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HME-PREMIO30-ENG                        ENGLISH                               4/28 

S

AFETY INSTRUCTIONS

,

 RESIDUAL RISKS AND PRECAUTIONS FOR USE

 

 

 

The 

Premio 30 laser duo

 is an infrared laser which emits a laser 

beam at a rate of 905 nm.  
The  Maximum  Permitted  Emissions  (MPE)  are  0.269  J/m

2

  for 

the skin and 2.47*10

-4

 J/ m

2

 for the cornea. 

The "Laser danger" symbol

, placed on the end of your device, 

represents  the  "opening  indicator  plate"  designating  an 

"opening for laser radiation"

 

 

Safety for the skin 

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  must 

never  be  used  to  treat 

the globe of the eye

The  Nominal  Ocular  Danger  Distance  (NODD)  is  the  distance 
from  which  the  light  applied  to  the  eye  must  be  less  than  the 
MPE for the cornea.  
The NODD for the Premio 30 laser duo is 50 cm.  
Whenever the laser is handled less than 50 cm from the eyes, it 
is therefore recommended that anyone who could accidentally 
look  at  the  laser  beam  wears  the  protective  glasses  intended 
for this purpose. 
 
 
 
 
 

 

Summary of Contents for Premio 30 laser duo

Page 1: ...HME PREMIO30 ENG ENGLISH 1 28 User manual Keep with your instrument English...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 26: ...HME PREMIO30 ENG ENGLISH 26 28 VISUAL EXAMINATION Date Performed by Comments OPERATING CHECK Date Performed by Comments...

Page 27: ...HME PREMIO30 ENG ENGLISH 27 28 ENERGY EMISSION CHECK Date Performed by Results Comments TECHNICAL SAFETY CHECK Date Performed by Comments...

Page 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...

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