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TECHNICAL SPECIFICATIONS

FISIOLASER IRD / FISIOLASER IRD 2

Mains voltage:

230 Vac, 50-60Hz,

±10%

115 Vac, 50-60Hz,

±10% *

Max. Power absorption:

20 VA

Double fuse protection:

230 V

315 mA - T 5 x 20

115 V

630 mA - T 5 x 20

Interlock socket/Safety key (contacts normally closed)

3 contact DIN socket

Backlit LCD Display, to visualise and control operating
parameters:

graphic w/b 320 x

240 pixel

Programmable treatment time:

up to 99 minutes

Diode Laser wave length emission

905 nm

Laser classification according to EN 60825-1

Device class in according to the 93/42/CEE directive

II B

Electrical insulation / applied parts class in according to the
UNI EN 60601-1 standard

I/BF

Degree of protection by the liquid access in according to the
UNI EN 60601-1 standard

IPX0

DO (Optic Density) 905 nm 25 mW

0.1

DO (Optic Density) 905 nm 100 mW

0.7

Sensor for detecting IR radiation of the external handpiece

on the front

Programmable pulse frequency

(200-10.000) Hz

Pulse duration

100 nsec

Automatic scanning

5 frequencies per

decade

Pointer

Solid-state Laser ,

3mW @ 650nm

Pulsed mode

(10 – 100 ) %

Peak power for single diode

25 W

100 W

Total peak power

depends on handpiece-applicator

(See accessories)

Target

poi

ing d

evi

char

act

ist

ics

Target pointing device in conformity with the UNI
EN 60601-2-22 standard

2 light-drive

Light-drive device

Led-diode

Light-drive color

red

Light-drive representation on the impact point

Spot with red as

colour

Laser-beam positioning

Always to the centre

of the simmetry axis

of 2 red spots

Typology for emission of the treatment

manual emission

automatic emission

continuous emission

Output channels

FISIOLASER IRD 2

2 independents

FISIOLASER IRD

Stored protocols

Storable protocols on the smart-card

Table container, external size (width x height x depth)

39 x 13 x 32 cm

without probe-holders

Summary of Contents for FISIOLASER IRD

Page 1: ...mod 14 2013 07 15 17 30 A01 gb docx FISIOLASER IRD EL12061 A01 FISIOLASER IRD2 EL12062 A01 FISIOLASER IRD FISIOLASER IRD 2 USER S MANUAL 0476 Rev 02 07 2018 ...

Page 2: ...ORIES 13 DESCRIPTION OF THE EQUIPMENT 14 CONTROL PANEL 14 FRONT PANEL 14 BACK PANEL 15 INDICATIONS 15 CONTRA INDICATIONS 15 HOW TO USE THE EQUIPMENT 16 DESIGNATED USE 17 BEST USE 17 SET UP 18 DISPLAY 19 PROBE 20 VARIOUS 23 LANGUAGE 24 DIRECT PROCEDURE 24 LOADING PROGRAMMES 25 APPLICATION OF THE THERAPY 26 LASER TEST 28 SETTING UP PROGRAMMES 28 MAINTENANCE 29 TECHNICAL PROBLEMS 31 ELECTROMAGNETIC I...

Page 3: ... all directions The phases of the different waves emitted from the source are not related to one another On the other hand laser radiation has some properties that do not exist in other types of electromagnetic radiation 1 Mono chromaticity means that the laser has only one wavelength and therefore only one vibration frequency It also has only one colour defined by the active medium that produces ...

Page 4: ...pn junction The most common technique is by the p n junction The pn junction refers to a p type semiconductor attached to an n type This junction conducts electricity in a preferred direction The increased directional conductivity is the normal mechanism that all diodes and transistors in electronics work on The distribution of the energy bands in the junction is the basis of the laser diode actio...

Page 5: ...100 nsec Number of diodes 1 8 or more Emission frequency Up to 10 000 Hz Type of emission CW Pulsed Guide light He Ne red or green ANSI safety standard 3B and 4 Method of treatment Single multiple diode handpiece scanning Display Backlit LCD Areas of use Dermatology Laser injections Sports medicine Neurology Dentistry Ophthalmology Orthopaedics Rheumatology Analgesic therapy Table 1 Main features ...

Page 6: ...sed it can lead to photothermal effects which give rise to skin burning By A Vasta therapeutic lasers Marrapese Pub Rome 1998 Figure c illustration of a typical Gaussian distribution of laser beam power The energy density is high at the centre of the beam surgical laser and decreases gradually towards the edges therapeutic effects By A Vasta Therapeutic lasers Published by Marrapese Rome 1998 5 Qu...

Page 7: ...For example if a 10000 Hz pulsed laser emits 5 Ju pulse its average power is 10000 x 5 1000 mW 50 mW Generally single pulsed lasers are ineffective if the pulse frequency is less than 1000 Hz For example a laser with a pulse energy of 1 Ju and a pulse frequency of 1 KHz 1000 Hz has an average power of only 0 1 mW If an area of cm2 5x5 needs a laser amount of 1 J cm2 the exposure time should be the...

Page 8: ...ed out may harm the operator WARRANTY CHINESPORT SpA guarantees the quality of its products for a period of twelve months from the date of purchase when information contained in this manual regarding installation use and maintenance is strictly adhered to and the warranty coupon is returned within 15 days of purchase The guarantee covers the replacement of faulty parts The warranty does not howeve...

Page 9: ...st safety ensure that FISIOLASER IRD series equipment is of the highest quality The equipment FISIOLASER IRD series were planned and built in manner that their use if it happens at the conditions indicated doesn t compromise the health and safety of the patients of the users and of third taking into consideration the benefit to the patient Such equipment are not bound to diagnosis prevention monit...

Page 10: ... normally closed Such circuit is an external safety accessory it allows to interrupt the laser therapy treatments if the door of the treatment room has been opened If the treatment room has only one door the referring diagram is the following one Fig D If the treatment room has more than one door the referring diagram is the following one Fig E WARNING If you want to install an extern interlock ci...

Page 11: ...plate on the side of the unit WARNING The power supply to the unit is VERY DANGEROUS Make sure that the cable has been unplugged from the mains supply before connecting or disconnecting from the unit WARNING For safety purposes the cable set is provided with an earthed plug Make sure that power supply socket has been earthed The equipment must only be connected to power supply units that comply wi...

Page 12: ...erence drive for the revealing of the position of the spot of the laser beam LIGHTING OF THE DEVICE WARNING It is recommended not to start the emission of treatment if the device isn t in perfect mechanical conditions When the Unit is switched on the LCD display lights up and FISIOLASER IRD series unit is ready for use The following will appear on the screen see fig 2 Fig 2 Following that screen a...

Page 13: ...e light 5 diode 100 mW 500mW total X Accessories list Supplied Optional MLA8 200 Laser probe 905nm guide light 8 diode 25 mW 200mW total X MLA8 800 Laser probe 905nm guide light 8 diode 100 mW 800mW total X Laser power meter 0 200 mW X Probe for acupuncture X Probe holder MLA1 MLA3 X Probe holder MLA5 MLA8 X Laser goggles X Model Total peak power MLA1 25 Probe with a laser diode 25 W MLA1 100 100 ...

Page 14: ...phisticated microprocessor electronic circuit which clearly displays its functions accompanied by acoustic signalling CONTROL PANEL The front panel of the unit which comprises the controls and signals can be seen in fig 1 with corresponding key Fig 5 Control front panel Key 1 LCD graphic display 2 Left side function buttons 3 Right side function buttons 4 START button 5 Encoder knob with functions...

Page 15: ...he 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 p...

Page 16: ...or the operator to communicate with the unit by means of a large clear graphic backlit liquid crystal display screen LCD through which all operational messages required by the operator work status during operation and errors are visualised The following paragraphs illustrate the procedures to be carried out and the technical specifications of the FISIOLASER IRD series unit They also deal with the ...

Page 17: ...ations present in the user s manual Different types of pain in different areas Inflammatory disorders of the tendons and soft tissues tendonitis bursitis enthesitis insertional disorders superficial limb pain Assists in the treatment of ulcers and bedsores In scars and treatment of oedema BEST USE WARNING In order to guarantee an absolutely safe operation of the unit on the patient it is advisable...

Page 18: ...eady for use see 2 Following that screen another will be loaded in which the user is asked to enter an access code see fig 3 When you have typed this code it is loaded the main screen see Fig 4 that it allows to choice among 4 operative modes by pressing the relative function taste NOTE The following figures refer specifically to FISIOLASER IRD 2 however the FISIOLASER IRD unit functions can also ...

Page 19: ...t the brightness settings please follow these instructions 6 press the function taste relative to the SETTINGS button in the principal menu 7 rotate the encoder knob until to position the cursor on Brightness menu 8 press the encoder knob on the selected menu for enable the modification routine 9 rotate the encoder knob in clockwise way for increasing values in counter clockwise way for decreasing...

Page 20: ...appears to video Settings saved message that it confirms the correct saving of the settings see fig 12 Fig 12 Otherwise pushing the function taste relative to the CANCEL button the setting is aborted you return to the screen of fig 9 When you have saved the setting Press the function taste relative to the EXIT button you return to the screen of fig 4 Press the function taste relative to the FREE P...

Page 21: ... release the contact sensor and will restart by the interruption point when the contact sensor has been pressed again 12 For to stop definitively the emission of the treatment press the STOP button Emission in Automatic modality 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 2 Rotate the encoder ...

Page 22: ...e probe emits now in continuous modality not depending by the contact with the patient for to suspend the treatment press the STOP button this operation will enter the device in paused state 12 For to restart the treatment by the interruption point press again the START button otherwise for to stop definitively the emission of the treatment press again the STOP button Pushing the function taste re...

Page 23: ...d to the centre of the axis of symmetry of the two red spots VARIOUS 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 see fig 18 Fig 18 It is possible to activate or deactivate the acoustic signal using the Buzzer ON check box this action allows the appearing disappearing of a check po...

Page 24: ... 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 After a short wait while the new dictionary is loading the menu will appear in the selected language You can repeat the procedure at any time to change the language DIRECT P...

Page 25: ...se stage both last for the same amount of time TIME expressed in minutes It indicates the total time that the therapy should take this treatment time is calculated depending on the probes used for the emission of the treatment Once you have customized the default program that can t be stored Push the START button for to run its emission or Push the function taste relative to the EXIT button for to...

Page 26: ...ransmitted by the device in case of default to the indications given CHINESPORT SpA shall not be consider responsible for any accidents WARNING The laser radiation that outgoings from the device is dangerous always use the appropriate glasses Always avoid the exposition of the eyes to the direct or reflected laser beam WARNING To avoid contamination of the use environment for FISIOLASER IRD series...

Page 27: ...ig 30 channel 2 is not active but a programme is running on channel 1 The writing on the top left of channel 1 shows that the programme displayed is being run from channel 1 N B Output channel 1 is the only one available in FISIOLASER IRD If you want to visualise the programme loaded on the other channel you just have to press the corresponding function button The count down and the emission conti...

Page 28: ... detector once properly detected the surface to treat will automatically activate the emission of treatment and the time parameter will start to count 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...

Page 29: ...he end of the operation it appears the screen of correct saving see fig 28 Fig 28 18 After some seconds of wait at the end of the saving operation it appears the updated screen with the programs stored on the smart card It shows that the customized program is correctly stored on the smart card Pressing the function taste relative to the EXIT button you return to the screen of fig 4 For the stored ...

Page 30: ...nternal conductors o check the condition of the cable and the cylinder applicator connector CAUTION 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 tampering will cause the warranty to immediately lapse CAUTION When cleaning the outer part of the equipment do not use diluents detergents acid...

Page 31: ...t a technical and qualified service or in alternative contact CHINESPORT SpA or its authorized service centre WARNING With the purpose to guarantee the operation of the device under conditions of absolute safety for the patient we recommend to submit the device to a cycle of periodic verifications lilt at least 2 years because the device contains some parts submitted to an electric degrade or agin...

Page 32: ... 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...

Page 33: ... Contact CHINESPORT SpA Service centre Some of the buttons on the front control panel do not function correctly Faulty keys or buttons Contact CHINESPORT SpA Service centre Electronic control circuit malfunction The unit lights up but does not emit Parameters not set correctly Check that the parameters have been set correctly energy Laser source does not function or has run out Check laser source ...

Page 34: ...y 905 nm 100 mW 0 7 Sensor for detecting IR radiation of the external handpiece on the front Programmable pulse frequency 200 10 000 Hz Pulse duration 100 nsec Automatic scanning 5 frequencies per decade Pointer Solid state Laser 3mW 650nm Pulsed mode 10 100 Peak power for single diode 25 W 100 W Total peak power depends on handpiece applicator See accessories Target pointing device characteristic...

Page 35: ...ser diodes 3 Wavelength 905nm Divergence of the beam 192x436mrad Duration of the impulse 100ns Programmable pulse frequency 100 10 000 Hz Peak power 75 W EMP Maximum allowed exposure single pulse 5 14 mJ m2 EMP Maximum allowed exposure pulse train 2 06 mJ m2 EMP Maximum allowed exposure average 2 57 mJ m2 DNRO Nominal eye hazard distance direct light 116 3 mm MLA3 300 pulsed laser diode Number of ...

Page 36: ...e frequency 100 10 000 Hz Peak power 800 W EMP Maximum allowed exposure single pulse 5 14 mJ m2 EMP Maximum allowed exposure pulse train 2 06 mJ m2 EMP Maximum allowed exposure average 2 57 mJ m2 DNRO Nominal eye hazard distance direct light 251 mm APPENDICES Appendix A ENVIRONMENTAL CONSIDERATIONS FISIOLASER IRD series unit for laser therapy equipment has been designed and manufactured to have mi...

Page 37: ...vice Texts on the label Signification Warning Warning Visible and invisible laser radiation Presence of visible and invisible laser radiation Avoid exposure to beam Avoid a direct exposure to laser beam Class 3B laser product Product with 3B as laser class Label placed on the left side panel of the device showing the characteristics of the laser probes Texts on the label Meaning Maximum output las...

Page 38: ...DARD 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 device only for FISIOLASER IRD 2 Label applied near the output channel 1 of the ...

Page 39: ...000 26 Decubitus 3 0 75 5 5000 27 Gonarthrosis 1 0 75 5 5000 28 Gonarthrosis 2 0 75 5 5000 29 Gonarthrosis 3 4 50 15 10000 30 Gonarthrosis 4 4 50 15 10000 31 Herpes Simplex 0 02 1 500 32 Lombalgia 4 50 15 10000 33 Sciatalgia 3 00 10 10000 34 Burns 1 0 03 1 1000 35 Burns 2 0 30 2 5000 36 Burns 3 0 75 5 5000 37 Burns 4 0 02 1 500 38 Burns 5 0 03 1 1000 39 Shoulder pain 1 painful shoulder 1 3 00 10 1...

Page 40: ...0000 74 Superspinal Muscle Tendinopathy 0 12 2 2000 75 Frontal Tibial Tendinopathy 1 0 12 2 2000 76 Frontal Tibial Tendinopathy 2 0 12 2 2000 77 Brachial Triceps Tendinopathy 0 03 1 1000 78 Patellar Tendon Tendinopathy 1 1 05 7 5000 79 Patellar Tendon Tendinopathy 2 1 05 7 5000 is not possible to define a number of sessions depending on the therapeutic suggestion used as the duration of a session ...

Page 41: ...unity FOR ALL ME EQUIPMENT The FISIOLASER IRD series ME EQUIPMENT is intended for use in the electromagnetic environment specified below The customer or the user of the FISIOLASER IRD series ME EQUIPMENT should assure that it is used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6kV contact ...

Page 42: ... fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the FISIOLASER IRD series ME EQUIPMENT is used exceeds the applicable RF compliance level above the FISIOLASER IRD series ME EQUIPMENT should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orie...

Page 43: ...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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