Mettler Electronics Laser Sys Stim 540, Инструкция по эксплуатации

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Laser Sys*Stim 540, Therapeutic Laser— Rev.F_07/03/12
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1 Introduction
1.1 Introduction to the Laser Sys*Stim 540
Thank you for purchasing the Laser Sys*Stim 540 therapeutic laser for the temporary relief of muscle
and joint aches, pains and stiffness. The laser applicator has a AlGaAs Diode that emits coherent light
at the infrared wavelength of 785 nm. Blue LEDs at 470 nm illuminate the treatment field to show the
clinician when the laser is active. An optional LED cluster applicator, with 950 nm SLDs and 660 nm
LEDs is also available.
The control unit allows the clinician to set treatment time, continuous/pulse modulation modes and
laser output energy. All treatment parameters are displayed on the LED displays and controlled via
the membrane keypad. There are holders integrated into the unit to store applicators when not in use.
Figure 1.1— The Laser Sys*Stim 540
The Laser Sys*Stim 540 has been certified by SGS United Kingdom Ltd. to meet the following
requirements:

EN60601-1 1990, Medical Electrical Equipment General Requirements

EN 60601-2-22, 1996, Medical Electrical Equipment Particular Requirements for Safety -
Diagnostic and Therapeutic Laser Equipment

IEC 60825-1, 2001
In addition, the Laser Sys*Stim 540 meets the following standards for radio frequency emissions:

IEC/EN 60601-1-2, 2002
The Laser Sys*Stim 540 complies with the light-emitting and laser product performance standards set
forth in the Code of Federal Regulations, Title 21 (Food and Drugs), Parts 1040.10 and 1040.11.
Mettler Electronics Corp. has been certified by VTT Expert Services LTD to be compliant with EN ISO
13485:2003 and MDD 93/42/EEC Annex II requirements. In addition, Mettler is certified by DQS
Medizinprodukte GMBH to be compliant with ISO 13485:2003 (CMDCAS) Canadian Medical Device
requirements.