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1. OWNER S MANUAL Safe Laser products The new generation of soft laser devices ye YO ao FIERTA Wi 3334 Bit gt Shs ae Nia ee 92574 E v 2 4 Contents e Laser basics c ccecccssccssceccuceccaccecsccvsccsecsecacevcevscceceacevecescsavsecsevscsaesscsaces e Description of the Safe Laser devices esssssssssessesrrrrrsrsesrrrrerreserresrrresns Soft laser effects ccccccsssccssssceccceccsccescssscccecsccssesesccececssccccsscecsteceesesceses e The diseases witch can be treated with Safe Laser devices e Treatment time and frequency ccceccccssseceecssseeceeesseseecesseecesceceseseaeeeeses First steps and USAC cccsssszscnsanscesmesnccancettoasoncarteauesduetavasosenonsdeeeatiuaweecetonaed Technical details ccccccecccsscscccssscccscccccssscenscecscessscesscsccasscecsescensceas Laser safety INStPUCH GIS scsssiscensacncnos ta ninunsesensshancececesdeabedeuesceiassversisoeenbeass e CONTAIN GICA TIONS vastncencnecossncevensssaviedsvosecesvaacestadentavdecsedatevdedinaenisydeareedeesiees e Service repair and storage ccscssccessssssecsteceseceeccseecescesseseaeseeeesesseeeseeees e CO 0 0 a A S e Warranty e Manufacturer s Proof of Compliance ee sessessesseesssseressreersseesessreessreeresese e Medical Certification eseseosenesesesnsnesernsrrsesererresesrrresesesresrrrsesesrreerreeee Laser basic2. because there is a biological limit after the cells can t be further stimulated Cure with nasal laser irradiation e It is recommended for continuous daily use separately for each nostril First steps and usage e Please read the instruction manual carefully before use e Before first use clean parts of the laser directly in contact with skin e Place the batteries into the equipment Observe the correct polarity of the batteries sign forward as indicated in Fig 1 and Fig 2 Oe AAA AAA fan ean em a m Ve SL30 Fig 1 On Off Switch AA hE Nasal accessary Radiation absorbing head SL150 Fig 2 e Apply the laser to the desired skin surface first and then turn on the laser by the switch according Fig 1 and 2 This way you can avoid the accidental eye irradiation e After using always close the laser in a safe place to avoid incompetent usage e If the laser is damaged or does not work properly do not use the laser There is no user repairable part of the laser inside Technical details 2 x 1 5V DC 2 x 1 5 V DC 2x AAA batteries 2x AA batteries Life expectancy 10 000 hours 10 000 hours Laser Safety instructions The light of the Safe Laser devices is less dangerous than the beam of ordinary lasers However the laser safety rules have to be kept by everybody and it is the duty and the responsibility of all the users of the lasers e Class 2 laser product a
3. 61000 4 4 Noise immunity to shock 1 kV Not applicable waves Surge L N between Battery operation IEC 61000 4 5 2 kV L N ground Noise Voltage chamfers lt 5 Ut gt 95 DIP Not applicable DIP voltage outages 0 5 per Interruption Battery operation interference resistance 40 Ut 60 DIP 5 per IEC 60601 4 11 70 Ut 30 DIP 25 per lt 5 Ur gt 95 DIP 5s Voltage 50 60 Hz Passed The magnetic field of magnetic field supply voltage must have Qualifications a traditional or typical normal operation hospital atmosphere within the location characteristics prescribed limits Note Ut supply voltage level prior to application of the test 11 Az EN 61601 1 2 2007 5 2 2 1 4 according to table Manufacturer s declaration electromagnetic immunity The Safe Laser 30 150 devices intended for use in the electromagnetic environment specified below The customer or the user must make sure to use the device in such an environment Immunity test IEC 60601 Compliance Level Electromagnetic environment According test Noise immunity to 3 Vrms Passed Portable and mobile RF conducted RF signals on communications equipment can power line 150 KHz 80 MHz Qualifications normal Inot be used closer to the Safe operation within the Laser 30 150 devices within the prescribed limits recommended separation distance which can be calculated V1 V as shown in the following formula d 3 5
4. Test Compliance Electromagnetic environment RF emissions CISPR 11 1 class RF emissions CISPR 11 B class EMC 110119 1 Passed 30 1000 MHz Harmonic emissions B class EMC 110119 1 IEC 61000 3 2 Passed 0 15 30 MHz Voltage change flicker emission Passed IEC 61000 3 3 Safe Laser 30 150 RF radio frequency energy is used only for internal functions Therefore its RF emissions are very low it is unlikely to cause any interference in the immediate near located devices The devices Safe Laser 30 150 are suitable for use with in all establishments including the household as well 10 Az EN 61601 1 2 2007 5 2 2 1 2 according to table Manufacturer s declaration electromagnetic immunity The Safe Laser 30 150 devices intended for use in the electromagnetic environment specified below The customer or the user must make sure to use the device in such an environment Immunity test IEC 60601 Compliance Level Electromagnetic According test environment Noise immunity against 6 kV contact Passed The floors should be electrostatic discharge discharge wood concrete or ceramic ESD Qualifications tile reason In case of 8 kV air discharge normal operation _ synthetic material floor of IEC 61000 4 2 within the the relative humidity prescribed limits should be at least 30 EFT Electrical fast 2 kV Not applicable transient burst Noise immunity to signals L N PE ground Battery operation IEC
5. V1 v P Noise immunity to 3 V m Passed d 3 5 E1 v P radiated RF signals 80 MHz 2 5 GHz Qualifications normal 80 MHz 800 MHz operation within the prescribed limits E1 V m d 7 E1 v P 800 MHz 2 5 GHz where P is the max power W in terms of the instructions manual and d is the recommended separation distance m For a mobile phone d 7 2 1 41 4 935 m Close to the devices interference can occur between devices with the following symbol Q 12 Az EN 61601 1 2 2007 5 2 2 1 6 according to table Recommended separation distances between portable and mobile communications equipment and the Safe Laser 30 150 devices The Safe Laser 30 150 devices must be operated in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Safe Laser 30 150 devices can prevent electromagnetic interference in compliance with the minimum separation distance The maximum transmit Separation distance according to frequency of transmitter m power 150 KHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz d 3 5 V1 v P d 3 5 E1 v P d 7 E1 v P 100 11 6667 11 6667 23 3333 Based on the above the devices meet the EMC requirements for medical devices Explanation of labels affixed to the device C ae CE Conformity marking wl Symbol of Manufacturer ow Date of production Type B patient classification SN Serial number K Electronic waste DO NOT throw away to trash l
6. ainless with regular use the healing time can bee reduced and has no known adverse side effects Can be combined with any other drug and therapy Soft laser biological effects For the clinical practice there are three major fields of utilization of the soft laser effect pain killing antiphlogistic and biostimulating effect Biostimulation promotes metabolism assists cell processes stimulates reproduction helps immunization and increases the number of collagen cells In summary in promotes self healing It has no allergic reactions neither harmful electrical of radiation load In a considerable part of cases the therapeutic effect and clinical improvement are simultaneously due to two or sometimes all the three factors Thus reviewing the medical fields the following main groups should be mentioned e pain diseases or diseases accompanied by pain e inflammatory diseases or lesions associated with inflammation e non epithelizing ulcers or associated diseases The wavelength of Safe Laser 30 and Safe Laser 150 devices is 660nm red This is the therapeutical window which has several benefits for living tissues The diseases indications witch can be treated with Safe Laser devices Prior to and during therapy depending on the nature and severity of the disease it is essential to consult the competent specialist in a polyclinic clinic or hospital Skin diseases e chronic inflammation herpes simplex herpes z
7. aser beam directed to the nostrils e accelerates the healing colds flu relieve symptoms of nasal inflammation e relieve symptoms of allergy asthma hay fever e The laser light s biostimulation effect has an additional beneficial effect on the circulatory system Treatment time and frequency Two kind of treatments are possible with the Safe Laser devices 1 Skin surface treatment SL30 SL150 2 Mouth nose ear treatment SL30 SL150 with nasal accessary Safe Laser 30 Safe Laser 150 Safe Laser 150 with nasal accessary 3 3 minutes on each nose l l and ear 3 minutes placed on skin 3 3 minutes on each nostril Treatment of acute illnesses the disease has recently been generated e The treatment should be applied for the first 1 2 weeks every day than three times a week until resolution of symptoms Treatment of chronic prolonged illness generated previously 6 8 weeks e The extended period of illness should be treated less often The first two weeks 3 4 times a week and 2 3 times a week until significant decrease in their symptoms e Chronic long standing diseases to cure naturally take longer days weeks months After the first treatment the pain may increase but this is a temporary phenomenon e With long term several months recovery processes first apply a 10 day daily treatment later a 3 5 occasions a week e A longer term treatment is not necessarily speed up the healing process
8. ccording to MSZ EN60825 1 IEC 60825 1 4 2007 At the categorization the requirements for scattered radiation were applied e The measurement was made by Wigner Research Centre for Physics Hungarian Academy of Sciences Optical Laboratory e It is forbidden to stare directly into the beam e The radiation emitted by the laser equipment is not dangerous for the eye because of the eye s automatic blink reflex for which 0 25s his reaction time provides protection There is not need for safety glasses e The laser must be closed from the reach of children e Do not use the laser if damaged or did not work properly Repairing of the laser can only be made in manufacturer s service Contraindications e Irradiating the lower abdomen or the nasal mucosa of pregnant women or the open fontanelles of babies is prohibited because of the potentially dangerous increase of hyperemia e The use of the laser device is prohibited for people suffering from severe blood clotting problem or a state of acute stroke e Do not beam the area of Malignant tumors The thyroid and breasts Fungal skin surfaces e Direct radiation of paint moles can be dangerous since it constitutes pre cancer forming state e Do not beam deliberately into the eyes or around the eyes e Do not treat the area of unknown pain e Ask your doctor or pharmacist about the use of Laser device Service and repair e The laser does not need service e Optical
9. i Read the Owner s Manual IP21 Protected against 12 5 mm rigid bodies and vertically falling water drops A Laser warning sign 13 Manufacture s Proof of Compliance We as the manufacturer Safe Laser Bt Headquarters Hungary 2011 Budakalasz Fecske u 7 make a statement about it that our product Name Therapeutic Low intensity Laser Devices Safe Laser 30 and Safe Laser 150 Serial number from 2013 0015 Meets the requirements of the related requirements of the directive 93 42 EEC on Medical Devices Annex l V Organization for certification and testing CE Certiso Ltd NB2409 2040 Budaors Gy r u 2 EC Certificate number 144446 13 08 16 First issued 16 August 2013 Expires 15 August 2018 Budakalasz 02 April 2014 gt 7 CEO Safe Laser 14 144446 13 08 16 certiso EC CERTIFICATE Production Quality Assurance Directive 93 42 EEC on Medical devices Annex V CE Certiso Ltd Organisation for Certification and Testing on the Field of Medical and Hospital Engineering NB 2409 certifies that the following manufacturer s quality management system concerning to the listed devices and device categories meets the requirements of the related requirements of the directive Name of the manufacturer Safe Laser Bt Headquarters 2011 Budakalasz Fecske u 7 HUNGARY Scope Therapeutic laser equipment The certificate covers the following devices Start date wi geen Type Inte
10. nded use of certified the device status therapeutic low laser light 16 August Safe Laser laser light 04 April This certificate is valid only in case of successfully conducted annual surveillz ID number of the related audit report 56 CE 130704 Issue 2 Issued 04 April 2014 First issued 16 August 2013 Expires 15 August 2018 CE Certiso Ltd Organisatio H 2040 Buda rs Gy r u 2 B Tel 36 23 880 830 Fax 36 NB ID number 2409 Field of Medical and Hospital En so hu www cecertiso hu
11. ooster e ulcus cruris non healing ulcers multiform exudative erythema hypertrophic scars alopecia areata Oral cavity diseases e aphta herpes chronic inflammation trigeminuse neuralgia posttraumatic pain postoperative pain parodontosis parodontitis gingivitis temporo mandibular joint lesions asyalia f Oto rhino laryngologic diseases e chronic rhinitis allergic chronic rhinitis pharyngitis Ophthalmology e ophthalmic herpes zooster Laser acupuncture e according to the indication circle of the profession Vascular diseases e obliterative vascular diseases postthrombotic syndrome ulcus developed on the ground of varicosity and vasculitis sicca pregangrenic condition decubitus Musculoskeletal symptoms rheumatology sports injuries e Small joint muscle and tendon injuries inflammation strain sprain contusion abrasion bruise e reumatoid arthritis arthropathies arthrosis other motility organ lesions Neurology e pain syndromes degenerative spinal pain radiculopathies rehabilitation of those with locomotor disorders lesions associated with hypertonicity childhood motility disorders contractions Little disease conditions following brain vascular events paresis motility disturbances flexural contractions inactivity muscular hypotrophy atrophy solution of forced Ear Complaints e inflammation pain tinnitus ear itching Diseases can be treated with nostril light l
12. s In terms of biological effects lasers can be divided into two main categories e High power hard lasers surgical lasers gt e Low power soft lasers therapeutic lasers High power lasers due to the very strong thermal effect are capable of different surgical procedures eg surgery thermal effects cutting vaporization coagulation Soft lasers are using the laser light s photochemical effect to start the beneficial biological processes Safe Laser devices are low power 30 150mW therapeutic soft lasers Description of the Safe Laser devices Safe Laser devices are medical devices within a risk class Il a based on the regulation 4 2009 of the Minister of Health III 17 The devices are made with a special Safe Laser technology which means that the laser s parallel to eye hazardous beam is transformed with a special scattering surface in a way that is completely safe for the eyes www safelaser eu With the presenting of Safe Laser devices a new generation of soft lasers was created which can bee safely used not only in hospitals medical stations but even at home without the laser safety goggles The devices allow for multiple therapies Suitable for direct use to the skin surface as local treatment or to the mouth ear or guided into nostril to cure more diseases Safe Laser devices can be used effectively as a primary or as a complementary therapy The use of laser phototherapy is p
13. surfaces have to be kept clean in case of need it can be cleaned with soft tissue and mild detergents e The equipment can only be serviced by the manufacturer Storage During storage the safety rules also have to kept keeping in mind that children and unauthorized personnel must not have access to the laser The laser have to be stored in a clean place and have to be protected from direct heat Contact Us Dealer s name www laserforhome com by Innova Group Ltd Dealer s address Hat r t 12 2724 Ujlengyel Hungary Dealer s phone No 36203367264 info laserforhome com Service phone No 36203367264 info laserforhome com Warranty The manufacturer guaranties repair or replacement of of the laser against material and productions defects within 1 year form purchase Warranty can not be applied for damages due to elementary diseases or improper usage as described by the manual Last day of the warranty P Signature stamp 1 Annex For the Safe Laser devices SL30 and SL150 electromagnetic compatibility EMC conform to the following tables for devices electromagnetic compatibility EMC have been identified Az EN 61601 1 2 2007 5 2 2 1 1 according to table Manufacturer s declaration electromagnetic immunity The Safe Laser 30 150 devices intended for use in the electromagnetic environment specified below The customer or the user must make sure to use the device in such an environment Emissions
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