HME-PREMIO30-ENG ENGLISH 1/28
User manual
Keep with your instrument
English
Страница 1: ...HME PREMIO30 ENG ENGLISH 1 28 User manual Keep with your instrument English...
Страница 2: ...nment into our products consistent with the highest level medical standards so that you can practice comfortably and effectively We are pleased to work with our excellent permanent research partners a...
Страница 3: ...OF THE PREMIO 30 LASER DUO 9 HOW TO USE THE PREMIO 30 LASER DUO 11 TECHNICAL SPECIFICATIONS 14 FREQUENCIES PROGRAMMES 15 MAINTENANCE 15 TROUBLESHOOTING RECYCLING 16 APPENDIX 1 REGULATORY AND STANDARD...
Страница 4: ...kin The laser emission from the Premio 30 laser duo is under this MPE and the beam can be directed onto the skin entirely safely without causing harm Safety for the eyes Important note The instrument...
Страница 5: ...ect it to ionising irradiation eg X rays Not to store it at temperatures of under 20 C or over 50 C Never to immerse it in a liquid The Premio 30 laser duo contains a Li Ion technology battery which m...
Страница 6: ...y 24 months These must be carried out by people who have knowledge equipment and experience to carry out these checks cf appendix 2 The Sedatelec technical department carries out all of the appropriat...
Страница 7: ...biostimulation coherent light or locally on painful pathological areas of the body The indications are those recognized for acupuncture Ear Acupuncture Its use requires skilled staff who have sufficie...
Страница 8: ...chest region in a patient with a cardiac pacemaker Exposure to sunlight or artificial UV light for 3 to 4 weeks before treatment Hypersensitivity to light at 905 nm Previous use of anticoagulants and...
Страница 9: ...r duo is supplied in a bag containing A handpiece Premio 30 laser duo A specific laser key A test laser box A battery charger A pair of protective glasses with its manual An instruction for use manual...
Страница 10: ...ion Acupuncture Dispersion Tonification Nogier frequencies scanning Ear Acupuncture Type of laser stimulation selection key R Re ea ar r p pa an ne el l Superficial penetration indicator Deep penetrat...
Страница 11: ...act from the documentation Yellow Charging steady then flashing at the end of charging Solid Green Fully charged the battery Flashing green The PREMIO is not connected See charger manual for LED off o...
Страница 12: ...ur instrument adjusted Note After using disconnect the Premio 30 laser duo test laser in order that the battery does not discharge Starting and operating information a Insert the key into its socket o...
Страница 13: ...ted automatically e Press on the key the light indicator and a continuous audible signal inform the user that the laser is being emitted After 30 seconds a beep is emitted and the laser emission is au...
Страница 14: ...z 73 4672 Hz Beam divergence 9 x 25 Electrical supply Internal battery Li Ion 3 6V 850 mAh Li Ion charger 90 264V 47 63Hz Mechanics Handpiece 213mm x 25mm Weight of handpiece 111g Operating conditions...
Страница 15: ...100Hz 100 10kHz MAINTENANCE We recommend routine disinfection of parts which may come into contact with patients Your Premio 30 laser duo does not require specific maintenance and can be cleaned with...
Страница 16: ...placed You must not attempt to change or repair the parts inside the instrument or its accessories Any such attempt will invalidate the guarantee and may cause serious risks to yourself those around y...
Страница 17: ...01 1 2012 IEC 60601 1 2 2014 IEC 60601 2 22 2012 IEC 60825 1 2014 NF EN1041 2008 ISO 15223 1 2017 S SY YM MB BO OL LS S U US SE ED D Manufacturer Refer to the manual instruction booklet Dispose with e...
Страница 18: ...box UDI identifier Medical Device Positioning Towards the laser output of the device Laser danger indication by the tip of the warning laser opening Positioning In this manual Warning laser opening L...
Страница 19: ...labels commands and control markings current method of use etc Operating control depending on method of use Starting Setting commands and indicators Confirming the frequencies emitted Checking timer...
Страница 20: ...ical supply network and domestic building supplies The Premio 32D laser uses RF energy only for its internal operation As a result its RF emissions are therefore very low and are not liable to cause i...
Страница 21: ...iance Comments Emission of conducted disturbance YES CISPR 11 Class B Group 1 Emission of irradiation disturbance YES CISPR 11 Class B Group 1 Emission of harmonics NA Power less than 75W Emission of...
Страница 22: ...ir 8 kV on contact 15 kV in air Direct pressure on the keys can stop the laser emission Floors should be wood concrete or ceramic tiles If the floors are covered with synthetic material the relative h...
Страница 23: ...for 5 cycles 70 UT 30 drop of UT for 25 cycles The appliance stops then restarts when powering back up The quality of the power supply must be identical to a commercial or hospital environment As the...
Страница 24: ...kHz to 80 MHz 3 V m 80 MHz to 2 7 GHz Discrete 9 27 or 28 V m frequencies 3 Veff 3 V m Discrete 9 27 or 28 V m frequencies WARNING RF portable communication devices should not be used including periph...
Страница 25: ...HME PREMIO30 ENG ENGLISH 25 28 APPENDIX 4 INSTRUMENT BOOKLET Type of instrument Premio 30 laser duo Serial number Manufacturer Sedatelec Chemin des M riers F 69540 IRIGNY Distributor Acquisition date...
Страница 26: ...HME PREMIO30 ENG ENGLISH 26 28 VISUAL EXAMINATION Date Performed by Comments OPERATING CHECK Date Performed by Comments...
Страница 27: ...HME PREMIO30 ENG ENGLISH 27 28 ENERGY EMISSION CHECK Date Performed by Results Comments TECHNICAL SAFETY CHECK Date Performed by Comments...
Страница 28: ...of acupuncture and Ear Acupuncture points by an infrared laser ray the Premio 30 laser duo guarantees you the results of traditional practice It frees you from all the restrictions and unpleasant aspe...
