct working parameters for “personalised” application”. The laser beam is always found to the centre
of the axis of symmetry of the two red spots .
! WARNING ! in the event of default , CHINESPORT SpA
It is recommended to clean with caution the equipment and the accessories supplied shall not be consider responsible for any accidents
after every treatment and before their use on other patients .
! WARNING !
The cleaning and relative disinfection must have effected in a systematic way ,
before the execution of the therapeutic treatment which to submit the patient . Do not use your FISIOLASER IRD-series unit
in the presence of flammable materials
DESIGNATED USE
( for example , paper ) ; in the event of default , CHINESPORT SpA shall not be
The FISIOLASER IRD-series unit is a electro-medical device that delivers laser- consider
therapy treatments, with the help of mono-diode and multi-diode probes for the
provision of treatment . responsible for any accidents
The use of FISIOLASER IRD-series unit is reserved , under the supervision and
responsibility of an expert in the problems of the laser radiation, for operators such ! WARNING !
as physiatrists, physiotherapists and pain therapists,that , by their training, provide Do not use your FISIOLASER IRD-series unit in
assurance of proper use and safe for the patient .
the presence of oxygen-rich environments ;
In fact, the operator must be appropriately qualified and carefully studied the
contents of the user manual in order to use the device; or, it must operate under the in the event of default , CHINESPORT SpA
supervision of a health professional adequately qualified to use the machine, able to shall not be consider responsible for any accidents
understand the benefits and the limits of therapy and to work in conditions of safety
for the person undergoing treatment.
! WARNING !
Such equipment can be used in hospital environment outpatient; nevertheless, it is
important to know that the user follow the medical instructions to use the equipment The laser therapy treatments must be provided,
or that he follow the indications present in the user’s manual. under the strict control of the operator,
Different types of pain in different areas . to patients conscious , able to interact with
Inflammatory disorders of the tendons and soft tissues (tendonitis, bursitis, the operator in response to stresses transmitted
enthesitis), insertional disorders, superficial limb pain.
by the device ; in case of default to the indications
Assists in the treatment of ulcers and bedsores. In scars and treatment of oedema .
given , CHINESPORT SpA shall not be consider responsible for any accidents
BEST USE
! WARNING ! ! WARNING !
In order to guarantee an absolutely safe operation It is important that the operator ensures
of the unit on the patient, it is advisable to carry out periodical inspections (at 2 the machine’s correct electrical installation
years intervals). before turning on the device.
! WARNING ! ! WARNING !
Do not use your FISIOLASER IRD-series unit in It is recommended not to start the emission of treatment
the presence of flammable anaesthetic mixture ; if the device isn’t in perfect mechanical conditions .
CAUTION
It is not possible to define for the devices
FISIOLASER IRD-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
Fig.8
to guarantee to the patient the execution of
WARNING
an effective treatment in the time and developed
A new Smart-Card must be formatted with the “Format” function before it can
under conditions of absolute safety .
be used.
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 ON/OFF main ! WARNING !
switch on the back panel of the unit.
It is advisable to suspend the therapeutic
Once turned on, the LCD display lights up and FISIOLASER IRD-series unit is
ready for use (see .2 ). treatment if it were to appear some
Following that screen, another will be loaded in which the user is asked to enter an disturbances during its emission .
access code ( see fig .3 ) .
When you have typed this code , it is loaded the main screen ( see Fig.4 ) , that it SET UP
allows to choice among 4 operative modes by pressing the relative function taste .
This enables the basic settings to be memorised and saved within the machine
NOTE memory and will automatically be called up each time the machine is turned on.
The following figures refer specifically to Pressing the function taste relative to the SETTINGS button , it appears to video the
FISIOLASER IRD 2 , however the FISIOLASER IRD unit functions can also be next screen ( see fig. 9 ) :
inferred from them as it has only one channel and is therefore even simpler.
If you want to use the Smart-Card to create new customised programmes or to run
those already stored, insert it as shown in the following figure :
2. rotate the encoder knob until to position the cursor on “Contrast” menu
3. press the encoder knob on the selected menu for enable the modification
routine
4. rotate the encoder knob ( in clockwise way for increasing values , in counter-
clockwise way for decreasing values ) until to reach the desired value that
you want to assign at the selected parameter
5. press the encoder knob for to confirm the value to assign at the selected
parameter and to exit by the modification routine
For to adjust the brightness settings , please follow these instructions :
Exit
6. press the function taste relative to the SETTINGS button in the principal
menu
Fig. 9
7. rotate the encoder knob until to position the cursor on “Brightness” menu
If you turn the Encoder control knob you can choose the function.
8. press the encoder knob on the selected menu for enable the modification
The choice is confirmed by pressing the knob routine
DISPLAY 9. rotate the encoder knob ( in clockwise way for increasing values , in counter-
Rotate the encoder knob until to position the cursor on the DISPLAY menu , then clockwise way for decreasing values ) until to reach the desired value that
press the encoder knob for to confirm the choice ; it appear to video the next screen you want to assign at the selected parameter
(see fig. 10): 10. press the encoder knob for to confirm the value to assign at the selected
parameter and to exit by the modification routine
For to enable the “Negative” functionality , please follow these instructions :
11. press the function taste relative to the SETTINGS button in the principal
menu
12. rotate the encoder knob until to position the cursor on “Negative” menu
13. press the encoder knob on the selected checkbox for to enable the
functionality desired
This action trains the appearing of a check point to the inner of the selection box ,
Save Exit
and generate a chromatic inversion between the fore-colour and the back-colour .
14. For to restore the visualization modality , press again the encoder knob .
Fig. 10 In order to store the settings that best suit the visibility conditions of room , press the
In correspondence of this screen is possible to adjust the brightness and contrast SAVE button .
settings , and to activate too the “negative” functionality , that allows to invert the Otherwise , press the CANCEL button for to return to the screen of fig. 9 .
fore-colour and the back-colour .
For to adjust the contrast settings , please follow these instructions :
1. press the function taste relative to the SETTINGS button in the main menu
PROBE
Rotate the encoder knob until to position the cursor on the PROBE menu , then press
the encoder knob for to confirm the choice ; it appears the next screen ( see Fig.11) :
Save Cancel
Fig. 12
Save Cancel Otherwise , pushing the function taste relative to the CANCEL button , the setting is
aborted ; you return to the screen of fig. 9 .
Fig. 11 When you have saved the setting :
In correspondence of this screen is possible :  Press the function taste relative to the EXIT button ; you return to the screen
 To select the emission modality of the treatment among those available ( of fig. 4
manual , automatic , continuous )  Press the function taste relative to the FREE PROCEDURE button ( see fig.
 To select the laser probe that you want to use for the emission of the 4 ) ; it appears to video the next screen ( see fig. 13 ) :
treatment * * CHANNEL <1> * * CHANNEL 1
 To select the treatment area for everyone of the laser probe used MLA 1/25 Personalized
00:00
At the end of the setting phase , you can save the desired settings pushing the
function taste relative to the SAVE button ; it appears to video “Settings saved !” CHANNEL 2
message , that it confirms the correct saving of the settings see fig. 12) :
00:00
Channel 2 Exit
Fig. 13
 Press the START button : as default , the device runs the emission with the
modality saved in the last session .
It’s possible to select the next modalities for the emission of the treatment :
 “Manual” emission modality
 “Automatic” emission modality
 “Continuous” emission modality 12) For to stop definitively the emission of the treatment , press the STOP
button
Emission in “Manual” modality
Emission in “Automatic” modality
For to emit the treatment in manual modality , please follow these instructions :
For to emit the treatment in automatic modality , please follow these instructions :
1) Press the function taste relative to the SETTINGS button ( see fig. 4 )
1) Press the function taste relative to the SETTINGS button ( see fig. 4 )
2) Rotate the encoder knob until to position the cursor on the “probe” menu
2) Rotate the encoder knob until to position the cursor on the “probe” menu
3) Press the encoder knob in correspondence of the PROBE menu ( see fig. 9 )
4) Press the encoder knob on the first menu
5) Rotate the encoder knob until to select the “Manual emission” option
5) Rotate the encoder knob until to select the “Automatic emission” option (
6) Press the encoder knob for to confirm the choice
see fig. 15 ) :
7) For to abort the operation , press the function taste relative to the CANCEL
button , otherwise press the function taste relative to the SAVE button ( see
fig. 11 ) : you return to the screen of fig. 9
8) Press the function taste relative to the EXIT button ( see fig. 9 ) : you
return to the screen to fig. 4
9) Press the function taste relative to the FREE PROCEDURE button ( see fig.
4 ) ; it appears the screen of fig. 13
10) Press the START button for to run the default treatment in the selected
modality : the device enters in stand-by , so you can note by the running
icon of the therapy , now with a shape of an hand ( see fig. 14 ) :
Save Cancel
* * CHANNEL <1> * * CHANNEL 1
MLA 1/25 Personalized
Fig. 15
15:00
6) Press the encoder knob for to confirm the choice
CHANNEL 2 7) For to abort the operation , press the function taste relative to the CANCEL
15:00 fig. 15 ) : you return to the screen of fig. 9
8) Press the function taste relative to the EXIT button ( see fig. 9 ) : you
Channel 2 return to the screen to fig. 4
9) Press the function taste relative to the FREE PROCEDURE button ( see fig.
Fig. 14 4 ) ; it appears the screen of fig. 13
11) Press the contact sensor on the laser probe for to start the emission 10) Press the START button for to run the default treatment in the selected
treatment ; the emission will stop temporarily when you will release the modality ; the treatment will be stopped when there is an interruption of the
contact sensor , and will restart by the interruption point when the contact contact between the laser probe and the patient to treat ; the treatment
sensor has been pressed again restart by the interruption point when the contact will be restored
11) For to stop definitively the emission of the treatment , press the STOP 11) The probe emits now in continuous modality , not depending by the contact
button with the patient ; for to suspend the treatment press the STOP button ; this
operation will enter the device in “paused” state
Emission in “Continuous” modality
12) For to restart the treatment by the interruption point , press again the
For to emit the treatment in continuous modality , please follow these instructions :
START button ; otherwise , for to stop definitively the emission of the
1) Press the function taste relative to the SETTINGS button ( see fig. 4 ) treatment , press again the STOP button
2) Rotate the encoder knob until to position the cursor on the “probe” menu Pushing the function taste relative to the channel , is possible to alternate the screens
relative to the programs loaded on both the channels ( see fig. 17 ) :
MLA 1/25 Personalized
5) Rotate the encoder knob until to select the “Continuous emission” option ( 15:00
see fig. 16 ) :
CHANNEL 2
15:00
Channel 2 Exit
Fig. 17
IMPORTANT: The amount of power which appears in the display refers to the
transmission power of a single god. For handpieces with more diodes each diode
emit the indicated power.
Save Cancel
Otherwise , pushing the function taste relative to the EXIT button , you return to the
screen of fig. 4 .
Fig. 16
NOTE
6) Press the encoder knob for to confirm the choice Any time a different hand-piece is used,
7) For to abort the operation , press the function taste relative to the CANCEL it must be set within this section.
fig. 16 ) : you return to the screen of fig. 9 N.B. Output channel 1 is the only one available in the FISIOLASER IRD .
8) Press the function taste relative to the EXIT button ( see fig. 9 ) : you NOTE
return to the screen to fig. 4 You must also enter the area of the part to be treated.
9) Press the function taste relative to the FREE PROCEDURE button ( see fig. The surface area to be treated must be entered in the probe entry (“Area 1”, “Area
4 ) ; it appears the screen of fig. 13 2”) ( see fig. 11 ) .
10) Press the START button for to run the default treatment in the selected The power emitted will be adjusted in inverse proportion to the area .
modality
! WARNING !
As the laser radiation that escapes
from the laser-probes for the emission of the
laser-therapy treatments is invisible , the probes
foresee on board the assemblage of
two diodes led, of red colour .
! WARNING !
The device of target pointing
of the probe supplied to the device Save Cancel
is characterized by two drive-lights

Fig.18
(led diodes), what they have a driving function ,
It is possible to activate or deactivate the acoustic signal, using the “Buzzer ON”
in conformity to the EN 60601-2-22 standard . check-box ; this action allows the appearing / disappearing of a check point to the
inner of the check-box ( see fig. 18 and fig. 19 ) :
! WARNING !
The red led-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 produce some red spot on
the point of impact, and they delimit the region
where it will revert the spot of the laser beam ,
Save Cancel
that is invisible to human eye.
The laser beam is always found to the centre Fig.19
of the axis of symmetry of the two red spots . The screens of fig. 18 and fig. 19 alternate it by pressing repeatedly the encoder ,
that allows to deactivate or activate respectively the buzzer .
VARIOUS
The Smart-Card can be formatted .
Rotate the encoder knob until to position the cursor on the VARIOUS menu , then
press the encoder knob for to confirm the choice ; it appears to video the next screen All new cards that have never been previously used must be formatted.
(see fig. 18 ) : You can also use the “Format Smart-card” function to delete it completely.
If you do this it can be used on a different unit. In order to avoid accidental deletion,
you are asked to confirm the operation
Pressing the encoder knob in correspondence of the “Format Smart-card” menu , the After a short wait while the new dictionary is loading, the menu will appear in the
formatting operation is executed ; for to avoid accidental cancellations , you must to selected language.
confirm the operation.
You can repeat the procedure at any time to change the language .
Pushing the function taste relative to the CANCEL button , you return to the screen
of fig. 18 or fig. 19 . DIRECT PROCEDURE
Pushing the function taste relative to the FORMAT button : This means you can create customised programmes on the spot. They cannot
however be stored .
 If the smart-card is not correctly inserted in its slot, the machine alerts you
with a warning message; Pushing the function taste relative to the FREE PROCEDURE button (see fig. 4) , it
appears the next screen ( see Fig.21):
 If the smart-card is correctly inserted in its slot, starting the format
operation. The operator is informed when the formatting operation is * * CHANNEL <1> * * CHANNEL 1
finished. MLA 1/25 Personalized
00:00
LANGUAGE
Rotate the encoder knob until to position the cursor on the LANGUAGE menu , CHANNEL 2
then press the encoder knob for to confirm the choice ; it appears the next screen
(see fig. 20) : 00:00
Channel 2 Exit
Fig. 25
N.B. Output channel 1 is the only one available in the FISIOLASER IRD .
Press the channel button to select the output channel .
The term Channel <1> that appears on the top left indicates that the displayed
programme will be operated from Channel 1. If you press the corresponding button,
the Channel <2> programme will be displayed .
Save Cancel The type of probe entered will also be noted.
On the right of the display you can monitor the status of both channels .
Fig. 20
The last programme that was used on each output channel is shown on the page .
For to choose the language where will be written all of the commands and messages
of the device :
 Select the language rotating the encoder knob
 Push the encoder knob on the selected language for to confirm the choice
 For to abort the operation , push the function taste relative to the CANCEL
button ; you return to the screen of fig. 9
 instead , for to confirm the operation , push the function taste relative to the
SAVE button for to load the new language
! WARNING !  Push the function taste relative to the EXIT button for to exit by the “free
To avoid contamination of the use environment for FISIOLASER IRD-series unit procedure” modality ; you return to the screen of fig. 4
and / or persons involved in its use, do not apply to contact with patients laser of the application time (expressed in J/cm2).
probes that have not been thoroughly cleaned and disinfected at the end of the
previous treatment . This will vary in accordance with the other settings (including those found under the
section “Various”).
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 ! WARNING !
modified programme cannot be stored . The laser radiation that outgoings from
For to modify one of the parameters , please follow these instructions : the device is dangerous:
1. rotate the encoder knob until to position the cursor on the menu of the always use the appropriate glasses!
function that you want to modify
Always avoid the exposition of the eyes
2. press the encoder knob on this menu for to enable the modification routine
to the direct or reflected laser beam.
3. rotate the encoder knob ( in clockwise way for increasing values , in
counter-clockwise way for decreasing values ) until to reach the desired LOADING PROGRAMMES
value to assign at the selected parameter
Pushing the function taste relative to the LOAD PROGRAM button (see fig. 4),
4. push the encoder knob for to confirm the assignation of the value and to exit opens the section where you can choose the program of therapy among those pre-set
by the modification routine in the internal memory of the machine.
N.B.: the parameters are highlighted in black if they are being modified. You cannot If you access this section, you can choose from the pre-set therapy programmes
modify other parameters or exit the function if you don’t first confirm by pressing stored in the unit’s memory .
the knob, or wait a few seconds until the item is no longer highlighted. .
You cannot delete these programmes.
The following parameters can be modified :
You can temporarily modify them but the modifications will not be stored in the
 FREQUENCY : the frequency emitted from the knob is noted and the memory .
corresponding power calculated in mW for each diode assembled on the
probe. Pushing the function taste relative to the EXIT button , you return to the screen of
fig. 4 .
 PULSED : The percentage value that defines the “Pulsed” mode is the
percentage of active time compared to the entire duration of the operative Instead, pushing the function taste relative to the SMART-CARD button , you select
cycle (1 second) . the customized programs , eventually stored in the Smart-Card, created with the
“Create Program” function.
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 ; Pushing it again, to proceed with the formatting of the Smart-Card.
 TIME : expressed in minutes. It indicates the total time that the therapy NOTE : If the Smart-Card is not inserted or inserted incorrectly, displayed an error
should take ; this treatment time is calculated depending on the probes used message.
for the emission of the treatment . The stored programmes reflect the fruit of many years experience supporting expert
Once you have customized the default program ( that can’t be stored ) : professional operators.
 Push the START button for to run its emission , or Appendix C shows a list of the programmes available .
NOTE: Output channel 1 is the only one available in FISIOLASER IRD
The last programme that was used for each output channel is shown on the page.
! WARNING !
If a channel is in use, you obviously cannot set a new programme on it until it
The laser radiation that outgoings from
finishes.
the device is dangerous:
You can change the output channel and modify any parameter, as already seen in
“free procedure”. always use the appropriate glasses!
Always avoid the exposition of the eyes
The modified programme can be stored in the Smart-Card card (if it is inserted) .
to the direct or reflected laser beam.
After you have pressed the encoder knob on the selected program ( for example ,
acne ) , it appears the next screen (see fig. 22) :
! WARNING !
To avoid contamination of the use environment for FISIOLASER IRD-series unit
MLA 1/25 Acne
and / or persons involved in its use, do not apply to contact with patients laser
00:00
probes that have not been thoroughly cleaned and disinfected at the end of the
previous treatment .
CHANNEL 2
! WARNING !
00:00
Do not use your FISIOLASER IRD-series unit in
the presence of flammable anaesthetic mixture ;
Channel 2
in the event of default , CHINESPORT SpA
Fig. 22 shall not be consider responsible for any accidents
In this screen there is a menu that indicates what are the suggested density of energy
for the emission of therapeutic treatment .
The operator can choose to emit the therapeutic treatment using this suggestion . ! WARNING !
Once that to the video is appeared the screen relative to the selected program , you Do not use your FISIOLASER IRD-series unit
can run it pushing the START button . in the presence of flammable materials
APPLICATION OF THE THERAPY ( for example , paper ) ; in the event of default , CHINESPORT SpA shall not be
consider
! WARNING !
The laser therapy treatments must be provided, responsible for any accidents
under the strict control of the operator,

to patients conscious , able to interact with ! WARNING !
the operator in response to stresses transmitted Do not use your FISIOLASER IRD-series unit in
by the device ; in case of default to the indications the presence of oxygen-rich environments ;
given , CHINESPORT SpA shall not be consider responsible for any accidents . in the event of default , CHINESPORT SpA
shall not be consider responsible for any accidents
! WARNING ! The writing on the top left of channel <1> shows that the programme displayed is
being run from channel 1.
The laser therapy treatments must be provided,
N.B. Output channel 1 is the only one available in FISIOLASER IRD.
under the strict control of the operator,
If you want to visualise the programme loaded on the other channel, you just have to
to patients conscious , able to interact with press the corresponding function-button.
the operator in response to stresses transmitted The count-down and the emission continue until :
by the device ; in case of default to the indications
 the set time finishes: when the system will sound intermittent signal tones
given , CHINESPORT SpA shall not be consider responsible for any accidents . for a few seconds.
 when the STOP button is pressed: the emission cycle is paused ( Fig.24)
! WARNING !
Before every treatment, it is recommended to clean MLA 1/25 Acne
with caution all of the accessories and the parts of the equipment that have been to 04:57
contact with the patient , particularly the ferrule of the laser probes .
CHANNEL 2
After to have selected, for example, the program "Acne" from the internal memory
of the equipment, push on the START button to run the execution of the treatment; 00:00
the following screen will be displayed (see fig.23) :
Channel 2
MLA 1/25 Acne
04:57
Fig. 24
CHANNEL 2 - the unit will take up again from the point where it was interrupted when you
press the START button
00:00
- if you press the STOP button again, the emission will be stopped
completely.
Channel 2 As previously noted, the FISIOLASER IRD-series unit is an IR diode laser beam
designed and manufactured in full accordance with national and international safety
Fig. 23 standards (see Appendix) .
Once you press the START button, a countdown will start on the TIMER. It is classified as a 3B-CLASS LASER .
This is also noted by an arrow next to the channel (a square indicates non active This equipment should always be used with caution in order to reduce any risk
channels). (although the risk is contained due to the specific power from IR diode radiation)
N.B.: the parameters are highlighted in black if they are being modified. You cannot that may arise from a laser source which is inherently distinguished by mono-
modify other parameters, exit the function, or start the therapy if you don’t first chromaticity, collimation, coherency and brilliance.
confirm by pressing the knob, or wait a few seconds until it is no longer highlighted.
For example, in Fig.30, channel 2 is not active, but a programme is running on
channel 1.
3) press the encoder knob for to confirm the choice ; it appears to video the
WARNING
next screen (see fig.25) :
Laser radiation from the equipment is inherently dangerous :
CREATION PROGRAM
 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 . Save Exit
If a channel is in use, you obviously cannot set a new program on it until it finishes.
Fig. 25
! WARNING !
4) Rotate the encoder knob until to position the cursor on the parameter that
To avoid contamination of the use environment for FISIOLASER IRD-series unit
you wants to modify
and / or persons involved in its use, do not apply to contact with patients laser
probes that have not been thoroughly cleaned and disinfected at the end of the 5) Press the encoder knob for to confirm the choice to customize the value of
previous treatment . the selected parameter
Once the chosen treatment program appears on the display, press the START button 6) rotate the encoder knob ( in clockwise way for increasing values , in
to start it up . counter-clockwise way for decreasing values ) until to reach the desired
value to assign at the selected parameter
LASER TEST
7) press the encoder knob for to confirm the value assignation
The laser probe is provided with a contact detector that allows the emission only
when the head of the probe is located in proximity of the treatment point. 8) repeat the steps from 4) to 7) for all of the parameters that you want to
modify
It is possible to verify the correct emission, by close the probe to a non-reflecting
surface after setting the device in automatic mode and pushing the start button. The 9) Rotate the encoder knob until to position the cursor on the last menu of the
contact detector once properly detected the surface to treat will automatically page , then press the encoder knob in correspondence of this menu ; it
activate the emission of treatment, and the time parameter will start to count. appears the next screen (see fig.26)
SETTING UP PROGRAMMES
This function can be only used with the Smart Card inserted as it is the only memory
available for storing new programmes .
For to create a customized program , please follow these instructions :
1) push the function taste relative to the CREATE PROGRAM button ( see
fig. 4 ) ; it appears an empty list in which you can enter new programs
2) rotate the encoder knob until to position the cursor on the desired row for to
save the new program (if the smart-card is just partially filled)
CREATION PROGRAM 16) For to abort the saving operation of the customized program onto the
smart.-card , press the function taste relative to the EXIT button ; you return
to the screen of fig.22
17) Otherwise , for to confirm the operation of storing of the customized
program , press the function taste relative to the SAVE button; at the end of
the operation , it appears the screen of correct saving (see fig. 28):
CREATION PROGRAM
Save Exit
Fig. 26
10) Rotate the encoder knob until to position the cursor on the desired insertion
point
11) Press the encoder knob for enable the routine for to assign the name at the
Save Exit
program
12) Rotate the encoder knob for to select the character that you want to insert
Fig. 28
13) Press the encoder knob for to confirm the insertion of the selected character
18) After some seconds of wait at the end of the saving operation , it appears
14) repeat the steps from 10) to 13) until to type the complete name that you the updated screen with the programs stored on the smart-card. It shows
want to assign at the customized program (for example , “prova”) that the customized program is correctly stored on the smart-card .
15) At the end of the typing , press the function taste relative to the OK button Pressing the function taste relative to the EXIT button, you return to the screen of
(see fig.27) ; fig. 4 .
CREATION PROGRAM For the stored programs , the treatment time is calculated depends on the probe used
for the emission of therapeutic treatment .
MAINTENANCE
The FISIOLASER IRD-series device for laser therapy does not require any
particular maintenance operations , but only a periodic maintenance and cleanliness
of the laser probes, in order to ensure the better operating conditions, guarantee the
effectiveness of the treatment and the safety of the patient .
A special intervention is not required in the event of failure of the medical device ,
but just a normal maintenance / repair .
Save Exit
! WARNING !
Fig. 27 For safety reasons before carrying out
any maintenance or cleaning the unit,
YOU MUST CAUTION
turn off the equipment with the power switch In no circumstances should anybody that is not authorised by CHINESPORT SpA
open or disassemble the laser probes: in addition to damaging the accessory, this
at the back and unplug the socket connected to the
tampering will cause the warranty to immediately lapse.
mains before carrying out any maintenance or cleaning.
CAUTION
When cleaning the outer part of the equipment, make sure to use a soft, clean cloth When cleaning the outer part of the equipment,
dampened with luke-warm water or very mild non inflammable detergents.
do not use diluents, detergents, acid solutions, abrasive
The front panel can be cleaned in the same way .
or aggressive solutions, or inflammable substances.
Do not place on the equipment any objects that can produce heat or that contains
water or other liquids . Use of any of the above mentioned substances or improper use of the accessories
will cause
Do not place the equipment in proximity of other equipment that can produce
electric , magnetic or electro-magnetic fields with high intensity (equipment for irreparable damage to the equipment and
diathermy, for X-rays, etc.) . the guarantee will be no longer valid.
The laser probes, particularly the head of treatment, periodically should be cleaned
with water and denatured alcohol . Do not spray or pour liquid onto the external parts of the FISIOLASER IRD-series
equipment and onto the laser-probes .
Store with care the laser probes at the conclusion of every treatment .
Do not immerse the unit in water .
Contact authorised dealers of CHINESPORT SpA for information regarding
original spare parts or components . After cleaning the external part of the equipment, make sure to dry it perfectly before
turning on the unit.
CAUTION The unit must under no circumstances be opened or dismantled in order to clean or
Use with care the probe-applicator : a bad check inner parts – FISIOLASER IRD-series equipment does not require cleaning of
inner parts and in all cases, only specialised technicians or CHINESPORT SpA
manipulation can influence negatively authorised personnel should carry out such operations
its performances and characteristics .
NOTE
CAUTION For best use of the unit and in order to ensure its best
The operator should be reminded to perform regular checks on the functioning of the performance, we advise you to carry out regular maintenance as described.
cylinders/applicators, and especially :
o check the cylinder surface for any cracks that could affect the insulation of the
internal conductors; CAUTION
o check the condition of the cable and the cylinder / applicator connector Check the integrity of the cable set
and the cables connecting the handpiece/applicator
at frequent intervals : they should never
be damaged or display signs of wear and team.
CAUTION for the patient, we recommend to submit the device
In order to make a correct substitution of the fuses housed in FISIOLASER IRD- to a cycle of periodic verifications (lilt at least 2 years),
series unit , please follow these instructions : because the device contains some parts submitted
- disconnect the power supply and open the fuse box using a screwdriver, to an electric degrade or aging, as the laser source if is constantly used under
makingsure you insert the screwdriver in the slot on the fuse box and conditions by maximum power .
levering up outwards;
The expected work life of device is 10 years.
- insert a screwdriver into the two side holes for fuse expulsion
TECHNICAL PROBLEMS
- remove the old fuses
FISIOLASER IRD-series laser-therapy equipment has been designed and
- insert a new fuse at a time by using a slight pressure to the left, with a manufactured using highly advanced technology and first class components for
finger reliable and efficient performance.
- push the box back to fit into the slot. 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 !
! WARNING !
We recommend that the fuses substitution
DO NOT OPEN
is performed by qualified technical personnel ,
FISIOLASER IRD-series equipment as
in order to execute this operation in safety conditions .
HIGH VOLTAGE ELECTRICITY is present
CAUTION
and may prove VERY DANGEROUS.
It is advisable to carry out periodic maintenance (every two years), making sure:
! WARNING !
 the intensity of any leakage currents
DO NOT OPEN the handpiece/applicator :
 the continuity / integrity ground wire
this will cause damage to the accessories
 the correctness of the value of insulation resistance
and cause the warranty to lapse
 the characteristics of the laser emission
perform such audits ensures electrical safety of FISIOLASER IRD-series unit , CAUTION
ensuring that the unit operates under security conditions guaranteed, and allows you Only CHINESPORT SpA authorised technicians may carry out service on the
to verify the correctness of the calibration of laser diodes . internal parts of the equipment.
For this kind of interventions we suggest to contact a technical and qualified service,
or in alternative contact CHINESPORT SpA or its authorized service centre . ! WARNING !
The equipment contains an IR LASER SOURCE
! WARNING ! which emits dangerous radiation .
With the purpose to guarantee the operation of For repairs and further information, contact CHINESPORT SpA or authorised
the device under conditions of absolute safety service centres .
If any of the following situations occur, disconnect the machine and contact
CHINESPORT SpA 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
FISIOLASER IRD-series laser-therapy equipment has been designed and
manufactured according to the ELECTROMAGNETIC COMPATIBILITY
DIRECTIVE 2014/30/UE 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 external specialised
laboratories .
The customer, upon prior request, may view the reports relative to EMC measures
within the company .
The FISIOLASER IRD-series unit for 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,
electro-medical 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 .
TROUBLESHOOTING CHART energy
Laser source does not Check laser source
function or has run out. emission is operating.
PROBLEM POSSIBLE CAUSE SOLUTION
LCD display on Faulty components on
Plug incorrectly inserted Check that the socket is electronic control circuit.
front panel does not Contact CHINESPORT
into socket. working correctly.
light up. Faulty supply on laser SpA Service centre .
circuit.
Power cable incorrectly
inserted into the Insert the plug correctly The unit functions Faulty or depleted laser
connector on the rear of into the socket. normally but with a source.
the unit. Contact CHINESPORT
significant decrease Possible break down in SpA Service centre .
in efficiency of power generator circuit
treatment. of the unit.
Cable is worn, damaged Replace the worn out or
or blocked. damaged power cable. The equipment
starts up, or seems Insert the DIN safety key
Unit does not The switch on the rear of No safety key or the
Turn on the switch. to work normally, into the back socket or
function. the unit is turned off. interlock circuit is open.
but there is no reset the safety conditions.
Replace any missing, emission.
Fuses missing, blown or
blown or interrupted
blocked.
fuses.
Electronic control circuit

does not work Contact CHINESPORT
SpA Service centre .
No power reaching the
socket.
LCD display on Presence of faulty
Contact CHINESPORT
front panel does not components on electronic
SpA Service centre .
light up. control card.
Some of the buttons Faulty keys or buttons.
on the front control Contact CHINESPORT
panel do not Electronic control circuit SpA Service centre .
function correctly malfunction.
The unit lights up Parameters not set Check that the parameters
but does not emit correctly. have been set correctly.
TECHNICAL SPECIFICATIONS 5 frequencies per
Automatic scanning
decade
FISIOLASER IRD / FISIOLASER IRD 2 Solid-state Laser ,
Pointer
3mW @ 650nm
230 Vac, 50-60Hz,
±10% Pulsed mode (10 – 100 ) %
Mains voltage:
115 Vac, 50-60Hz, 25 W
±10% * Peak power for single diode
100 W
Max. Power absorption: 20 VA
Total peak power depends on handpiece-applicator (See accessories)
315 mA - T 5 x 20 Target pointing device in conformity with the UNI
230 V 2 light-drive
mm EN 60601-2-22 standard
Double fuse protection:
630 mA - T 5 x 20
Target pointing device

115 V Light-drive device Led-diode
mm
characteristics
Interlock socket/Safety key (contacts normally closed) 3 contact DIN socket
Light-drive color red
Backlit LCD Display, to visualise and control operating graphic w/b 320 x
parameters: 240 pixel Spot with red as
Light-drive representation on the impact point
colour
Programmable treatment time: up to 99 minutes
Always to the centre
Diode Laser wave length emission 905 nm Laser-beam positioning of the simmetry axis
Laser classification according to EN 60825-1 3B of 2 red spots
Device class in according to the 93/42/CEE directive II B manual emission
Electrical insulation / applied parts class in according to the Typology for emission of the treatment automatic emission
I/BF
UNI EN 60601-1 standard continuous emission
Degree of protection by the liquid access in according to the FISIOLASER IRD 2 2 independents
IPX0
UNI EN 60601-1 standard Output channels
FISIOLASER IRD 1
DO (Optic Density) 905 nm 25 mW 0.1
Stored protocols 79
DO (Optic Density) 905 nm 100 mW 0.7
Storable protocols on the smart-card 50
Sensor for detecting IR radiation of the external handpiece on the front
39 x 13 x 32 cm
Programmable pulse frequency (200-10.000) Hz Table container, external size (width x height x depth)
without probe-holders
Pulse duration 100 nsec
FISIOLASER IRD 2 4.30 Kg MLA3 (75) – pulsed laser diode
Unit body weight Number of laser diodes 3
FISIOLASER IRD 4.30 Kg Wavelength 905nm
Divergence of the beam 192x436mrad
Room temperature (+10 ÷ +40) °C Duration of the impulse 100ns
Use conditions (10 ÷ 80) % Programmable pulse frequency 100 – 10.000 Hz
Relative humidity Peak power 75 W
without condensation
EMP (Maximum allowed exposure) single pulse 5,14 mJ/m2
Room temperature (+10 ÷ +40) °C EMP (Maximum allowed exposure) pulse train 2,06 mJ/m2
EMP (Maximum allowed exposure) average 2,57 mJ/m2
(10 ÷ 80) %
Stocking / transport conditions Relative humidity DNRO (Nominal eye-hazard distance) direct light 116.3 mm
without condensation
MLA3 (300) – pulsed laser diode
Atmospheric pressure (500 ÷ 1060) hPa Number of laser diodes 3
Wavelength 905nm
* on demand Duration of the impulse 100 ns
Programmable pulse frequency 100 – 10.000 Hz
LASER PROBES SPECIFICATION Peak power 300 W
MLA1 (25) – pulsed laser diode EMP (Maximum allowed exposure) pulse train 2,06 mJ/m2
Number of laser diodes 1 EMP (Maximum allowed exposure) average 2,57 mJ/m2
Wavelength 905nm DNRO (Nominal eye-hazard distance) direct light 251 mm
Duration of the impulse 100ns
Number of laser diodes 5
Peak power 25 W
Wavelength 905nm
EMP (Maximum allowed exposure) pulse train 2,06 mJ/m2
DNRO (Nominal eye-hazard distance) direct light 116.3 mm
Peak power 125 W
Wavelength 905nm
Duration of the impulse 100 ns
MLA5 (500)– diodo laser pulsato
Peak power 100W
Wavelength 905nm
DNRO (Nominal eye-hazard distance) direct light 251 mm
Peak power 500 W
EMP (Maximum allowed exposure) single pulse 5,14 mJ/m2 APPENDICES
EMP (Maximum allowed exposure) average 2,57 mJ/m2 Appendix A ENVIRONMENTAL CONSIDERATIONS
FISIOLASER IRD-series unit for laser therapy equipment has been designed and
MLA8 (200) – pulsed laser diode manufactured to have minimal negative environmental impact, in line with its
Number of laser diodes 8 operational and safety requirements.
Wavelength 905nm
Rigorous standards were followed in order to minimise the amount of waste, use of
toxic materials, noise, non-required radiation and energy consumption.
Programmable pulse frequency 100 – 10.000 Hz In accordance with careful research, the unit has been designed to optimise power
Peak power 200 W consumption in keeping with energy saving principles.
MLA8 (800)– pulsed laser diode
Wavelength 905nm 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.
Peak power 800 W
Appendix B LABELS Table 2
Here are the table containing the symbols on the label plate and their meanings.
Table 1
SYMBOL SIGNIFICATION
This product complies with regulations issued under the certification from a
0476 Notified Body
Applied part BF
“Caution Laser Beam” label , placed on the back of the device
Date of manufacture
Texts on the label Signification
Manufacturer
Warning Warning
Attention Presence of visible and invisible laser
Visible and invisible laser radiation
radiation
Avoid exposure to beam Avoid a direct exposure to laser beam
Consult instructions for use
Class 3B laser product Product with 3B as laser class
The product must be dispose of as “electronic waste”, not as “domestic waste”
Input characteristics
Input voltage to the device (mains)
Fuses: 2xT315mAL250V / 2xT630mAL250V
Input power of the device (absorbed power)
Input frequency of the device
Device model
Label placed on the left side panel of the device, showing the characteristics of the laser probes.
Serial number
Texts on the label Meaning
Output characteristics of the device
Maximum output laser radiation (MLA1 – Maximum output laser radiation (MLA1 –
25): 25W I.R 25): 25W I.R
Output frequency of the device (laser probe)
Output power of the laser probe 100): 100W I.R 25): 25W I.R
75): 3x25W I.R 75): 3x25W I.R
300): 3x100 W I.R 300): 3x100 W I.R
125): 5x25 W I.R 125): 5x25 W I.R
500): 5x100 W I.R 500): 5x100 W I.R
200): 8x25 W I.R 200): 8x25 W I.R
800): 8x100 W I.R 800): 8x100 W I.R
PULSE DURATION (ALL PROBES): 100 PULSE DURATION (ALL PROBES):
ns 100 ns
EMITTED WAVE LENGTH (ALL EMITTED WAVE LENGTH (ALL
PROBES): 905 nm PROBES): 905 nm
STANDARD IEC EN 60825-1:2014 STANDARD IEC EN 60825-1:2014
Label showing devices sensitive to electrostatic charges,

placed near the serial connection connector.
“INTERLOCK” label , placed on the rear panel

of the device near the interlock connector
“Caution laser beam” label , placed near the laser
probe connector
Label applied near the output channel 2 of the Label applied near the output channel 1 of the
device device
( only for FISIOLASER IRD 2 )
Label applied on the laser probe, showing

Label indicating "LASER APERTURE", the Manufacturer's name or trade mark and
placed near the firing part of the laser probe. the model or type reference of the laser
probe.
Appendix C List of programs 31 Herpes Simplex 0.02 1 500 *
32 Lombalgia 4.50 15 10000 *
Suggested 33 Sciatalgia 3.00 10 10000 *
D Duration Frequency
Laser Therapy Treatments sessions 34 Burns 1 0.03 1 1000 *
(J/cm2) ( min. ) ( Hz )
( N° ) 35 Burns 2 0.30 2 5000 *
1 Acne 0.75 5 5000 * 36 Burns 3 0.75 5 5000 *
2 Arthritis, small joints 0.75 5 5000 * 37 Burns 4 0.02 1 500 *
Cervical Syndrome 1 38 Burns 5 0.03 1 1000 *
3 0.02 1 500 *
( Cervicalgias 1 ) Shoulder pain 1
Cervical Syndrome 2 39 3.00 10 10.000 *
4 3.00 10 10000 * (painful shoulder 1)
Cervical Syndrome 3 40 0.75 5 5000 *
Cervical Arthrosis 1 41 3.00 10 10000 *
( Cervico-arthrosis 1 ) Shoulder pain 4
( Cervico-arthrosis 2 ) External Lateral Pulled
8 0.12 2 2000 * Ligament 1
( Cervico-arthrosis 3 ) External Lateral Pulled
9 Hypertrophic Scars 3.00 10 10000 * 44 0.75 5 5000 *
Ligament 2
10 Scars up to 2 months 0.03 1 1000 * External Lateral Pulled
11 Chondromalacia Patellae 1 4.50 15 10000 * 45 0.03 1 1000 *
Ligament 3
12 Chondromalacia Patellae 2 4.50 15 10000 * Internal Lateral Pulled
13 Chondromalacia Patellae 3 1.05 7 5000 * 46 0.03 1 1000 *
Ligament 1
14 Coxarthrosis 1 4.50 15 10000 * Internal Lateral Pulled
47 0.75 5 5000 *
15 Coxarthrosis 2 4.50 15 10000 * Ligament 2
16 Dorsalgia 3.00 10 10000 * Internal Lateral Pulled
48 0.03 1 1000 *
17 Recent Oedema 3.00 10 10000 * Ligament 3
18 Hard Oedema 1 4.50 15 10000 * 49 Tennis elbow 1 0.03 1 1000 *
19 Hard Oedema 2 4.50 15 10000 * 50 Tennis elbow 2 0.75 5 5000 *
20 Old Oedema 1 0.03 4 10000 * 51 Tennis elbow 3 0.03 1 1000 *
21 Old Oedema 2 0.75 3 10000 * 52 Skin Graft 1 0.03 1 1000 *
22 Haematoma 1 0.03 1 1000 * 53 Skin Graft 2 0.75 5 5000 *
23 Haematoma 2 0.75 5 5000 * 54 Leg Ulcer 1 0.02 1 500 *
24 Decubitus 1 0.02 1 500 * 55 Leg Ulcer 2 0.03 1 1000 *
27 Gonarthrosis 1 0.75 5 5000 * 58 Verrucas 1 3.00 10 10000 *
28 Gonarthrosis 2 0.75 5 5000 * 59 Verrucas 2 3.00 10 10000 *
29 Gonarthrosis 3 4.50 15 10000 * 60 Epicondylitis 0.03 1 1000 *
30 Gonarthrosis 4 4.50 15 10000 * 61 Epitrocleitis 0.03 1 1000 *
62 Adductor Tendinopathty 1 0.75 5 5000 *
63 Adductor Tendinopathty 2 0.12 2 2000 *
Biceps Brachii
64 6.00 20 10000 *
Tendinopathy 1
Biceps Brachii
65 1.05 7 5000 *
Tendinopathy 2
Biceps Femoris
66 0.75 5 5000 *
Tendinopathy
Gluteus Medius and
67 4.50 15 10000 *
minimus Tendinopathy
Long and short lateral
68 3.00 10 10000 *
peroneal Tendinopathy 1
Long and short lateral
69 0.75 5 5000 *
peroneal Tendinopathy 2
70 Quadriceps Tendinopathy 1.05 7 5000 *
71 Sartorius Tendinopathy 1.05 7 5000 *
Semi-Membranous
72 3.00 10 10000 *
Tendinopathy 1
Semi-Membranous
73 3.00 10 10000 *
Tendinopathy 2
Superspinal Muscle
74 0.12 2 2000 *
Tendinopathy
Frontal Tibial Tendinopathy
75 0.12 2 2000 *
1
Frontal Tibial Tendinopathy
76 0.12 2 2000 *
2
Brachial Triceps
77 0.03 1 1000 *
Tendinopathy
Patellar Tendon
78 1.05 7 5000 *
Tendinopathy 1
Patellar Tendon
79 1.05 7 5000 *
Tendinopathy 2
* is not possible to define a number of sessions, depending on the therapeutic

suggestion used , as the duration of a session is not uniquely defined but depends on
the pathology to be treated, by the patient subjected to special treatment and by the
amount of power emitted by the device and absorbed by the patient treated, so the
number of sessions required is defined by the medician based on patient's clinical
condition and characteristics of the device with which the treatment is emitted
Appendix D Electro-magnetic compatibility tables
13.4.1 Guidance and manufacturer’s declaration – electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic emissions FOR ALL ME EQUIPMENT
FOR ALL ME EQUIPMENT The FISIOLASER IRD-series ME EQUIPMENT is intended for use in the electromagnetic
The FISIOLASER IRD-series ME EQUIPMENT is intended for use in the electromagnetic environment specified below.
environment specified below. The customer or the user of the FISIOLASER IRD-series ME EQUIPMENT should assure that
The customer or the user of the FISIOLASER IRD-series ME EQUIPMENT should assure that it it is used in such an environment.
is used in such an environment. IEC 60601 Compliance Electromagnetic environment –
Immunity test
Emissions test Compliance Electromagnetic environment – guidance Test level level guidance
The FISIOLASER IRD-series ME Floors should be wood, concrete
EQUIPMENT uses RF energy only for its Electrostatic ± 6kV contact Complies or ceramic tile.
RF Emissions discharge (ESD) If floors are covered with
Group 1 internal function. Therefore, its RF emissions are
CISPR 11 synthetic material , the relative
very low and are not likely to cause any
interference in nearby electronic equipment. IEC 61000-4-2 ± 8kV air Complies humidity should be at least 30 %.
The FISIOLASER IRD-series ME
EQUIPMENT is suitable for use in all Electrical fast ± 2kV per power
Complies Mains power quality should be
establishments, including domestic transient/burst supply lines
RF Emissions that of a typical commercial or
Class B establishments and those directly connected to ± 1kV for hospital environment
CISPR 11 IEC 61000-4-4 Complies
the public low voltage power supply network input / output lines
that supplies buildings used for domestic
± 1kV line(s) to
purposes . Surge Complies Mains power quality should be
line(s)
The FISIOLASER IRD-series ME that of a typical commercial or
IEC 61000-4-5 ± 2kV line(s) to hospital environment
EQUIPMENT is suitable for use in all Complies
earth
establishments, including domestic
Harmonic emissions <5% UT (>95% dip Mains power quality should be
Class A establishments and those directly connected to
IEC 61000-3-2 in UT ) for 0.5 Complies that of a typical commercial or
the public low voltage power supply network
that supplies buildings used for domestic cycles hospital environment. If the user
purposes . Voltage dips, short 40% UT (60% dip of the FISIOLASER IRD-series
The FISIOLASER IRD-series ME interruptions and in UT ) for 5 Complies ME EQUIPMENT requires
EQUIPMENT is suitable for use in all voltage variations cycles continued operation during power
Voltage fluctuations/ establishments, including domestic on power supply 70% UT (30% dip mains interruptions, it is
flicker emissions Complies establishments and those directly connected to input lines in UT ) for 25 Complies recommended that the
IEC 61000-3-3 the public low voltage power supply network cycles FISIOLASER IRD-series ME
that supplies buildings used for domestic IEC 61000-4-11 EQUIPMENT be powered from
purposes. <5% UT (>95% dip an uninterruptible power supply
Complies or a battery.
in UT ) for 5 sec
Power frequency Power frequency magnetic fields

(50/60 Hz) should be at levels characteristic
magnetic field 3A/m Complies of a typical location in a typical
commercial or hospital
IEC 61000-4-8 environment
NOTE : UT is the a.c. mains voltage prior to application of the test level.
*1 :
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
13.4.2 Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
FOR ME EQUIPMENT THAT ARE NOT LIFE-SUPPORTING cannot be predicted theoretically with accuracy.
The FISIOLASER IRD-series ME EQUIPMENT is intended for use in the electromagnetic To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
environment specified below. The customer or the user of the FISIOLASER IRD-series ME survey should be considered. If the measured field strength in the location in which the
EQUIPMENT should assure that it is used in such an environment. FISIOLASER IRD-series ME EQUIPMENT is used exceeds the applicable RF compliance level
IEC 60601 Electromagnetic environment – above, the FISIOLASER IRD-series ME EQUIPMENT should be observed to verify normal
Immunity test Compliance level
Test level guidance operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the FISIOLASER IRD-series ME EQUIPMENT .
Portable and mobile RF communications equipment should be used no closer to any part of the *2 :
FISIOLASER IRD-series ME EQUIPMENT, including cables, than the recommended separation Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation Recommended separation distances between

distance portable and mobile RF communications equipment and the FISIOLASER IRD-series ME
EQUIPMENT
Conducted RF 3Vrms 3V 3,5 The FISIOLASER IRD-series ME EQUIPMENT is intended for use in an electromagnetic
IEC 61000-4-6 150kHz to 80MHz ( V1 ) d=   P environment in which radiated RF disturbances are controlled.
 V1  The customer or the user of the FISIOLASER IRD-series ME EQUIPMENT can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
3,5 communications equipment (transmitters) and the FISIOLASER IRD-series ME EQUIPMENT as
d=   P recommended below, according to the maximum output power of the communications equipment.
 E1  Separation distance according to frequency of transmitter ( m )
Radiated RF 3V/m 3V/m 80MHz to 800 MHz Rated maximum output 150 kHz ÷ 80 MHz 80 MHz ÷ 800 MHz 800 MHz ÷ 2.5 GHz
IEC 61000-4-3 80MHz to 2,5GHz ( E1 )
7
power of transmitter  3,5   3,5  7
(W) d=   P d=   P d=   P
d=   P  V1   E1   E1 
 E1 
800MHz to 2,5 GHz 0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
where P is the maximum output power rating of the transmitter in watts (W) according to the
1 1.17 1.17 2.33
transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, *1 10 3.69 3.69 7.38
should be less than the compliance level in each frequency range.*2 100 11.67 11.67 23.33
Interference may occur in the vicinity of equipment marked with the following symbol : For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is
NOTE 1 : At 80 MHz and 800 MHz, the higher frequency range applies. affected by absorption and reflection from structures, objects and people.
NOTE 2 : These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and Version SW : 4.0
people.
Via Croazia 2 – 33100 Udine – Italy
Tel. +39.0432.621621 Fax +39.0432.621620
Technical assistance : Tel. +39.0432.621699
www.chinesport.it

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FISIOLASER IRD

FISIOLASER IRD EL12061 – A01

CAUTION You should insure the postal package.

Installation of the laser therapy equipment is fast and simple .

rating plate on the side of the unit).

LIGHTING OF THE DEVICE

Fig. 4 Model Total peak power

Fig. 5: Control front panel

is characterized by two drive-lights

under the strict control of the operator,

Direct exposure to laser radiation for a fraction of a second is not dangerous,

Electronic control circuit

Target pointing device

Device class in according to the 93/42/CEE directive II B manual emission

The product must be dispose of as “electronic waste”, not as “domestic waste”

Input voltage to the device (mains)

Fuses: 2xT315mAL250V / 2xT630mAL250V

Input power of the device (absorbed power)

Input frequency of the device

Label showing devices sensitive to electrostatic charges,

“INTERLOCK” label , placed on the rear panel

Label applied on the laser probe, showing

* is not possible to define a number of sessions, depending on the therapeutic

Power frequency Power frequency magnetic fields

Recommended separation Recommended separation distances between

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